Opposition Brief — Helsinn Healtcare S.A. v. Teva Pharm. USA, Inc., 139 S. Ct. 358 (2018) (No. 17-1229)

No. 17-1229

In the Supreme Court of the United States

HELSINN HEALTHCARE S.A., PETITIONER

v.

TEVA PHARMACEUTICALS USA, INC., AND

TEVA PHARMACEUTICAL INDUSTRIES, RESPONDENTS

ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED

STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

BRIEF IN OPPOSITION TO CERTIORARI

GEORGE C. LOMBARDI STEFFEN N. JOHNSON

JULIA M. JOHNSON Counsel of Record

TYLER G. JOHANNES ANDREW C. NICHOLS

Winston & Strawn LLP JOVIAL WONG

35 W. Wacker Drive CHRISTOPHER E. MILLS

Chicago, IL 60601 Winston & Strawn LLP

(312) 558-5600 1700 K Street, N.W.

Washington, DC 20006

(202) 282-5000

sjohnson@winston.com

Counsel for Respondents

QUESTION PRESENTED

Whether this Court should review the Federal

Circuit’s factual conclusion that Helsinn’s sale

agreement with a third party publicly disclosed its

claimed invention “in detail” (Pet. 33a) more than a

year before it filed its patent application, thus trig-

gering the “on sale” bar on patentability set forth in

35 U.S.C. §102(a).

ii

CORPORATE DISCLOSURE STATEMENT

The parent companies of Respondent Teva Phar-

maceuticals USA, Inc. are: Orvet UK Unlimited, Teva

Pharmaceutical Holdings Cooperative U.A., [vax LLC

(f/k/a IVAX Corporation), Teva Pharmaceuticals Eu-

rope, B.V., and Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. is the only pub-

licly traded company that owns 10% or more of Teva

Pharmaceuticals USA, Inc.

TABLE OF CONTENTS

Page

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

CORPORATE DISCLOSURE STATEMENT............. ii

TER CE BF IE BID wicsccccccccevececevsescesecosescesecess Vv

RAC A a OE 1

TT iirc nnescunnbetenininintliinisibebidingiebinasnbietpiaaneins 4

A. The history of the on-sale bar........................... 4

1. The 1790 and 1793 Patent Acts and

this Court’s decision in Pennock ................. 5

2. Congress adopts the on-sale and

public use bars in 1836................................ 6

3. In the AIA, Congress considers

removing the on-sale bar, but declines

RUE ccdinncabscieccliagdanbintidetinbidtndmbniaiiastedasenonen 8

B. The invention, the publicized agreement for

its sale, and the district court’s ruling ............. 3)

C. The Federal Circuit finds the invention “on

sale” under the particular agreement and

circumstances involved here........................... 10

D. The Federal Circuit unanimously denies

ITI icin itdnienincineeriiinsintaitinbssempenibanimmesnesinesees 11

REASONS FOR DENYING THE PETITION .......... 13

|. Certiorari should be denied because the

decision below is narrow, fact-bound, and rife

with vehicle problems.................................se0e00000+ 13

A. The Federal Circuit limited its decision to

the unusual agreement here and declined

to reach the secret-sale issue.......................... 14

iv

B. This case is a poor vehicle to decide the

scope of the AIA’s on-sale bar......................... 16

1. The court concluded that Helsinn’s

sale was public, and the petition

contests that factual determination. ........ 16

2. Below, Helsinn forfeited key points

that it asks this Court to take up. ............ 18

Il. Certiorari should also be denied because,

whether public or secret, the invention here

a ie ccereeccenienhierctnnnteneeinnicsicinniaitniauincianantestinn 19

A. The AIA’s plain text confirms that

Congress did not change the settled

meaning of “on sale,” which Helsinn

conceded was a term of art. ....................-....... 19

B. Helsinn has no answer for §102(b), which

expressly distinguishes between public and

PTIVALS GISCIOGUTOS. ...........ceccccccccsesccccccvececseeses 25

C. Congress repeatedly declined to adopt bills

that did what Helsinn wishes......................... 27

D. Two centuries of this Court’s precedents

and the Constitution confirm that the on-

sale bar is triggered by all types of sales. ...... 30

E. Helsinn’s policy arguments do not support

DI ccnsacrinentacertnnsiinininenintiigaidamenie 32

IIIS ‘neonisccesccsosiepicunidentetvecindienidiiniguiamaniiie 34

APPENDIX

Order on Motion to Stay Mandate (Jan. 22, 2018)...1la

v

TABLE OF AUTHORITIES

Cases

Air Wis. Airlines Corp. v. Hoeper,

I le 2, 21

Barnhart v. Thomas,

I 23, 24, 25

Boyden v. Burke,

EE 21

Chevron U.S.A. Inc. vy. Natural Resources

Defense Council, Inc.,

ER 4,19

Chickasaw Nation v. United States,

cements 29

Clark v. Martinez,

TS 32

Cont! Plastic Containers v. Owens Brockway

Plastic Prods., Inc.,

141 F.3d 1073 (Fed. Cir. 1998)......................... 8, 31

Cutter v. Wilkinson,

a LA 4

Dart Indus., Inc. v. E. 1. Du Pont De

Nemours & Co.,

468 F.2d 1360 (7th Cir. 1973)................................. 7

Dep't of Homeland Sec. v. MacLean,

I ceenencnens 3, 21

Diomed, Inc. v. Angiodynamics, Inc.,

450 F. Supp. 2d 130 (D. Mass. 2006) ................... 20

Egbert v. Lippmann,

EE 7, 21, 23

vi

Exxon Mobil Corp. v. Allapattah Services,

a i ennsonennation 29

FDA v. Brown & Williamson Tobacco Corp.,

ae 27

FTC v. Mandel Bros.,

I Ea eR 25

Hamdan v. Rumsfeld,

LL a eC Ca EE 29

Hobbs v. U.S. Atomic Energy Comm'n,

451 F.2d 849 (Gth Cir. 1971) ...................cc000-ce000-00- 8

In re Klopfenstein,

380 F.3d 1345 (Fed Cir. 2004)........................ 20, 22

Kendall v. Winsor,

a a ticincisihchbciamiains 6, 31

Lockhart v. United States,

tLe anor 22, 23

Medicines Co. vy. Hospira, Inc.,

827 F.3d (Fed. Cir. 2016) (en banc) ....................... 8

Metallizing Engineering Co. v. Kenyon

Bearing & Auto Parts Co.,

153 F.2d 516 (2d Cir. 1946).......................... 7, 8, 32

Mfg. Research Corp. v. Graybar Elec. Co.,

679 F.2d 1356 (11th Cir. 1962) .............................. 8

Mims v. Arrow Fin. Servs., LLC,

I il 29

Paroline v. United States,

I i 3, 21

Pennock v. Dialogue,

BU WEE. 3 GRR ccccececceccssessscceses 3, 5, 6, 8, 30, 31, 32

Pfaff v. Wells Elec., Inc.,

ee 6, 7, 8, 31, 32

Rodriguez v. United States,

eee 34

Shaw v. Cooper,

ee 6

United States v. Standard Brewery, Inc.,

CK EE 22

Whitman v. Am. Trucking Ass'n,

SR a a 20

Statutes

35 U.S.C

| SENS eeeney sesamin eer Mneenre ie sca e 14, 20, 28

| ae 3, 4, 9, 13, 21, 22, 23, 25, 26

LER RE ee 4, 9, 16, 25, 26, 32

nineties neeceeneeiatilinmiansth 12, 25, 26, 27

| RC cee ee ee RB ce 27

I ii icccencctnnndtcnactniditineniameninnn 24

5

Fe Ne) en 5

eB 8 | ren 6

Other Authorities

154 Cong. Rec. 22,631 (2008) ................0...000000000. 9, 28

78 Fed. Reg. 11062 (Feb. 14, 2013) ........................... 18

H.R. Rep. No. 110-314 (2007) ....................cccc cee eeeeeeee 33

8 Se 29

Lemley, Does “Public Use” Mean the Same

Thing It Did Last Year?, 93 Tex. L. Rev.

SETI <sticniniscitnistitensinnnithidinbiasiniantidnibialibaieisnaiasnss 26, 32

Merges & Duffy, Patent Law and Policy (7th

ees 20, 26, 29, 30

Merges, Priority and Novelty Under the AIA,

27 Berkeley Tech. L.J. 1023 (2012) ............... 26, 34

Mueller, Patent Law (5th ed. 2016) .............. 15, 16, 20

Random House Webster’s Unabridged

Dictionary (3d ed. BOO1) ............000.....-0eceeceecereeeeeee 19

IRIS SL an Ea ae OED 17

SESS ES CORES EOe aoe a NER 15

S. Rep. No. 111—18 (BOOB) ..................ccceeeceececseeeeeeees 28

INTRODUCTION

This case involves the first Federal Circuit deci-

sion addressing the scope of the AIA’s on-sale bar.

Helsinn insists that the decision warrants immediate

review because it “swept broadly” and was “unteth-

ered to the statutory text.” Pet. 33, 3. Yet Helsinn

has presented a caricature of the decision, which not

only is a unanimous, fact-bound ruling limited to “the

circumstances involved” and “this particula: [sales]

{algreement,” but is grounded in the Patent Act’s

text, structure, and 200-year history. Pet. 20a, 43a.

Helsinn did not contest that history below. It con-

ceded that “on sale” was a “term{] of art”—an “estab-

lished term{]” that historically covered secret sales—

and that even today the on-sale bar may be triggered

without “disclosure of ‘the details of the * * * inven-

tion.” Beyond the vehicle problems created by these

concessions, Helsinn asks this Court to second-guess

the lower court’s factual conclusion that the sale here

was “public” rather than “secret.” It thus turns out

that the “question presented” is not really presented.

Not surprisingly, no Federal Circuit judge supported

en banc review—or even requested a vote.

Helsinn offers no convincing reason for this Court

to grant review either. First, as to the ruling’s scope,

Helsinn criticizes the court below for stating that “if

the existence of the sale is public, the details of the

invention need not be publicly disclosed” to trigger

the bar. Pet. 33. But the court did not just find that

the existence of Helsinn’s sale was public; it found

that Helsinn disclosed the claimed drug formulation

“in detail.” Pet. 33a. The court declined to rule “more

broadly than necessary,” deferring any decision on

“cases involv[ing] a public use where the invention

2

was not * * * disclosed” or “secret sale’ cases.” Pet.

37a, 38a, 39a. Helsinn ignores this.

Helsinn also ignores that the government did not

support en banc review, having stated at argument:

“[I}f this Court concludes that this was in fact a sale

that made the invention available to the public, that

will not cause us any heartburn.” That is what the

court concluded. As Judge O’Malley explained, “the

standard governing secret sales *** simply is not

implicated” here, and Helsinn’s contrary view rests

on the “mischaracterization[]” of “a single sentence.”

Pet. 4a, 6a n.1.

According to Helsinn, Judge O’Malley’s opinion is

“revisionist.” Pet. 33. But in denying Helsinn’s stay

motion, the other two panel members fully endorsed

her opinion, reiterating that the decision is “narrow.”

App., infra, 2a. Remarkably, Helsinn does not men-

tion this order—or even provide it to the Court. But

it confirms that this case is a poor vehicle to address

the question presented, and that Helsinn and its pro-

patentee amici seek review not to narrow a broad de-

cision, but to broaden a narrow one.

Second, even if the sale here were secret, the deci-

sion was correct for additional reasons given by the

panel and Judge O’Malley. Indeed, that Helsinn pub-

licized its claimed formulation “in detail” (Pet. 33a)

makes this an especially easy case. Helsinn’s petition

glosses over the statute’s text, structure, and history

—and its own concessions. “On sale” is a term of art

with centuries of pre-AIA history; both its ordinary

and specialized meanings include ali sales, public and

private. And “when Congress employs a term of art,

it presumably knows and adopts the cluster of ideas

that were attached.” Air Wis. Airlines Corp. v.

3

Hoeper, 134 S. Ct. 852, 861-862 (2014). In fact, even

before the on-sale bar existed, this Court held that

the Patent Act and the Constitution barred commer-

cially exploiting inventions before patenting them.

Pennock v. Dialogue, 27 U.S. 1 (1829).

The AIA retained the term “on sale” unmodified,

without limiting it to public s*les, while embedding it

in a list of bars that, by contrast, do repeatedly in-

clude the word “public.” Those are powerful textual

confirmations that Congress did not “work a founda-

tional change in the theory of the statutory on-sale

bar.” Pet. 39a. “Congress generally acts intentional-

ly when it uses particular language in one [part] of a

statute but omits it in another.” Dep't of Homeland

Sec. v. MacLean, 135 S. Ct. 913, 919 (2015) (citations

omitted). And as the court below observed, if Con-

gress intended “a sweeping change” to the law, “it

would do so by clear language” (Pet. 39a, 43a)—such

as “publicly on sale.”

Helsinn nonetheless insists that Congress worked

just such a change—-without amending “on sale”—by

creating a new bar for claimed inventions “otherwise

available to the public.” According to Helsinn, “avail-

able to the public” is a “series modifier” that works

backwards through the list of statutory bars, upend-

ing settled precedent as it goes. Pet. 15-16. But such

a construction is proper only when the final clause “is

applicable as much to the first and other words as to

the last.” Paroline v. United States, 134 S. Ct. 1710,

1721 (2014). As Judge O'Malley explained, §102(a)’s

catchall clause is not as applicable “to the first and

other words as to the last,” since that reading would

create massive “redundancies.” Pet. 9a n.2. All the

listed words except “on sale” are already inherently

public or pre-labeled as public. Pet. 8a—9a & n.2.

4

Thus, the more natural reading is that, in adding

“otherwise available to the public” to the statute,

Congress confirmed that all public disclosures trigger

the bar—even when made orally, or via new technol-

ogies. Congress did not shrink the distinct category

of sales that invalidate patents.

Further, the AIA’s next subsection distinguishes

between “disclosures” and “public disclosures,” which

makes no sense if all §102(a) disclosures are public.

Helsinn says the disclosures in §102(b) are “different”

and “antecedent” (Pet. 19), but never says how. And

as we will show, Helsinn’s policy arguments fail on

their own terms.

This Court is “a court of review, not of first view”

(Cutter v. Wilkinson, 544 U.S. 709, 718, n.7 (2005)),

and Helsinr presents a “secret sale” question that

was not reached below. And since Helsinn’s sale was

invalidating under either view of that question, the

answer does not matter. “[T]his Court reviews judg-

ments, not opinions” (Chevron U.S.A. Inc. v. Natural

Resources Defense Council, Inc., 467 U.S. 837, 842

(1984)), and both the panel’s and Judge O’Malley’s

opinions support the judgment. Certiorari is not

warranted to say which opinion is most powerful.

STATEMENT

A. The history of the on-sale bar

Helsinn briefly mentions the pre-AlA on-sale bar,

but neglects its history. To understand the bar's cur-

rent scope, however, it is vital to understand that be-

ginning nearly 200 years ago—before the on-sale bar

existed—this Court has repeatedly held that both the

Patent Act and the Constitution bar commercially

exploiting inventions before patenting them.

5

1. The 1790 and 1793 Patent Acts and this

Court’s decision in Pennock

Congress’s first patent statute—the Patent Act of

1790—limited patents to matter “not before known or

used.” Ch. 7, §1, 1 Stat. 110. Similarly, the Patent

Act of 1793 barred patenting matter “known or used

before the [patent] application.” Ch. 11, §1, 1 Stat.

319. Thus, the question arose early whether patents

could cover inventions that had already been sold.

This Court addressed that question in Pennock v.

Dialogue, 27 U.S. 1 (1829) (Story, J.). The patent

there claimed a process of making hose wit! pres-

sure-resistant joints. Jd. at 3, 14. The joints did not

reveal the process. But years before seeking a patent,

the inventor authorized sales of the hose. Id. at 9.

Thus, the defendant argued that the invention was

“known or used before the application.” Jd. at 11—12.

The Court agreed. Inventions are “known or used”

if “known or used by the public,” and public use in-

cludes “sell[ing] [the] invention publicly.” Jd. at 19.

The Court stressed that allowing inventors to ex-

ploit inventions commercially before patenting them

would violate not only the Patent Act, but the Consti-

tution. The Patent & Copyright Clause authorizes

Congress “to promote the progress of science and use-

ful arts, by securing for limited times, to authors and

inventors, the exclusive right to their respective writ-

ings and discoveries,” and “contemplates, therefore,

that this exclusive right shall exist but for a limited

period.” Jd. at 16—17 (quoting U.S. Const. Art. I, § 8,

cl. 8). If inventors could profit from secret inventions,

only to patent them later, it would “retard the pro-

gress of science”:

6

If an inventor should be permitted to hold back

from the knowledge of the public the secrets of his

invention; if he should for a long period of years

retain the monopoly, and make, and sell his in-

vention publicly, and thus gather the whole profits

of it * * * and then, and then only, when the dan-

ger of competition should force him to secure the

exclusive right, he should be allowed to take out a

patent *** it would materially retard the pro-

gress of science and the useful arts, and give a

premium to those who should be least prompt to

communicate their discoveries.

Id. at 19. Even before the on-sale bar, therefore, the

law barred patenting inventions that had been pub-

licly sold. Id. at 23; accord Shaw v. Cooper, 32 U.S.

292, 322-323 (1833); Pfaff v. Wells Elec., Inc., 525

U.S. 55, 64 (1998). And as the Court later reaffirmed,

“the inventor who designedly, and with the view of

applying [his invention] indefinitely and exclusively

for his own profit, withholds his invention from the

public, comes not within the policy or objects of the

Constitution or acts of Congress.” Kendall v. Winsor,

62 U.S. 322, 328 (1858).

2. Congress adopts the on-sale and public

use bars in 1836

The Patent Act of 1836 continued to bar patenting

inventions “known or used by others.” Ch. 357, §6, 5

Stat. 117. But Congress also added language barring

patents on inventions that were “in public use or on

sale.” Ibid. These distinct restrictions are now

known as the “public use” and “on sale” bars.

Early on, this Court read “public use” to bar pa-

tenting where “an inventor, having made his device,

gives or sells it to another, to be used * * * without

7

limitation or restriction, or injunction of secrecy.”

Egbert v. Lippmann, 104 US. 333, 336 (1881).

“[S]uch use is public, even though the use and

knowledge of the use may be confined to one person”

and the invention “cannot be seen or observed by the

public eye.” Jbid. (invalidating a patent on a corset

stay previously worn under a woman’s dress).

Unlike items in “public use,” however, items “on

sale” have never had to be sold publicly to defeat pa-

tentability. As then-Judge Stevens once explained,

“the ‘public use’ and the ‘on sale’ objections” are “dis-

tinct”; “[t]here may be a public use prior to any sale,”

and, “alternatively, there may be sales which neither

the vendor nor the purchaser desires to make public

but which nevertheless” trigger the bar. Dart Indus.,

Inc. v. E. I. Du Pont De Nemours & Co., 489 F.2d

1359, 1364 n.8 (7th Cir. 1973). Following this ap-

proach, courts have consistently invalidated patents

on commercially exploited inventions.

The leading lower-court case is Metallizing Engi-

neering Co. v. Kenyon Bearing & Auto Parts Co., 153

F.2d 516 (2d Cir. 1946), which this Court endorsed in

Pfaff. 525 U.S. at 68. As Judge Learned Hand ex-

plained, an inventor “shall not exploit his discovery

competitively after it is ready for patenting; he must

content himself with either secrecy, or legal monopo-

ly.” Ibid. (quoting Metallizing, 153 F.2d at 520). This

rule “had its origin” in Pennock’s holding that “it

would materially retard the progress of science” if in-

ventors could profit from their inventions while

“hold[ing] back from the knowledge of the public the

secrets [thereof].” 153 F.2d at 520, 518 (quoting Pen-

nock, 27 U.S. at 19). And the rule applies “regardless

of how little the public may have learned about the

invention.” Jd. at 520.

8

Following Pennock and Metallizing, myriad courts

have held that the on-sale bar reaches confidential

sales.' As these courts recognize, “[t/he primary poli-

cy underlying the ‘public use’ case is that of detri-

mental public reliance, whereas the primary policy

underlying an ‘on-sale’ case is that of prohibiting the

commercial exploitation of the design beyond the

statutorily prescribed time period.” Contl Plastic

Containers v. Owens Brockway Plastic Prods., Inc.,

141 F.3d 1073, 1079 (Fed. Cir. 1998). Thus, “[a]ny

attempt to use [an invention] for a profit * * * for a

longer period than [one year] before the application,

would deprive the inventor of his right to a patent.”

Pfaff, 525 U.S. at 65 (citation and emphasis omitted).

Helsinn thus conceded below that “on sale” was a

“term[] of art” under pre-AlA law—an “established

term[]” that has always appeared in a list of “public”

activities, yet captured secret sales. C.A. Br. 41.

3. In the AIA, Congress’ considers

removing the on-sale bar, but declines

to do so

In 2011, Congress passed the AIA. Previously, the

Act provided that “[a] person shall be entitled to a pa-

tent unless”:

the invention was patented or described in a

printed publication in this or a foreign country

or in public use or on sale in this country, more

than one year prior to the date of application|.|

' Pet. App 35a n.7, 40a (collecting cases); Medicines Co. v.

Hospira, Inc., 827 F.3d 1363, 1376-1377 (Fed. Cir. 2016)

(en banc) (same); Mfg. Research Corp. v. Graybar Elec.

Co., 679 F.2d 1355, 1362 (11th Cir. 1982); Hobbs v. U.S.

Atomic Energy Comm'n, 451 F.2d 849, 860 (5th Cir. 1971).

35 U.S.C. §102(b) (2010).

For several years, Congress considered removing

the on-sale bar, thus eliminating “secret activities as

grounds for invalidity.” 154 Cong. Rec. 22,631 (2008)

(Sen. Kyl). For example, in 2005, Congress consid-

ered stating:

(1) the claimed invention was patented, de-

scribed in a printed publication, or otherwise

publicly known|[.}

H.R. 2795, 109th Cong.; see also, e.g., S. 3818, 109th

Cong.; S. 3600, 110th Cong. These versions failed.

The AIA, however, restored the term of art “on

sale” to the statutory list. Today, “[a] person shall be

entitled to a patent unless”:

the claimed invention was patented, described

in a printed publication, or in public use, on

sale, or otherwise available to the public before

the effective filing date of the claimed inven-

tion|[.]

35 U.S.C. §102(a) (2011).

B. The invention, the publicized agreement

for its sale, and the district court’s ruling

Helsinn’s ’219 patent, issued in 2013, claims a

low-dosage form of palonosetron, a drug long used to

treat chemotherapy-induced nausea and vomiting. In

2001, over a year before the relevant patent applica-

tion, Helsinn contracted with MGI Pharma “to dis-

tribute, promote, market, and sell” Helsinn’s later-

patented “0.25 mg and 0.75 mg palonosetron prod-

ucts,” or “whichever” dosage FDA approved. Pet. 29a,

23a.

10

MGI disclosed the sale, and a partially redacted

copy of the Agreement, to the SEC. Pet. 5a. Togeth-

er, the parties publicly announced the Agreement,

which “described the claimed drug formulation ‘in de-

tail.” Ibid. (quoting Pet. 33a). Only the drug’s

“price” and “specific dosage[s]” were not publicly dis-

closed. Pet. 24a.

When Helsinn sued Teva, Teva answered that the

MGI Agreement triggered the on-sale bar. The dis-

trict court agreed that the Agreement “was a contract

for a future commercial product.” Pet. 164a. Never-

theless, it deemed the on-sale bar inapplicable, rea-

soning that the invention was not “ready for patent-

ing” or “available to the public.” Pet. 210a, 180a.

C. The Federal Circuit finds the invention

“on sale” under the particular agreement

and circumstances involved here

Teva appealed, invoking the AIA’s text, structure,

and history. Helsinn rejoined that the legislative his-

tory was “authoritative,” complaining that “Teva de-

nounce[d] [it].”. C.A. Br. 50, 53 (citations omitted).

Helsinn cited “the additional statutory language”

(‘otherwise available to the public”), numerous floor

statements, and various committee reports. Pet. 37a;

C.A. Br. 50-58.

The panel reversed, finding the invention “over-

whelming|ly|” ready for patenting. Pet. 47a. Fur-

ther, the panel held that, under the UCC, the Agree-

ment “constituted a sale of the claimed invention—

the 0.25 mg dose—before the critical date.” Pet. 43a.

The Agreement “described the palonosetron formula-

tion in detail and Helsinn does not assert that the

0.25 mg dose described in the [MGI] Agreement does

11

not embody the asserted claims.” Pet. 33a. Helsinn

does not contest these rulings.

The court also held that the sale triggered the on-

sale bar. In so holding, it emphasized that it “d[id]

not find that distribution agreements will always be

invalidating,” just “that this particular Supply and

Purchase Agreement is.” Pet 43a. Helsinn had both

publicly announced its sale and described the claimed

formulation “in detail.” Pet. 33a. The court conclud-

ed that the AIA “did not change the statutory mean-

ing of ‘on sale’ in the circumstances involved here”

(Pet. 20a), adding that, even if Helsinn had not dis-

closed the invention in detail, Congress would use

“clear language” if it intended “a sweeping change to

our on-sale bar jurisprudence” (Pet. 43a).

As to Helsinn’s “floor statements,” the court noted

that they are “typically not reliable.” Pet. 36a. Re-

gardiess, the statements nowhere suggested that

Congress overruled the numerous decisions “explicit-

ly reject[ing] a requirement that the details of the in-

vention be disclosed.” Pet. 40a. Helsinn’s sale thus

triggered the on-sale bar.

D. The Federal Circuit unanimously denies

rehearing

Helsinn sought rehearing, but no judge requested

a vote and review was denied. Judge O'Malley con-

curred, emphasizing the narrowness of the decision,

providing additional “principles of statutory interpre-

tation” that support it (Pet. 9a—12a), and correcting

Helsinn’s “mischaracterizations” thereof (Pet. 4a—7a).

As Judge O'Malley observed, Helsinn mischarac-

terized the decision by suggesting that: (1) the on-sale

bar will be triggered “every time the fact of a sale is

disclosed to the public”; (2) “all supply-side agree-

12

ments with third-party distributors will constitute

invalidating transactions”; and (3) “our holding is in-

consistent with our en banc decision in Medicines Co.

v. Hospira, 827 F.3d 1363 (Fed. Cir. 2016).” Pet. 4a.

As she explained, the decision “does not suggest that

publicly announced agreements will always trigger

the on-sale bar,” or “that secret sales never will.” Pet.

4a—5a. Rather, “the confidential nature of a transac-

tion is just one of several factors” in a “fact-intensive”

analysis, and “[ajll that our panel opinion held was

that the particular agreement at issue triggered the

on-sale bar, in part—but not exclusively—because it

was made public.” Pet. 5a, 6a.

Judge O’Malley also noted that Helsinn made “few

legal arguments” to support its interpretation. Pet.

8a. “Helsinn’s only argument directed to the text”

was “that the new phrase ‘or otherwise available to

the public” modifies “on sale,” but that reading had

“several problems.” /bid. For example, such “series

modifiers” work only when the modifier “applijes] as

much to the first and other words as to the last”; but

“otherwise available to the public” is “not equally ap-

plicable to all preceding phrases because each phrase

*** recites a disclosure that is necessarily public.

Helsinn’s reading * * * would therefore create redun-

dancies.” Pet. 9a & n.2.

Numerous other factors confirmed “that Congress

meant to leave the on-sale bar intact.” Pet. 9a. For

instance, “Congress chose not to modify the term ‘on

sale,” confirming that it “intended for that term to

take on the meaning that courts had attributed to it

for well over a century.” /d. at 9a—-10a. Further,

§102(b)(1) refers to both “disclosures” and “public dis-

closures”; but “[i}f all prior art events—.i.e., all ‘disclo-

sures’—recited in §102(a) were already public disclo-

13

sures, the word “publicly * * * would be redundant.”

Pet. 10a—lla. In short, “[a]s the panel opinion noted,

‘filf Congress intended to work such a sweeping

change to our on-sale bar jurisprudence * * * it would

{have done] so by clear language,” not in a manner

“at odds with so many principles of statutory inter-

pretation.” I/bid.

Helsinn moved to stay the mandate. In its order

denying the stay, which Helsinn omits from its ap-

pendix, the panel endorsed “the reasons set forth” in

“Judge O’Malley’s concurrence” and reiterated that

“the decision is a narrow one.” App., infra, 2a. The

Chief Justice likewise denied a stay. 17A785. Teva

has since launched generic palonosetron.

REASONS FOR DENYING THE PETITION

Certiorari should be denied because the

decision below is narrow, fact-bound, and

rife with vehicle problems.

According to Helsinn, this case “involves a secret

sale” and the decision below “swept broadly.” Pet. 22,

33 (quoting Pet. 43a). Both contentions require ig-

noring much of what the Federal Circuit actually

said, and Helsinn’s own concessions. The decision be-

low is expressly narrow, fact-bound, and confined to

the unusual circumstances here; and it is the first to

interpret the AIA’s on-sale bar. Further, the petition

rests on a factual challenge to the court’s conclusion

that Helsinn’s sale was public—a major vehicle prob-

lem. Even if the court had incorrectly resolved that

issue, its decision would not warrant certiorari. Not

surprisingly, no judge below supported rehearing.

14

A. The Federal Circuit limited its decision to

the unusual agreement here and declined

to reach the secret-sale issue.

Judge O’Malley explained that “[ajll that our pan-

el opinion held was that the particular agreement at

issue triggered the on-sale bar.” Pet. 5a. By Hel-

sinn’s lights, that represents only Judge O’Malley’s

view. Pet. 13, 33. Helsinn is mistaken.

First, in language that Helsinn never mentions,

the court limited its ruling to “the circumstances in-

volved here” and “this particular * * * Agreement.”

Pet. 20a, 43a. “We do not find that distribution

agreements will always be invalidating under § 102,”

the court held. Pet. 43a. “We simply find that this

particular Supply and Purchase Agreement is.” /bid.

The court declined “to decide this case more broadly

than necessary,” purposely not reaching “cases in-

volv[ing] a public use where the invention was not

* * * disclosed to the public” or “secret sale[s].” Pet.

37a, 38a, 39a. Helsinn ignores these passages. But

even its own amicus below admitted that the court

“cabin[ed] the decision to the facts.” Dkt. 166 at 4.

Second, the court’s reasoning follows from Hel-

sinn’s unique distribution agreement, its extensive

disclosures, and its exploitation of its product. Ex-

plaining that patentees “must unambiguously place

the invention on sale, as defined by the patent's

claims,” the court observed: “that is clearly the case

here.” Pet. 33a. Helsinn did not merely publicize the

sale’s existence; the sale documents “described the

claimed drug formulation ‘in detail.” Pet. 5a (quoting

Pet. 33a). As Judge O’Malley elaborated:

Helsinn did not just disclose the fact that it had

entered into a supply agreement with MGI; a par-

15

tially-redacted copy of the Agreement itself was

included with MGI’s Form 8-K filing. As the panel

noted, the Agreement described the claimed drug

formulation “in detail.” The Agreement also “ex-

pressly contemplated” the passage of title, and

made clear that Helsinn “commercially marketed

its invention before the critical date.”

Ibid. (citations omitted).

In other words, that a sale is “publicly announced”

is “not dispositive.” Pet. 5a. Rather, courts must also

consider “the nature of the disclosure”’—a “fact-

intensive” inquiry. Pet. 4a, 6a. Thus, to “suggest

that publicly announced agreements will always trig-

ger the on-sale bar” is a “mischaracterization[]” based

“on a single sentence.” Jd. at 4a. Helsinn and its

amici repeat the mischaracterization here.

Third, Helsinn never mentions that the full panel

endorsed Judge O’Malley’s concurrence. In denying

Helsinn’s motion for a stay pending certiorari, the

panel explained: “For the reasons set forth in the ma-

jority opinion, and in Judge O’Malley’s concurrence to

the denial of rehearing, the decision is a narrow one.”

App., infra, 2a. Yet Helsinn accuses Judge O'Malley

of “revisionis[m]” without acknowledging the stay or-

der—or even including it in its appendix. Pet. 33.

And since that order speaks directly to whether the

ruling below is “narrow,” Helsinn’s omission contra-

venes Rule 14.1(i)'s mandate that the appendix “shall

contain” all “relevant opinions [and] orders.”

Finally, no judge even requested a poll on rehear-

ing en banc. Helsinn says the on-sale bar “is proba-

bly the greatest source of litigation involving * * *

challenges to patent validity.” Pet. 28 (citing

Mueller, Patent Law 263 (5th ed. 2016)). But the full

16

quotation says “35 U.S.C. §102(b) (2006) challeng-

es”—meaning pre-AlIA challenges including often-

litigated issues such as anticipation. And even as to

the on-sale bar, the author explains that “many” of

the pre-AlA cases addressed “what state of develop-

ment the invention must be in”—which has nothing

to do with whether the invention is on sale. Mueller,

supra, at 265.

Further, in the years since the AIA passed in

2011, this case “provid[ed] the * * * first potential op-

portunity to determine whether the AIA changed the

law of on sale bar.” Jd. at 333 n.375. It is thus fanci-

ful to call review “urgent.” Pet. 29. Future Federal

Circuit panels remain free to resolve the question

Helsinn (incorrectly) says is presented here. Rather

than credit the prognostications of Helsinn and its

amici, this Court should let that question percolate.

B. This case is a poor vehicle to decide the

scope of the AIA’s on-sale bar.

The opinions below confirm that this case is a poor

vehicle to address the question presented. Yet Hel-

sinn ignores both the court’s narrowing language and

Helsinn’s concession that inventions may be on sale

without “disclosure of ‘the detai's.” Pet. for Reh’g En

Banc 10.

1. The court concluded that Helsinn’s

sale was public, and the petition

contests that factual determination.

a. Having found that this case involves a public

sale, the court below “decline[d] to address” “cases

[that] involved a public use where the invention was

not * * * disclosed to the public,” or “secret sale’ cas-

es.” Pet. 38a, 39a. These passages place in proper

context the court’s statement that “if the existence of

17

the sale is public, the details of the invention need

not be publicly disclosed” to trigger the bar. Pet. 33.

As Judge O’Malley explained, the decision below did

not turn on this “single sentence,” and “the standard

governing secret sales * * * simply is not implicated”

here. Pet. 4a, Ga n.1. In short, the court found that

the sale was public, and there will be time enough for

this Court to address secret sales where actually pre-

sented in a future case.

Helsinn’s petition thus challenges the court’s fac-

tual conclusion that the sale here was “public,” not

“secret.” Pet. 22 (this case “involves a secret sale”).

Attempting to avoid this difficulty, Helsinn suggests

that Teva “conceded that ‘the allegedly invalidating

sale at issue did not make the invention publicly

available.” Pet. 11, 22 (citation omitted). But Teva

conceded no such thing, and Helsinn’s assertion is

supported only by a citation of the government’s brief.

Teva has consistently contended not only that the bar

may be triggered by either public or secret sales, but

that “even if the on-sale bar under the AIA does in-

clude a ‘public’ requirement—which it does not—the

Supply and Purchase Agreement still constitutes an

invalidating offer for sale.” E.g., Dkt. 312 at 3

(D.N.J.); see ibid. (“the plain fact is that the commer-

cial contract between Helsinn and MGI was ‘public”);

Pet. 151a (“Teva additionally argues that Helsinn vio-

lated the on-sale bar even under Helsinn’s proposed

interpretation of the AIA, as the supply agreement

was publicized and MGI is a member of the public.”);

C.A. Reply Br. 12. And even if the court below had

erred in resolving that issue, review is not warranted

to correct “erroneous factual findings.” Rule 10.

b. Nor does the ruling here portend “uncertainty”

at the PTO. Pet. 28. Helsinn never mentions it, but

18

the government, after participating at the panel

stage, did not support en banc review. That is not

surprising. The PTO’s guidance, which lacks the

force of law, states only that a “secret sale or use ac-

tivity does not qualify as prior art” (78 Fed. Reg.

11062 (Feb. 14, 2013)); and the court below found

that the sale “described the claimed drug formulation

‘in detail.” Pet. 5a (quoting Pet. 33a).

As the government’s counsel stated at argument

below, “if this Court concludes that this was in fact a

sale that made the invention available to the public,

that will not cause us any heartburn.”? That is what

the court concluded. But even if it had reached the

secret-sale question, it would not have been disrup-

tive to hold that “on sale,” a term of art, still covers

nonpublic sales.

2. Below, Helsinn forfeited key points

that it asks this Court to take up.

Helsinn’s positions below further confirm that this

case is anything but an “ideal vehicle” to resolve the

question presented. Pet. 32. For example, Helsinn

complains that the court below “completely ignored”

the statutory definition of “claimed invention” (Pet.

22), while ignoring that Helsinn never cited it.

But it is worse than that. Helsinn affirmatively

disclaimed the position “that an invalidating offer re-

quires disclosure of ‘the details of the *** inven-

tion.” Pet. for Reh’g En Banc 10. According to Hel-

sinn, to trigger the on-sale bar, disclosing “the exist-

ence” of the sale was not enough, disclosing “the de-

tails” of the invention was more than enough, and

disclosing the claimed invention without the details

2 https://bit.ly/2I8s3bo (minute 32:52—33: 10).

19

was just right. Helsinn now abandons its “Goldi-

locks” theory—demanding that every detail of “the

claimed invention” be disclosed (Pet. 22) and assail-

ing the statement that “if the existence of the sale is

public, the details of the invention need not be public-

ly disclosed” (id. at 43a). Pet. 4, 12-13, 21, 32-33.

Helsinn should be held to its position below.

Regardless, Helsinn neglects portions of the opin-

ions below explaining how the sale documents here

“described the claimed drug formulation ‘in detail”

(id. at 5a (quoting Pet. 33a)) and “constituted a sale of

the claimed invention” (Pet. 43a). Such passages con-

firm that Helsinn faults the Federal Circuit’s applica-

tion of its legal framework to these facts, not the

framework itself. Review should be denied.

Il. Certiorari should also be denied because,

whether public or secret, the invention here

was on sale.

Certiorari should also be denied because, whether

the sale here was “public” or “secret,” the decision be-

low is firmly grounded in the AIA’s text, structure,

history, and purpose. See Chevron, 467 U.S. at 842

(“this Court reviews judgments, not opinions”).

A. The AIA’s plain text confirms that

Congress did not change the settled

meaning of “on sale,” which Helisinn

conceded was a term of art.

1. Under the on-sale bar’s plain terms, offering to

sell an invention will start the one-year clock to apply

for a patent regardless of whether the offer discloses

all “details.” Pet. 40a—43a. A “sale” is a “transfer of

property for money or credit” (Random House Web-

ster’s Unabridged Dictionary 1693 (2d ed. 2001)), a

definition that covers private transfers; and myriad

20

courts so held before the ALA. And as the court below

recognized: “If Congress intended * * * a sweeping

change to our on-sale bar jurisprudence,” “it would do

so by clear language.” Pet. 43a.

After all, Congress “does not alter the fundamen-

tal details of a regulatory scheme in vague terms or

ancillary provisions—it does not, one might say, hide

elephants in mouseholes.” Whitman v. Am. Trucking

Ass’n, 531 U.S. 457, 468 (2001). Yet if Helsinn is cor-

rect, Congress “hid[] an awfully big elephant in a tiny

mousehole,” as it reads “a ‘residual clause’ and a few

passages of legislative history to overturn nearly two

centuries of consistent U.S. patent policy.” Merges &

Duffy, Patent Law and Policy 360 (7th ed. 2017). As

Helsinn’s own authority admits, “the AIA did not sub

silentio overrule th{is] well-established case law.”

Mueller, supra, at 331.

By adding “otherwise available to the public” to

§102, Congress simply confirmed that patents will

always be barred by public disclosures—even if made

orally, or via new technologies, rather than, as before,

in a “printed publication.” The lower courts were di-

vided on that question, so Congress had reason to ad-

dress these “known unknowns.” See, e.g., In re

Klopfenstein, 380 F.3d 1345, 1349 n.4 (Fed Cir. 2004)

(oral presentations); Diomed, Inc. v. Angiodynamics,

Inc., 450 F. Supp. 2d 130, 141 (D. Mass. 2006) (video).

Although Helsinn never mentions it, Helsinn con-

ceded below that “on sale” was a “term|] of art”—an

“established term[]” that has always been listed to-

gether with “public” activities, yet also captured non-

public sales. C.A. Br. 41. The court agreed, citing

numerous authorities. Pet. 35a n.7, 39a—43a. And if

21

“on sale” covers confidential sales, the claimed inven-

tion need not be made public.

This reading is hardly “untethered to the statuto-

ry text” (Pet. 3); it reflects the natural, historic mean-

ing of “on sale.” After all, “when Congress employs a

term of art, it presumably knows and adopts the clus-

ter of ideas that were attached.” Hoeper, 134 S. Ct. at

861-862. Had Congress wished to overrule settled

law, it could have said “publicly on sale.” Including

some form of the word “public” is how Congress lim-

ited the surrounding bars, and “Congress generally

acts intentionally when it uses particular language in

one [part] of a statute but omits it in another”’—

particularly where, as here, the disparate terms ap-

pear “in the same sentence.” MacLean, 135 S. Ct. at

919. Further, public sales are already covered by the

public use bar. E.g., Egbert, 104 U.S. at 336 (selling

“to another * * * without limitation” is public use).

2. Helsinn’s sole textual response—that “other-

wise available to the public” is a “series modifier” re-

stricting the whole list to public activities (Pet. 15—

16)—creates glaring redundancies. A clause is a se-

ries modifier only if it “is applicable as much to the

first and other words as to the last.” Paroline, 134

S. Ct. at 1721. But as Judge O'Malley explained,

§102(a)’s catchall clause is not equally applicable “to

the first and other words as to the last,” because all

the words except two—“on sale”—are inherently pub-

lic or pre-labeled as public. Pet. 8a—9a & n.2.

The AIA bars a patent if the invention “was pa-

tented, described in a printed publication, or in public

use, on sale, or otherwise available to the public”

(emphases added). “Patented” needed no modifica-

tion because “[p]atents are public records.” Boyden v.

22

Burke, 55 U.S. 575, 582 (1852). So too with “printed

publications” and items “in public use.” Klopfenstein,

380 F.3d at 1348 (“the key inquiry” is whether refer-

ences are “publicly accessible”). To read “otherwise

available to the public” as modifying these terms cre-

ates “hopeless[{] redundan|cies].” Lockhart v. United

States, 136 S. Ct. 958, 965 (2016)). And a clause is

not a series modifier where “it takes more than a lit-

tle mental energy to process the individual entries in

the list, making it a heavy lift to carry the modifier

across them all.” /d. at 963.

According to Helsinn, United States v. Standard

Brewery, Inc., 251 U.S. 210 (1920), shows otherwise.

Pet. 16. The items listed there, however, were not

pre-labeled. Rather, the statute referred to “beer,

wine, or other intoxicating [beverages].” 251 U.S. at

218. For that statute to be analogous to §102(a), it

would have to refer to “intoxicating wine”; and “beer”

would have to be a term of art that captured nonalco-

holic beer. That is the situation here, where multiple

terms are pre-labeled “public” and “on sale” is a term

of art covering nonpublic sales.

3. Recognizing these textual difficulties, Helsinn

initially omits “patents” and “described in a printed

publication” from its quotation of the statute (Pet. 4),

but ultimately concedes that such disclosures “are, by

their very nature, publicly available.” Pet. 15. Not to

worry, says Helsinn—the backwards work of “other-

wise available” stops abruptly at the “or” in the se-

ries, such that the modifier applies only to a subse-

ries in the list—which Helsinn dubs “the final three-

item series.” Pet. 18 n.4. But that is just the kind of

mental gymnastics that show why §102(a)’s catchall

clause is not a series modifier. Carrying the modifier

23

across the list is such a “heavy lift” (Lockhart, 136 S.

Ct. at 963) that Helsinn must cut down the list.

Even this drastic measure, moreover, cannot save

Helsinn’s interpretation. Because items in “public

use” are already public, applying “otherwise available

to the public” to Helsinn’s preferred subseries creates

a “hopeless{] redundan|[cy]” (id. at 965)}—“in public

use available to the public.” Helsinn answers that,

before the ALA, “public use” was interpreted “to in-

clude certain types of secret uses.” Pet. 17. Not so.

This Court’s longstanding test for “public use” is

providing “to another * * * without limitation or re-

striction”—“such use is public.” Egbert, 104 U.S. at

336. And if “public use” covered secret uses, it would

be odd for Congress to change the statute’s meaning

by repeating that very word (“public”) in a later

catchall phrase.

No matter how Helsinn slices §102(a), it cannot

make “on sale” mean “publicly on sale.” Congress did

not say that. And Helsinn’s contrary reading—that

Congress changed a term of art with a carom shot, by

adding a later catchall phrase—creates incurable “re-

dundancies.” Pet. 8a—9a & n.2 (O'Malley, J.).

4. Rather than modifying the preceding series,

the catchall phrase in §102(a) falls within the default

rule that a “limiting clause” applies “only to the last

antecedent.” Barnhart v. Thomas, 540 U.S. 20, 27

(2003). That is, “to the public” limits only “otherwise

available.” Helsinn says the issue “is not whether ‘to

the public’ modifies ‘otherwise available’ (it does), but

whether the whole phrase “or otherwise available to

the public” informs the meaning of the two parallel

phrases that precede it (again, it does).” Pet. 17. But

Barnhart rejected an indistinguishable attempt to

24

rewrite the first half of a sentence based on a modifi-

er attached to the second half. Like Helsinn’s reli-

ance on “otherwise,” the argument in Barnhart de-

pended on over-reading the word “other.”

Barnhart involved a catchall clause in a statute

governing disability benefits:

An individual shall be determined to be under

a disability only if * * * he is not only unable to

do his previous work but cannot * * * engage in

any other kind of substantial gainful work

which exists in the national economy|.}

42 U.S.C. §423(d)(2)(A). The agency refused to label

an applicant disabled because she could do her previ-

ous work, declining to inquire whether that work still

“exist[ed] in the national economy.” 540 U.S. at 22.

That is, the agency would not read “which exists in

the national economy” to modify “previous work.” /d.

at 22-23.

This Court sided with the agency, holding that the

“limiting clause” (“which exists in the national econ-

omy”) applied only to the “last antecedent” (“any oth-

er kind of substantial gainful work”). 540 U.S. at 26.

In so holding, the Court followed precedent that simi-

larly read another catchall clause. Ibid. (citing FTC

v. Mandel Bros., 359 U.S. 385, 389 & n.4 (1959),

which held “that the ‘limiting clause is to be applied

only to the last antecedent,” which did not include

any item in the preceding list). This was not just a

matter of deferring to the agency; the Court endorsed

the agency’s reasoning with an illustration of its own.

Specifically, the Court cited “the case of parents

who, before leaving their teenage son alone in the

house for the weekend, warn him, ‘You will be pun-

ished if you throw a party or engage in any other ac-

25

tivity that damages the house.” 540 U.S. at 27. The

Court continued: “If the son nevertheless throws a

party and is caught, he should hardly be able to avoid

punishment by arguing that the house was not dam-

aged. The parents proscribed (1) a party, and (2) any

other activity that damages the house. As far as ap-

pears from what they said, their reasons for prohibit-

ing the home-alone party may have had nothing to do

with damage to the house—for instance, the risk that

underage drinking or sexual activity would occur.”

Ibid. “And even if their only concern was to prevent

damage,” the parents “might have wished to preclude

all argument,” “by specifying and categorically pro-

hibiting the one activity—-hosting a party—that was

most likely to cause damage.” /d. at 28.

As in Barnhart and Mandel, the phrase “to the

public” modifies only the last antecedent-——“otherwise

available.” Congress had powerful reasons for with-

holding patents on items “on sale” privately; other-

wise, inventors could extend their monopolies by

gaming the system. I/nfra at 30-32. And even if

Congress aimed only to encourage inventors to publi-

cize their discoveries, Congress may have wished to

preclude all argument by categorically barring pa-

tents after all sales, public or private. Certiorari is

unwarranted.

B. Helsinn has no answer for §102(b), which

Helsinn’s reading of §102(a) also runs headlong

i.vo the Act’s next subsection—which distinguishes

between “disclosures” and “public disclosures.” Spe-

cifically, §102(b)(1) creates “[e]xceptions” to §102(a)—

including a grace period whereby “[a] disclosure made

1 year or less before” the filing date “shall not be pri-

or art” if either “(A) the disclosure was made by the

inventor”; or “(B) the subject matter disclosed had,

before such disclosure, been publicly disclosed by the

inventor.” (Emphasis added.) Thus, an inventor's

“[‘disclosure’] will not bar her from patenting * * *

within a year after that disclosure”; and an inventor's

“public disclosure” immunizes her filing “from all

prior art, not just [her own].” Lemley, Does “Public

Use” Mean the Same Thing It Did Last Year?, 93 Tex.

L. Rev. 1119, 1128 (2015).

If, as Helsinn posits, all §102(a) disclosures are

“public,” then distinguishing between “disclosures”

and “public disclosures” is incoherent. But if “public

use’ and ‘on sale’ have the same meaning they have

always had” —if “on sale” captures confidential sales

“the distinction between disclosures and public dis-

closures makes sense.” Ibid. Why? Because “disclo-

sures’ means all types of ‘prior art”—‘“includ[ing]

some that are not public.” Jbid.; see 42 Intellectual

Property Professors’ C.A. Amicus Br. (Dkt. 43) 2—5.

Further, the distinction between “public disclo-

sures” and “disclosures” goes to §102(b)(1)'s “animat-

ing principle”—namely, that “to earn a grace period

as against a third party who has begun to bring an

invention to the attention of the public, an inventor

must confer some benefit on the public.” Merges, Pri-

ority and Novelty Under the AIA, 27 Berkeley Tech.

L.J. 1023, 1042 (2012). And that benefit must be “a

full-on public disclosure.” Jbid. Helsinn’s reading

thus guts “the essence of the new third-party grace

period.” /bid.; see Merges & Duffy, supra, at 360-361.

Helsinn and its amici have no comprehensible an-

swer. Helsinn speculates as to why “Congress did not

27

use the word ‘publicly” in parts of §102(b). Pet. 19

(emphasis added); see ibid. (‘Congress had no need to

use the term ‘public’ to describe those disclosures”).

Yet Helsinn never explains why Congress did refer to

“public disclosure|s|"—except to say that such disclo-

sures are “different” and “antecedent.” Pet. 19. How?

Helsinn never says. Instead, it declares that “the

term ‘public[{]’ in that provision does nothing to un-

dermine the proposition that all Section 102(a)(1) pri-

or art must be ‘available to the public.” Pet. 19-20.

That is merely a conclusion.

Helsinn postulates that a mere “disclosure” (un-

like a “public disclosure”) might refer to patent appli-

cations. Pet. 20 n.5. But Congress devoted the very

next subsection (§102(b)(2)) to the effect of “Disclo-

sures appearing in applications and patents.” That

subsection would be superfluous if §102(b)(1) cap-

tured such applications.

In short, Helsinn’s reading gives no meaning to

“public disclosure.” That violates the “fundamental

canon” that “the words of a statute must be read in

their context and with a view to their place in the

overall statutory scheme”—as a “coherent,” “harmo-

nious whole.” FDA v. Brown & Williamson Tobacco

Corp., 529 U.S. 120, 133 (2000) (quotations omitted).

C. Congress repeatedly declined to adopt

bills that did what Helsinn wishes.

The AIA’s drafting history further supports the

decision below, as Congress repeatedly rejected bills

that did what Helsinn wishes. Ignoring this, Helsinn

calls the decision below “indefensible,” “profoundly

flawed,” and “outmoded” (Pet. 15, 34) for considering

floor statements. But it was Helsinn that said “[the

court] should look to the floor statements.” Pet. 36a.

28

And both the drafting history and floor statements

support the decision below.

1. As Judge O'Malley observed, “Congress several

times considered, but rejected, the very changes to

the on-sale bar Helsinn urges us to conclude were ac-

tually made.” Pet. 12a. Early bills proposed repeal-

ing the on-sale bar, thus “eliminating confidential!

sales” as “grounds for invalidity.” 154 Cong. Rec.

22,631 (2008) (Sen. Kyl). But consider how the legis-

lation evolved:

2005 “(1) the claimed invention was patented,

described in a printed publication, or oth-

erwise publicly known” (H.R. 2795)

2008 “(1) the claimed invention was patented,

described in a printed publication, or oth-

erwise made available to the public (other

than through testing undertaken to reduce

the invention to practice) (S. 3600)

Thus, from 2005 to 2008, the bills eliminated the on-

sale bar. By 2011, however, it was back to stay,

prompting Senator Kyl and two others to object that

Congress had put “non-public” uses back into the def-

inition of prior art. S. Rep. No. 111-18, at 60 (2009).

After losing in committee, some senators took to

the floor, announcing that the new §102 did not mean

what it said. But their statements are “strategic ma-

nipulations of legislative history to secure results

[members] were unable to achieve through the statu-

tory text.” Exxon Mobil Corp. v. Allapattah Services,

Inc., 545 US 546, 568 (2005); see Merges & Duffy, su-

pra, at 361 (calling Senator Kyl’s statements “wishful

thinking”). Courts may “not assume that Congress

intended to enact statutory language that it has ear-

lier discarded.” Chickasaw Nation v. United States,

534 U.S. 84, 93 (2001). Rather, when Congress re-

jects “the very language that would have achieved the

result [that a party] urges,” that “weighs heavily

against [its] interpretation.” Hamdan v. Rumsfeld,

548 U.S. 557, 579-580 (2006).

2. Rather than grapple with the drafting history,

Helsinn presses floor statements (Pet. 21), as it did

below, prompting Teva to reply that “the statutory

text” is “authoritative” (C_A. Br. 21-22). The Federal

Circuit agreed that “floor statements are typically not

reliable,” but considered them at Helsinn’s insistence.

Pet. 36a. The court's caution was warranted, as

“even a bill’s sponsor[s views] are not controlling.”

Mims v. Arrow Fin. Servs., LLC, 132 8. Ct. 740, 752

(2012); cf. Exxon, 545 U.S. at 568 (same for “commit-

tee reports”).®

Even the floor statements, however, “[a]t most”

voiced concern with “extreme” cases holding “certain

secret uses to be invalidating under the ‘public use’

[bar]”; they “do not identify any sale cases that would

be overturned.” Pet. 37a—38a. No legislators “in-

5 Helsinn cites the House Committee Report (Pet. 7), but

it referenced Senate floor statements for the unrelated fact

that the “current law’s grace period’ ‘is maintained.” H.R.

Rep. No. 112-98, at 43 & n.20 (2011).

30

dicatjed] that they intended to allow parties who

have exploited inventions as trade secrets for years to

be able nonetheless to patent those inventions.”

Merges & Duffy, supra, at 361. Further, “[e]ven if

the floor statements were intended to overrule thie]

secret or confidential sale cases,” “that would have no

effect here since those cases were concerned entirely

with whether the existence of a sale or offer was pub-

lic.” Pet. 38a. Thus, Helsinn’s approach to legislative

history—cherry-picking floor statements while ignor-

ing the drafting history—fails on its own terms.

D. Two centuries of this Court’s precedents

and the Constitution confirm that the on-

sale bar is triggered by all types of sales.

Under centuries of precedent, the decision below

would be correct even if the sale here were secret.

This Court has repeatedly held that the Patent Act

and the Constitution bar commercially exploiting in-

ventions before patenting them.

In the leading decision, which predates the on-sale

bar, this Court invalidated a patent on a process of

making hose with improved joints, where the inven-

tor had earlier authorized sales cf the hose. Pennock,

27 U.S. at 3, 9. Although the sales did not disclose

the claimed process, the Court held that where an in-

ventor allows the invention “to be publicly sold for

use, before he makes application for a patent,” that

“creates a disability to comply with the terms and

conditions on which [the government] is authorized to

grant him a patent.” /d. at 24.

The Court relied heavily on the Constitution,

which requires reading the patent laws to “promote

the progress of science” and secure patents only for

“limited times.” Id. at 16 (Story, J.) (quoting U.S.

31

Const. Art. I, § 8, cl. 8). If inventors could profit from

their inventions while “hold{ing] back from the

knowledge of the public the[ir] secrets”—but patent

them later—that “would materially retard the pro-

gress of science” and “give a premium to those who

should be least prompt to communicate their discov-

eries.” Id. at 19.

Later, in Kendall, this Court held that an “inven-

tor who designedly, and with the view of applying

{his invention] indefinitely and exclusively for his

own profit, withholds his invention from the public,

comes not within the policy or objects of the Constitu-

tion or acts of Congress.” 62 U.S. at 328. Further,

Pfaff reaffirmed Pennock and later cases, stating that

“[a]ny attempt to use [an invention] for a profit, and

not by way of experiment, for a longer period than

[the prescribed grace period] before the application,

would deprive the inventor of his right to a patent.”

525 U.S. at 65 (quoting Elizabeth v. Am. Nicholson

Pavement Co., 97 U.S. 126, 137 (1877)). Thus, “it is a

condition upon an inventor's right to a patent that he

shall not exploit his discovery competitively after it is

ready for patenting; he must content himself with ei-

ther secrecy, or legal monopoly.” Pfaff, 525 U.S. at 68

(quoting Metallizing, 153 F.2d at 520).

Helsinn never acknowledges that its reading of

the AIA would require overruling the Pennock line of

cases and eviscerate the Patent Act’s only language

preventing private commercial exploitation of inven-

tions before patenting. See Pet. 39a—40a (discussing

Pennock); Pet. 13a—14a (O'Malley, J.) (citing Pfaffs

statement that “the ‘overriding’ concern [of the on-

sale bar] is the risk that an inventor will commercial-

ly exploit his invention beyond the statutory term”);

Continental Plastics, 141 F.3d at 1079. Indeed, Hel-

32

sinn attempts to recast the on-sale bar as existing

solely to protect what is “in the public domain.” Pet.

27. But under this Court's longstanding view, ex-

pressed in cases such as Pfaff, the on-sale bar pre-

vents exactly what Helsinn attempted to do here

extend its commercial monopoly.

Helsinn assures the Court that “under the AIA’s

first-inventor-to-file system,” “[ajn inventor cannot

secretly exploit its invention while waiting for compe-

tition to come along because the competition might

beat the first inventor to the Patent Office.” Pet. 24.

As Pennock and Metallizing confirm, however, many

inventions—especially manufacturing processes—are

“easily concealled].” Lemley, supra, at 1132. Thus,

inventors “could keep their process inventions secret

for years or even decades and then surface and file a

patent application.” Jbid. The prospect of that revo-

lutionary change in the law may explain the presence

of Helsinn’s pro-patentee amici—most of whom are

industry stakeholders who stand to gain from indefi-

nite monopolies. Indeed, even Congressman Smith is

represented by Eli Lilly’s former general counsel.

“If one of [two plausible statutory constructions]

would raise * * * constitutional problems, the other

should prevail.” Clark v. Martinez, 543 U.S. 371,

380-381 (2005). Here, allowing inventors to exploit

inventions privately before patenting them would up-

end venerable policy and violate the Constitution.

E. Helsinn’s policy arguments do not

support review.

Helsinn’s policy arguments would not justify cer-

tiorari even if they had merit. But they do not

1. Helsinn says the ruling below conflicts with

Congress's elimination of “territorial restrictions”

33

that “restricted disqualifying sales to those occurring

in the United States.” Pet. 25. That is no reason to

think the meaning of “sale” changed. Secret overseas

sales will rarely invalidate patents, and regardless

the geographic limitation is unnecessary “[g]iven ad-

vances in communications technology and transpor-

tation” that provide knowledge “about activities in a

foreign land.” H.R. Rep. No. 110-314, at 57 (2007).

2. Helsinn complains that the ruling could harm

“small” companies that rely on pre-launch confiden-

tial distribution agreements and have regulatory dis-

closure obligations. Pet. 5, 29-31. But even if Hel-

sinn were small—it has over $500 million in annual

revenue and products “in approximately 190 coun-

tries”*—such companies can avoid the bar by apply-

ing for patents for up to a year after any sale. See al-

80 Pet. 7a (O'Malley, J.). As the court below held, the

“completion of Phase III studies and final FDA ap-

proval are not pre-requisites for the invention here to

be ready for patenting”; and Helsinn’s data “showed

that the invention worked,” from “the 1995 Phase II

trial” onward. Pet. 47a, 51a. Thus, Helsinn’s difficul-

ty was caused by its own delay.

3. Helsinn next says the decision, by requiring

searches for foreign sales, interferes with Congress's

desire for “more efficient” post-grant review. Pet. 25.

But Congress’s purpose in amending a ground of in-

validity applied primarily by courts and examiners

was not driven by what would be most convenient for

post-grant proceedings, and courts are not “simplisti-

cally to assume that whatever furthers” one “[statu-

‘ https://www.helsinn.com/news-and-events/helsinn-

pharmaceuticals-beijing-co-|td-opens-office-in-shanghai-

china/.

34

tory] objective must be the law.” Rodriguez v. United

States, 480 U.S. 522, 526 (1987).

4. Nor will the decision below thwart Congress's

goal of “harmoniz{ing]” prior-art rules with interna-

tional practice. Pet. 23. The AIA harmonized U.S.

and foreign law in some ways, but not others. For

example, some “foreign patent systems” lack “grace

period|s],” but Congress provided “a significant num-

ber” of grace periods. Merges, supra, at 1032 & n.25,

1030. Finally, it harmonizes U.S. and foreign law to

read the “otherwise available” clause to capture dis-

closures not “described in a printed publication.”

CONCLUSION

For the foregoing reasons, the petition for certio-

rari should be denied.

Respectfully submitted.

GEORGE C. LOMBARDI STEFFEN N. JOHNSON

JULIA M. JOHNSON Counsel of Record

TYLER G. JOHANNES ANDREW C. NICHOLS

Winston & Strawn LLP — JOVIAL WONG

35 W. Wacker Drive CHRISTOPHER E. MILLS

Chicago, IL 60601 Winston & Strawn LLP

(312) 558-5600 1700 K Street, N.W.

Washington, DC 20006

(202) 282-5000

sjohnson@winston.com

Counsel for Respondents

MAY 2018

APPENDIX

la

APPENDIX

NOTE: This order is nonprecedential.

United States Court of Appeals

for the Federal Circuit

HELSINN HEALTHCARE §&.A.,

Plaintiffs-Appellees

Vv.

TEVA PHARMACEUTICALS USA, INC., TEVA

PHARMACEUTICAL INDUSTRIES, LTD.,

Defendants-Appellants

2016-1284, 2016-1787

Appeals from the United States District Court for the

District of New Jersey in Nos. 3:11-cv-03962-MLC-

DEA, 3:11-cv-05579-MLC-DEA, 3:13-cv-05815-MLC-

DEA, Judge Mary L. Cooper.

ON MOTION TO STAY MANDATE

Before DYK, MAYER, and O'MALLEY, Circuit

Judges. PER CURIAM.

ORDER

The motion to stay is denied. The parties agree

that granting a stay requires finding, at least, (1) “a

reasonable probability that the Supreme Court will

grant certiorari; [and] a reasonable possibility that at

least five Justices would vote to reverse this Court's

judgment,” and (2) “a likelihood of irreparable injury”

to the moving party. Nara v. Frank, 494 F.3d 1132,

1133 (3d Cir. 2007); see also Doe v. Miller, 418 F.3d

950, 951 (8th Cir. 2005); United States ex rel. Chandler

v. Cook County, 282 F.3d 448, 450 (7th Cir. 2002) (Rip-

ple, J., in chambers).

2a

For the reasons set forth in the majority opinion,

and in Judge O’Malley’s concurrence to the denial of

rehearing, the decision is a narrow one. There also has

been no showing of irreparable injury. See Teva

Pharm. USA, Inc. v. Sandoz, Inc., 134 8. Ct. 1621,

1621 (2014) (Roberts, Circuit J.)

IT IS ORDERED THAT:

The motion is denied. Pursuant to Rule 41(b) the

mandate will issue seven days from the date of this or-

der.

FOR THE COURT

January 22, 2018 /s/ Peter R. Marksteiner

Peter R. Marksteiner

Clerk of Court