Petition for Writ of Certiorari — Purdue Pharma L.P., et al., Petitioners v. Accord Healthcare, Inc.

Supreme Court briefApr 30, 2025

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No. ______

In the

Supreme Court of the United States

PURDUE PHARMA L.P.,

PURDUE PHARMACEUTICALS L.P.,

RHODES TECHNOLOGIES,

Petitioners,

ACCORD HEALTHCARE, INC.,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

DANIEL G. BROWN

LATHAM & WATKINS LLP

1271 Avenue of the

Americas

New York, NY 10020

(212) 906-1200

GREGORY G. GARRE

Counsel of Record

MARGARET A. UPSHAW

ALEXANDER G. SIEMERS

TIMOTHY J. BORGERSON

LATHAM & WATKINS LLP

555 11th Street, NW

Suite 1000

Washington, DC 20004

(202) 637-2207

gregory.garre@lw.com

Counsel for Petitioners

QUESTION PRESENTED

In Graham v. John Deere Co., this Court

established four factors for evaluating whether a

patent is obvious, and therefore invalid, under 35

U.S.C. § 103. 383 U.S. 1 (1966). The first three

factors examine technical aspects of the invention and

the prior art. To help avoid hindsight bias and an

overly narrow approach to obviousness, Graham also

requires courts to evaluate a fourth factor focused on

“economic and motivational” considerations—known

as the objective “indicia” of non-obviousness or

“secondary considerations.” Id. at 17-18, 36. These

include “commercial success, long felt but unsolved

needs, [and] failure of others.” Id. at 17-18. As this

Court explained in KSR International Co. v. Teleflex

Inc., courts must analyze “any secondary

considerations that would prove instructive” in

conducting an “expansive and flexible” analysis of

obviousness. 550 U.S. 398, 415 (2007).

Despite this clear instruction, the Federal Circuit

has adopted a rigid “nexus” requirement to dismiss

out of hand clear objective indicia of non-obviousness.

It doubled down on that practice in this case.

Invoking lack of “nexus,” the Federal Circuit held that

Purdue’s novel abuse-deterrent formulation of

OxyContin was obvious even though the formulation

indisputably filled a long-felt need in the market, was

initially met by skepticism by the Food & Drug

Administration, and averted the impending collapse

of OxyContin sales. The question presented is:

Whether, as this Court has held, the objective

indicia of non-obviousness should be analyzed flexibly

to combat hindsight bias or instead subject to the

Federal Circuit’s rigid rules restricting the inquiry.

RULE 29.6 STATEMENT

Pursuant to Rule 29.6 of the Rules of this Court,

Petitioners

Purdue

Pharma

L.P.,

Purdue

Pharmaceuticals L.P., and Rhodes Technologies state

that they have no parent corporations and no publicly

held corporation owns 10% or more of their stock.

RELATED PROCEEDINGS

The following proceedings are directly related to

this petition:

Purdue Pharma L.P. v. Accord Healthcare, Inc.,

No. 23-1953, United States Court of Appeals for the

Federal Circuit, judgment entered December 30, 2024

(2024 WL 5244764).

Purdue Pharma L.P. v. Accord Healthcare, Inc.,

Civil Action No. 20-1362-RGA, United States District

Court for the District of Delaware, order entered April

11, 2023 (669 F. Supp. 3d 286) and judgment entered

April 26, 2023.

iii

TABLE OF CONTENTS

Page

QUESTION PRESENTED ......................................... i

RULE 29.6 STATEMENT.......................................... ii

RELATED PROCEEDINGS ...................................... ii

TABLE OF AUTHORITIES .......................................v

OPINIONS BELOW ....................................................1

JURISDICTION ..........................................................1

CONSTITUTIONAL

AND

STATUTORY

PROVISIONS INVOLVED .................................1

INTRODUCTION .......................................................2

STATEMENT OF THE CASE ....................................5

A. Purdue’s Groundbreaking Invention ...........5

B. Proceedings Below ........................................9

REASONS FOR GRANTING THE WRIT................13

THE

FEDERAL

CIRCUIT’S

RIGID

APPROACH

THE

OBJECTIVE

INDICIA

NON-OBVIOUSNESS

CONFLICTS WITH THIS COURT’S

PRECEDENTS ..................................................14

A. The Objective Indicia Are Critical To

The Obviousness Analysis .........................14

B. The Federal Circuit Routinely Negates

The Objective Indicia Of Nonobviousness

Through

Rigid

Requirements Like Its Home-Grown

“Nexus” Test ...............................................18

TABLE OF CONTENTS—Continued

Page

C. The Decision Below Exemplifies The

Federal

Circuit’s

Unduly

Rigid

Approach .....................................................29

II.

THE

QUESTION

PRESENTED

RECURRING AND IMPORTANT ...................34

CONCLUSION ..........................................................37

APPENDIX

Opinion of the United States Court of Appeals

for the Federal Circuit, Purdue Pharma

L.P., Purdue Pharmaceuticals L.P., and

Rhodes Technologies v. Accord Healthcare,

Inc., No. 23-1953, 2024 WL 5244764 (Fed.

Cir. Dec. 30, 2024) ..............................................1a

Trial Opinion of the United States District

Court for the District of Delaware, Purdue

Pharma L.P., Purdue Pharmaceuticals

L.P., and Rhodes Technologies v. Accord

Healthcare, Inc., 669 F. Supp. 3d 286 (D.

Del. 2023) ..........................................................34a

Final Judgment of the United States District

Court for the District of Delaware, Purdue

Pharma L.P., Purdue Pharmaceuticals

L.P., and Rhodes Technologies v. Accord

Healthcare, Inc., No. 20-1362 (D. Del. Apr.

26, 2023), Dkt. No. 126 (Appx50-51) ................96a

U.S. Const. art. I, § 8, cl. 8 ......................................99a

35 U.S.C. § 103 ......................................................100a

35 U.S.C. § 282(a)..................................................101a

TABLE OF AUTHORITIES

Page(s)

CASES

Acorda Therapeutics, Inc. v. Roxane

Laboratories, Inc.,

903 F.3d 1310 (Fed. Cir. 2018) ............................27

Amgen Inc. v. Sanofi,

598 U.S. 594 (2023) ..............................................34

Apple Inc. v. Samsung Electronics Co.,

839 F.3d 1034 (Fed. Cir. 2016) ................ 27, 28, 34

Arkie Lures, Inc. v. Gene Larew Tackle,

Inc.,

119 F.3d 953 (Fed. Cir. 1997) ..............................15

Ashland Oil, Inc. v. Delta Resins &

Refractories, Inc.,

776 F.2d 281 (Fed. Cir. 1985) ..............................19

Brown & Williamson Tobacco Corp. v.

Philip Morris Inc.,

229 F.3d 1120 (Fed. Cir. 2000) ............................22

Crocs, Inc. v. International Trade

Commission,

598 F.3d 1294 (Fed. Cir. 2010) ............................21

Cubist Pharmaceuticals, Inc. v.

Hospira, Inc.,

805 F.3d 1112 (Fed. Cir. 2015) ......................22, 23

In re DBC,

545 F.3d 1373 (Fed. Cir. 2008) ......................22, 24

TABLE OF AUTHORITIES—Continued

Page(s)

Demaco Corp. v. F. Von Langsdorff

Licensing Ltd.,

851 F.2d 1387 (Fed. Cir. 1988) ................ 15, 20, 21

E.I. du Pont De Nemours & Co. v.

MacDermid Printing Solutions,

L.L.C.,

657 F. App’x 1004 (Fed. Cir. 2016) ......................23

eBay Inc. v. MercExchange, L.L.C.,

547 U.S. 388 (2006) ..............................................29

Eurand, Inc. v. Mylan Pharmaceuticals

Inc. (In re Cyclobenzaprine

Hydrochloride Extended-Release

Capsule Patent Litigation),

676 F.3d 1063 (Fed. Cir. 2012) ......................16, 28

Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co.,

535 U.S. 722 (2002) ..............................................29

Fox Factory, Inc. v. SRAM, LLC,

944 F.3d 1366 (Fed. Cir. 2019) ............................29

Galderma Laboratories, L.P. v. Tolmar,

Inc.,

737 F.3d 731 (Fed. Cir. 2013) ..............................23

Graham v. John Deere Co.,

383 U.S. 1 (1966) .................................. 2, 14, 15, 16

In re Huang,

100 F.3d 135 (Fed. Cir. 1996) ..............................24

vii

TABLE OF AUTHORITIES—Continued

Page(s)

Intercontinental Great Brands LLC v.

Kellogg North America Co.,

869 F.3d 1336 (Fed. Cir. 2017) ............................35

J.T. Eaton & Co. v. Atlantic Paste &

Glue Co.,

106 F.3d 1563 (Fed. Cir. 1997) ............................21

KSR International Co. v. Teleflex Inc.,

550 U.S. 398

(2007) ...................... 4, 14, 15, 17, 23, 25, 28, 29, 34

Leo Pharmaceutical Products, Ltd.

v. Rea,

726 F.3d 1346 (Fed. Cir. 2013) ......................15, 34

In re Mageli,

470 F.2d 1380 (C.C.P.A. 1973) ............................19

Media Technologies Licensing, LLC

v. Upper Deck Co.,

596 F.3d 1334 (Fed. Cir. 2010) ......................26, 27

Merck & Co. v. Teva Pharmaceuticals

USA, Inc.,

395 F.3d 1364 (Fed. Cir. 2005) ............................16

Merck & Co. v. Teva Pharmaceuticals

USA, Inc.,

405 F.3d 1338 (Fed. Cir. 2005) ............................26

Microsoft Corp. v. i4i Limited

Partnership,

564 U.S. 91 (2011) ..........................................14, 34

viii

TABLE OF AUTHORITIES—Continued

Page(s)

Minerals Separation v. Hyde,

242 U.S. 261 (1916) ........................................16, 31

Novo Nordisk A/S v. Caraco

Pharmaceutical Laboratories, Ltd.,

719 F.3d 1346 (Fed. Cir. 2013) ............................36

Octane Fitness, LLC v. ICON Health &

Fitness, Inc.,

572 U.S. 545 (2014) ..............................................29

Reiner v. I. Leon Co.,

285 F.2d 501 (2d Cir. 1960) .................................17

Richdel, Inc. v. Sunspool Corp.,

714 F.2d 1573 (Fed. Cir. 1983) ............................20

Ritchie v. Vast Resources, Inc.,

563 F.3d 1334 (Fed. Cir. 2009) ............................20

Sanofi-Aventis Deutschland GMBH

v. Mylan Pharms. Inc.,

791 F. App’x 916 (Fed. Cir. 2019) ........................27

Sinclair & Carroll Co. v. Interchemical

Corp.,

325 U.S. 327 (1945) ..............................................34

Smith v. Goodyear Dental Vulcanite

Co.,

93 U.S. 486 (1876) ..........................................17, 31

Stratoflex, Inc. v. Aeroquip Corp.,

713 F.2d 1530 (Fed. Cir. 1983) ................ 17, 19, 34

Tokai Corp. v. Easton Enterprises, Inc.,

632 F.3d 1358 (Fed. Cir. 2011) ............................26

TABLE OF AUTHORITIES—Continued

Page(s)

W.L. Gore & Associates, Inc. v. Garlock,

Inc.,

721 F.2d 1540 (Fed. Cir. 1983) ............................19

WBIP, LLC v. Kohler Co.,

829 F.3d 1317 (Fed. Cir. 2016) ................ 16, 25, 26

WesternGeco LLC v. ION Geophysical

Corp.,

889 F.3d 1308 (Fed. Cir. 2018) ......................22, 25

Wm. Wrigley Jr. Co. v. Cadbury Adams

USA LLC,

683 F.3d 1356 (Fed. Cir. 2012) ............................24

CONSTITUTIONAL AND STATUTORY

PROVISIONS

U.S. Const. art. I, § 8, cl. 8 ........................................36

28 U.S.C. § 1254(1)......................................................1

35 U.S.C. § 103 ............................................................2

35 U.S.C. § 103(a)......................................................14

35 U.S.C. § 103(c)(2)(A) .............................................15

35 U.S.C. § 282(a)......................................................14

OTHER AUTHORITIES

Donald S. Chisum, Chisum on Patents

(2025, Lexis) .........................................................34

TABLE OF AUTHORITIES—Continued

Page(s)

Iain M. Cockburn et al., Patents and the

Global Diffusion of New Drugs, 106

Am. Econ. Rev. 136 (2016)...................................36

Daralyn J. Durie & Mark A. Lemley,

A Realistic Approach to the

Obviousness of Inventions,

50 Wm. & Mary L. Rev. 989 (2008) .....................35

Ryan T. Holte & Ted Sichelman, Cycles

of Obviousness, 105 Iowa L. Rev. 107

(2019) ....................................................................25

Dmitry Karshtedt, Nonobviousness:

Before and after, 106 Iowa L. Rev.

1609 (2021) ...........................................................28

News Release, U.S. FDA, FDA requests

removal of Opana ER for risks

related to abuse (June 8, 2017),

https://www.fda.gov/newsevents/press-announcements/fdarequests-removal-opana-er-risksrelated-abuse..........................................................9

Jason Reinecke, Assessing Evidence of

Secondary Considerations, 68 Vill.

L. Rev. 633 (2023) ..........................................22, 34

U.S. FDA, FDA Actions on OxyContin

Products, 4/16/2013 (current as of

2022), https://www.fda.gov/drugs/

information-drug-class/fda-actionsoxycontin-products-4162013..................................7

PETITION FOR A WRIT OF CERTIORARI

Petitioners Purdue Pharma L.P., Purdue

Pharmaceuticals L.P., and Rhodes Technologies

(collectively, “Purdue”) respectfully petition this

Court for a writ of certiorari to review the judgment

of the United States Court of Appeals for the Federal

Circuit in this case.

OPINIONS BELOW

The opinion of the court of appeals (App.1a-33a) is

not reported but available at No. 23-1953, 2024 WL

5244764 (Fed. Cir. Dec. 30, 2024). The decision of the

district court (App.34a-95a) is published at 669 F.

Supp. 3d 286. The final judgment of the district court

(App.96a-98a) is unreported.

JURISDICTION

The court of appeals entered its judgment on

December 30, 2024 (App.1a-33a). On March 13, 2025,

Chief Justice Roberts extended the time to file a

petition for a writ of certiorari to April 30, 2025. This

Court has jurisdiction under 28 U.S.C. § 1254(1).

CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED

Relevant constitutional and statutory provisions

are reproduced in the petition appendix. App.99a101a.

INTRODUCTION

The Federal Circuit in recent years has

systematically negated a critical check against

hindsight bias in determining whether a patent is

“obvious”—and therefore invalid—under 35 U.S.C.

§ 103. This has destabilized the patent system and

swung the pendulum too far in the direction of

invalidating patents earned through hard work,

ingenuity, and investment. The decision below, which

held

that

Purdue’s

patents

claiming

its

groundbreaking abuse-deterrent formulation of

OxyContin were obvious, is the latest example of this

troubling trend. This Court should grant certiorari to

bring the Federal Circuit in line with this Court’s

precedent and preserve the incentives for innovation

that the patent system is designed to protect.

In Graham v. John Deere Co., this Court made

clear that, in conducting the obviousness inquiry,

courts must evaluate “economic and motivational”

considerations—known as the objective “indicia” of

non-obviousness or “secondary considerations”—to

assess whether a patented invention was truly

obvious at the time of invention. 383 U.S. 1, 36 (1966).

These indicia consist of a range of practical

considerations, including “commercial success, long

felt but unsolved needs, [and] failure of others.” Id.

at 17-18. The objective indicia act as an indispensable

check on hindsight bias, which can easily infect the

more technical aspects of the obviousness inquiry and

lead to the over-invalidation of patent claims.

Contrary to that precedent, however, the Federal

Circuit has eroded the role of the objective indicia in

the obviousness analysis in the years since Graham

was decided. Most strikingly, in this case and many

others, the Federal Circuit has invented and deployed

a stringent analysis and so-called “nexus” test that

demands evidence of a direct connection between the

objective indicia and a particular claim limitation,

while foreclosing recourse to broader inferences and

common-sense. The Federal Circuit’s cramped and

rigid approach has no basis in this Court’s precedent,

and it has led to fractured and inconsistent decisions

in the Federal Circuit. Whatever its intentions, the

“nexus” requirement has become a straightjacket on

the objective indicia that, in practice, has neutralized

even compelling objective indicia of non-obviousness

and distorted the obviousness analysis as a whole.

This case epitomizes the problems with the

Federal Circuit’s “nexus” requirement.

Purdue

invested nearly a decade of research by

extraordinarily talented scientists, and hundreds of

millions of dollars, in completely reformulating

OxyContin so that it would deter misuse and abuse of

the drug. That new abuse-deterrent formulation—

produced through a novel curing process—addressed

a long-felt and pressing public-health need and

produced a formulation with undisputed commercial

success.

After rigorous studies, Purdue’s new

formulation received approval from the Food & Drug

Administration

(“FDA”)

for

abuse-deterrent

labeling—the first FDA-approved label of its kind for

any opioid pain medication.

Once the new

formulation was available, the FDA withdrew its

approval for, and refused to approve, any formulation

that was not abuse-deterrent.

Accord Healthcare, Inc. (“Accord”) sought to

piggyback on that success. Unable to develop its own

abuse-deterrent formulation, Accord copied Purdue’s

invention and sought FDA approval through an

Abbreviated New Drug Application. After Purdue

sued, Accord stipulated to infringement but claimed

Purdue’s patents were obvious, despite the decadelong effort to develop a solution in the face of the

growing and overwhelming public-health need for an

abuse-deterrent formulation of an oxycodone pain

medication—when there were no patents covering the

use of oxycodone generally.

In the proceedings below, Purdue presented

extensive evidence related to the objective indicia of

non-obviousness—including original OxyContin’s

withdrawal from the market, the reformulation’s

substantial commercial success, the fact that

competitors were racing to develop their own abusedeterrent versions of opioid pain-relief medications,

and FDA’s initial skepticism of Purdue’s invention.

Even Accord’s own witnesses recognized that the

patented invention addressed a long-felt but unmet

need and that OxyContin sales would have been

substantially lower absent the abuse-deterrent

features—strong indicators that Purdue’s invention

was not in fact obvious. But the Federal Circuit gave

this evidence no weight. Instead, it applied its rigid

“nexus” rule and inexplicably deemed the evidence

“unconnected to the patented features of the claimed

invention.” App.24a.

Apart from the illogic of that reasoning, the

Federal Circuit’s decision starkly conflicts with this

Court’s precedents admonishing courts to consider

the objective indicia as a check against hindsight bias

and to conduct an “expansive and flexible” analysis of

obviousness. KSR Int’l Co. v. Teleflex Inc., 550 U.S.

398, 415 (2007). And it is only one of many decisions

in which the Federal Circuit has applied its “nexus”

test to arbitrarily limit consideration of the objective

indicia. By diminishing the objective indicia’s role in

the obviousness inquiry, these decisions threaten to

erode patent protections and diminish incentives to

invest in research and development. This Court

should grant certiorari to provide much-needed

clarity on the role of the objective indicia in the

obviousness inquiry and to reject the Federal Circuit’s

artificial and unduly rigid analysis.

STATEMENT OF THE CASE

A. Purdue’s Groundbreaking Invention

1. In the 1990s, Purdue developed the original

formulation of OxyContin®, an extended-release pain

medication with the active ingredient oxycodone

hydrochloride. Federal Circuit Appendix (“Appx”)

5038; Appx8926. OxyContin provided critical pain

relief to millions of people when taken as directed.

But, by the early 2000s, it became clear that

OxyContin, like other opioid pain medications, was

vulnerable to abuse and misuse. App.2a. Tablets

could be crushed into a powder that could be either

snorted or liquified and injected to achieve an

immediate high by those who abused it.

To address this serious public-health risk, Purdue

invested nearly a decade and hundreds of millions of

dollars in developing a tablet that both deterred abuse

and preserved the essential extended-release feature

of the original OxyContin formulation. Appx6854; see

also Appx8915-8916; Appx5531. This combination—

an effective yet abuse-deterrent opioid pain

medication—was “one of the highest unmet needs in

the market.” Appx5374 (Rosen 341:24-25); see also

Appx5376 (343:22-23).

Purdue explored a range of possibilities to meet

that need and produce an abuse-deterrent tablet.

Initially, Purdue focused on adding an antagonist to

the original formulation that would negate the

opioid’s euphoric effects if the tablet were tampered

with. See Appx5450-5453. But that approach failed.

See Appx5337-5338.

Purdue also experimented

extensively with the use of polymers to harden the

tablets. Purdue began by preparing batches with the

polymer Eudragit, which was used in the original

OxyContin formulation, as well as the polymer

polyethylene oxide (“PEO”). Id.; Appx5344-5346.

These initial batches with PEO failed: One batch

containing PEO “did not process on the melt

extruder”; another “produced an immediate [rather

than extended] release dissolution profile.”

Appx8893. Given those results, PEO was “not

progressed further” at that time. Id.

Despite those setbacks, Purdue ultimately

returned to its experimentation with PEO-based

formulations. Eventually, it succeeded in developing

the hardened, abuse-resistant formulation claimed in

the patents at issue.

Purdue’s abuse-deterrent

patents recite a pharmaceutical composition (or a

method for producing such a composition) comprising

an “extended release dosage form” with PEO and

oxycodone, made by a specific curing method.

Appx302 (cl. 1). That curing method requires that the

tablet first be “compression shaped,” and then “air

cured by heated air, without compression”—for

example, in an oven. See, e.g., id.; Appx106 (19:11-12,

19:43-47); see also Appx5352. The heating must be

done for “about 10 minutes to about 10 hours,” above

the softening temperature of PEO. Appx175-176 (cls.

1, 3); Appx302 (cls. 1, 3); Appx434 (cls. 1-3, 5-6).

Applying this method results in a stronger, abuse-

deterrent formulation of OxyContin. Appx1805-1806

(¶¶ 41, 44-45).

Purdue’s process is unique. Before Purdue’s

invention, no one had ever cured PEO-based tablets

without simultaneous compression of the tablet.

Appx1818-1819. That was for good reason: There

was concern that heating PEO tablets above their

melting point without simultaneous compression

would result in tablet deformation or puddling,

altering the extended-release dissolution profile of the

medication. Appx5353-5354. Indeed, the closest prior

art—Bartholomaus—taught the curing of PEO-based

tablets with simultaneous compression and heating

using an unwieldy contraption, in which the inventor

placed a tablet press inside a heating cabinet.

Appx5248-5261; Appx9417-9430. While that process

produced a hardened tablet, it was not suitable for

large-scale production, and thus not commercially

viable.

See App.8.

By contrast, Purdue’s

groundbreaking formulation was commercially

viable, abuse-deterrent, and medically effective.

2. In late 2007, Purdue sought FDA approval for

reformulated OxyContin through a New Drug

Application. Appx5351. FDA approved Purdue’s new

formulation in 2010, but it did not approve abusedeterrent labeling at that time. Appx5462. Rather,

skeptical that the new formulation would actually

deter abuse, FDA required Purdue to conduct

extensive post-marketing studies. Appx6814. Three

years later, after scrutinizing Purdue’s studies, FDA

approved labeling stating that reformulated

OxyContin has abuse-deterrent properties—the first

time it had ever approved such a label for any opioid

pain medication. See U.S. FDA, FDA Actions on

OxyContin Products, 4/16/2013, (current as of 2022),

https://www.fda.gov/drugs/information-drug-class/

fda-actions-oxycontin-products-4162013; Appx5462;

Appx6809-6818.

At the same time, FDA formally withdrew original

OxyContin from the market as comparatively unsafe,

underscoring the existential threat that OxyContin

faced if an abuse-deterrent formulation were not

developed. Appx6809-6818. FDA also prohibited all

non-abuse-deterrent extended-release oxycodone

products, including generic versions of original

OxyContin. Id. In other words, without Purdue’s new

invention, OxyContin sales would have gone to zero.

3. Purdue’s reformulated OxyContin was a

resounding commercial success—allowing patients to

receive much-needed pain relief while reducing the

risk of abuse and misuse of the medication. Whereas

the original formulation was withdrawn from the

market due to safety concerns, reformulated

OxyContin is both the highest-selling extendedrelease opioid and the most-prescribed brand-name

extended-release opioid on the market. Appx5401

(368:20-25).

As Accord’s own expert acknowledged in the

proceedings below, Purdue’s abuse-deterrent patents

“definitely” solved “a long felt, but unmet need in the

art.” Appx5704-5705 (Appel 671:22-672:2). And, as

another Accord witness conceded, “[t]here’s no doubt”

that OxyContin’s sales would have been lower

without its abuse-deterrent features.

Appx5693

(Hoffman 660:19-22); see also Appx5402 (Sharma

369:3-6). Indeed, given the specter of abuse, Purdue’s

invention was critical to preserving OxyContin as a

viable product for sale in the marketplace.

In particular, because of the acute need and high

market demand for abuse-deterrent opioids, any

competitor that could have beat Purdue in developing

an abuse-deterrent extended-release opioid would

have undercut, and likely supplanted, original

OxyContin sales.

Despite the overwhelming

incentives to develop such a product, however, no

other manufacturer managed to do so.

Endo Pharmaceuticals, for example, withdrew its

competing product, Opana® ER (“Opana”), because it

was not sufficiently abuse-deterrent. See Appx53395340; Appx5366 (Mannion 306:22-307:8, 333:1-7);

Appx5469 (Bley 436:5-9); Appx6819-6825 at

Appx6819; News Release, U.S. FDA, FDA requests

removal of Opana ER for risks related to abuse (June

2017),

https://www.fda.gov/news-events/pressannouncements/fda-requests-removal-opana-er-risksrelated-abuse. Meanwhile, as evidenced by this

litigation, Accord resorted to copying Purdue’s

invention, rather than develop its own abusedeterrent product.

In short, only Purdue succeeded in filling the longfelt but unmet need of developing an abuse-deterrent,

extended-release opioid pain medication. And it did

so at great expense.

B. Proceedings Below

1. In August 2020, Accord sought FDA approval

to manufacture and sell a generic version of

OxyContin, using Purdue’s patented abuse-deterrent

technology.

Appx1807.

Purdue filed this

infringement action, and Accord stipulated to

infringement. Appx1808. Accord argued, however,

that Purdue’s patents were invalid for obviousness.

The district court held a three-day bench trial on

Accord’s obviousness defense. At trial, Accord’s own

expert acknowledged that PEO could turn into “a

puddle” if heated at too high a temperature without

compression, Appx5265 (Appel 233:6-9), echoing

Purdue’s evidence about the substantial risks of

tablet deformation that made its novel curing method

far from obvious, see, e.g., Appx5353-5354 (Mannion

320:10-321:5).

Purdue also presented extensive evidence of

objective indicia of non-obviousness, including

reformulated OxyContin’s commercial success in a

highly competitive market, Appx5367-5377 (Rosen

334:23-344:21); Appx5401-5402 (Sharma 368:20369:6); FDA’s initial skepticism regarding the abusedeterrent formulation, Appx5462 (Bley 429:17-24);

Appx9122; and the failures of other manufacturers to

develop a comparable product, Appx5461-5462,

Appx5469 (Bley 428:3-429:8, 436:5-9); Appx5340

(Mannion 307:3-8). Purdue’s witnesses testified, for

example, that abuse deterrence was “one of the

highest unmet needs in the market,” Appx5374

(Rosen 341:24-25); that “[w]ithout abuse-deterrent

features, the OxyContin sales would have been

significantly lower,” Appx5402 (Sharma 369:3-6); and

that Purdue’s competitors were not “able to achieve

th[e]

equivalent

abuse-deterrent

profile

reformulated oxycodone,” Appx5469 (Bley 436:4-9).

Accord’s own witnesses similarly acknowledged

that Purdue’s abuse-deterrent patents “definitely”

solved “a long felt, but unmet need in the art,”

Appx5704-5705

(Appel

671:22-672:2);

that

reformulated

OxyContin

had

substantial

“marketplace success”; and that “[t]here’s no doubt”

that OxyContin’s sales would have been lower

without its abuse-deterrent features, Appx5690,

Appx5693 (Hoffman 657:7-13, 660:19-22); see also

Appx5402 (Sharma 369:3-6).

2. The district court nevertheless found all of the

asserted claims invalid for obviousness. App.35a.

Without seriously considering the risks of tablet

deformation, the court declared that it was “not much

of a leap to infer that ovens would” be “useful” for

scaling up Bartholomaus’s simultaneous heating

process. Id. at 50a.

The district court then discounted each of Purdue’s

objective indicia of non-obviousness. It reasoned that

reformulated OxyContin’s commercial success was

solely due to “Purdue’s existing monopoly,” id. at

62a—even though Purdue had no patent or monopoly

on oxycodone that would have precluded competitors

from developing an abuse-deterrent oxycodone

medication. The court recognized, but discounted, the

importance of developing an abuse-deterrent product

to maintaining OxyContin’s commercial viability,

asserting that “a lack of commercial failure is not the

same as commercial success.” Id. Yet, the court

ignored evidence that reformulated OxyContin

contained only two ingredients from the original

formulation.

Compare Appx8330-8332, with

Appx1807 (¶ 49). It thus failed to appreciate that

reformulated OxyContin was an entirely new product

that supplanted original OxyContin sales because of

its innovative abuse-deterrent features.

As to industry skepticism, the court agreed that

FDA had displayed “skepticism” but dismissed it as

“commensurate with the fact that this was the first

extended-release opioid to receive abuse-deterrent

labelling.” App.63a. The court further dismissed

evidence of the failure of others, reasoning that the

evidence of prior failures lacked a sufficient

connection to “claimed features” of Purdue’s patent.

Id. at 64a-65a (citation omitted). The district court

thus concluded that the objective indicia could not

overcome the court’s initial finding of obviousness.

3. The Federal Circuit affirmed. It first concluded

that Purdue’s novel curing process would have been

“obvious to try” given the market need to develop a

scalable, abuse-deterrent product. Id. at 15a-17a. It

then considered the objective indicia.

As to commercial success, it concluded that the

district court had correctly found “no nexus between

the claimed invention and the commercial success,”

because Purdue’s abuse-deterrent formulation

replaced sales of the original formulation and the

record did not demonstrate an increase in OxyContin

sales. Id. at 24a. The Federal Circuit did not

acknowledge that the patented invention had

preserved OxyContin’s commercial viability, averting

both the risk that FDA would pull OxyContin from

the market for safety reasons (as it ultimately did)

and the risk that a competitor would fill that void

with

its

own

abuse-deterrent

oxycodone

formulation—completely displacing Purdue. Nor did

the Federal Circuit acknowledge Accord’s admission

that “[t]here’s no doubt” that OxyContin’s sales would

have been lower without its abuse-deterrent features.

Appx5693 (Hoffman 660:19-22).

The Federal Circuit similarly dismissed Purdue’s

evidence of skepticism because that evidence

purportedly lacked a sufficient connection with

specific claim limitations of the patent. App.25a. It

reasoned that FDA’s skepticism was “about applying

the abuse-deterrent label”—a feature not expressly

claimed in the asserted patents, even though abuse

deterrence was the undisputed purpose and result of

the unique process claimed in those patents. Id.

Finally, the Federal Circuit deemed Purdue’s

evidence of failure of others irrelevant. It again

reasoned that Purdue “had not established a nexus

between the alleged” failures “and the claimed

invention,” because it was unclear whether those

failures were caused by a lack of “the claimed

features” of Purdue’s patents. App.26a (citation

omitted).

At no point did the Federal Circuit

holistically consider the undisputed facts that Purdue

had managed to develop a desperately needed and

enormously valuable abuse-deterrent formulation in

a highly competitive market in which no other

competitor had succeeded in doing so.

REASONS FOR GRANTING THE WRIT

This Court’s precedents have long made clear that

the objective indicia are an indispensable element of

the obviousness analysis, and are critical to

combatting hindsight bias and ensuring an expansive

and flexible assessment of patent validity. Yet

Federal Circuit panels routinely and increasingly are

invoking home-grown limits on these indicia—like the

Federal Circuit’s stringent and artificial “nexus”

requirement—that negate the role of the objective

indicia in the obviousness analysis and ignore the

broader marketplace dynamics necessary to

understand whether an invention is truly obvious.

The decision below exemplifies this concerning trend,

which has resulted in the over-invalidation of patents

and, in turn, undermined incentives to invest in the

development of novel and transformative products,

like the innovations at issue here. This Court’s review

is needed to restore the objective indicia to their

proper role in the obviousness analysis.

I. THE

FEDERAL

CIRCUIT’S

RIGID

APPROACH TO THE OBJECTIVE INDICIA

OF NON-OBVIOUSNESS CONFLICTS WITH

THIS COURT’S PRECEDENTS

A. The Objective Indicia Are Critical To The

Obviousness Analysis

Because a patent, once issued, “shall be presumed

valid,” 35 U.S.C. § 282(a), any party attempting to

show that an issued patent is invalid bears the heavy

burden of proving the facts supporting that defense by

“clear and convincing evidence.” Microsoft Corp. v. i4i

Ltd. P’ship, 564 U.S. 91, 95-96 (2011). A patent is

invalid if a party establishes by clear-and-convincing

evidence that the claimed invention as a whole would

have been obvious to a person of ordinary skill in the

art at the time of the invention. 35 U.S.C. § 103(a).

In Graham v. John Deere Co., this Court identified

four factors that must be considered collectively

before concluding that a patented invention is invalid

for obviousness. 383 U.S. 1, 17-18 (1966). Those

factors are (1) “the scope and content of the prior art”;

(2) “differences between the prior art and the claims

at issue”; (3) “the level of ordinary skill in the

pertinent art”; and (4) objective “indicia” of nonobviousness, such as “commercial success, long felt

but unsolved needs, [and] failure of others.” Id. As

this Court reaffirmed in KSR International Co. v.

Teleflex Inc., Graham “set[s] forth a broad inquiry,”

which requires courts to consider “any secondary

considerations that would prove instructive.” 550

U.S. 398, 415 (2007).

Graham stressed that the objective indicia of nonobviousness—including commercial success, long felt

but unsolved needs, and failure of others—are

important to the obviousness analysis for two

reasons. 383 U.S. at 35-36. First, by “focus[ing]

attention on economic and motivational” issues that

are “more susceptible of judicial treatment,” the

objective indicia “lend a helping hand to the judiciary”

in assessing the complex subject matter often at issue

in patent cases. Id. Second, and relatedly, the

objective indicia help prevent courts from “‘slipping

into use of hindsight’” and impermissibly “read[ing]

into the prior art the teachings of the invention in

issue.” Id. at 36 (citation omitted). This check is

necessary because obviousness must be assessed from

the perspective of a person having ordinary skill in

the art “before the effective filing date of the claimed

invention.”

35 U.S.C. § 103(c)(2)(A) (emphasis

added); Graham, 383 U.S. at 35-36. Accordingly, a

“factfinder should be aware . . . of the distortion

caused by hindsight bias and must be cautious of

arguments reliant upon ex post reasoning.” KSR, 550

U.S. at 421. The objective indicia are essential to

resisting that distortion and thus form “a critical

piece of the obviousness analysis.” Leo Pharm.

Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir.

2013).

To accomplish these goals, courts must examine

the objective indicia with an eye to “how the patented

device is viewed in the marketplace, by those directly

interested in the product.” Demaco Corp. v. F. Von

Langsdorff Licensing Ltd., 851 F.2d 1387, 1391 (Fed.

Cir. 1988); see Arkie Lures, Inc. v. Gene Larew Tackle,

Inc., 119 F.3d 953, 957 (Fed. Cir. 1997) (similar). This

broader, common-sense perspective has a salutary

effect on what would otherwise risk becoming an

opaque and arcane exercise based on “highly technical

facts.” Graham, 383 U.S. at 35-36.

Evidence of commercial success, for example,

supports the common-sense notion that “an idea

would successfully have been brought to market

sooner, in response to market forces, had the idea

been obvious to persons skilled in the art.” Merck &

Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1376

(Fed. Cir. 2005).

Similarly, evidence that an

invention filled a long-felt, unmet need weighs

against obviousness because “it is reasonable to infer

that the need would not have persisted had the

solution been obvious.” WBIP, LLC v. Kohler Co., 829

F.3d 1317, 1332 (Fed. Cir. 2016).

Meanwhile, evidence that others tried but failed to

develop a claimed invention can carry “significant

weight,” given that “‘there can be little better evidence

negating an expectation of success than actual reports

of failure.’” Eurand, Inc. v. Mylan Pharms. Inc. (In re

Cyclobenzaprine Hydrochloride Extended-Release

Capsule Pat. Litig.), 676 F.3d 1063, 1081 (Fed. Cir.

2012) (citation omitted).

This practical approach toward evaluating

obviousness is well-rooted in this Court’s

jurisprudence. Decades before Graham, the Court

noted that, where the patented process was

“immediately generally accepted” as a great

“advance” and “largely replaced all earlier processes,”

that was “persuasive evidence” of the inventiveness of

the patent. Mins. Separation v. Hyde, 242 U.S. 261,

270 (1916). And, even earlier, the Court explained

that evidence that an invention had “wrought a

revolution in dental practice” and was being used “in

preference to older devices” raised an “inference” that

it was “in truth, invention.” Smith v. Goodyear Dental

Vulcanite Co., 93 U.S. 486, 495 (1876); see also Reiner

v. I. Leon Co., 285 F.2d 501, 504 (2d Cir. 1960) (Hand,

J.) (identifying “sign posts” for non-obviousness,

including “how long did the need exist” and “how

many tried to find the way”). In short, “evidence of

secondary considerations may often be the most

probative and cogent evidence in the record.”

Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538

(Fed. Cir. 1983).

To perform their intended role, however, the

objective indicia must be analyzed practically and

flexibly. This is nothing new. As in all aspects of the

obviousness analysis, “[r]igid preventative rules that

deny factfinders recourse to common sense . . . are

neither necessary under [this Court’s] case law nor

consistent with it.” KSR, 550 U.S. at 421.

Indeed, in KSR, this Court emphasized the

importance of conducting an expansive and flexible

obviousness analysis. The KSR Court rejected the

Federal Circuit’s “rigid” “teaching, suggestion,

motivation” or “TSM test” for analyzing the technical

Graham factors. Id. at 407, 415. Under the TSM test,

prior art references were required to address “the

precise problem that the patentee was trying to

solve,” in order to show a motivation to combine. Id.

at 413-14 (citation omitted). This Court rejected that

approach, explaining that it was “inconsistent” with

the “expansive and flexible approach” required in

assessing obviousness. Id. at 415. Courts should

instead flexibly consider “design incentives and other

market forces” that might “prompt variations” of the

prior art. Id. at 417. In other words, even as to the

technical obviousness factors, courts must maintain a

broad, flexible, and common-sense perspective.

The necessary corollary is that the objective

indicia of non-obviousness must also be viewed

through the same expansive and flexible lens, with an

eye to market forces and practical considerations that

undercut a finding of obviousness.

Indeed, if

anything, the objective indicia are an even more

natural place for a flexible, common-sense analysis

than the technical obviousness factors. That is the

whole point of the inquiry—as a check on hindsight

bias by conducting a more holistic, real-world inquiry.

Only by applying a flexible lens to all aspects of the

obviousness inquiry can the objective indica serve as

a meaningful check on hindsight bias.

B. The Federal Circuit Routinely Negates

The Objective Indicia Of Non-obviousness

Through Rigid Requirements Like Its

Home-Grown “Nexus” Test

Despite the importance of the objective indicia, the

Federal Circuit has increasingly eschewed the flexible

and common-sense approach required by this Court’s

precedents. In its place, the Federal Circuit has

developed an overly exacting and rigid analysis of the

objective indicia, including a specific “nexus”

requirement of its own creation that demands that

evidence of objective indicia have a strict connection

to a specific claim limitation. That test renders the

objective indicia meaningless in many cases—

including this one. In doing so, it undermines the

Court’s holding in Graham, creates an imbalance

with KSR’s expansive analysis of the other

obviousness factors, and leaves the obviousness

inquiry vulnerable to hindsight bias. Unsurprisingly,

this deviation from the Court’s precedent has

produced inconsistent results and fractured opinions.

1. In the wake of Graham, the Federal Circuit

(and its predecessor, the U.S. Court of Customs and

Patent Appeals) initially recognized the importance of

the objective indicia.

The Federal Circuit

emphasized, for example, that the objective indicia

“serve as insurance against the insidious attraction of

the siren hindsight,” W.L. Gore & Assocs., Inc. v.

Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983),

and that they “may often establish that an invention

appearing to have been obvious in light of the prior

art was not,” Stratoflex, 713 F.2d at 1538.

The Federal Circuit also routinely cautioned that

objective indicia “must always when present be

considered en route to a determination of

obviousness” and that “a court must not stop until all

pieces of evidence . . . have been fully considered and

each has been given its appropriate weight.” Id. at

1538-39; see also In re Mageli, 470 F.2d 1380, 1383

(C.C.P.A. 1973) (explaining that evidence of objective

indicia “is always to be considered”). And it often

reiterated that “[s]econdary considerations may be

the most pertinent, probative, and revealing evidence

available to the decision maker in reaching a

conclusion on the obviousness/nonobviousness issue.”

Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,

776 F.2d 281, 306 (Fed. Cir. 1985).

In applying the Graham framework, the Federal

Circuit also understood that an appropriately flexible

approach was not an indiscriminate one: Objective

indica such as commercial success and failure of

others must have some connection to the patented

invention to be probative of non-obviousness. For

example, the Federal Circuit sensibly concluded that

where “commercial success of a product” has a clear

“cause[] unrelated to patentable inventiveness,” such

as “skillful marketing of the product,” the success is

unlikely to be probative of non-obviousness. Ritchie

v. Vast Res., Inc., 563 F.3d 1334, 1336 (Fed. Cir. 2009).

The Federal Circuit thus held that, for the objective

indicia to be probative of non-obviousness, there must

be “a sufficient relationship”—or “nexus”—between

the objective indicia and the patented invention.

Demaco Corp., 851 F.2d at 1392.

The burden to establish this “nexus” was never

meant to be high, however. In early Federal Circuit

cases involving commercial success, for example,

patentees needed only to provide evidence or

testimony that supported an “inference” that the

“claimed invention itself was responsible for [the]

commercial success.” Id. at 1393 (citation omitted).

For instance, “testimony as to the advantage” of the

patented feature could support an inference that the

patented feature—and not some other feature or

external cause—was “responsible for” the product’s

commercial success.

Id. (citation omitted).

Conversely, if a patentee failed to show that the

marketed product “correspond[ed] to the system

disclosed in the patent,” evidence of commercial

success would carry little weight. Richdel, Inc. v.

Sunspool Corp., 714 F.2d 1573, 1580 (Fed. Cir. 1983).

In line with this broad and flexible approach, the

Federal Circuit often afforded a “presumption of

nexus” when the marketed product embodied the

patented invention: “When a patentee can

demonstrate commercial success, usually shown by

significant sales in a relevant market, and that the

successful product is the invention disclosed and

claimed in the patent, it is presumed that the

commercial success is due to the patented invention.”

J.T. Eaton & Co. v. Atlantic Paste & Glue Co., 106

F.3d 1563, 1571 (Fed. Cir. 1997).

At this point, “the burden shifts to the challenger

to prove that the commercial success is instead due to

other factors extraneous to the patented invention,

such as advertising or superior workmanship.” Id.;

see Demaco Corp., 851 F.2d at 1394 (“A patentee is not

required to prove as part of its prima facie case that

the commercial success of the patented invention is

not due to factors other than the patented invention

itself.” (emphasis omitted)). Merely gesturing to

other “market forces” alone was not enough;

challengers were themselves required to “make a

convincing case that those market forces indeed were

the likely cause of success.”

Crocs, Inc. v.

International Trade Comm’n, 598 F.3d 1294, 1310-11

(Fed. Cir. 2010). Absent such a showing, courts would

presume nexus and draw common-sense inferences

regarding the import of the evidence in the

obviousness analysis.

Accordingly, as conceived, the Federal Circuit’s

“nexus” requirement was merely shorthand to

effectuate Graham’s common-sense evaluation of the

objective indicia and properly assess the

persuasiveness of the evidence.

2. Over time, however, the Federal Circuit’s

“nexus” test has warped into a rigid rule used to

categorically dismiss even compelling evidence of

objective indicia of non-obviousness. This approach

undermines the role of the objective indicia in the

obviousness analysis, has flipped the burden of proof

on obviousness from challenger to patentee, and has

created a glaring incongruity between KSR’s

expansive analysis of the technical obviousness

factors and the Federal Circuit’s cramped approach to

the objective indicia of non-obviousness.

As currently applied, the “nexus” test often

requires direct evidence of a strict connection to a

particular claim element. For example, in the context

of commercial success, panels have stated that a

patentee must show “that the driving force behind the

product sales was a direct result of the unique

characteristics

the

claimed

inventions.”

WesternGeco LLC v. ION Geophysical Corp., 889 F.3d

1308, 1330-31 (Fed. Cir. 2018) (discounting

commercial success); see also In re DBC, 545 F.3d

1373, 1384 (Fed. Cir. 2008) (similar).1 That rule

frequently forecloses any meaningful consideration of

the objective indicia, because courts can regularly

point to the underlying product as the more likely

“source” of commercial success, while ignoring the

role that the invention itself played in that success.

Cubist Pharmaceuticals, Inc. v. Hospira, Inc., is

illustrative. 805 F.3d 1112 (Fed. Cir. 2015). There,

the Federal Circuit affirmed a district court’s decision

discounting evidence of commercial success in a

pharmaceuticals case by reasoning that the success

1 In line with its more restrictive approach, the Federal

Circuit has cabined the “presumption of nexus” to circumstances

where the product is “coextensive” with the claimed features.

Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229

F.3d 1120, 1129-30 (Fed. Cir. 2000). That subsidiary nexus

inquiry has itself spawned inconsistency and confusion. See

Jason

Reinecke,

Assessing

Evidence

Secondary

Considerations, 68 Vill. L. Rev. 633, 637 (2023) (explaining that

the Federal Circuit has “applied multiple tests” to determine

whether a product is coextensive). And, as a practical matter,

panels often ignore the presumption entirely—as the Federal

Circuit did here.

was “mainly attributable to [the drug] itself,” rather

than the novel dosing and interval protocol patents at

issue. Id. at 1126. But by that logic, the objective

indicia can be deemed irrelevant in virtually every

case involving a pharmaceutical improvement,

because by definition, the drug is the baseline

necessity driving sales. The Federal Circuit’s rigid

analysis thus fails to give meaningful weight to the

role that improvements may play in cementing a

product’s place in the market, foreclosing threats

from competitors, or otherwise strengthening a

company’s position in ways that support an inference

of novelty. See also, e.g., E.I. du Pont De Nemours &

Co. v. MacDermid Printing Sols., L.L.C., 657 F. App’x

1004, 1011 (Fed. Cir. 2016) (summarily affirming

district court’s finding that du Pont failed to show

nexus because it was already a dominant player in the

market); Galderma Laboratories, L.P. v. Tolmar, Inc.,

737 F.3d 731, 740 (Fed. Cir. 2013) (finding novel

medication obvious even though it had “quickly

gained and maintained market share” in an “overall

declining market” and against stiff competition from

generic formulations (citation omitted)). That result

is diametrically opposed to the “broad” and “flexible”

inquiry established by Graham. KSR, 550 U.S. at

399, 415.

Furthermore, in some cases, the Federal Circuit

has required patentees to affirmatively disprove other

potential causes of commercial success before

attributing success to the patented invention. In In

re DBC, for example, the Federal Circuit dismissed

evidence of “substantial” “sales” because a patentee

had not provided “evidence” that those sales “were not

merely attributable to the increasing popularity of

mangosteen fruit”—the patented invention’s key

ingredient—“or the effectiveness of the marketing

efforts employed.” 545 F.3d at 1384 (emphasis

added); see also In re Huang, 100 F.3d 135, 140 (Fed.

Cir. 1996) (speculating that sales may have been “due

to lower manufacturing costs” or “features of the

product” “unrelated to the patented subject matter”).

The Federal Circuit again took a stringent

approach in Wm. Wrigley Jr. Co. v. Cadbury Adams

USA LLC, where Wrigley faced an obviousness

challenge from Cadbury regarding Wrigley’s patent

for chewing gum that produced a “cooling sensation.”

683 F.3d 1356, 1362 (Fed. Cir. 2012). Despite

evidence that Wrigley’s patented cooling system

threatened to cost Cadbury millions in sales, and a

Cadbury internal report identifying the cooling

system as a “key driver” of consumer loyalty, the

Federal Circuit found no “nexus” between Wrigley’s

patent claim and its commercial success. Id. at 1369

(Newman, J., concurring in part, dissenting in part).

Specifically, the court concluded that the evidence

failed to demonstrate that “the success of Wrigley’s

product was directly attributable” to the unique

formula of the patented invention. Id. at 1364

(emphasis added). The Federal Circuit similarly

invoked “nexus” to dismiss Wrigley’s evidence that

Cadbury had copied its patented product, noting that

the evidence did not show that it was the patented

invention’s “novel combination” of elements that “led

Cadbury to copy Wrigley’s Chewing gums.” Id. at

1364. Dissenting in part, Judge Newman found the

majority’s conclusion “that nexus was not established

hard to fathom.” Id. at 1369 (citation omitted).

Cases like DBC and Wrigley make clear that the

Federal Circuit’s “nexus” test has swallowed the

holistic, common-sense analysis that Graham

requires. And that is particularly true in the context

of novel improvements to the prior art, where direct

evidence of a specific “nexus” may be difficult—if not

impossible—to obtain.

Though problematic in itself, this development is

particularly concerning because of the imbalance it

creates with courts’ expansive analysis of the other

Graham factors. Under KSR, “design incentives and

other market forces”—untethered to any particular

teaching in the prior art or claim limitation of the

patent—can supply a motivation to combine and

demonstrate obviousness. 550 U.S. at 417. Yet

comparable evidence of market forces showing nonobviousness is deemed irrelevant absent proof that it

is a “direct result” of a particular claim limitation.

WesternGeco, 889 F.3d at 1331. That imbalance has

unduly skewed the obviousness analysis in favor of

the over-invalidation of patents. See infra at 35-36;

see also Ryan T. Holte & Ted Sichelman, Cycles of

Obviousness, 105 Iowa L. Rev. 107, 141-42 (2019)

(finding that after KSR, “obviousness determinations

became about 20% more likely in the district courts”

and 10% more likely in the Federal Circuit).

3. The Federal Circuit’s unduly restrictive

approach, as exemplified by its rigid “nexus” test, has

elicited substantial criticism from a portion of its

bench and generated a host of split opinions.

In WBIP, for example, Judge Moore wrote for the

panel to explain that “[r]equiring patentees to prove

that objective evidence is tied to a specific claim

element—and only that claim element—runs counter

to the statutory” scheme. 829 F.3d at 1331-32. In

doing so, she emphasized that “appellate-created

categorical rules and hierarchies as to the relative

weight or significance of proffered evidence” risk

distorting the “highly fact-dependent” analysis that

obviousness requires. Id. at 1331. The panel thus

rejected an argument that objective evidence of nonobviousness had to be tied to the specific features of a

product not disclosed in the prior art, as opposed to a

novel combination of features, explaining that “proof

of nexus is not limited to only when objective evidence

is tied to the supposedly ‘new’ feature(s).” Id.

Other judges have voiced their concerns with the

Federal Circuit’s rigid approach in dissent. In Tokai

Corp. v. Easton Enterprises, Inc., for example, the

majority affirmed summary judgment on obviousness

after discounting the patentee’s uncontested evidence

of commercial success because of lack of “nexus.” 632

F.3d 1358, 1370 (Fed. Cir. 2011). Judge Newman

dissented, arguing that the majority improperly

“ignore[d]” the patentee’s “evidence that its

commercial success was due to its improved childsafety mechanism” by applying an unduly stringent

nexus requirement. Id. at 1379.

Similarly, in Merck & Co. v. Teva Pharmaceuticals

USA, Inc., Judge Lourie explained, in a dissent from

denial of rehearing en banc, that the majority had

applied an “unsound” nexus rule that “holds in effect

that commercial success for an improvement is

irrelevant when a prior patent dominates the basic

invention.” 405 F.3d 1338, 1339 (Fed. Cir. 2005). And

in Media Technologies Licensing, LLC v. Upper Deck

Co., Judge Rader likewise criticized the majority,

which had found a lack of nexus, for finding a patent

obvious “[w]ithout even so much as a cursory review

of . . . unexpected results, the skepticism of experts,

the commercial success, the flattery of copying, or any

other objective facts.” 596 F.3d 1334, 1339-40 (Fed.

Cir. 2010) (dissenting).2

The Federal Circuit’s en banc decision in Apple

Inc. v. Samsung Electronics Co., only underscores the

confusion. 839 F.3d 1034 (Fed. Cir. 2016). There, a

majority of the Federal Circuit held that the Apple

iPhone’s commercial success was attributable in part

to Apple’s patented slide-to-unlock feature, such that

the success provided objective evidence of that

feature’s non-obviousness.

Id. at 1054-56.

affirming the “nexus” between the slide-to-unlock

feature and the iPhone’s success, the majority relied

on contextual evidence, including the prominence of

the slide-to-unlock feature in advertising and a video

of a crowd “burst[ing] into cheers” when Steve Jobs

highlighted the feature at the iPhone’s product

launch.

Id. at 1055-56 (alteration in original)

(citation omitted).

But several judges disagreed with this more

flexible approach, advancing a stricter view of the

“nexus” requirement that would have required Apple

to provide direct evidence that the iPhone’s success

was due to the slide-to-unlock feature. See id. at 1068

(Prost, J., dissenting) (arguing that Apple failed to

“establish a nexus” between its commercial success

and “the patented feature”); id. at 1080, 1082 (Dyk, J.,

dissenting) (arguing that there must be “a nexus to

2 See also, e.g., Acorda Therapeutics, Inc. v. Roxane

Laboratories, Inc., 903 F.3d 1310, 1353-54 (Fed. Cir. 2018)

(Newman, J., dissenting) (arguing that majority improperly

discounted compelling evidence of non-obviousness); SanofiAventis Deutschland GMBH v. Mylan Pharms. Inc., 791 F. App’x

916, 930 (Fed. Cir. 2019) (Newman, J., dissenting) (criticizing

majority for ignoring continued commercial success of

reformulated drug).

what is new in comparison to the prior art” and

criticizing majority for “elevating secondary

considerations of nonobviousness beyond their role”).

As Judge Reyna explained in dissent, it is

apparent that members of the Federal Circuit

“disagree[] over the role objective indicia play in the

court’s analysis of the ultimate determination of

obviousness”—an “important issue[]” that demands

further review. Id. at 1089. Yet the majority decision

in Apple did not “claim to change the law or lead to a

greater understanding of the law.” Id. at 1087. As a

result, confusion reigns and inconsistent and

inflexible treatment of the objective indicia persists.

See supra at 22-27; In re Cyclobenzaprine, 676 F.3d at

1075 (explaining that the court “has inconsistently

articulated” the standards for assessing the objective

indicia); Dmitry Karshtedt, Nonobviousness: Before

and after, 106 Iowa L. Rev. 1609, 1639 (2021) (“It is

no secret that the treatment of secondary

considerations at the Federal Circuit is highly paneldependent . . . .”).

4. In short, the Federal Circuit’s “nexus”

requirement has become a rigid tool that panels have

repeatedly invoked to brush aside compelling

evidence of objective indicia in many cases.

That evolution should look familiar to this Court.

In KSR, this Court rejected the Federal Circuit’s

“teaching, suggestion, or motivation” test for

obviousness insofar as it transformed Graham’s

“‘functional approach’” into “a rigid rule that limits

the obviousness inquiry.” 550 U.S. at 415, 419

(citation omitted). In doing so, it recognized that the

Court of Customs and Patent Appeals had “captured

a helpful insight” when it “first established” that test.

Id. at 418. Yet, as the Court explained, “[h]elpful

insights . . . need not become rigid and mandatory

formulas . . . incompatible with [this Court’s]

precedents.” Id. at 419.

Just as the Court stepped in to restore a flexible

and expansive approach to the technical Graham

factors in KSR, it should now step in to do the same

for the objective indicia of non-obviousness. This

Court has not hesitated to intervene when Federal

Circuit rules ossify to the point of undermining their

utility. See, e.g., Octane Fitness, LLC v. ICON Health

& Fitness, Inc., 572 U.S. 545, 555 (2014) (rejecting

Federal Circuit approach to attorneys’ fees that

“superimpose[d] an inflexible framework onto

statutory text that is inherently flexible”); eBay Inc.

v. MercExchange, L.L.C., 547 U.S. 388, 393-94 (2006)

(rejecting Federal Circuit’s categorial rule for

granting permanent injunctions in lieu of traditional

equitable test); Festo Corp. v. Shoketsu Kinzoku

Kogyo Kabushiki Co., 535 U.S. 722, 737-38 (2002)

(rejecting Federal Circuit’s “per se” approach to

prosecution history estoppel in favor of “flexible”

application).

Here, the Court’s intervention is

especially critical because a cramped application of

the objective indicia severely undermines their role as

a common-sense check on hindsight bias.

C. The Decision Below Exemplifies The

Federal Circuit’s Unduly Rigid Approach

The decision below exemplifies the Federal

Circuit’s trend of negating the objective indicia of nonobviousness by applying a rigid inquiry that

eliminates the objective indicia as a meaningful part

of the analysis. App.22a (citing Fox Factory, Inc. v.

SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019)).

The record reflects that Purdue’s reformulated,

abuse-deterrent OxyContin addressed a severe

public-health need and preserved the commercial

viability of a highly valuable medication, fending off

competitors who would have undercut Purdue’s

market position had they developed their own abusedeterrent opioid medication. Yet the Federal Circuit

gave that evidence no weight.

To start, the Federal Circuit disregarded Purdue’s

evidence of commercial success on the basis of its

“nexus” requirement. According to the panel, there

was “no nexus between the claimed invention and the

commercial success.” App.24a. This makes no sense.

The record demonstrates that abuse deterrence was

“one of the highest unmet needs in the market,”

Appx5374, and healthcare providers viewed abusedeterrent information as “the most important data”

they reviewed, Appx5376. As Accord’s own expert

admitted,

Purdue’s

abuse-deterrent

patents

“definitely” solved “a long felt, but unmet need in the

art.” Appx5704-5705 (Appel 671:22-672:2).

The original formulation of OxyContin faced an

existential threat in the marketplace because of the

well-known abuse epidemic. As is evidenced by FDA’s

subsequent withdrawal of its approval for the original

formulation of OxyContin, the patented invention

was essential to preserving OxyContin’s commercial

viability. As Accord’s own witness testified, “[t]here’s

no doubt” that OxyContin’s sales would have been

lower without its abuse-deterrent features.

Appx5690, Appx5693 (Hoffman 657:7-13, 660:19-22);

see also Appx5402 (Sharma 369:3-6) (explaining that

“[w]ithout abuse-deterrent features, the OxyContin

sales would have been significantly lower”).

After FDA approved reformulated OxyContin’s

abuse-deterrent labeling, it both withdrew original

OxyContin from the market and prohibited all nonabuse-deterrent

extended-release

oxycodone

products. Appx6809-6818. This alone establishes a

direct connection between reformulated OxyContin’s

commercial success and the abuse-deterrent features

achieved through the patented invention. Yet the

Federal Circuit discounted all of this because the

record did not demonstrate an increase in OxyContin

sales. App.24a.

The Federal Circuit’s complete dismissal of this

evidence is irreconcilable with this Court’s

precedents. This Court has found, going back more

than a century, that evidence that a new product was

“generally accepted” as a great “advance” or “replaced

all earlier processes” is “persuasive evidence” of nonobviousness. Mins. Separation, 242 U.S. at 270; see

also Smith, 93 U.S. at 495 (evidence that invention

was being used “in preference to older devices” raised

inference of inventiveness). Here, the reformulated

version of OxyContin literally led to the withdrawal

of FDA’s approval for the initial formulation, and so

replaced that product. So the nexus between Purdue’s

invention and the commercial success of reformulated

OxyContin could not be more clear. Yet the panel

refused to draw the straightforward inference that

reformulated OxyContin’s success was due to its

abuse-deterrent properties—and that this success

was a strong indicator of non-obviousness.

The Federal Circuit’s rigid application of objective

indicia stands in stark contrast to the flexible

approach the panel applied to the technical Graham

factors.

The panel inferred, for example, that

Purdue’s novel heating approach was “obvious to try”

based on market pressures to develop a scalable

product, applying KSR’s broad approach. App.14a-

15a. But it refused to engage in any practical

assessment of how market incentives demonstrated

non-obviousness in the context of the objective

indicia. As this case illustrates, KSR’s flexible

approach must be applied evenhandedly to the

technical and non-technical factors alike to prevent

over-invalidation of non-obvious patents.

The Federal Circuit’s error is underscored by

considering what would have happened if a

competitor, rather than Purdue, had developed an

abuse-deterrent formulation of an oxycodone pain

medication. The competitor would have reaped the

benefit of Purdue’s sales, replacing OxyContin as the

market leader—and perhaps displacing Purdue’s nonabuse-deterrent formulation altogether. Meantime,

OxyContin’s approval would have been withdrawn (as

it was when Purdue introduced its abuse-deterrent

formulation). This would have been an extraordinary

commercial success for the separate company. The

result is no different simply because Purdue

succeeded in avoiding a commercial disaster as a

result of its hard-earned abuse-deterrence invention.

The panel repeated the same flawed analysis with

respect to Purdue’s evidence of FDA skepticism and

the failure of other manufacturers to develop a

comparable product. Again, the panel held that the

evidence purportedly lacked a sufficient connection to

specific claim limitations of the patent, without ever

considering the evidence more broadly to determine

what, if any, inferences it might support. It reasoned

that FDA’s skepticism was “about applying the abusedeterrent label,” and concluded such skepticism was

irrelevant because “abuse deterrence” is not expressly

claimed in the asserted patents. App.25a. In doing

so, it refused to consider the common-sense fact that

Purdue’s novel invention produced an effective abusedeterrent formulation, overcoming FDA skepticism to

solve “a long felt, but unmet need.” Appx5704-5705

(Appel 671:22-672:2).

Similarly, the panel simply ignored Purdue’s

evidence that its competitors sought—and failed—to

produce abuse-deterrent formulations, once more

insisting that such evidence would be relevant only if

directly connected to a “claimed feature[]” of Purdue’s

patents. App.26a (citation omitted); see also App.64a65a (finding that competitor’s failure to develop

comparable drug formulation “due to difficulties with

scaling” was irrelevant, even though court had found

a “production-scale-based motivation to combine”).

But again, that analysis skips over the flexible and

expansive inquiry KSR requires, ignoring the

common-sense inference that if Purdue’s invention

had truly been obvious, its competitors, which were

actively trying to develop comparable products to

stem a public-health tragedy and replace Purdue in

the market, would have succeeded in doing so.

The objective indicia of non-obviousness are

especially powerful in this case. And they are directly

tied to the patented invention. It is undisputed that

there was a long-felt but unmet need for a

commercially viable abuse-deterrent oxycodone

medication. And there was a huge financial incentive

for developing such a product—the potential to

overtake Purdue’s position as the market leader in

extended-release oxycodone and capture its sales. So

if Purdue’s invention was so obvious, why did others

fail to develop the product and supplant Purdue? The

answer is, well, obvious.

II. THE

QUESTION

PRESENTED

RECURRING AND IMPORTANT

The question presented is also exceptionally

important.

1. This Court has long recognized the “great[]

public importance” of the question of patent validity,

Sinclair & Carroll Co. v. Interchemical Corp., 325

U.S. 327, 330 (1945), and routinely grants review of

questions related to the implementation of the Patent

Act. See, e.g., Amgen Inc. v. Sanofi, 598 U.S. 594, 599

(2023) (addressing the degree of specificity required

by the Patent Act’s “enable[ment]” clause); KSR, 550

U.S. at 415 (considering standard for obviousness

inquiry); Microsoft Corp., 564 U.S. at 95 (considering

standard of proof for invalidity defenses, including

obviousness).

Proper administration of the obviousness analysis

is a critical component of the patent system.

Obviousness is the most common challenge to patent

validity in district courts and in post-grant

proceedings before the U.S. Patent and Trademark

Office, and it is becoming more common. See Apple,

839 F.3d at 1074 (Dyk, J., dissenting); 2A Donald S.

Chisum, Chisum on Patents § 5.06 (2025, Lexis) (“The

nonobviousness requirement of Section 103 is the

most important and most litigated of the conditions of

patentability.”); Jason Reinecke, Assessing Evidence

of Secondary Considerations, 68 Vill. L. Rev. 633, 635

(2023) (“[N]onobviousness is so important in United

States patent law that it is in dispute in almost every

patent case.”). The objective indicia are, in turn, “a

critical piece of the obviousness analysis,” Leo Pharm.

Prods., 726 F.3d at 1358, which “must always when

present be considered,” Stratoflex, 713 F.2d at 1538.

Courts are thus routinely confronted with the

question of how to analyze the objective indicia.

While this Court has recognized the importance of

the objective indicia, it has yet to provide meaningful

guidance on how they should be analyzed, including

with respect to any nexus requirement. The Federal

Circuit has filled the void by demanding an inflexible

“nexus,” and ignoring the common-sense, holistic

inquiry that this Court established in Graham.

Without clear guidance on how to apply the Graham

factors, obviousness has become a “vexing doctrine”

that courts and litigants alike struggle to understand

and apply. See Daralyn J. Durie & Mark A. Lemley,

A Realistic Approach to the Obviousness of Inventions,

50 Wm. & Mary L. Rev. 989, 990-1015 (2008).

2. Unless this Court intervenes, the Federal

Circuit will continue to apply its flawed analysis and

undermine the role of the objective indicia in the

obviousness inquiry. See, e.g., Intercontinental Great

Brands LLC v. Kellogg N. Am. Co., 869 F.3d 1336,

1359 (Fed. Cir. 2017) (Reyna, J., dissenting-in-part)

(explaining that under the majority’s approach to

objective indicia, “it is hard to imagine a situation in

which” the objective indicia could ever “make a

difference”). That, in turn, will render the inquiry

susceptible to hindsight bias by judges and ultimately

result in the over-invalidation of patents, to the

detriment of the system as a whole.

That risk is especially acute for technically

complex products like pharmaceuticals. Where the

process embodied in the patent is particularly

complex or nuanced—as in the fields of chemistry and

pharmaceutical development—it is all the more

important to give the objective criteria their due

weight. Otherwise, patents for genuinely surprising,

commercially successful products that fill a long-felt

but unmet need may face invalidation due to

hindsight bias or misunderstandings about

differences between the patented invention and the

prior art. See, e.g., Novo Nordisk A/S v. Caraco

Pharm. Laboratories, Ltd., 719 F.3d 1346, 1360 (Fed.

Cir. 2013) (Newman, J., concurring in part, dissenting

in part) (arguing that the obviousness inquiry must

account for “the realities and challenges of

discovering a new medicinal product”).

This dynamic will erode the incentives to innovate

that the patent system is designed to protect. See

U.S. Const. art. I, § 8, cl. 8 (conferring on Congress the

power to “promote the Progress of Science and useful

Arts” by securing exclusive rights for inventors).

Without any assurance that they will be able to

recoup their investments, companies will hesitate to

take risks to develop cutting-edge technology. See

Novo Nordisk A/S, 719 F.3d at 1365-66 (Newman, J.,

concurring in part, dissenting in part). This is

especially true for the pharmaceutical industry,

where patents are crucial to ensuring that companies

can recover the significant costs of research and

development. See, e.g., Iain M. Cockburn et al.,

Patents and the Global Diffusion of New Drugs, 106

Am. Econ. Rev. 136, 138-39 (2016). And the ultimate

result will be to deprive the public of transformative

innovations like those at issue here.

CONCLUSION

The petition for a writ of certiorari should be

granted.

DANIEL G. BROWN

LATHAM & WATKINS LLP

1271 Avenue of the

Americas

New York, NY 10020

(212) 906-1200

Respectfully submitted,

GREGORY G. GARRE

Counsel of Record

MARGARET A. UPSHAW

ALEXANDER G. SIEMERS

TIMOTHY J. BORGERSON

LATHAM & WATKINS LLP

555 11th Street, NW

Suite 1000

Washington, DC 20004

(202) 637-2207

gregory.garre@lw.com

Counsel for Petitioners

April 30, 2025

APPENDIX

TABLE OF CONTENTS

Page

Opinion of the United States Court of Appeals

for the Federal Circuit, Purdue Pharma

L.P., Purdue Pharmaceuticals L.P., and

Rhodes Technologies v. Accord Healthcare,

Inc., No. 23-1953, 2024 WL 5244764 (Fed.

Cir. Dec. 30, 2024) ..............................................1a

Trial Opinion of the United States District

Court for the District of Delaware, Purdue

Pharma L.P., Purdue Pharmaceuticals

L.P., and Rhodes Technologies v. Accord

Healthcare, Inc., 669 F. Supp. 3d 286 (D.

Del. 2023) ..........................................................34a

Final Judgment of the United States District

Court for the District of Delaware, Purdue

Pharma L.P., Purdue Pharmaceuticals

L.P., and Rhodes Technologies v. Accord

Healthcare, Inc., No. 20-1362 (D. Del. Apr.

26, 2023), Dkt. No. 126 (Appx50-51) ................96a

U.S. Const. art. I, § 8, cl. 8 ......................................99a

35 U.S.C. § 103 ......................................................100a

35 U.S.C. § 282(a)..................................................101a

[2024 WL 5244764]

UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

PURDUE PHARMA L.P., PURDUE

PHARMACEUTICALS L.P., RHODES

TECHNOLOGIES,

Plaintiffs-Appellants

ACCORD HEALTHCARE, INC.,

Defendant-Appellee

2023-1953

Appeal from the United States District Court for

the District of Delaware in No. 1:20-cv-01362-RGA,

Judge Richard G. Andrews.

Decided: December 30, 2024

Before PROST, REYNA, and TARANTO, Circuit

Judges.

PROST, Circuit Judge.

Purdue Pharma L.P., Purdue Pharmaceuticals

L.P., and Rhodes Technologies (collectively, “Purdue”)

appeal from the final judgment of the U.S. District

Court for the District of Delaware, which held all

asserted claims of the five challenged patents invalid

as obvious under 35 U.S.C. § 103. Purdue Pharma

L.P. v. Accord Healthcare, Inc., 669 F. Supp. 3d 286

(D. Del. 2023). We affirm.

BACKGROUND

This case involves patents related to Purdue’s

formulation of extended-release oxycodone, sold as

Oxycontin. Oxycodone was first developed in the

1910s. J.A. 1822. In the 1990s, Purdue developed an

extended-release formulation, approved by the FDA

in 1995. Appellants’ Br. 5. “Unfortunately, oxycodone

has become one of the most frequently abused

prescription medications and some formulations can

be dissolved and injected intravenously.” Oxycodone,

https://www.ncbi.nlm.nih.gov/books/NBK547955/#:~:

text=Oxycodone; Appellants’ Br. 1 (“The original

[OxyContin] tablets could easily be crushed and then

snorted or injected to produce an immediate high,

causing severe risks of addiction, overdose, and

death.”).

Additionally, the process of creating

oxycodone hydrocholoride, “a well-known molecule

[that] has been synthesized for decades,” Appellee’s

Br. 4 (citing J.A. 5066–67), results in the creation of

14-hy-droxy. 14-hydroxy, an alpha beta unsaturated

ketone (“ABUK”), is “a potentially genotoxic (i.e.,

carcinogenic) impurity.” Appellants’ Br. 2. In other

words, oxycodone is often abused and may be

genotoxic when consumed in large quantities.

The asserted patents in this case attempt to

address these two problems. The first group of

patents—U.S. Patent Nos. 9,763,933 (“the Mannion

’933 patent”), 9,775,808 (“the ’808 patent”), and

9,763,886 (“the ’886 patent”) (collectively, “the AbuseDeterrent Patents”)—are directed to a crushresistant formulation of OxyContin, “mak[ing] it hard

enough to resist crushing and viscous enough to deter

intravenous users.” Purdue Pharma, 669 F. Supp. 3d

at 292. These two qualities help to minimize some of

the more common methods of abusing OxyContin.

The second group of asserted patents—U.S. Patent

Nos. 9,073,933 (“the ’933 patent”) and 9,522,919 (“the

’919

patent”)

(collectively,

“the

Low-ABUK

Patents”)—are directed to a formulation and process

of reducing 14-hydroxy in OxyContin, thereby

reducing toxicity concerns. Each group of patents is

discussed in more detail below.

The Abuse-Deterrent Patents, which share a

common specification, claim a “formulation of

oxycodone using the polymer polyethylene oxide

(‘PEO’).” Appellants’ Br. 1. Claim 3 of the ’808 patent,

which depends from claim 1, is illustrative. Together

they recite:

1. A pharmaceutical composition comprising:

at least one active agent comprising oxycodone or

a pharmaceutically acceptable salt thereof;

at least one high molecular weight polyethylene

oxide (PEO), having an approximate molecular

weight of from 1 million to 15 million;

at least one of an additive and a film coating; and

optionally at least one low molecular weight PEO

having an approximate molecular weight of less

than 1,000,000; wherein

(a) the active agent and high molecular weight

PEO are combined in a solid oral extended release

dosage form that is (i) compression shaped, (ii) air

cured by heated air, without compression, for at

least about 5 minutes at a temperature above the

softening temperature of the high molecular

weight PEO, (iii) cooled, and (iv) hardened;

(b) the high molecular weight PEO comprises at

least about 30% (by weight) of the dosage form;

rheological measurements; and

(d) the total weight of the dosage form is

calculated by excluding the combined weight of

said film coatings.

Id. at claim 1.

3. A pharmaceutical composition according to

claim 1, wherein the curing temperature is from

about 70° C. to about 85° C. and the curing time is

from about 10 minutes to about 10 hours.

Id. at claim 3.

Relevant to this appeal is the curing method

recited in these claims. The curing method has four

general steps: (1) “the tablet must be ‘compression

shaped,’” e.g., id. at claim 1; (2) the tablet “must be

‘air cured by heated air, without compression,’” e.g.,

id.; (3) “the heating must be done for ‘about 10

minutes to about 10 hours,’” e.g., id. at claim 3; and

(4) “the heating must be done above the softening

temperature of PEO and at about 70–85° C or 65–90°

C,” Mannion ’933 patent claim 3; ’808 patent claim 3;

’886 patent claim 6. See Appellants’ Br. 7–8. “This

process produces a hardened tablet resistant to

crushing, but also capable of dissolving and relieving

pain over an extended period of time.” Id. at 11.

Purdue identifies two alleged points of novelty: (1)

“[N]o one had ever cured PEO tablets using heated air

without simultaneous compression or at the times

and temperatures”—i.e., the claims here require the

alleged novel concept of compression then heating.

And (2) the recited process had the “surprising

benefit” of “decreas[ing] . . . tablet density that

promoted faster gelling.” Id. Allegedly, this faster

gelling makes it more difficult to abuse the oxycodone

tablets because the drug becomes gelatinous in the

nasal cavity (making it harder to ingest) and making

it hard to expel through a syringe. Id. at 11–12.

The Low-ABUK Patents, which share a common

specification, address a different problem: reducing

the potential of genotoxicity from the molecule

14-hydroxy created during the manufacturing of

oxycodone. “The synthesis process involves three

steps: (1) oxidation of thebaine to form 14-hydroxy;

(2) hydrogenation of 14-hydroxy to form oxycodone;

and (3) addition of hydrochloric acid to form a salt.”

Appellee’s Br. 4–5; see also Appellants’ Br. 16.

By the early 2000s, the FDA had grown concerned

about this potential toxicity and began requesting

that drug manufactures reduce 14-hydroxy in their

oxycodone products. To reduce 14-hydroxy levels,

Purdue first attempted to ensure that the

hydrogenation step was run to completion—i.e.,

ensuring “all detectable 14-hydroxy was converted to

oxycodone base.” Appellants’ Br. 16. But this did not

solve the problem. During the third step of the

process, 14-hydroxy would reform in the drug.

Through further research, Dr. Kupper, listed as an

inventor on the Low-ABUK Patents, identified

another impurity in oxycodone, known as 8α. Id. at

17. The Low-ABUK Patents explain that 8α is

converted to 14-hydroxy under acidic conditions, such

as salt formation, which explains why residual

14-hydroxy was reappearing in the third

manufacturing step. It is undisputed that “[t]he Low

ABUK Patents were the first to report the presence of

the molecule 8α in the synthesis of oxycodone.”

Appellee’s Br. 5; see also Appellants’ Br. 17 (“Dr.

Kupper . . . discover[ed] a previously unknown

impurity called 8α.”).

Relevant to this appeal are the low levels of

14-hydroxy and the 8α limitations. The asserted LowABUK Patent claims have slight differences among

them regarding the amount of 14-hydroxy and 8α

recited. For example, claim 3 of the ’933 patent,

which depends from claim 1, recites:

1. An oxycodone hydrochloride composition which

comprises at least 95% oxycodone hydrochloride,

8α, 14-dihydroxy-7, 8-dihydrocodeinone, and less

than 25 ppm of 14-hydroxycodeinone.

Id. at claim 1.

3. The oxycodone hydrochloride composition of

claim 1, having less than 10 ppm of 14-hydroxycodeinone.

Id. at claim 3.

Claim 11 of the ’933 patent, which depends from

claim 10, recites “removing 8α” from the composition,

and claim 21 of the ’919 patent recites a specific ratio

involving 8α and 14-hydroxy in the composition: “the

ratio of 8α, 14-dihydroxy-7, 8-dihydrocodeinone to

oxycodone HCl is 0.04% or less.”

In 2010, Purdue developed, and the FDA

approved, a new formulation of OxyContin. Four out

of the five asserted patents are listed in the FDA’s

Orange Book as purportedly covering this

reformulation.1

In August 2020, Accord Healthcare, Inc. (“Accord”)

submitted an Abbreviated New Drug Application

(“ANDA”) for approval to market a generic version of

OxyContin. Purdue then filed suit in October 2020,

asserting that Accord had infringed, among others,

the Mannion ’933 patent, the ’808 patent, the ’886

patent, the ’933 patent, and the ’919 patent through

the act of filing the ANDA.

See 35 U.S.C.

§ 271(e)(2)(A). Accord stipulated to infringement, and

the district court held a three-day bench trial in

September 2021 on the sole issue of invalidity. The

claims at issue were claim 3 of the Mannion ’933

patent, claim 3 of the ’808 patent, claim 6 of the ’886

patent, claims 3 and 11 of the ’933 patent, and claim

21 of the ’919 patent. The court held all asserted

claims were invalid as obvious.

As to the Abuse-Deterrent Patents, Accord argued

that the asserted claims were obvious in view of five

references: Bartholomaus,2 McGinity,3 and three

other references referred to as “Oven Art.”4

“The Mannion ’933, ’808, ’933, and ’919 patents are all

listed in the FDA’s Orange Book for OxyContin. The ’886 patent

is not.” Purdue Pharma, 669 F. Supp. 3d at 293.

U.S.

Patent

Publication

(“Bartholomaus”), J.A. 9417–30.

No.

2005/0031546

U.S. Patent No. 6,488,963 (“McGinity”), J.A. 9408–16.

Zezhi J. Shao et al., Effects of Formulation Variables and

Post-compression Curing on Drug Release from a New SustainedRelease Matrix Material: Polyvinylacetate-Povidone, 6 Pharm.

Dev. and Tech. 2, 257 (2001) (“Shao”), J.A. 9431–38; Nashiru

Billa et al., Diclofenac Release from Eudragit-Containing

Matrices and Effects of Thermal Treatment, 24 Drug Dev. and

Indus. Pharm. 1, 45–50 (1998), J.A. 9439–45; Marcelo O.

“Bartholomaus and McGinity broadly teach PEO

matrix tablets formed with simultaneous compression

and heating. The three Oven Art references broadly

teach curing non-PEO matrix tablets in ovens after

compression.” Purdue Pharma, 669 F. Supp. 3d at

297. The district court summarized the dispute as

follows:

The parties disagree about whether a [person of

ordinary skill in the art] would have been

motivated to make PEO tablets with sequential

compression and heating, and whether there

would have been a reasonable expectation of

success in doing so. Second, no prior art used

the same combinations of curing time and

temperature ranges as those disclosed in the

Abuse-Deterrent Patents. The parties disagree

about whether routine experimentation by a

[person of ordinary skill in the art] would have

yielded the times and temperatures disclosed in

the patents.

Id. (internal citations omitted).

As to the first dispute (i.e., sequential compression

and heating), the district court agreed with Accord

that a person of ordinary skill in the art would be

motivated “to modify Bartholomaus and McGinity

because the processes disclosed in those references

would not have been suitable for large-scale

production,” and a person of ordinary skill in the art

would have “naturally turn[ed] to ovens in either

scaling up Bartholomaus or adapting McGinity to

Omelczuk & James W. McGinity, The Influence of Thermal

Treatment on the Physical-Mechanical Properties of Tablets

Containing Poly(DLLactic Acid), 10 Pharm. Rsch. 4, 542 (1992)

(“Omelczuk”), J.A. 9446–96.

more commonly available equipment.” Id. at 297–98.

The district court also found that a person of ordinary

skill in the art would have had a reasonable

expectation of success in producing hardened tablets

with sequential compression and then heating the

tablets. As to the second dispute (the times and

temperatures for curing tablets), the district court

again agreed with Accord, based on expert testimony,

that the times and temperatures recited in the

patents’ claims would have been the “product of

routine experimentation.” Id. at 303. The court also

considered Purdue’s alleged secondary considerations

and concluded that they do not weigh in favor of

nonobviousness.

Therefore, the district court

concluded that the Abuse-Deterrent Patents would

have been invalid as obvious over the prior art. Id.

at 306.

As to the Low-ABUK Patents, “the parties’

disputes [fell] into two categories: the obviousness of

low levels of 14-hydroxy and the obviousness of the

inventors’ discovery of 8α.” Id. at 312. The district

court concluded that a person of ordinary skill in the

art would have been motivated to lower 14-hydroxy

levels based on FDA communications suggesting that

it might require lower ABUK levels in the future and

that such person would have had a reasonable

expectation of success in doing so based on routine

experimentation. Id. at 313–17. With respect to the

8α limitations, the court addressed the parties’

arguments on a limitation-by-limitation basis. For

claim 3 of the ’933 patent, the claim recited only the

existence of 8α in the composition, and because

Purdue did not dispute 8α would be present, the court

found this inherent property would have been obvious

and that “the identification of 8α itself was merely

10a

routine.” Id. at 318. With respect to claim 11 of the

’933 patent (reciting “removing 8α”) and claim 21 of

the ’919 patent (reciting a specific ratio of 8α), the

court agreed with Accord’s unrebutted expert

testimony that a person of ordinary skill in the art

“would be able to monitor the levels of 8α in order to

reduce the ratio of 8α to oxycodone,” and given that a

person of ordinary skill in the art “would have been

able to routinely identify 8α or [a related impurity] 8β

as the source of extra 14-hydroxy, . . . removing 8α,

either directly or by removing 8β—is also obvious.”

Id. at 320. The court therefore concluded that the

Low-ABUK Patents’ asserted claims would have been

obvious.

Purdue timely appealed. We have jurisdiction

under 28 U.S.C. § 1295(a)(1).

DISCUSSION

“Obviousness is a question of law, reviewed de

novo, based upon underlying factual questions which

are reviewed for clear error following a bench trial.”

Aventis Pharma Deutschland GmbH v. Lupin, Ltd.,

499 F.3d 1293, 1300 (Fed. Cir. 2007) (cleaned up).

“The presence or absence of a motivation to arrive at

the claimed invention, and of a reasonable

expectation of success in doing so, are questions of

fact.” Amgen Inc. v. Sandoz Inc., 66 F.4th 952, 960

(Fed. Cir. 2023). “A factual finding is only clearly

erroneous if, despite some supporting evidence, we

are left with the definite and firm conviction that a

mistake has been made.” Merck Sharp & Dohme

Corp. v. Hospira, Inc., 874 F.3d 724, 728 (Fed. Cir.

2017) (citations omitted).

“A patent for a claimed invention may not be

obtained . . . if the differences between the claimed

11a

invention and the prior art are such that the claimed

invention as a whole would have been obvious before

the effective filing date of the claimed invention . . . .”

35 U.S.C. § 103. “Obviousness is based on underlying

factual findings, including: (1) the level of ordinary

skill in the art; (2) the scope and content of the prior

art; (3) the differences between the claims and the

prior art; and (4) secondary considerations of

nonobviousness, such as commercial success, long-felt

but unmet needs, failure of others, and unexpected

results.” Prometheus Labs., Inc. v. Roxane Labs., Inc.,

805 F.3d 1092, 1097 (Fed. Cir. 2015) (citing KSR Int’l

Co. v. Teleflex, Inc., 550 U.S. 398, 406 (2007); Graham

v. John Deere Co., 383 U.S. 1, 17–18 (1966)).

Purdue appeals the district court’s obviousness

conclusions regarding both the Abuse-Deterrent

Patents and the Low-ABUK Patents. We address

each set of patents, and the alleged district court

errors identified by Purdue, in turn.

For the Abuse-Deterrent Patents, Purdue argues

that the district court erred in (A) finding a

motivation to combine with a reasonable expectation

of success and (B) dismissing Purdue’s arguments

related to secondary considerations. We disagree.

Purdue raises a litany of arguments related to

motivation to combine and reasonable expectation of

success: that the district court (1) failed to consider

the claims as a whole; (2) made improper “inferential

leaps” by focusing solely on oven tools without

addressing the effect of heating tablets without

compression; (3) improperly invoked KSR’s obviousto-try rationale; (4) “applied the wrong legal

12a

standard” with respect to reasonable expectation of

success; (5) erred by relying on “a general discussion”

in the prior art to support its conclusion that

compressing, then heating, would have been obvious;

and (6) erred by relying on “routine experimentation”

to find that the time and temperature limitations of

the Abuse-Deterrent Patent claims would have been

obvious. The first of these arguments is not directed

to a specific limitation in the claims; the next four

arguments are directed to whether a person of

ordinary skill would have found it obvious to

compress and then heat the tablets (as recited by the

claims) rather than simultaneously compression and

heating; and the last argument is directed at the

various time and temperature requirements for

curing a tablet as recited in the claims.

We start with Purdue’s argument that the district

court erred by failing to analyze the claims as a whole.

Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1086

(Fed. Cir. 2008) (“The determination of obviousness is

made with respect to the subject matter as a whole,

not separate pieces of the claim.”). The requirement

to address “claims as a whole” has normally been

invoked when a tribunal has ignored elements of the

claims, looked solely to the inventive aspects of the

claims, or erred by failing to address specific (rather

than generalized) claim limitations. See, e.g., ParaOrdnance Mfg., Inc. v. SGS Importers Int’l, Inc., 73

F.3d 1085, 1087 (Fed. Cir. 1995) (“[T]he claimed

invention should be considered as a whole; there is no

legally recognizable ‘heart’ of the invention.”).

The district court did not make such an error here.

Purdue’s argument essentially relies on a single

13a

footnote in the district court’s opinion as the basis for

asserting a legal error. The footnote states:

This issue relates to both of the differences

between the claims and the prior art

noted previously.

I discuss whether the

experimentation would be routine when

discussing the second difference of time and

temperature ranges.

For the purposes of

reasonable expectation of success, I only ask

whether a [person of ordinary skill in the art]

could reasonably expect to make hardened

tablets by combining Bartholomaus and

McGinity at the claimed times and

temperatures.

Purdue Pharma, 669 F. Supp. 3d at 301 n.5. The

footnote appears during a discussion of reasonable

expectation of success of the “sequential compression

and heating” limitations. Purdue reads this footnote

as “analyz[ing] the claim limitations in isolation—

looking initially (1) to whether the change from

simultaneous to sequential compression and heating

would have been obvious; and then separately (2) to

whether the time and temperature parameters for the

applicable process would have been obvious as

discoverable through routine experimentation.”

Appellants’ Br. 32.

We read this footnote as clarifying the specific

issues the district court discussed at that portion of

its opinion. As a practical matter, a court must

normally address one issue at a time, and in patent

cases, it is the norm for both parties and courts to

discuss disputed claim limitations sequentially.

Purdue’s argument is particularly unpersuasive

because, despite this footnote, the court substantively

discussed the “time and temperature” limitations

14a

while analyzing the parties’ arguments directed to the

“sequential compression and heating” limitations.

See Purdue Pharma, 669 F. Supp. 3d at 302

(discussing “how generally to find optimal ranges,”

the reasonable expectation of success in achieving

those ranges, and the application of common sense in

conjunction with the Oven Art in finding that

“heating times in ovens might be longer”). Therefore,

we disagree that the court erred by failing to address

the claims as a whole.5

Next, Purdue argues that the district court made

an improper “inferential leap” in determining that a

person of ordinary skill in the art would have been

motivated to combine Bartholomaus and McGinity

with the Oven Art when the court said, “[i]t is not

much of a leap to infer that ovens would also be useful

for applying heat to harden the matrix tablets.” Id. at

300.

The court relied on multiple factual findings that

all support the conclusion that it would have been

obvious to try ovens for heating tablets. For example,

Accord presented expert testimony on the availability

of ovens and the prior use of ovens to heat tablets

(including matrix tablets made from several different

Purdue similarly argues that the court erred in its

reasonable-expectation-of-success analysis based on alleged

“piecemeal analysis.” Appellants’ Br. 42 (“[T]he district court

ignored the relevant time and temperature parameters

entirely.”). This argument fails for the same reasons articulated

here—the court did in fact address the claims as a whole. It

thoroughly addressed the “time and temperature” limitations,

even in discussing the “sequential compression and heating”

limitations.

15a

polymers), and “Shao specifically taught that the heat

curing made its tablets harder.” Id. at 299–300.

“Plaintiffs’ witnesses did not provide any testimony to

the contrary.” Id. at 299. Thus, Purdue’s claims that

the court relied on a “naked inference” is unsupported

by the record. Appellants’ Br. 34.

Purdue next argues that the district court legally

erred by invoking KSR’s obvious-to-try test when it

concluded that “employing a commonly available tool

[i.e., ovens] to apply heat to tablets is obvious to try.”

Id. at 36 (quoting Purdue Pharma, 669 F. Supp. 3d at

300). KSR explained that a particular combination of

elements may be obvious to try “[w]hen there is a

design need or market pressure to solve a problem

and there are a finite number of identified,

predictable solutions.” 550 U.S. at 421. Purdue

argues that the district court ran afoul of this

standard because it “made no finding that there were

a finite number of predictable solutions, and the

record plainly shows the opposite.” Appellants’ Br.

36. We again disagree.

To set the stage for this argument, Purdue frames

the problem to be solved as “abuse by crushing” and

identifies several possible solutions to opioid abuse

unrelated to physically hardening tablets. Id. at 36–

40 (listing antagonists, aversive agents, and

covalently-bound inactive moieties). In contrast,

Accord frames the problem to be solved as a scalable

process for heating PEO with a finite number of

possible solutions: ovens, pan coaters, and fluid bed

dryers. Appellee’s Br. 21. We disagree with Purdue’s

framing of the problem to be solved that underlies the

motivation to combine Bartholomaus and McGinity

16a

with the Oven Art at least because it ignores what

was already known and taught in the prior art.

As Purdue recognizes, KSR involved a situation,

where “there were only a very small number of

possible locations for attaching the pedal sensor at

issue because the prior art already taught the need to

place it on a fixed, non-moving point on the pedal.”

Appellants’ Br. 36. Baked into this characterization

is the recognition that KSR was focused on why a

person of ordinary skill would be motivated to address

certain problems in view of the prior art. Indeed, the

Court’s detailed description of the prior art and its

application in the obvious-to-try rationale supports

the notion that the problem to be solved (and the

possible solutions) should take into consideration the

advancements and teachings already in the prior art.

See KSR, 550 U.S. at 424–25 (“For a designer starting

with Asano [a prior-art reference], the question was

where to attach the sensor. The consequent legal

question, then, is whether a pedal designer of

ordinary skill starting with Asano would have found

it obvious to put the sensor on a fixed pivot point. The

prior art discussed above leads us to the conclusion

that attaching the sensor where both KSR and [the

inventor] put it would have been obvious to a person

of ordinary skill.”). KSR did not abstract back out to

the larger problem (e.g., designing an adjustable

pedal having an electronic sensor) and ask how many

different ways that could be done (e.g., redesigning

the whole car), completely disconnected from where

the prior art would have already led a person of

ordinary skill in the art.

Similarly, here, Bartholomaus and McGinity

already taught making hardened tablets, including

PEO antiabuse tablets with compression and heating.

17a

We therefore conclude that Accord’s and the district

court’s framing of the problem—scalability of

hardened tablets—is more apt here. See Appellee’s

Br. 21; Purdue Pharma, 669 F. Supp. 3d at 297 (“[A]

[person of ordinary skill in the art] would then seek to

modify Bartholomaus and McGinity because the

processes disclosed in those references would not have

been suitable for large-scale production.”). To address

this problem, Accord’s expert testified “that ovens

were commonly available and used to heat tablets.”

Purdue Pharma, 669 F. Supp. 3d at 299. As explained

above, “Plaintiffs’ witnesses did not provide any

testimony to the contrary.” Id. In other words, the

court based its conclusion on unrebutted expert

testimony and “the absence of testimony about other

heating tools.” Id. at 300. In this absence, the court

was presented with a finite number of solutions to the

problem of scalability for creating antiabuse tablets

with compression and heating. On this record, the

court’s reliance on the obvious-to-try rationale was a

natural choice.

Because we reject the premise that the problem to

be solved here is general “abuse deterrence,” and

Purdue’s entire argument was based on this framing

of the problem, we reject Purdue’s argument that the

district court erred as a matter of law.

Next, Purdue argues that the court “applied the

wrong legal standard” with respect to reasonable

expectation of success by asking whether a person of

ordinary skill in the art “might” or “could” have

reasonably expected success instead of asking

whether a person of ordinary skill in the art “would”

have reasonably expected success. Appellants’ Br. 41.

18a

We disagree that the court applied the wrong

standard.

While the district court did use the words “could”

and “might” when discussing the reasonable

expectation of success in some circumstances, Purdue

takes these isolated uses of “could” and “might” out of

context. For example, at least two instances of the

use of “could” were based on a framing of what Purdue

argued—not what question the court was addressing.

Purdue Pharma, 669 F. Supp. 3d at 301 (“Plaintiffs

argue that there could not have been a reasonable

expectation of success . . . .”); id. (“They argue that . . .

a [person of ordinary skill in the art] could not have

reasonably expected success.”); cf. id. at 302 (“I was

not persuaded, based on [Purdue’s expert] testimony

. . . that a [person of ordinary skill in the art] could

not still reasonably expect . . . .”).

Regardless, the court made numerous findings

about what a person of ordinary skill in the art

“would” have reasonably expected. See id. at 300 (“I

consider whether a [person of ordinary skill in the art]

would have had a ‘reasonable expectation of success’

. . . .”); id. at 301 (“I think there is a reasonable

expectation of success . . . .” (emphasis added)); id. (“a

[person of ordinary skill in the art] would expect . . .

to be able to achieve . . .” (emphasis added)); id. at 302

(“I find there was clear and convincing evidence that

a [person of ordinary skill in the art] would

reasonably expect . . .” (emphasis added)). These

findings and conclusions demonstrate that the court

applied the correct legal standard and support the

court’s conclusion that a person of ordinary skill in the

art “would reasonably expect to produce hardened

tablets by heating PEO tablets to their melting points

in an oven.” Id. A few references as to what “could”

19a

be expected does not necessarily indicate the court

legally erred. For example, in Belden Inc. v. Berk-Tek

LLC, even where the Patent Trial and Appeal Board

(“Board”) twice opined on what “could” have been

done, we still concluded that the Board’s findings

were sufficient because the Board “did not stop there”

but additionally made findings as to what the prior

art taught and what a person of ordinary skill in the

art “would have recognized.” 805 F.3d 1064, 1073–74

(Fed. Cir. 2015). The same is true here.

Read in context, we conclude that the court did not

apply the incorrect legal standard.

Next, Purdue argues that the district court erred

by relying on “a general discussion” in the prior art to

support its conclusion that a person of ordinary skill

in the art would have had a reasonable expectation of

success of compressing and then heating the tablets.

We disagree.

It is undisputed that Bartholomaus teaches crushresistant PEO tablets. Purdue Pharma, 669 F. Supp.

3d at 299 (agreeing that Bartholomaus and McGinity

“each . . . discloses an effective crush-resistant

tablet”). And Bartholomaus explains that “[t]he solid,

abuse-proofed dosage form according to the invention

is preferably produced by mixing the components (A),

(B), and (C) and/optionally (D) and at least one of the

optionally

present

further

abuse-preventing

components (a)-(f) and, optionally after granulation,

press-forming the resultant mixture to yield the

dosage form with preceding, simultaneous, or

subsequent exposure to heat.” J.A. 9423, [0065]; see

also id. at [0067]. Before the district court, Accord

argued that this passage supported a finding of

20a

reasonable expectation of success; Purdue disagreed

arguing that this passage was “generic.” Purdue

Pharma, 669 F. Supp. 3d at 301. The court agreed

that the statement was “generic” but nonetheless

found it “sufficient to support a [person of ordinary

skill in the art]’s expectations.” Id.

The court did not clearly err in finding that the

Bartholomaus passage supports a reasonable

expectation of success.

The passage refers to

(1) mixing various components, including component

(C), which the patent identifies as optionally PEO,

J.A. 9420, [0018]; (2) press-forming the mixture (i.e.

compressing); and (3) “preceding, simultaneous, or

subsequent exposure to heat.” J.A. 9423, [0065]. This

disclosure, whether generic or not, discusses a

procedure

for

creating

hardened

tablets,

incorporating PEO, and recites an option for

compression and subsequent heating—i.e., it

identifies a method of tablet production that mirrors

the disputed limitations. We see no clear error in the

court’s reliance on this passage, as well as numerous

other findings supported by expert testimony, to

support the conclusion that “there is a reasonable

expectation of success in producing a hardened tablet

from sequential compression and then heating of

PEO.” Purdue Pharma, 669 F. Supp. 3d at 301.

Finally, Purdue argues that the court erred by

relying on the doctrine of “routine experimentation”

to find that the time and temperature limitations of

the Abuse-Deterrent claims would have been obvious.

“Where the general conditions of a claim are disclosed

in the prior art, it is not inventive to discover

the optimum or workable ranges by routine

21a

experimentation.” In re Applied Materials, Inc., 692

F.3d 1289, 1295 (Fed. Cir. 2012) (cleaned up). Purdue

argues that here the prior art did not teach “the

general conditions”; Accord argues just the opposite.

The district court relied on the following evidence

to conclude that the general conditions surrounding

the time and temperature ranges were taught in the

prior art:

Of the three asserted claims, two claim curing

temperatures of 70° C to 85° C, while the third

claims 65° C to 90° C. All three claim heating

times from ten minutes to ten hours. The times

taught in Shao overlap with the time ranges in

the patents, but Shao does not use PEO. The

temperatures in Bartholomaus and Omelczuk

are consistent with those in the asserted

claims, but Bartholomaus teaches shorter and

Omelczuk longer heating times.

Because

McGinity teaches melting the PEO, its

temperatures are also consistent with those in

the patent.

Purdue Pharma, 669 F. Supp. 3d at 302 (internal

citations omitted); see also J.A. 9427 (Bartholomaus

teaching heating PEO to 80° C); J.A. 9416 (McGinity

teaching heating “at a temperature range of about 75°

C. to 130° C. . . . so that melting or softening of the

PEO occurred”); J.A. 9432 (Shao teaching heating of

non-PEO tables in an oven at 60° C “for varying

lengths of time ranging from 10 minutes to 18 h”).

The court considered the claims and found that the

prior art taught general conditions that overlap with

the claim limitations. Again, we see no clear error in

the court’s findings. Thus, we do not agree with

Purdue that reliance on “routine experimentation” in

these circumstances was a legal error.

22a

We now turn to Purdue’s argument that the court

erred in its treatment of the alleged secondary

considerations of nonobviousness. “[Secondary

considerations] must always when present be

considered in the overall obviousness analysis. But

they do not necessarily control the obviousness

determination. Indeed, a strong showing of

obviousness may stand even in the face of

considerable evidence of [secondary considerations].”

Adapt Pharma Operations Ltd. v. Teva Pharms. USA,

Inc., 25 F.4th 1354, 1372 (Fed. Cir. 2022) (cleaned up).

“The evidence of secondary considerations must have

a nexus to the claims, i.e., there must be a legally and

factually sufficient connection between the evidence

and the patented invention. The patentee bears the

burden of showing that a nexus exists. To determine

whether the patentee has met that burden, we

consider the correspondence between the objective

evidence and the claim scope.” Fox Factory, Inc. v.

SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019)

(cleaned up).

Purdue alleges that the district court committed

two legal errors. First, Purdue argues that the court

“asked only whether the secondary considerations

‘undermine’ an existing finding of obviousness.”

Appellants’ Br. 47. In Adapt Pharma, the plaintiffs

argued that the “district court committed legal error

because, according to [plaintiffs], it concluded that the

asserted claims would have been obvious before

considering [plaintiffs’] evidence of [secondary

considerations].” 25 F.4th at 1372. This argument is

substantively identical to Purdue’s first alleged legal

error. And as in Adapt Pharma, “[w]e are not

persuaded.” Id. “[I]t is evident from the district

23a

court’s opinion that it considered all of the evidence

on the issue of obviousness, including the [secondary

considerations], in coming to its ultimate legal

conclusion. Although the district court’s analysis of

the [secondary considerations] in the opinion follows

its discussion of the prima facie case of obviousness,

there is nothing inherently wrong with that.” Id. Nor

does the use of the word “undermine” in the district

court’s opinion persuade us that this case is different

from Adapt Pharma, particularly in light of KSR’s

analogous phrasing—secondary considerations did

not

“dislodge

the

determination

[of]

...

obvious[ness].” 550 U.S. at 426 (emphasis added).

Second, Purdue argues that the district court

“misevaluated—and improperly dismissed—each

[secondary consideration] separately.” Appellants’

Br. 48. Below, we address each of the secondary

considerations that Purdue raises—commercial

success, skepticism, failure of others, and unexpected

results.

Purdue argues that “reformulated OxyContin—

with abuse deterrent qualities—has had commercial

success” and that “detailed evidence establish[es] a

nexus between OxyContin’s commercial success and

its abuse-deterrent features.”

Id. at 48–49.

Specifically, Purdue argues that “after Purdue

reformulated OxyContin, [the] FDA concluded that

original OxyContin was withdrawn from the market

because of safety concerns related to its abuse. [The]

FDA also prohibited all non-abuse-deterrent

extended-release oxycodone products . . . .” Id. at 49

(internal citations omitted).

24a

We see no clear error in the court’s finding that

Purdue failed to “prove[] commercial success due to

the claimed features of the invention.” Purdue

Pharma, 669 F. Supp. 3d at 305. Here, expert

testimony confirmed “that the new formulation

replaced the original formulation, with all sales

transferred to the new formulation.” Id. And the

court found that “there was no demonstrated increase

in the success of OxyContin relative to other opioids

when the patented features were introduced.” Id.

Simply stated, the court found no nexus between the

claimed invention and the commercial success. Bald

assertions of commercial success unconnected to the

patented features of the claimed invention are not

given patentable weight. See, e.g., Pentec, Inc. v.

Graphic Controls Corp., 776 F.2d 309, 316 (Fed. Cir.

1985) (“Because GC was clearly the market leader

well before the introduction of the [claimed

invention], its sales figures cannot be given

controlling weight in determining the effect of

commercial success in this case on the question of

obviousness.”).

Purdue next turns to industry skepticism as a

purported secondary consideration.

Specifically,

Purdue argues that the FDA was skeptical about

“applying an abuse-deterrent label until they had

seen how [reformulated OxyContin] functioned in the

real world and if it really did deter abuse.”

Appellants’ Br. 53 (quoting J.A. 5709). Purdue alleges

that the court excluded the FDA’s skepticism from the

weight of secondary considerations because the FDA

“is not in the industry.” Id. (citing Purdue Pharma,

669 F. Supp. 3d at 306).

25a

We disagree that the court disregarded Purdue’s

argument simply because the FDA is not in the

industry. The court merely noted that the FDA is not

in the industry but weighed the evidence regardless:

[T]he FDA, which is not in the industry,

displayed

amount

skepticism

commensurate with the fact that this was the

first extended-release opioid to receive abusedeterrent labelling. It seems natural that the

FDA, as a regulatory body, would require real

world studies before being satisfied that a hard

tablet was indeed abuse-deterrent.

Purdue Pharma, 669 F. Supp. 3d at 306. Moreover,

as Accord notes, the FDA’s skepticism was about

applying the abuse-deterrent label, not about

the creation (even at large scale) and utility of the

claimed product. The asserted patents “contain[] no

limitations requiring any level of abuse deterrence.”

Appellee’s Br. 39. For these reasons, we see no clear

error in the court’s conclusion that “Plaintiffs have

[not] proven industry skepticism by a preponderance

of the evidence.” Purdue Pharma, 669 F. Supp. 3d

at 306.

With respect to the failure of others, Purdue

identifies two products whose producers failed

“develop[]

successful

abuse-deterrent

formulation”—Develco and Opana. Appellants’ Br.

54–55.

With respect to Develco, the court found that “the

production failures of Develco seem to weigh in favor

of the production-scale-based motivation to combine

. . . rather than in favor of the nonobviousness of the

patents.” Purdue Pharma, 669 F. Supp. 3d at 306.

26a

With respect to Opana, the court found that “the

record is not clear on why Opana was removed from

the market,” and “[Purdue] did not establish by a

preponderance of the evidence that Opana’s removal

was related to its lack of ‘the claimed features.’” Id.

With respect to both Develco and Opana, “the

evidence does not suggest [on this record] that these

prior attempts failed because the [formulation] lacked

the claimed features.” Ormco Corp. v. Align Tech.,

Inc., 463 F.3d 1299, 1313 (Fed. Cir. 2006). In other

words, the court again concluded that Purdue had not

established a nexus between the alleged secondary

consideration and the claimed invention. Based on

these findings, “[w]e are not left with a definite and

firm conviction that the district court erred in this

regard. We thus see no clear error in the district

court’s finding that this evidence is not significantly

probative of nonobviousness.” Adapt Pharma, 25

F.4th at 1376.

Finally, with respect to unexpected results,

Purdue argues that “the district court agreed that the

claimed invention exhibited an unexpected property

by decreasing tablet density—which Purdue’s expert

testified could enhance abuse deterrence by causing

the tablet to gel more quickly if crushed.” Appellants’

Br. 57. But, according to Purdue, the court erred by

“declining to afford [unexpected results] any weight.”

Id. We disagree.

In fact, the court found that Purdue “ha[d]

established by a preponderance of the evidence the

existence of unexpected results.” Purdue Pharma,

669 F. Supp. 3d at 304. But these unexpected results

did “not alone undermine the clear and convincing

27a

evidence that the invention’s claimed properties

[would have been] obvious.” Id.; see also W. Union Co.

v. MoneyGram Payment Sys., Inc., 626 F.3d 1361,

1371 (Fed. Cir. 2010) (“[W]eak secondary

considerations generally do not overcome a strong

prima facie case of obviousness.”).

We see no

reversible error in this overall assessment.

For the reasons above, we affirm the court’s

holding that claim 3 of the Mannion ’933 patent, claim

3 of the ’808 patent, and claim 6 of the ’886 patent are

invalid.

Turning to the Low-ABUK Patents, Purdue first

advances two sweeping legal principles: (1) “[w]here

the problem is unknown, there can be no reasonable

expectation of success in solving it”; and (2) “an

invention is non-obvious where the inventor discovers

‘the source’ of a problem.” Appellants’ Br. 59.

Applying these principles, Purdue contends that the

Low-ABUK Patents are nonobvious because Purdue

discovered the “previously unknown problem” that

14-hydroxy reappeared after its removal during the

synthesis of oxycodone, and it discovered the source of

the problem, the impurity 8α. Id. at 60.

With respect to the alleged discovery of an

unknown problem, Purdue’s argument necessarily

fails because the problem was known. Specifically,

the district court found that “testimony at trial . . .

indicated that an understanding or suspicion that

ABUKs were toxic existed even before September

2002.” Purdue Pharma, 669 F. Supp. 3d at 315.

While Purdue attempts to suggest a narrower

problem statement—i.e., 14-hydroxy reappeared after

its removal during the synthesis of oxycodone—this

28a

effectively transforms Purdue’s argument from an

alleged legal error to an alleged factual error. And on

the factual point, the court agreed with Accord that “a

[person of ordinary skill in the art] would have two

clear starting points: either adding a final

hydrogenation

step

remove

14-hydroxy

hydrochloride or attempting to remove 14-hydroxy at

an earlier stage.” Id. Even between these two

starting points, the district court considered the

parties’ arguments, reviewed the expert testimony,

and concluded that Accord had “presented clear and

convincing argument that a [person of ordinary skill

in the art] would try to intervene at an earlier stage

of the oxycodone synthesis to ensure that all

14-hydroxy was converted to oxycodone prior to salt

formation. I am also persuaded that a [person of

ordinary skill in the art] would have the knowledge

and skill to do so successfully.” Id. at 316. We see no

clear error in the court’s factual findings on this

record.

Regarding discovery of “the source” of a problem,

even Eibel Process Co. v. Minnesota & Ontario Paper

Co., upon which Purdue heavily relies, demonstrates

that obviousness is based upon underlying factual

questions. See 261 U.S. 45, 52 (1923) (“The issue is

one largely of evidence.”). “In Eibel Process, the

invention was a machine that could make quality

paper at high speeds. At the time, paper-making

machines could not operate at high speeds without

producing wrinkled paper. Eibel discovered that the

unequal speeds of paper stock and a wire in the

machine produced the wrinkled paper. . . . The

Supreme Court upheld the validity of Eibel’s patent,

reasoning that the discovery of the problem—unequal

speeds of paper stock and the wire—was nonobvious,

29a

and thus the solution was as well.” Purdue Pharma

L.P. v. Epic Pharma, LLC, 811 F.3d 1345, 1352 (Fed.

Cir. 2016). But even in concluding that the patent

was nonobvious, the Court laid out different factual

scenarios that may have led to a different conclusion:

Had the trouble which Eibel sought to remedy

been the well-known difficulty of too great

wetness or dryness of the web at the dandy roll,

and had he found that a higher rather than a

lower pitch would do that work better, a patent

for this improvement might well have been

attacked on the ground that he was seeking

monopoly for a mere matter of degree. But that

is not this case. On the other hand, if all knew

that the source of the trouble Eibel was seeking

to remedy was where he found it to be, and also

knew that increased speed of the stock would

remedy it, doubtless it would not have been

invention on his part to use the pitch of the wire

to increase the speed of the stock, when such

pitch had been used before to do the same thing,

although for a different purpose and in less

degree.

Eibel Process, 261 U.S. at 68.

Between Eibel’s discussion of different factual

scenarios and KSR’s warning to avoid “[r]igid

preventative rules that deny factfinders recourse to

common sense,” we believe the proper inquiry here is

one of fact. In other words, even recognizing that

Purdue may have discovered 8α, we disagree that,

“[t]hat should have ended the inquiry.” Appellants’

Br. 61. Therefore, we turn to the two alleged factual

flaws that Purdue identified—i.e., the court’s reliance

on inherency and routine experimentation.

30a

“[I]nherency may supply a missing claim

limitation in an obviousness analysis.” PAR Pharm.,

Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1194–95

(Fed. Cir. 2014). “It is long settled that in the context

of obviousness, the ‘mere recitation of a newly

discovered function or property, inherently possessed

by things in the prior art, does not distinguish a claim

drawn to those things from the prior art.’” Persion

Pharms. LLC v. Alvogen Malta Operations Ltd., 945

F.3d 1184, 1190 (Fed. Cir. 2019) (citation omitted).

Purdue relies on Honeywell International Inc. v.

Mexichem Amanco Holding S.A. de C.V., 865 F.3d

1348 (Fed. Cir. 2017), for the proposition that, “that

which ‘may be inherent is not necessarily known’ and

that which is unknown cannot be obvious.’”

Appellants’ Br. 62 (quoting Honeywell, 865 F.3d at

1354). But Honeywell does not help Purdue because

it was a case about motivation to combine. See Cytiva

BioProcess R&D AB v. JSR Corp., 122 F.4th 876, 890

(Fed. Cir. 2024). In Honeywell, the claimed invention

was a composition that comprised two components.

Both components were disfavored in the art for the

claimed purpose, but the combination of the two

components had unexpected properties. In this

circumstance, even though the unexpected properties

were inherent, “a person of ordinary skill in the art

would not have been motivated to combine the two

compounds in the first place.” Id. Thus, Honeywell is

not applicable here.

Instead, we turn to each of the asserted LowABUK Patent claims individually, as the district

court did, because the disputed limitations in each

claim are slightly different. First, “[c]laim 3 of the

’933 patent requires only that 8α be present in the

composition.” Purdue Pharm., 669 F. Supp. 3d at 318

31a

(citing ’933 patent claim 3). The court concluded that

claim 3 was obvious because 8α was inherently

present in the prior art compositions. Indeed,

“Plaintiffs d[id] not dispute that 8α was present in

prior art compositions.” Id. In other words, like in

Cytiva (where we found the claims unpatentable

based on an undisputedly inherent property), Purdue

attempts to claim an inherent part of the

composition—8α.

Because this limitation was

undisputedly present in the prior art, nothing more is

needed because there is no “difference[] between the

claimed invention and the prior art.” 35 U.S.C. § 103.

Second, claim 21 of the ’919 patent recites a

different limitation with respect to 8α—“the ratio of

8α,14-dihy-droxy-7,8-dihydrocodeinone to oxycodone

HCl is 0.04% or less, ’919 patent claim 18 (from

which claim 21 depends); and claim 11 of the ’933

patent recites “removing 8α,14-di-hydroxy-7,8dihydrocodeinone”, ’933 patent claim 10 (from which

claim 11 depends). Here, the court relied on a

sequence of facts to arrive at the conclusion that both

limitations would have been obvious to a person of

ordinary skill in the art conducting routine

experimentation. Purdue Pharm., 669 F. Supp. 3d at

315–20.

On appeal, Plaintiffs contend it was

improper for the court to rely on routine

experimentation because “routine experimentation

applies only where the claimed invention merely

identifies the ‘optimum or workable ranges’ of

previously disclosed conditions.” See Appellants’ Br.

63 (citing E.I. DuPont de Nemours & Co. v. Synvina

C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018)) (emphasis

added). We are unaware of such a brightline rule. For

example, in Merck, we agreed that it was “reasonable

for the district court to deduce from the evidence that

32a

the order and detail of the steps, if not already known,

would

have

been

discovered

routine

experimentation

while

implementing

known

principles.” Merck, 874 F.3d at 730. The disputed

limitations there were not only “optimum or workable

ranges” but included “the order of the steps, the

simultaneous addition of base, the specific

temperature range, and a final moisture content of

less than 10%.” Id.

Similarly, here, the court “looked to testimony

provided by both sides’ experts” and was “persuade[d]

. . . that a [person of ordinary skill in the art] would

have quickly postulated and easily confirmed the

existence of 8α.” Purdue Pharm., 669 F. Supp. 3d at

319. Purdue only makes two factual arguments that

allegedly undermine the court’s finding of routine

experimentation—i.e., that the court ignored

Noramco’s attempt to develop Low-ABUK oxycodone

and that the court acknowledged “routine

experimentation with early removal of 14-hydroxy

‘would not immediately succeed.’” Appellants’ Br. 63.

As to Noramco, the court did not ignore this evidence.

See Purdue Pharm., 669 F. Supp. 3d at 317. The court

simply did not find it “sufficient” to overcome Accord’s

expert testimony. Purdue fails to explain why the

court erred in finding Noramco’s failure insufficient

in light of the expert testimony, and we see no clear

error in the court’s analysis on this point. As to

Purdue’s argument that a person of ordinary skill in

the art “would not immediately succeed” in early

removal of 14-hy-droxy, we are not aware of a test for

routine experimentation that requires a person of

ordinary skill in the art to “immediately succeed.”

Absent an argument why the district’s analysis was

clear error, we conclude it was “reasonable for the

33a

district court to deduce from the evidence that the

[disputed claim limitations] . . . would have been

discovered by routine experimentation while

implementing known principles.” Merck, 874 F.3d at

730.

Having confirmed that the district court did not

err in its determination that routine experimentation

would lead a person of ordinary skill to “quickly

postulate[] and easily confirm[] the existence of 8α,”

and because the remainder of the court’s analysis

with respect to claim 21 of the ’919 patent and claim

11 of the ’933 patent is not contested, we affirm the

district court’s holding that the challenged claims of

the Low-ABUK Patents would have been obvious. See

Purdue Pharm., 669 F. Supp. 3d at 319–20.

CONCLUSION

We have considered Purdue’s remaining

arguments and find them unpersuasive. For the

foregoing reasons, we affirm the district court’s final

judgment, holding claim 3 of the Mannion ’933 patent,

claim 3 of the ’808 patent, claim 6 of the ’886 patent,

claims 3 and 11 of the ’933 patent, and claim 21 of the

’919 patent invalid as obvious under 35 U.S.C. § 103.

AFFIRMED

34a

[669 F. Supp. 3d 286]

UNITED STATES DISTRICT COURT,

D. Delaware

PURDUE PHARMA L.P., Purdue Pharmaceuticals L.P., and Rhodes Technologies,

Plaintiffs,

ACCORD HEALTHCARE INC., Defendant.

Civil No. 21-11558-LTS

Signed April 11, 2023

TRIAL OPINION

ANDREWS,

JUDGE:

UNITED

STATES

DISTRICT

Plaintiffs

Purdue

Pharma

L.P.,

Purdue

Pharmaceuticals L.P., and Rhodes Technologies

brought this patent infringement action under 35

U.S.C. § 271(e)(2)(A) against Defendant Accord

Healthcare. (D.I. 1 ¶ 2). I held a three-day bench trial

from September 19 to September 21, 2022. The

parties narrowed the issues to invalidity for

obviousness of each of six asserted claims from five

remaining patents.

The asserted patents fall into two groups, each of

which shares a substantively identical specification.

(D.I. 89-1 ¶¶ 10, 21). One group consists of U.S.

Patent Nos. 9,763,933 (“the Mannion ’933 patent”),

9,775,808 (“the ’808 patent”), and 9,763,886 (“the ’886

patent”). The parties refer to these patents as the

“Tamper Resistant” or “Abuse-Deterrent Patents.” I

refer to them as the “Abuse-Deterrent Patents.” The

claims at issue are claim 3 of the Mannion ’933 patent,

35a

claim 3 of the ’808 patent, and claim 6 of the ’886

patent.

The second group consists of U.S. Patent Nos.

9,073,933 (“the ’933 patent”) and 9,522,919 (“the ’919

patent”). The parties (and I) refer to these as the “Low

ABUK Patents.” The claims of the “Low ABUK

Patents” at issue are claims 3 and 11 of the ’933

patent and claim 21 of the ’919 patent.

For the following reasons, I find all six of the

asserted claims invalid for obviousness under 35

U.S.C. § 103.

BACKGROUND

Purdue holds New Drug Application (“NDA”) No.

022272 for OxyContin (oxycodone hydrochloride).

OxyContin is an extended-release analgesic. (D.I.

89-1 ¶ 32). The Abuse-Deterrent Patents relate to an

abuse-deterrent reformulation of OxyContin that

make it hard enough to resist crushing and viscous

enough to deter intravenous users. (D.I. 106 at 3, 5).

The reformulation was approved in 2010, and the

Food and Drug Administration (“FDA”) approved an

abuse-deterrent label for the reformulation in 2013,

following postmarketing studies. (D.I. 107 ¶ 20).

I will refer to the pre-reformulation version of

OxyContin as “Original OxyContin.”

The Low-ABUK Patents relate to compositions

oxycodone

containing

8α-14-dihydroxy-7,8dihydrocodeinone (“8α”) and having particularly low

levels of the impurity 14-hydroxycodeinone

(“14-hydroxy”). (Id. ¶¶ 48-49). 14-hydroxy is an

alpha beta unsaturated ketone (“ABUK”), a class of

compounds thought to be genotoxic. The evolution of

the scientific understanding of these compounds’

36a

genotoxicity is a factual issue in this case. (D.I. 100

¶ 158).

Accord submitted an Abbreviated New Drug

Application (“ANDA”) No. 213564 for approval to

market a generic version of OxyContin. Plaintiffs

then initiated this lawsuit. (D.I. 1 ¶¶ 1-2). The

Mannion ’933, ’808, ’933, and ’919 patents are all

listed in the FDA’s Orange Book for OxyContin. The

’886 patent is not. (Id. ¶ 1).

II. LEGAL STANDARD

A patent claim is invalid as obvious under 35

U.S.C. § 103 “if the differences between the claimed

invention and the prior art are such that the claimed

invention as a whole would have been obvious before

the effective filing date of the claimed invention to a

person having ordinary skill in the art to which the

claimed invention pertains.” 35 U.S.C. § 103; see also

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406-07,

127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). “As patents

are presumed valid, a defendant bears the burden of

proving invalidity by clear and convincing evidence.”

Shire, LLC v. Amneal Pharms., LLC, 802 F.3d 1301,

1306 (Fed. Cir. 2015) (citations omitted). “Under

§ 103, the scope and content of the prior art are to be

determined; differences between the prior art and the

claims at issue are to be ascertained; and the level of

ordinary skill in the pertinent art resolved. Against

this background, the obviousness or nonobviousness

of the subject matter is determined.” KSR, 550 U.S.

at 406, 127 S.Ct. 1727 (internal citation and quotation

marks omitted).

A court is required to consider secondary

considerations, or objective indicia of nonobviousness,

before reaching an obviousness determination,

37a

as a “check against hindsight bias.” See In re

Cyclobenzaprine Hydrochloride Extended-Release

Capsule Patent Litig., 676 F.3d 1063, 1078-79 (Fed.

Cir. 2012).

“Such secondary considerations as

commercial success, long felt but unsolved needs,

failure of others, etc., might be utilized to give light to

the circumstances surrounding the origin of the

subject matter sought to be patented.” Graham v.

John Deere Co. of Kansas City, 383 U.S. 1, 17–18, 86

S.Ct. 684, 15 L.Ed.2d 545 (1966).

III. THE ABUSE-DETERRENT PATENTS

A. The Asserted Claims

The claims at issue are claim 3 of the Mannion ’933

patent, claim 3 of the ‘808 patent, and claim 6 of the

’886 patent. Claim 3 of the Mannion ’933 patent is a

product-by-process claim that depends on claim 1.

Claims 1 and 3 read,

1. A pharmaceutical composition comprising:

at least one active agent;

at least one high molecular weight polyethylene

oxide (PEO) having an approximate molecule

weight of from 1 million to 15 million;

optionally at least one additive;

optionally at least one film coating; and

optionally at least one low molecular weight PEO

having an approximate molecular weight of

less than 1,000,000; wherein

(a) the active agent and high molecular weight

PEO are combined in a solid oral extended

release dosage form that is (i) compression

shaped, (ii) air cured by heated air, without

compression, for at least about 5 minutes at a

temperature above the softening temperature

38a

of the high molecular weight PEO, (iii) cooled,

and (iv) hardened;

(b) the high molecular weight PEO comprises at

least about 30% (by weight) of the dosage

form;

rheological measurements; and

(d) the total weight of the dosage form is

calculated by excluding the combined weight

of said film coatings.

...

3. A pharmaceutical composition according to

claim 1, wherein the curing temperature is

from about 70° C. to about 85° C. and the

curing time is from about 10 minutes to about

10 hours.

(Mannion ’933 patent at 158:61-159:16, 159:20-23).

Claim 3 of the ’808 patent is a product-by-process

claim that depends on claim 1. The two claims read,

1. A pharmaceutical composition comprising:

at least one active agent comprising oxycodone or

a pharmaceutically acceptable salt thereof;

at least one high molecular weight polyethylene

oxide (PEO) having an approximate molecule

weight of from 1 million to 15 million;

at least one additive and a film coating; and

optionally at least one low molecular weight PEO

having an approximate molecular weight of

less than 1,000,000; wherein

(a) the active agent and high molecular weight

PEO are combined in a solid oral extended

release dosage form that is (i) compression

39a

shaped, (ii) air cured by heated air, without

compression, for at least about 5 minutes at a

temperature above the softening temperature

of the high molecular weight PEO, (iii) cooled,

and (iv) hardened;

(b) the high molecular weight PEO comprises at

least about 30% (by weight) of the dosage form;

rheological measurements; and

(d) the total weight of the dosage form is

calculated by excluding the combined weight of

said film coatings.

...

3. A pharmaceutical composition according to

claim 1, wherein the curing temperature is

from about 70° C. to about 85° C. and the

curing time is from about 10 minutes to about

10 hours.

(’808 patent at 159:37-57, 159:61-64).

Claim 6 of the ’886 patent is a method claim, which

depends on claims 5, 3, 2, and

1. The claims read,

1. A method of producing a plurality of solid

oral extended release pharmaceutical dosage

forms comprising the steps of:

mixing at least one active agent, at least one

high molecular weight polyethylene oxide

(PEO) having an approximate molecular

weight of from 1 million to 15 million, to

provide a PEO composition;

compressing the PEO composition to provide a

plurality of shaped matrix compositions;

40a

curing the shaped matrix compositions by

exposure to heated air at a curing

temperature that is at least the softening

temperature of the high molecular weight

PEO for a curing time of at least about 5

minutes, to provide a plurality of cured

matrix compositions;

cooling the cured matrix compositions;

optionally combining any of the matrix

compositions with at least one additive,

before or after curing; and

optionally providing the cured matrix

compositions with at least one film coating,

after curing and cooling; wherein

(a) the molecular weight of each PEO is based

on rheological measurements;

(b) the high molecular weight PEO comprises

at least about 30% (by weight) of each

dosage form;

calculated by excluding the combined

weight of said film coatings.

(d) each cured matrix composition comprises

a solid oral pharmaceutical dosage form

that provides an extended release of at

least one active agent.

2. A method according to claim 1, wherein the

curing temperature is at least about 60° C.

and the curing time is at least 10 minutes.

3. A method according to claim 2, wherein the

high molecular weight PEO has an

approximate molecular weight of from 1

million to 8 million.

41a

...

5. A method according to claim 3, wherein the

high molecular weight PEO comprises at least

about 50% (by weight) of each dosage form.

6. A method according to claim 5, wherein the

curing temperature is from about 65° C. to

about 90° C. and the curing time is from about

10 minutes to about 10 hours.

(’886 patent at 171:35-172:22, 172:26-32).

B. Findings of Fact

1. Both

Original

OxyContin

and

the

reformulation that the Abuse-Deterrent

Patents concern are extended-release matrix

tablets. (Tr. at 204:16-21;1 ’886 Patent at

171:42-50). Matrix tablets contain an active

ingredient embedded in a polymer matrix. (Tr.

at 202:23-203:9)

2. Polyethylene oxide (PEO) is among the most

commonly used matrix polymers. (Tr. at 204:68).

3. With respect to the Abuse-Deterrent Patents, a

person of ordinary skill in the art (“POSA”) has

an advanced degree and substantial experience

drawn from the fields of medicine, chemical

engineering,

polymers,

pharmaceutical

sciences, pharmaceutics, pharmacokinetics,

and pharmacology. (D.I. 89-1 at ¶ 134).

4. The Abuse-Deterrent Patents are directed to

compositions and methods of producing abuse-

The transcript is available at D.I. 102-105.

consecutively paginated.

It is

42a

deterrent pharmaceutical formulations. (D.I.

89-1 ¶¶ 21-22).

5. For purposes of this action, the priority date of

the patents is August 25, 2006. (D.I. 89-1

¶¶ 24, 27, 30).

6. Abuse by crushing was a known issue with

OxyContin. (DTX-008).

7. United States Patent No. 6,488,963 to

McGinity (“McGinity”) is prior art to the AbuseDeterrent Patents under 35 U.S.C. § 102(b).

(D.I. 89-1 ¶ 120).

8. A POSA would have understood that, because

McGinity’s tablets were made from melted

PEO, they had increased breaking strength

that provided resistance to crushing. (Tr. at

220:17-26).

9. McGinity teaches that its formulations can be

used on “analgesics” (DTX-009 at 6:10), which

a POSA would understand includes oxycodone.

(Tr. at 220:7-16).

10. McGinity teaches melting PEO in a hot-melt

extruder to create hardened tablets. (DTX-009

at 8:8-28). At the time of the invention, hot

melt extruders, though known, were not

common. (Tr. at 219:3-13). They could be used

at contract manufacturers. (Tr. at 257:17-19).

11. U.S. Patent Publication No. 2005/0031546

(“Bartholomaus”) is prior art to the AbuseDeterrent Patents under 35 U.S.C. § 102(b).

(DTX-010; D.I. 89-1 ¶ 123).

12. Bartholomaus teaches pressing PEO tablets in

a “heating cabinet.” (DTX-010 at [0117]). A

POSA would understand that the purpose of

43a

the heating was to melt the PEO. (Tr. at 227:513).

13. The method disclosed in the examples in

Bartholomaus was not scalable. (Tr. at 226:726, 332:5-24).

14. Bartholomaus contemplates pressing tablets

and heating them as separate steps. (Tr. at

227:20-228:4; DTX-010 at [0067]).

15. Zezhi J. Shao et al., Effects of Formulation

Variables and Post-compression Curing on

Drug Release from a New Sustained-Release

Matrix Material: Polyvinylacetate-Povidone, 6

Pharm. Dev. and Tech. 2, 257 (2001) (“Shao”) is

prior art to the Tamper Resistant Patents

under 35 U.S.C. § 102(b). (D.I. 89-1 ¶ 126).

Shao discloses matrix tablets made with the

polymer

Kollidon-SR

(polyvinylacetatepovidone). (DTX-011 at 0001).

16. Nashiru Billa et al., Diclofenac Release from

Eudragit-Containing Matrices and Effects of

Thermal Treatment, 24 Drug Dev. and Indus.

Pharm. 1, 45-50 (1998) (“Billa”) is prior art to

the Tamper Resistant Patents under 35 U.S.C.

§ 102(b). (D.I. 89-1 ¶ 127). Billa discloses

matrix tablets made with the polymer

EUDRAGIT

(ethyl

acrylate-methyl

methacrylate copolymer). (DTX-012 at 0002).

17. Marcelo O. Omelczuk & James W. McGinity,

The Influence of Thermal Treatment on the

Physical-Mechanical Properties of Tablets

Containing Poly(dl-Lactic Acid), 10 Pharm.

Rsch. 4, 542 (1992) (“Omelczuk;” together with

Billa and Shao, the “Oven Art”) is prior art to

the Tamper Resistant Patents under 35 U.S.C.

44a

§ 102(b). (D.I. 89-1 ¶ 128). Omelczuk discloses

matrix tablets made with the polymer PLA

(poly(DL-lactic acid)). (DTX-014 at 0001).

18. The Oven Art teaches heating various nonPEO polymers in ovens (Tr. at 229:20-25,

231:11-22, 232:1-11), though not to their

melting points. (Tr. at 286:5-14, 287:6-8).

19. Shao concluded that the curing process

increased the hardness of the tablets. (DTX011 at 0005; Tr. at 230:9-20).

20. Both Bartholomaus and the Oven Art disclose

cooling and hardening the tablet. (Tr. at 240:811).

C. Conclusions of Law

As a preliminary matter, the parties treat the

three asserted Abuse-Deterrent claims as though

they rise and fall together. Neither party contends

that their arguments or my analysis should apply

differently to the product-by-process than to the

method claims. Therefore, I too will treat the three

claims together. For the following reasons, I conclude

that each of the three claims is invalid for obviousness

under 35 U.S.C. § 103.

Defendant relies on five pieces of prior art in

arguing for the obviousness of the Abuse-Deterrent

Patents. Bartholomaus and McGinity broadly teach

PEO matrix tablets formed with simultaneous

compression and heating. The three Oven Art

references broadly teach curing non-PEO matrix

tablets in ovens after compression. The parties

generally agree on two ways in which the AbuseDeterrent Patents depart from the prior art. First,

the prior art that used PEO (Bartholomaus and

McGinity) taught simultaneous compression and

45a

heating (D.I. 99 at 5; D.I. 106 at 7), while the prior art

that taught sequential compression and heating (the

Oven Art) used polymers other than PEO. (D.I. 99 at

10-11; D.I. 106 at 13). The parties disagree about

whether a POSA would have been motivated to make

PEO tablets with sequential compression and

heating, and whether there would have been a

reasonable expectation of success in doing so. Second,

no prior art used the same combinations of curing

time and temperature ranges as those disclosed in the

Abuse-Deterrent Patents. (D.I. 99 at 6; D.I. 106 at

13). The parties disagree about whether routine

experimentation by a POSA would have yielded the

times and temperatures disclosed in the patents.

I focus in turn on each difference between the

asserted claims and the prior art, though some of the

parties’ arguments are common to both.

1. Sequential Compression and Heating

The first gap between the Abuse-Deterrent

Patents and the prior art can be bridged by combining

the PEO tablets of Bartholomaus and McGinity with

the heating techniques taught in the Oven Art. With

all elements of the claim present in the prior art, “[a]

party seeking to invalidate a patent on the basis of

obviousness must ‘demonstrate by clear and

convincing evidence that a skilled artisan would have

been motivated to combine the teachings of the prior

art references to achieve the claimed invention, and

that the skilled artisan would have had a reasonable

expectation of success in doing so.’” Kinetic Concepts,

Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360

(Fed. Cir. 2012) (quoting Procter & Gamble Co. v.

Teva Pharm. USA, Inc., 566 F.3d 989, 1014 (Fed. Cir.

2009)).

46a

a. Motivation to Combine

In arguing for a POSA’s motivation to combine the

prior art, Defendant asserts that a POSA would look

to Bartholomaus and McGinity in the first place

because abuse by crushing was a known problem.

(D.I. 99 at 7-8). A POSA would then seek to modify

Bartholomaus and McGinity because the processes

disclosed in those references would not have been

suitable for large-scale production. (Id. at 13). For

example, Defendant’s expert, Dr. Leah Appel,

testified that the Bartholomaus method applies heat

by placing a tablet press in a heated chamber, but

scaling this to produce many tablets at once would

require a large space heated to a high temperature—

and it is unclear how one would operate a tablet press

in those conditions. (Tr. at 226:1-18). Dr. Appel also

testified that the hot melt extruders used in McGinity

were “niche” at the time of invention—they were

available at some facilities, but access to one was not

a given. (Id. at 219:3-13). Researchers might have to

contract with other companies in order to use one.

(Id. at 258:8-16). Dr. Appel testified that ovens, by

contrast, were a common and readily accessible tool

for heating tablets. (Id. at 219:14-19). Defendant

argues that a POSA would therefore naturally turn to

ovens in either scaling up Bartholomaus or adapting

McGinity to more commonly available equipment.

The Oven Art would have provided guidance for a

POSA on how to cure matrix tablets in an oven,

leading to the claimed invention.2

Plaintiffs respond with several critiques of Dr.

Appel’s analysis. First, Plaintiffs argue that a POSA

Defendant also argues—in a footnote—for collateral

estoppel on the factual issue of whether simultaneous and

47a

presented with Bartholomaus and McGinity would

not have a motivation to modify those references,

because each of those references discloses an effective

crush-resistant tablet. (D.I. 106 at 10). As to

McGinity, Plaintiffs also challenge the idea that hotmelt extruders were niche, arguing that they were

available at certain facilities that could be contracted

with. (Id. at 8). Second, Plaintiffs assert that even if

a POSA sought to modify Bartholomaus and

McGinity, the POSA would not have a motivation to

combine Bartholomaus and McGinity with the Oven

Art in particular, because the Oven Art did not use

PEO and did not teach heating matrix tablets to their

polymers’ melting points. (Id. at 13). Third, Plaintiffs

argue that a POSA would never have looked to

Bartholomaus and McGinity in the first place and

would instead have sought to add an antagonist. (Id.

at 15). Plaintiffs’ expert, Dr. Bley, testified that the

prior art reference Mansbach “teaches that

antagonists are the way to go and particularly for

opioid analgesics . . . if there’s an antagonist

available, that’s the preferred path.” (Tr. at 425:23sequential heating and compression are equivalent. (D.I. 99 at

14 n.7). In prior litigation, Plaintiffs successfully argued that a

sequential heating process infringed, under the doctrine of

equivalents, a patent that disclosed simultaneous heating. See

In re Oxycontin Antitrust Litig., 994 F. Supp. 2d 367, 419

(S.D.N.Y. 2014). Plaintiffs respond that this case involved

different patents and products. (D.I. 106 at 9). The application

of collateral estoppel here was barely briefed. I think it is

extremely unlikely that collateral estoppel applies. Whether or

not it does, I do not think a factual determination that

simultaneous and sequential processes are equivalent is

necessary for a finding of obviousness. Therefore, I do not

address the application of collateral estoppel and disregard the

factual findings that Defendant offers in footnotes.

48a

25; PTX-131 at S19). Dr. Bley also testified that he

himself, as a POSA in the field at the relevant time,

did not pursue crush resistant tablets, characterizing

Dr. Appel’s analysis as “hindsight-driven.” (Id. at

398:16-399:14).3

On the first issue of whether a POSA would want

to modify Bartholomaus and McGinity, the parties

agree that the processes taught by those references

successfully produced hardened tablets. (D.I. 99 at

11; D.I. 106 at 10). They disagree on how this success

relates to the Abuse-Deterrent Patents. Defendant

argues that the processes’ viability would make them

a good starting point for a POSA trying to develop

hardened tablets, while Plaintiffs contend that the

successful processes would be a POSA’s ending point.

Plaintiffs’ position fails to address the crux of

Defendant’s argument. Defendant is arguing that

while the processes were successful for “one-off

tablets” (Tr. at 228:20-229:7), a POSA would have

sought a process that could be scaled up. Plaintiffs do

not make a plausible argument that a POSA would

not want to develop a scalable process. Plaintiffs also

do not make a plausible argument that a POSA would

have options other than modifying Bartholomaus and

McGinity if they wanted to produce hardened tablets

at scale.4 I also do not think the option to contract

Plaintiffs also argue, in a single paragraph, that the

problem of crushable tablets is not a sufficient “known problem”

to support a motivation to modify the prior art. (D.I. 106 at 17).

I do not think this is the case, and the briefing on this argument

was so summary that I will not address it further.

I note that the question of a POSA’s options for

producing hardened tablets at scale is distinct from the issue of

whether a POSA would want to pursue hardened tablets at all,

which I discuss below.

49a

with third-party research or manufacturing

facilities—in the case of McGinity’s hot-melt

extruders—would negate the motivation to adapt the

method to ovens.

A POSA’s “[m]otivation to combine may be found

in many different places and forms.” Par Pharm., Inc.

v. TWI Pharms., Inc., 773 F.3d 1186, 1197 (Fed. Cir.

2014) (quoting Allergan, Inc. v. Sandoz, Inc., 726 F.3d

1286, 1292 (Fed. Cir. 2013)). “[I]t often may be the

case that market demand, rather than scientific

literature, will drive design trends.” KSR, 550 U.S. at

419, 127 S.Ct. 1727. I think that a desire to

manufacture hardened tablets at scale and with

minimal switching costs is a motivation to modify the

prior art. Finding otherwise would run the risk of

“[g]ranting patent protection to advances that would

occur in the ordinary course without real innovation,”

which KSR cautioned against. Id. Therefore, while it

is true that Bartholomaus and McGinity’s processes

resulted in hardened tablets, I find that a POSA

would not stop at their teachings.

Plaintiffs also contend regarding the motivation to

modify Bartholomaus and McGinity that “the claims

are not limited to commercial manufacturing.” (D.I.

106 at 8). However, it is not necessary for commercial

manufacturing to be claimed for it to serve as a

motivation to combine. In Alcon Research Ltd. v.

Apotex, Inc., the Federal Circuit found that known

“antihistaminic efficacy” would be a valid motivation

to combine certain allergy treatment prior art

references. 687 F.3d 1362, 1368-69 (Fed. Cir. 2012).

However, the patent at issue claimed the treatment

for its ability to “stabiliz[e] conjunctival mast cells”—

a different allergy treatment mechanism. Id. at 136364. I also note that whether the inventors of the

50a

Abuse-Deterrent Patents themselves were motivated

a desire to produce at a commercial scale is

immaterial. The Federal Circuit has “repeatedly held

that the motivation to modify a prior art reference to

arrive at the claimed invention need not be the same

motivation that the patentee had.” Id. at 1368.

Overall, I find that Defendant presented clear and

convincing evidence of a POSA’s motivation to modify

Bartholomaus and McGinity. I am convinced by Dr.

Appel’s testimony that a POSA would seek a

commercially viable process for producing hardened

tablets.

Second, Plaintiffs argue that even with a

motivation to modify Bartholomaus and McGinity, a

POSA would not combine them with the Oven Art in

particular. I find that Dr. Appel presented clear and

convincing testimony that ovens were commonly

available and used to heat tablets. Plaintiffs’

witnesses did not provide any testimony to the

contrary. Plaintiffs did not attempt to show, for

example, that a POSA would not have access to ovens,

or that other equipment would be a more natural

choice than ovens for heating tablets.

I do not think Defendant’s theory of obviousness is

hampered by the fact that ovens had only been used

to heat polymers other than PEO. The Oven Art

taught the use of ovens to heat matrix tablets made

from several different polymers. (DTX-011 at 0001;

DTX-012 at 0002; DTX-014 at 0001).

Shao

specifically taught that the heat curing made its

tablets harder. (DTX-011 at 0005). It is not much of

a leap to infer that ovens would also be useful for

applying heat to harden the matrix tablets disclosed

by Bartholomaus and McGinity. At the very least, in

the absence of testimony about other heating tools,

51a

employing a commonly available tool to apply heat to

tablets is obvious to try. See KSR, 550 U.S. at 421,

127 S.Ct. 1727. While the Oven Art does not teach

heating tablets to their melting points, Bartholomaus

and McGinity both teach hardening PEO by heating

it to its melting point. (DTX-009 at 8:8-28; DTX-010

at [0117]). Dr. Appel credibly testified that a POSA

combining these references would seek the same

result in an oven. (Tr. at 233:6-13).

I turn to Plaintiffs’ third argument, that a POSA

would not be motivated to combine Bartholomaus and

McGinity with the Oven Art because adding an

antagonist would have been a more obvious path.

(D.I. 106 at 17). Plaintiffs offer evidence that

OxyContin had approved antagonists at the time of

the invention (Tr. at 419:8-420:8), and the prior art

explicitly taught using an antagonist for abuse

deterrence (Tr. at 417:25-419:5). Plaintiffs also offer

evidence that both Dr. Bley and Purdue itself first

pursued paths other than physical abuse deterrence.

(Tr. at 422:3-25, 304:18-305:4). However, a path does

not need to be the most obvious or preferred path in

order to be obvious. “[C]ase law does not require that

a particular combination must be the preferred, or the

most desirable, combination described in the prior art

in order to provide motivation for the current

invention.” In re Fulton, 391 F.3d 1195, 1200 (Fed.

Cir. 2004) (quoting In re Beattie, 974 F.2d 1309, 1311

(Fed. Cir. 1992)).

Dr. Bley’s testimony about his own research may

support the viability of the antagonist route, but it

does not undermine the viability of the hardness

route. Plaintiffs do not, as far as I can tell, argue that

the prior art taught away from hardened opioid

formulations for abuse deterrence—they simply

52a

argue that the prior art taught an alternative. I

likewise find that the Mansbach reference on which

Plaintiffs rely encourages the use of an antagonist,

but does not teach away from using physical abuse

deterrence. The passage that Dr. Bley discussed at

trial, (Tr. 425:3-25), says, “For drugs of abuse without

an approved antagonist, countermeasures against

physical tampering may represent the best means to

reduce the risk of oral or parenteral abuse.” (PTX-131

at S19). While this passage certainly suggests that a

POSA should pursue physical abuse deterrence for

drugs without an approved antagonist, it says

nothing about the inverse of that statement—that a

POSA should not use such methods for drugs with an

approved antagonist. Therefore, I do not find that the

prior art discourages physical abuse deterrence and I

am not persuaded by Plaintiffs’ third argument.

Overall, through Dr. Appel’s testimony, I find

Defendant has presented clear and convincing

evidence of a motivation to combine Bartholomaus

and McGinity with the Oven Art.

b. Reasonable Expectation of Success

Having found a motivation to combine the prior

art references, I consider whether a POSA would have

had a “reasonable expectation of success” in

“achiev[ing] the claimed invention.” Kinetic Concept,

688 F.3d at 1360. Defendant notes that a POSA

would need to balance opposing considerations in

arriving at the claimed invention, ensuring that the

PEO would harden, the active ingredient would not

degrade, and the method would be practical. (D.I. 99

at 17). Defendant asserts that a POSA would

reasonably expect there to be an optimal time and

temperature that balances these considerations,

53a

discoverable through routine experimentation.5 (Id.

at 16-17). In general support of its obviousness

argument, Defendant also notes that Bartholomaus

“teaches that its formulations can be made using

compression followed by heating.”

Id. at 10.

Specifically, Defendant points to passages of

Bartholomaus that refer to “subsequent exposure to

heat.”

(DTX-010 at [0065], [0067]).

In fact,

Bartholomaus notes, “In direct tableting with

subsequent exposure to heat, the formed tablets are

briefly heated at least to the softening temperature

. . . and cooled again.” (Id. at [0067]).

Plaintiffs argue that there could not have been a

reasonable expectation of success in arriving at the

claimed invention. Plaintiffs criticize Dr. Appel’s

testimony as conclusory (D.I. 106 at 18) and the

passages about subsequent exposure to heat from

Bartholomaus as “generic.” (Id. at 8-9). Plaintiffs

point to testimony by Dr. Richard Mannion, a named

inventor on each of the Abuse-Deterrent Patents, that

he had reasons to doubt that the method would work.

(Id. at 19). Specifically, Dr. Mannion testified that

heating the tablets without compression might cause

them to change shape or stick together. (Tr. at 320:118).6 Plaintiffs also note that Dr. Appel’s trial

his issue relates to both of the differences between the

claims and the prior art noted previously. I discuss whether the

experimentation would be routine when discussing the second

difference of time and temperature ranges. For the purposes of

reasonable expectation of success, I only ask whether a POSA

could reasonably expect to make hardened tablets by combining

Bartholomaus and McGinity at the claimed times and

temperatures.

6 Dr. Mannion also testified more generally about challenges

associated with PEO tablets, including achieving the same

54a

demonstrative does not suggest the same time and

temperature ranges disclosed in the patent. They

argue that this indicates that a POSA could not have

reasonably expected success. (D.I. 106 at 19-20).

“Obviousness

does

not

require

absolute

predictability of success . . . all that is required is a

reasonable expectation of success.” In re O’Farrell,

853 F.2d 894, 903-04 (Fed. Cir. 1988). I think there is

a reasonable expectation of success in producing a

hardened tablet from sequential compression and

then heating of PEO. I am persuaded by Dr. Appel’s

testimony that a POSA would understand that

applying heat to melt PEO would cause it to harden.

I think a POSA could reasonably expect similar

success by simply changing the heating tool.

I also find that Bartholomaus’s discussion of

subsequent exposure to heat contributes to a

reasonable expectation of success—a POSA would

expect, upon reading Bartholomaus, to be able to

achieve similar results with other heating methods.

The statement in Bartholomaus is generic, as

Plaintiffs contend, but I find it nevertheless sufficient

to support a POSA’s expectations. Plaintiffs argue

that the sentence in question “makes no sense”

because the phrase “cooled again” suggests some

undisclosed “prior heating step.” (D.I. 106 at 8).

extended release profile as original OxyContin (Tr. at 308:16-25)

and abuse by hot water extraction. (Tr. at 310:12-311:7). I do

not treat this testimony as part of the reasonable expectation of

success analysis because it does not relate to claimed aspects of

the invention. The patents do not claim a particular extended

release profile, nor do they claim tablets that cannot have their

contents extracted with hot water. I do address this testimony

as part of the secondary consideration of skepticism, infra pp.

305–06.

55a

I disagree. Just as one might say, “I threw a

boomerang, and it came back again,” having only

thrown the boomerang once, saying that tablets have

been “heated . . . and cooled again” seems to be a

commonplace, if somewhat vernacular, construction

in English.

I do not think that Dr. Mannion’s testimony about

his own expectations outweighs Dr. Appel’s testimony

about a POSA’s. It is possible that heating tablets

without simultaneously compressing them could

change their properties, causing some of the problems

Dr. Mannion listed. It is also possible that applying

heat with an oven rather than with the equipment

used by Bartholomaus or McGinity would simply no

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