Amicus Curiae Brief — Cellect, LLC, Petitioner v. Katherine K. Vidal, Under Secretary of Commerce for Intellectual Property and Director, United States Patent and Trademark Office

No. 23-1231

In the

Supreme Court of the United States

CELLECT, LLC,

Petitioner,

v.

KATHERINE K. VIDAL, UNDER SECRETARY OF

COMMERCE FOR INTELLECTUAL PROPERTY

AND DIRECTOR, UNITED STATES PATENT

AND TRADEMARK OFFICE,

Respondent.

On Petition for a Writ of Certiorari to the United

States Court of A ppeals for the Federal Circuit

BRIEF OF THE NEW YORK INTELLECTUAL

PROPERTY LAW ASSOCIATION AS AMICUS

CURIAE IN SUPPORT OF CERTIORARI

Robert J. Rando

Immediate Past President

New York Intellectual

Property Law Association

Greenspoon Marder LLP

1345 Avenue of the Americas,

Suite 2200

New York, NY 10105

Jeffrey I. D. Lewis

Counsel of Record

Lucas Watkins

David Surry

Foley Hoag LLP

1301 Avenue of the Americas,

Suite 2500

New York, NY 10019

(212) 812-0400

jidlewis@foleyhoag.com

Counsel for New York Intellectual Property Law Association

30164

A

(800) 274-3321 • (800) 359-6859

Paul Coletti

Johnson & Johnson

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

Charles R. Macedo

Gary J. Gershik

David Goldberg

A mster, Rothstein

& Ebenstein LLP

405 Lexington Avenue,

48th Floor

New York, NY 10174

Brittany J. Saunders

Foley Hoag LLP

Seaport West

155 Seaport Boulevard

Boston, MA 02210

Counsel for New York Intellectual Property Law Association

i

QUESTIONS PRESENTED

1. Can the judicially created obviousness-type

double patenting (“ODP”) doctrine vitiate Congressional

guarantees of timely patent examination—as set out in the

Patent Term Adjustment provisions of 35 U.S.C. §154(b)

(“PTA”)—thereby allowing the U.S. Patent & Trademark

Office (“PTO”) and courts to use those guarantees to

invalidate patents solely based upon the mandatory PTA?

2. Did a panel decision of the U.S. Court of Appeals for

the Federal Circuit (“Federal Circuit”) err when it created

a rigid rule, eliminating all equitable considerations

from the judicially created ODP analysis, disregarding

the reasons for ODP’s creation, and ignoring binding

precedent?

3. Was the judicially created ODP doctrine, established

at a time when a patent’s term was measured from

patent issuance, abrogated when Congress changed how

patent term is measured such that all patents sharing

a common priority application expire on the same day

unless a Congressionally mandated extension applies,

such as where those patents expire on different days

solely because the PTO was required to award PTA due

to PTO’s delays in violation of statutory guarantees for

prompt examination?

ii

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED . . . . . . . . . . . . . . . . . . . . . . . i

TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . ii

TABLE OF CITED AUTHORITIES . . . . . . . . . . . . . . iii

I.

INTEREST OF THE AMICUS CURIAE . . . . . . 1

II. SUMMARY OF ARGUMENT . . . . . . . . . . . . . . . . 2

III. ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

A. The Federal Circuit Usurped Congress’s

Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

B. ODP’s Origins . . . . . . . . . . . . . . . . . . . . . . . . 8

C. The Federal Circuit’s Cellect Decision

Rejected ODP’s Equities . . . . . . . . . . . . . . . 11

D. The Federal Circuit Improperly

Abrogated Congress’s Guarantees . . . . . . 13

E. ODP Is Not Necessary Post-URAA . . . . . 15

F.

Cellect Significantly Adversely Impacts

Innovation . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

IV. CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

iii

TABLE OF CITED AUTHORITIES

Page

Cases

Abbott Labs. v. Lupin Ltd.,

2011 U.S. Dist. LEXIS 53846 (D. Del. 2011) . . . . . . 12

Abbvie Inc. v.

Mathilda & Terence Kennedy Inst.,

764 F.3d 1366 (Fed. Cir. 2014) . . . . . . . . . . . . 16, 18, 19

ACADIA Pharm. Inc. v.

Aurobindo Pharma Ltd.,

2023 U.S. Dist. LEXIS 221663 (D. Del. 2023) . . . . . 17

Allergan USA, Inc. v. MSN Labs. Priv. Ltd.,

2023 U.S. Dist. LEXIS 172641 (D. Del.

Sept. 27, 2023) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7, 13

Barbed Wire Patent case,

143 U.S. 275 (1892) . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Barrett v. Hall,

2 F. Cas. 914 (C.C.D. Mass. 1818) . . . . . . . . . . . . . . . . 9

Bate Refrigerating Co. v. Sulzberger,

157 U.S. 1 (1895) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

In re Berg,

140 F.3d 1428 (Fed. Cir. 1998) . . . . . . . . . . . . . . . 11, 12

In re Borah,

354 F.2d 1009 (CCPA 1966) . . . . . . . . . . . . . . . . . . . . 13

iv

Cited Authorities

Page

In re Braat,

937 F.2d 589 (Fed. Cir. 1991) . . . . . . . . . . . . . . . . . . 17

In re Cellect,

81 F.4th 1216 (Fed. Cir. 2023) . . . . . . . . . 3, 4, 5, 6, 7, 8,

13, 14, 17, 20, 21, 22

De Forest Radio Co. v. General Elect. Co.,

283 U.S. 664 (1931) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Eldred v. Ashcroft,

537 U.S. 186 (2003) . . . . . . . . . . . . . . . . . . . . . . . . . 8, 15

Elec. Storage Battery Co. v. Shimadzu,

307 U.S. 5 (1939) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

In re Fallaux,

564 F.3d 1313 (Fed. Cir. 2009) . . . . . . . . . . . . . . . 16, 21

Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co.,

535 U.S. 722 (2002) . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Gilead Sciences, Inc. v. Natco Pharma Ltd.,

753 F.3d 1208 (Fed. Cir. 2014) . . . . . . . . . . . . . . . 11, 18

Graham v. John Deere Co.,

383 U.S. 1 (1966) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Henry Schein, Inc. v. Archer & White Sales, Inc.,

586 U.S. --, 139 S. Ct. 524 (2019) . . . . . . . . . . . . . . . . 15

v

Cited Authorities

Page

In re Hubbell,

709 F.3d 1140 (Fed. Cir. 2013) . . . . . . . . . . . . . . . . . . 21

Immunex Corp. v. Sandoz Inc.,

964 F.3d 1049 (Fed. Cir. 2020) . . . . . . . . . . . . . . . . . . 11

KSR Int’l. Co. v. Teleflex Inc.,

550 U.S. 398 (2007) . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

McCreary v. Penn. Canal Co.,

141 U.S. 459 (1891) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Milcor Steel Co. v. George A. Fuller Co.,

316 U.S. 143 (1942) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Miller v. Eagle Mfg. Co.,

151 U.S. 186 (1894) . . . . . . . . . . . . . . . . . . . . . . . 8, 9, 10

Murphy v. NCAA,

584 U.S. 453 (2018) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Novartis AG v. Ezra Ventures LLC,

909 F.3d 1367 (Fed. Cir. 2018) . . . . . . . . . . . . . 6, 11, 17

Novartis Pharms. Co. v.

Breckenridge Pharm. Inc.,

909 F.3d 1355 (Fed. Cir. 2018) . . . . . . . . . . 7, 12, 16, 18

Odiorne v. Amesbury Nail Factory,

18 F. Cas. 578 (1819) . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

vi

Cited Authorities

Page

Personalized Media Comm., LLC v. Apple Inc.,

57 F.4th 1346 (2023) . . . . . . . . . . . . . . . . . . . . . . . . . . 19

R.R. Ret. Bd. v. Alton R.R.,

295 U.S. 330 (1935) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

In re Schneller,

397 F.2d 350 (CCPA 1968) . . . . . . . . . . . . . . . 11, 12, 17

South Corp. v. U.S.,

690 F.2d 1368 (Fed. Cir. 1982) (en banc) . . . . . . . . . 12

In re Stanley,

214 F.2d 151 (C.C.P.A. 1954) . . . . . . . . . . . . . . . . . . . 12

Suffolk v. Hayden,

70 U.S. (3 Wall) 315 (1865) . . . . . . . . . . . . . . . . . . . . . 17

Supernus Pharm., Inc. v. Iancu,

913 F.3d 1351 (Fed. Cir. 2019) . . . . . . . . . . . . . . . . 7, 14

Thomson-Houston Elec. Co. v. Ohio Brass Co.,

80 F. 712 (6th Cir. 1897) . . . . . . . . . . . . . . . . . . . . . . . 14

U.S. v. Rutherford,

442 U.S. 544 (1979) . . . . . . . . . . . . . . . . . . . . . . . . 14, 15

Wyeth v. Kappos,

591 F.3d 1364 (Fed. Cir. 2010) . . . . . . . . . . . . . . 5, 7, 14

vii

Cited Authorities

Page

In re Zickendraht,

319 F.2d 225 (CCPA 1963) . . . . . . . . . . . . . . . . . . . 9, 11

Constitution & Statutes

U.S. Const. A rt. I, §8, Cl. 8 . . . . . . . . . . . . . . . . . . . . 8, 20

35 U.S.C. § 101 . . . . . . . . . . . . . . . . . . . . . . 9, 10, 11, 12, 17

35 U.S.C. § 121 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 16

35 U.S.C. § 154 . . . . . . . . . . . . . . . . . . . . . . . . . 3, 4, 6, 7, 14

35 U.S.C. § 156 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Pub. L. 106-113 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Uruguay Round Agreements Act, P.L. 103-465

(“URAA”) . . . . . . . . . . . . . 5, 8, 12, 13, 15, 16, 17, 18, 19

Legislative, Administrative and Executive Materials

H.R. Rep. No. 106-287, Part 1 (1999) . . . . . . . . . . . 4, 7, 14

Manual of Patent Examining Procedure § 1490 . . . . . 12

Manual of Patent Examining Procedure §§ 2731-2734 . . . 7

Sup. Ct. R. 10(a) & (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

viii

Cited Authorities

Page

Sup. Ct. R. 37.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Notice of Proposed Rulemaking, Terminal

Disclaimer Practice To Obviate Nonstatutory

Double Patenting, 89 Fed. Reg. 40439-49

(May 10, 2024) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Other Authorities

A. Hamilton, The Federalist Papers, No. 78, The

Judiciary Department . . . . . . . . . . . . . . . . . . . . . . . . 15

A. Hamilton, The Federalist Papers, No. 81, The

Judiciary Continued, and the Distribution of

Judicial Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Bullinger, Double Patenting and the 1952 Act, 10

Pat. Trademark & Copy. J. Res. & Ed. 389

(1967) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17, 19

Crouch, Patent Term Adjustment (PTA) Statistics,

Patently’O (July 27, 2021), www.patentlyo.com/

patent/2011/07/pta.html . . . . . . . . . . . . . . . . . . . . . . . . 2

Crouch, Prosecution Delays and Patent Term

Adjustment on the Rise Again, Patently ’O

( Novemb er 13 , 2 0 2 2), w w w.pat ent lyo.

com /patent /2 022 /11/prosecution- delaysadjustment.html . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Crouch, Terminal Disclaimers: A Growing Concern

in Patent Practice, Patently’O (May 10, 2024),

ix

Cited Authorities

Page

https://patentlyo.com/patent/2024/05/terminaldisclaimers-practice.html . . . . . . . . . . . . . . . . . . . . . 3-4

Kazhdan, Obviousness-Type Double Patenting:

Why It Exists And When It Applies, 53 Akron L.

Rev. 1017 (2019) . . . . . . . . . . . . . . . . . . . . . . 4, 16, 18, 19

Lew is, Cur ing Double Patenting Dur ing

Prosecution and After Issuance: When Once

is Never Enough and Twice is Too Much, 21

AIPLA Q.J. 34 (1993) . . . . . . . . . . . . . . . . . . . . 9, 11, 12

USP T O, Pa t e n t E x a mi n a t i o n R e s e a r c h

Dataset (PatEx), www.uspto.gov/ip-policy/

economic-research/research-datasets/patentexamination-research-dataset-public-pair

(last visited March 22, 2024) . . . . . . . . . . . . . . . . . . . . 2

Walterscheid, Historical Development of the Law

of Double Patenting Up Through The 1952 Act,

4 APLA Q.J. 243 (1975) . . . . . . . . . . . . . . . . . . 9, 10, 17

1

I. INTEREST OF THE AMICUS CURIAE1

The New York Intellectual Property Law Association

(“NYIPLA”) is a preeminent, regional bar association of

attorneys who practice in the area of intellectual property

(“IP”) law, such as patent law. Its members include both

in-house and private practice attorneys, who represent IP

owners and their adversaries, inventors, entrepreneurs,

businesses, universities, and industry/trade associations.

Members participate in patent prosecution, licensing, and

litigation on behalf of applicants, challengers, licensors,

and licensees. NYIPLA therefore brings the well-rounded

perspective of stakeholders in the present issues.

NYIPLA believes the Court should grant the Petition

for Certiorari because of the extreme importance of the

issues presented. NYIPLA takes no position, however,

on the underlying merits and has no view on whether the

patents-at-issue are or are not otherwise valid.

1. This brief is filed more than 10 days before its due date,

in compliance with Sup. Ct. R. 37.2.

NYIPLA’s identified counsel authored this brief; no party or

party’s counsel authored any part. Only NYIPLA, its members,

and its counsel funded preparing or submitting this brief. These

arguments were approved by an absolute majority of NYIPLA’s

officers and Board (including any who did not vote and recusals),

but do not necessarily reflect the views of a majority of the

NYIPLA’s members or their firms/employers. After reasonable

investigation, NYIPLA believes that no NYIPLA officer, director,

or member who voted in favor of filing this brief, nor any attorney

associated with them in any firm or corporate department,

represents a party in this litigation.

2

II. SUMMARY OF ARGUMENT

This case is about PTA and ODP. Half of all US

patents receive PTA, 2 making this a very important

matter for the innovation and patent community.

2. Based upon full year data for all patents issued 201622 and 2023 through mid-June, according to the PTO’s Patent

Examination Research Dataset (PatEx) | USPTO. www.uspto.

gov/ip-policy/economic-research/research-datasets/patentexamination-research-dataset-public-pair:

Year

Total

Patents

Patents

with PTA

Share

with PTA

Average

PTA

(days)

2016

333,582

176,673

53%

373

2017

351,403

168,708

48%

346

2018

339,992

158,827

47%

309

2019

391,097

186,543

48%

287

2020

388,847

181,834

47%

262

2021

362,029

168,471

47%

245

2022

358,661

186,665

52%

271

2023*

144,054

77,358

54%

297

2,669,665

1,305,079

49%

299

Total:

Overall

Average:

PTO data from 2005 to 2022 shows that the PTO had to

award PTA to between about 48% and 84% of utility patents each

year (only utility patents are reported), and that the average

PTA ranged from 6.5 months to 22 months. www.patentlyo.com/

patent/2022/11/prosecution-delays-adjustment.html; see www.

patentlyo.com/patent/2011/07/pta.html (data for 2005-11).

3

In In re Cellect, the Federal Circuit (and PTO) ran

roughshod over statutory guarantees requiring that the

PTO timely examine patent applications or extend the

resulting patent’s life for the undue delays. To do so,

Cellect ignored binding precedent; misapplied an equitable

doctrine as a rigid, strict liability standard; and explicitly

stated that equities do not matter.

It has been almost a century since the Court

substantively addressed double patenting, 3 and in

the interim Congress has significantly amended the

Patent Code at least five times. Accordingly, NYIPLA

respectfully urges the Court to grant the Petition for

Certiorari to consider double patenting for the following

reasons:

1. Cellect’s Widespread Impact. The PTO unduly

delayed about half of all US patents, by about 10 months

on average (note 2 above), meaning it was statutorily

required to award PTA (35 U.S.C. §154) for those patents.

Many of these patents are part of a multi-patent family,

i.e., they share a common priority application, so they

now risk invalidity at no fault of the patentee because

of the PTO’s undue delays, unless the Petition for

Certiorari is granted and the Court cures the situation.

In 2023 the number of patents issuing with a terminal

disclaimer—a surrender of rights that can obviate ODP

(see §III.C below)—increased significantly. patentlyo.

3. De Forest Radio Co. v. General Elect. Co., 283 U.S. 664

(1931); but see Milcor Steel Co. v. George A. Fuller Co., 316 U.S.

143 (1942) (which addressed disclaimers but arguably double

patenting); and Elec. Storage Battery Co. v. Shimadzu, 307 U.S.

5, 21 (1939) (stating “no double patenting involved” where “both

expired on the same day” so “no extension of the monopoly…”).

4

com/patent/2024/05/terminal-disclaimers-practice.html

(for 2023 “almost 60,000 utility patents were bound by a

terminal disclaimer.”). This shows Cellect’s impact.

NYIPLA believes the Federal Circuit’s Cellect

decision destroys “patent term guarantee[s]” that

Congress enacted to ensure prompt PTO examination, so

patentees get a full patent term.4 Given its importance

and widespread impact, this is an urgent issue for the

Court to consider.

4. The House Report for the 1999 American Inventors

Protection Act (Pub. L. 106-113) on §154 explains that PTA ensures

at least 17 years of exclusivity (premised upon up to 3 years for PTO

examination):

“Title III--Patent Term Guarantee

… Title III amends the provisions in the Patent

Act that compensate patent applicants for certain

reductions in patent term that are not the fault of

the applicant. … [Title III] adds a new provision

to compensate applicants fully for PTO-caused

administrative delays, and, for good measure,

includes a new provision guaranteeing diligent

applicants at least a 17-year term by extending the

term of any patent not granted within three years of

filing. Thus, no patent applicant diligently seeking to

obtain a patent will receive a term of less than the

17 years … . Only those who purposely manipulate

the system to delay the issuance of their patents

will be penalized under Title III, a result that the

Committee believes entirely appropriate.”

H.R. Rep. No. 106-287, pt. 1 (1999) (emphasis added); see Kazhdan,

Obviousness-Type Double Patenting: Why It Exists And When

It Applies, 53 Akron L. Rev. 1017 (2019) (“ODP Why/When”), at

1020-21 (explaining PTA gives “the same term-[of] 17 years …

as before.”).

5

2. Cellect Negates Congress’s Guarantees. The

Uruguay Round Agreements Act (“URAA”), P.L. 103-465,

set a patent’s term as 20 years from first application, so

undue PTO delays shorten the period a patent protects

the invention. Congress therefore created PTA to

“compensate[] patentees for PTO-caused delays during

prosecution,” ensuring patentees receive “a full patent

term adjustment for any delay during prosecution

caused by the PTO.” Wyeth v. Kappos, 591 F.3d 1364,

1366 (Fed. Cir. 2010) (emphasis added). Cellect not only

makes those guarantees worthless; it makes PTA a risk

to patent validity.

3. Cellect Improperly Ignores the Equities. ODP is

a judge-made, equitable doctrine addressing patentee

“gamesmanship.” Cellect, however, ignores precedent by

rejecting all equities and applying ODP as a strict legal

doctrine.

4. It is Time to Retire ODP. Cellect highlights why

ODP has outlived its usefulness; post-URAA, it is a

solution in search of a problem. Cellect applied ODP to

patents in the same family that have different expiration

dates only because of PTO’s delays and mandatory PTA.

This (i) significantly, adversely impacts innovation,

particularly for smaller and less-well funded entities;

(ii) upsets the patent system; and (iii) undermines longestablished expectations of patent owners and licensees.

***

Accordingly, the Petition presents questions of

exceptional importance. NYIPLA urges the Court grant

certiorari.

6

III. ARGUMENT

In Cellect, the Federal Circuit affirmed the PTO’s

Patent Trial and Appeal Board (“PTAB”) invalidating

commonly-owned patent family members under ODP

because some patents had received different PTA than

other patent-family members, since the PTO delayed

some more than others. ODP, it said, must be analyzed

“based on the expiration date of the patent after PTA

has been added,” not before, regardless of why PTA was

awarded. In re Cellect, 81 F.4th 1216, 1220 (Fed. Cir.

2023) (emphasis added). That decision misapplies ODP

and negates Congress’s “Patent Term Guarantee.” See

note 4 above.

This differs from the Federal Circuit’s treatment

of another Congressional guarantee adding patent

term. In Novartis AG v. Ezra Ventures LLC, 909 F.3d

1367 (Fed. Cir. 2018) (“Novartis-Ezra”), it considered

Patent Term Extension (“PTE”) under 35 U.S.C. §156,

a Congressional guarantee compensating for time taken

for the Food & Drug Administration (“FDA”) review

process. Novartis-Ezra equitably found PTE does not

result from gamesmanship, correctly holding that ODP

is analyzed based on the patent expiration before PTE.

Here, however, Cellect explicitly ignored gamesmanship/

equities, treating PTA’s impact on ODP differently, based

upon statute wording subtleties. 81 F.4th at 1226; cf. 35

U.S.C. §156(a) (PTE statute cross-referencing §154 PTA).

In doing so, the Federal Circuit rejected ODP’s

historical, equitable roots when patent term was

measured from a patent’s issue date and ODP was needed

to prevent applicant “gamesmanship” to unduly extend

7

patents. Novartis Pharm. Co. v. Breckenridge Pharm.

Inc., 909 F.3d 1355, 1362 (Fed. Cir. 2018) (“NovartisBreckenridge”); see id. at 1364 (ODP inapplicable when

expirations differ due to “intervening change in patent

term law,” not “gamesmanship”). Congress recognized

this in its PTA “Patent Term Guarantee,” noting “those

who purposely manipulate the system to delay the

issuance of their patents” are not entitled to a full patent

term. H.R. Rep. No. 106-287, pt. 1 (1999) (fuller quote

in note 4 above). PTA is only awarded for PTO-caused

delays exceeding applicant-caused delays. 5 Accordingly,

PTA was designed to nullify attempted gamesmanship.

Cellect, however, rejected equitable considerations,

stating “good faith during prosecution does not entitle

[an applicant] to a patent term to which it otherwise is not

entitled” (81 F.4th at 1230), disregarding that Congress

decided applicants were entitled to PTA based upon the

PTO’s undue delays that caused patent-term loss. This

fundamental change had an immediate effect; as one

decision summarized it: “Cellect … [held] ODP depends

solely on patent expiration dates and should not [be]

influenced by equitable concerns.” Allergan USA, Inc.

v. MSN Labs. Priv. Ltd., 2023 U.S. Dist. LEXIS 172641,

at *58-61 (D. Del. Sept. 27, 2023) (emphasis added).

5. 35 U.S.C. §154(b)(2)(C) (PTA “reduced” for applicant

delays, such as when “the applicant failed to engage in reasonable

efforts to conclude prosecution of the application.”); Wyeth, 591

F.3d at 1367 (summarizing PTA grounds); see Supernus Pharm.,

Inc. v. Iancu, 913 F.3d 1351, 1353 (Fed. Cir. 2019) (PTA is for PTO

delays reduced by applicant-caused delays); see also Manual of

Patent Examining Procedures (“MPEP”) §§2731-2734 (how PTO

calculates PTA).

8

A.

The Federal Circuit Usurped Congress’s

Authority

The Constitution assigns Congress the power to set

patent and copyright term. U.S. Const. A rt. I, §8, Cl.

8 (“[The Congress shall have Power ...] To promote the

Progress of Science and useful Arts, by securing for

limited Times to Authors and Inventors the exclusive

Right to their respective Writings and Discoveries.”). As

this Court has made clear, “Congress [is empowered] to

prescribe ‘limited Times’,” which “is a rational exercise

of the legislative authority conferred by [Art. I, §8, Cl.

8]. On this point, the Court defers substantially to

Congress.” Eldred v. Ashcroft, 537 U.S. 186, 199 (2003)

(emphasis added, citation omitted) (copyright term); Bate

Refrigerating Co. v. Sulzberger, 157 U.S. 1, 43 (“It is the

province of the legislative branch of the government to

say when a patent to an inventor shall expire, …”). This

“judicial deference” to Congress is “but a corollary to

the grant to Congress of any Article I power.” Eldred,

537 U.S. at 192 (citing Graham v. John Deere Co., 383

U.S. 1, 6 (1966)). The Cellect decision, however, defies

Congressional legislative authority and it fails to show

any deference to Congress’ intent, demonstrating why

certiorari should be granted.

B. ODP’s Origins

The history of ODP is tied to how Congress set

patent term prior to the URAA. Commentators often

associate the Court’s double patenting jurisprudence

to Miller v. Eagle Mfg. Co., 151 U.S. 186, 198 (1894),

although other decisions date from the mid-19 th Century.6

6. Justice Story arguably set the stage earlier when riding

the circuit in 1819, at a time that patent applications were not

9

See Walterscheid, Historical Development of the Law of

Double Patenting Up Through The 1952 Act, 4 APLA

Q.J. 243 (1975) (“Historical Development”), at 249 (“… no

other opinion has been so influential in the law of double

patenting”).7 Miller, which the Court heard in equity,

considered two patentably distinct cultivators with lifting

springs: an 1881 lifting spring patent and an 1879 patent

that required the spring be both lifting and depressing.

See id. at 250. In doing so, the Court summarized its

substantively examined. See Odiorne v. Amesbury Nail Factory,

18 F. Cas. 578, 579 (1819) (“It cannot be, that a patentee can have in

use at the same time two valid patents for the same invention … I

hold it to be the necessary conclusion of law, that the inventor can

have but a single valid patent for his invention …”); see Barrett

v. Hall, 2 F. Cas. 914, 924 (C.C.D. Mass. 1818) (Story, J.) (accord).

7. Nonetheless, many trace ODP’s specific origins to Judge

Giles Rich’s concurrence in In re Zickendraht, 319 F.2d 225 (CCPA

1963). While the Zickendraht majority found double patenting,

stating there was one invention (i.e., §101 “same invention” double

patenting (“§101 DP”)), Judge Rich said there were two inventions

and the second also should be unpatentable for double patenting.

Where there are in fact two inventions, … [§101] would

seem to be inapplicable and the second patent has

to be denied … on some other ground. … But since

the patented invention is not prior art, the basis for

denial is not a statutory basis; rather it is a caselaw

development.

319 F.2d at 231 n.4 (emphasis added); see id. at 233 (Smith, J.

joining in the concurrence); see also Lewis, Curing Double

Patenting During Prosecution and After Issuance: When Once

is Never Enough and Twice is Too Much, 21 AIPLA Q.J. 34 (1993)

(“Curing DP”), at 36 (double patenting applies even if reference

not prior art).

10

prior decisions, 8 which seemingly focused on what became

known as same invention §101 DP but extended that

doctrine to cover the patentably distinct springs:

that no patent can issue for an invention actually

covered by a former patent, especially to the

same patentee, although the terms of the claims

may differ; that the second patent, although

containing a broader claim, more generical in

its character than the specific claims contained

in the prior patent, is also void; but that where

the second patent covers matter described

in the prior patent, essentially distinct and

separable from the invention covered thereby

and claims made thereunder, its validity may

be sustained.

Miller, 151 U.S. at 198. Thus, Miller “made clear that

a mere distinction—without more—in the breadth or

scope of the claims of the patents would not avoid double

patenting.” Historical Development at 251.

8. For instance, Miller quoted McCreary v. Penn. Canal Co.,

141 U.S. 459, 467 (1891), as deciding:

that where a party owned two patents, showing

substantially the same improvement, the second was

void, the court saying: “It is true that the combination

of the earlier patent in this case is substantially

contained in the later. If it be identical with it, or only

a colorable variation from it, the second patent would

be void, as a patentee cannot take two patents for the

same invention.”

151 U.S. at 197-98.

11

As the law evolved, double patenting separated into

two doctrines as Judge Rich’s Zickendraht concurrence

(note 7 above) suggested: (i) same invention §101 DP, a

statutory prohibition preventing patents to the same

patentee claiming “identical” inventions under 35 U.S.C.

§101; and (ii) ODP, a judicial doctrine preventing patents

for “colorable variations” to the same patentee. In re

Berg, 140 F.3d 1428, 1431 (Fed. Cir. 1998); see Curing DP

35-36 (“‘double patenting’ … encompasses two different

invalidity doctrines … intended to prevent the extension

of a patent monopoly beyond the statutory limit ….”).

Congress also created a safe harbor in 35 U.S.C. §121

where ODP is not applicable if multiple patents issued

from a common priority application because of a PTO

“requirement for restriction.” Id. at 37-38 & nn.14-15.

C.

The Federal Circuit’s Cellect Decision Rejected

ODP’s Equities

While courts have found §101 DP rooted in statute,

ODP is not – it is intended to equitably prevent “improper”

patent term extensions.9 As such, potential ODP invalidity

usually can be cured by a “terminal disclaimer” – which

(i) disclaims, or dedicates to the public, the end portion

of the later-expiring patent’s life that extends beyond

that of the earlier-expiring patent; and (ii) also requires

the patents to have common ownership in order to be

9. See Immunex Corp. v. Sandoz Inc., 964 F.3d 1049,

1059 (Fed. Cir. 2020) (describing it as an “equitable doctrine”);

Novartis-Ezra, 909 F.3d at 1374-75 (accord); Gilead Sciences,

Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1215 (Fed. Cir. 2014)

(accord); In re Schneller, 397 F.2d 350, 354 (CCPA 1968) (prevent

“unjustified timewise extension of the right to exclude”); see also

Curing DP at 36.

12

enforceable. Id. at 41-44 (it is known as a terminal

disclaimer “because the end portion of the patent’s life is

disclaimed”); see MPEP §1490 (discussing statutory and

regulatory terminal disclaimer provisions).10

ODP was created to prevent a patentee’s improper

timewise extension of a patent, i.e., “gamesmanship.”

Novartis-Breckenridge, 909 F.3d at 1364 (ODP inapplicable

when extension was due to “intervening change in patent

term law,” not “gamesmanship”); see Abbott Labs. v.

Lupin Ltd., 2011 U.S. Dist. LEXIS 53846, at *26-27 (D.

Del.) (ODP prevents gamesmanship). Precedent thus

requires that any court consider the equities in light of

the case’s facts. In Berg, for instance, the Federal Circuit

considered staggered patent issuances that extended

pre-URAA patent term (which was then measured from

patent issuance date), and applied ODP equitably. 140

F.3d at 1434-35.

Prior to URAA, courts did not apply ODP as a strict

issue of the timewise extension of right to exclude, as the

Court of Customs and Patent Appeals (“CCPA”) phrased

it in Schneller, 397 F.2d at 354. For example, the CCPA, a

predecessor court to the Federal Circuit whose precedent

binds the Federal Circuit (South Corp. v. U.S., 690 F.2d

1368, 1370-71 (Fed. Cir. 1982) (en banc)), summarized its

ODP jurisprudence stating:

In Stanley, [214 F.2d 151 (CCPA 1954),] this

court sanctioned … the issuance of a dominating

10. A terminal disclaimer cannot be used to overcome

statutory §101 DP. MPEP §1490; Curing DP at 41, 44; see note 17

below (example where terminal disclaimer cannot overcome ODP).

13

patent to the owner of the improvement patent

which had issued in 1950, notwithstanding the

owner’s protection would thereby be extended

beyond the expiration of the improvement

patent by several years. We see, therefore, that

as a matter of law the extension of protection

objection is not necessarily controlling.

In re Borah, 354 F.2d 1009, 1017 (CCPA 1966) (emphasis

added).

The Cellect decision explicitly discards equities –

holding “gamesmanship” irrelevant and treating ODP as

a strict liability doctrine. 81 F.4th at 1230 (“[G]ood faith

during prosecution does not entitle [Cellect] to a patent

term to which it otherwise is not entitled.”); see Allergan,

2023 U.S. Dist. LEXIS 172641, at *59 (stating that Cellect

decision held ODP “should not [be] influenced by equitable

concerns.”).11

Such conf licting positions are ripe for review.

NYIPLA supports the Court granting certiorari to

determine whether ODP should be confirmed as an

equitable doctrine as precedent requires.

D.

The Federal Circuit Improperly Abrogated

Congress’s Guarantees

URAA changed how patent expiration dates are

calculated. Post-URAA, patents expire 20 years from the

11. The Court has admonished the Federal Circuit against

rigidly applying flexible doctrines. See, e.g., KSR Intern. Co. v.

Teleflex Inc., 550 U.S. 398, 415, 419 (2x), 421, 422, 428 (2007).

14

earliest-claimed U.S. or international filing date, instead

of 17 years from issuance. Congress recognized, however,

that with this change any PTO-caused prosecution delays

would reduce a patent’s effective life, so it simultaneously

guaranteed timely application examination and provided

a mandatory guaranteed adjustment—PTA—of “1 day

for each day” of PTO delay. 35 U.S.C. §154(b)(1); Wyeth,

591 F.3d at 1366; Supernus Pharms., 913 F.3d at 1358; see

H.R. Rep. No. 106-287, pt. 1 (Congress enacted PTA to

“protect patent term.”) (quoted at note 4 above).

T he Cell ec t dec i sion w rongly over rode t h i s

Congressional safeguard by analyzing for ODP based upon

patent expiration after PTA is added, instead of before,

and explicitly declaring Congressionally mandated PTA

as an “improper” unjustified patent extension. 81 F.4th at

1229. Thus, under Cellect, patents may be invalid simply

because the PTO has improperly delayed their issuance

requiring it to add PTA as a result. Courts historically

have sought to avoid such “hard” double patenting

consequences. See, e.g., Thomson-Houston Elec. Co. v.

Ohio Brass Co., 80 F. 712, 724 (6th Cir. 1897) (“where the

delay in the issuing of the patent … cannot be charged to

the laches or fraud of the patentee, [a rule invalidating a

late issuing patent] would be a hard one”).

Judicial nullification of an otherwise legal statute

violates a core Constitutional principle: administrative

agencies and courts may not usurp Congress’s legislative

role.12 The Constitution gives Congress authority to set

12. U.S. v. Rutherford, 442 U.S. 544, 555 (1979) (“Under our

constitutional framework, federal courts do not sit as councils of

revision, empowered to rewrite legislation in accord with their

15

patent terms. Eldred, 537 U.S. at 199. As the Court made

clear in Eldred, courts should defer to Congress when

Congress engages in “a rational exercise of the legislative

authority conferred by” the Constitution such as setting,

or guaranteeing its legally-set, patent term. Id.

Certiorari is necessary to address whether the

judicially created doctrine of ODP, as applied, may

override the clear statutory award of PTA that Congress

enacted pursuant to its Constitutional mandate. NYIPLA

submits that it may not.

E. ODP Is Not Necessary Post-URAA

ODP long-predates URAA – it comes from a time

when gamesmanship could result in improper extensions

own conceptions of prudent public policy.”) and 559 (“Whether,

as a policy matter, an exemption should be created is a question

for legislative judgment, not judicial inference.”); see Henry

Schein, Inc. v. Archer & White Sales, Inc., 586 U.S. --, 139 S.Ct.

524, 528 (2019) (“we may not engraft our own exceptions onto the

statutory text.”) and 531 (“we may not rewrite the statute simply

to accommodate [a recognized] policy concern.”); R.R. Ret. Bd. v.

Alton R.R., 295 U.S. 330, 362 (1935) (“we cannot rewrite a statute

and give it an effect altogether different from that sought by the

measure viewed as a whole”); Murphy v. NCAA, 584 U.S. 453,

482-83 (2018) (courts should not differ sharply from what Congress

contemplated); see also A. Hamilton, The Federalist Papers, No.

78, The Judiciary Department (“It can be of no weight to say that

the courts, on the pretense of a repugnancy, may substitute their

own pleasure to the constitutional intentions of the legislature.”

(emphasis added)), and No. 81, The Judiciary Continued, and the

Distribution of Judicial Authority (addressing the “danger of

judiciary encroachments on the legislative authority” and how

the Constitutional balance minimizes the risks).

16

of patent term. See Novartis-Breckenridge, 909 F.3d at

1364. However, “the change in the Patent Act from a

patent term of seventeen years from issuance to a term of

twenty years from filing” means that concerns over “the

unjustified patent term extension” have “limited force.”

In re Fallaux, 564 F.3d 1313, 1318 (Fed. Cir. 2009), quoted

in Abbvie Inc. v. Mathilda & Terence Kennedy Inst., 764

F.3d 1366, 1373-74 (Fed. Cir. 2014) (“Kennedy Inst.”)

(discussing ODP’s role post-URAA); see ODP Why/When

at 1019. NYIPLA therefore submits that the URAA made

at least the expiration portion of ODP obsolete,13 a vestige

of when patent term was computed from issuance that is

no longer necessary. Cf. Kennedy Inst., 764 F.3d at 137374 (discussing Federal Circuit’s reasons to keep ODP).

Moreover, counsel is aware of situations where ODP

has stifled innovation. In one instance, two research-based

companies developed foundational tools, and each patented

its advance. The two considered combining those tools

into what they anticipated would be a groundbreaking

medical treatment but did not do so – they did not invest

in a joint research project because of the likelihood that

ODP based upon their two basic patents would undermine

any patents resulting from their combined efforts.

13. After URAA, some argue, ODP should apply, at most (if

at all), in situations where obvious variant patents from the same

family are separately owned—this would avoid risk of harassment

by multiple assignees (although, as previously noted, Congress

has exempted the situation from ODP where the multiple patents

issued based upon PTO restriction requirements). See Fallaux,

564 F.3d at 1318. That, however, is not the issue presented in the

instant Petition and so NYIPLA limits its arguments to ODP in the

context of PTA, although the safe harbor provisions of 35 U.S.C.

§121 do allow such separate patents to not be commonly owned.

17

Post-URA A there is no risk of the “unjustified

timewise extension of right to exclude” that necessitates

disclaiming patent term amongst family members that

share a common filing date, which was the impetus for

courts creating ODP. See Schneller, 397 F.2d at 354; see

also Bullinger, Double Patenting and the 1952 Act, 10

Pat. Trademark & Copy. J. Res. & Ed. 389 (1967) (“DP

& 1952 Act”) 389, 398-99 (discussing impetus). This can

be further appreciated in light of this Court’s early §101

DP decisions such as Suffolk v. Hayden, 70 U.S. (3 Wall)

315, 319 (1865), and Barbed Wire Patent case, 143 U.S.

275 (1892), which focused on the date of patent issuance.

See Historical Development at 244-45.

Under current law, a later-issuing patent expires at

the same time as an earlier-issued patent from the same

family claiming the same priority date unless there is a

Congressionally awarded term extension – e.g., either

PTE or PTA based upon FDA or PTO delay, respectively.

There is nothing improper about PTA that justifies

invalidating a patent with PTA, just as there is nothing

improper about PTE. Novartis-Ezra, 909 F.3d at 1374

(“This case does not raise the traditional concern with

obviousness-type double patenting of a patent owner

‘extending his exclusive rights to an invention’…” by

PTE). If PTA is considered improper, then “the logic

and purpose of [ODP] is flipped on its head.” ACADIA

Pharm. Inc. v. Aurobindo Pharma Ltd., 2023 U.S. Dist.

LEXIS 221663, at *21 (D. Del. 2023). ODP is meant to

“prevent” an “improper timewise extension of the patent

right” (Braat, 937 F.2d at 592 (emphasis original; citation

omitted)), and since Congress mandated PTA to guarantee

patent term, it cannot be improper by definition – yet that

is what the Cellect decision held (81 F.4th at 1229).

18

Whether ODP has outlived its usefulness goes further

than the PTA Congressional guarantees. Surprisingly, the

Federal Circuit did not find URAA as a reason to confine

(or even eliminate) ODP; it used URAA’s enactment as

an opportunity to expand the double patenting doctrine,

notwithstanding binding precedent and statute.

In Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d

1208, 1214-15 (Fed. Cir. 2014), cert. denied, 135 S.Ct. 1530

(2015), a divided Federal Circuit panel held that URAA

allowed it to deviate from precedent. See 753 F.3d at

1217 (Rader, C.J., dissent) (“Today the court expands the

judicially-created doctrine of obviousness-type double

patenting . . . Because this expansion is unwarranted, I

respectfully dissent.”); see also Novartis-Breckenridge,

909 F.3d at 1362 (“URAA altered the analytic inquiry

. . .”). As PTO Associate Solicitor Kazhdan’s summarized

Gilead in ODP Why/When (at 1038), “[t]he majority

recognized that [before URAA] the Supreme Court held

that an earlier-issued patent could not be challenged based

on a later-issuing patent,” i.e., courts could use the patent

application date but not the issuance date to determine

double patenting, but after URAA “only the expiration

date mattered.”

In Kennedy Inst., 764 F.3d at 1373-74, the Federal

Circuit also discussed ODP in the post-URAA environment

and held that the doctrine should continue in order to

(i) prevent so-called submarine patents, where an applicant

uses continuation applications to patent unclaimed features

of an invention long after the original application (no longer

a concern now that pending applications are published14);

14. Concern over submarine patents was also addressed

by courts applying patent prosecution laches, which itself is

19

and (ii) to address where an “applicant chooses to file

separate applications for overlapping subject matter and

to claim different priority dates for the applications, [such

that] the separate patents will have different expiration

dates since the patent term is measured from the claimed

priority date.” Id. at 1373, see DP & 1952 Act at 397-98

(listing basis for double patenting). The Kennedy Inst.

panel, however, did not focus on whether that patentee

committed “gamesmanship.”15 See Kennedy Inst., 764

F.3d at 1373-74 & n.2; see also ODP Why/When at 1040

(panel “recognized that the patentee might have abused

the system … [but its] holding was not premised on that

possibility.” (emphasis original)).

While, seemingly, Kennedy Inst. shows that the

Federal Circuit agreed ODP is no longer necessary to

address the submarine patent example, it held ODP should

continue to address the second example of gamesmanship

because “[w]hen such situations arise, the doctrine of

[ODP] ensures that a particular invention (and obvious

variants thereof) does not receive an undue patent term

extension.” Id. This second example, however, is limited

to applications that “claim different priority dates” and,

therefore, does not apply to patents and applications in

the same family, which have the same priority date (as is

at issue in the instant case).

an “equitable and flexible doctrine” that renders such patents

unenforceable where appropriate. E.g., Personalized Media

Comm., LLC v. Apple Inc., 57 F.4th 1346, 1354 (2023) (citation

omitted).

15. The Kennedy Inst. facts are unusual. The patentee

selectively did not designating its earliest available application

date for priority, which was pre-URAA, but chose only to rely on

a post-URAA application (which could no longer occur).

20

NYIPLA submits that certiorari is appropriate to

address whether and if so how the ODP doctrine should

survive – as a rigid, strict legal doctrine or as an

equitable one – in light of the Federal Circuit’s decision.

F.

Cellect Significantly Adversely Impacts

Innovation

Patents are meant “[t]o promote the Progress of …

Science and useful Arts” encouraging innovation, U.S.

Const. Art. I, §8, Cl. 8, and this Court has cautioned

against “changes that disrupt the settled expectations

of the inventing community.” Festo Corp. v. Shoketsu

Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002)

(citation omitted). But Cellect’s brute-force application of

ODP harms the innovation economy, particularly small

businesses, by disrupting those settled expectations.

NYIPLA members, as discussed above, represent all

aspects of IP and those impacted by it. It is common for

applicants to quickly seek patent protection covering a

new invention/product and then file additional applications

within the same patent family to claim additional

commercially relevant aspects (without seeking additional

term). This is a routine strategy across all technologyfocused companies, but is particularly relevant for small

businesses and early-stage innovators (where resources

are restricted) whose IP strategy may need to be flexible

to respond to volatile market conditions.

One example of where this decision can create

problems is that it is common for the first application

in a patent family to issue having the broadest claims

and receive PTA because of PTO delays associated with

21

examining the broadest claims; under the Cellect decision,

the issuance of additional patents in the family may render

the first patent invalid, e.g., if those later and narrower

patents do not receive PTA. Thus, companies may hesitate

to seek additional patents to round out their portfolio, and

inventions that add to prior patented work may be lost in

fear that a subsequent patent may invalidate or devalue

an earlier one.

The Federal Circuit’s suggestion that the solution is

for parties to prophylactically “file terminal disclaimers

during prosecution” (81 F.4th at 1231) is no antidote.16 Not

only is it impossible in some scenarios,17 but this “solution”

challenges patent owners, many of whom are small

businesses and individual inventors, to roll the proverbial

dice by guessing whether their claims “might” run afoul of

ODP in situations where a patent examiner has not raised

an ODP rejection. As the example in Section III.E above

shows, some innovators chose not to roll those dice rather

than give up their statutory patent term.

16. Notably, the PTO seems to have accepted that invitation

in a recent Notice of Proposed Rulemaking, Terminal Disclaimer

Practice To Obviate Nonstatutory Double Patenting, 89 Fed. Reg.

40439-49 (May 10, 2024).

17. Other Federal Circuit precedent has created exceptions

that also prove why this “solution” is unworkable. For instance,

in In re Hubbell, 709 F.3d 1140, 1146 (Fed. Cir. 2013), it applied

ODP between patents invented by different inventor groups if

there is a common inventor, even if not commonly owned, and held

that a terminal disclaimer – the tool used to overcome ODP – is

not available if patents are not commonly owned. Id. at 1148-49;

Fallaux, 564 F.3d at 1319 n.5.

22

Under Cellect it is possible for a patent having PTA to

become invalid after issuance, such as in instances where

a later-filed application in the same family issues with no

PTA, thus creating a double patenting reference where

none existed before. E.g., Cellect, 81 F.4th at 1229 (‘369

patent issued 7/23/02 with 45-day PTA invalid over ‘036

patent issued 3/1/05 without PTA). This creates a new

burden: reconsidering already-issued patent portfolios,

lest ODP destroy valuable patent families. Hence, under

Cellect patentees must continuously monitor the need for

terminal disclaimers for the entire lifetime of each patent.

It forces the patentee to be responsible for delays caused

exclusively by the PTO.

The Cellect decision presents a patentee with an

unpalatable choice. If the PTO processes their broader

application claims slowly (resulting in PTA), the options

are to forgo filing any continuations (even if a separate,

narrower set of claims would move through the PTO more

quickly), or to file a continuation but jeopardize either

patent term (i.e., PTA-ODP) or the validity of the broader

patent/application. The PTO’s tardiness leaves the

patentee worse off no matter which of these bad choices

they opt for. This is manifestly inequitable, because the

PTO’s delay is outside the control of the patentee and

will impact some patentees but not others. Congress

created PTA to reduce the negative impact on patent term

resulting from the PTO’s lag in processing applications,

not to create a lottery for patentees.

These impacts, too, support this Court granting the

Petition.

23

IV. CONCLUSION

The Federal Circuit’s decision provides compelling

reasons for the Court to exercise its judicial discretion to

grant the Petition for Certiorari. The Petition does not

merely issue present an erroneous factual finding or the

misapplication of a properly stated rule of law. Rather,

as set out in Sup. Ct. R. 10(a) & (c), the Federal Circuit

has “entered a decision in conflict with” its own decisions

on an important question in a way that has “sanctioned”

lower courts to depart from precedent, such that the Court

should exercise its supervisory power; and did so, on an

important issue of federal law, in a way that conflicts with

relevant decisions of this Court.

Therefore, for the foregoing reasons, NYIPLA

respectfully urges the Court to grant the Petition for

Certiorari.

Respectfully submitted,

Robert J. Rando

Immediate Past President

New York Intellectual

Property Law Association

Greenspoon Marder LLP

1345 Avenue of the

Americas, Suite 2200

New York, NY 10105

Jeffrey I. D. Lewis

Counsel of Record

Lucas Watkins

David Surry

Foley Hoag LLP

1301 Avenue of the

Americas, Suite 2500

New York, NY 10019

(212) 812-0400

jidlewis@foleyhoag.com

24

Paul Coletti

Johnson & Johnson

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

Charles R. Macedo

Gary J. Gershik

David Goldberg

A mster, Rothstein

& Ebenstein LLP

405 Lexington Avenue,

48th Floor

New York, NY 10174

Brittany J. Saunders

Foley Hoag LLP

Seaport West

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Boston, MA 02210

Counsel for New York Intellectual Property

Law Association