Amicus Curiae Brief — Amgen Inc., et al., Petitioners v. Sanofi, et al.

No. 21-757

In the Supreme Court of the United States

AMGEN INC., ET AL., PETITIONERS

v.

SANOFI, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF FOR THE UNITED STATES AS AMICUS CURIAE

ELIZABETH B. PRELOGAR

Solicitor General

Counsel of Record

BRIAN M. BOYNTON

Principal Deputy Assistant

Attorney General

MALCOLM L. STEWART

Deputy Solicitor General

AUSTIN L. RAYNOR

Assistant to the Solicitor

General

DANIEL TENNY

BRIAN J. SPRINGER

Attorneys

Department of Justice

Washington, D.C. 20530-0001

SupremeCtBriefs@usdoj.gov

(202) 514-2217

QUESTIONS PRESENTED

The Patent Act of 1952, 35 U.S.C. 1 et seq., requires

a patent to describe “the invention,” and “the manner

and process of making and using it, in such full, clear,

concise, and exact terms as to enable any person skilled

in the art * * * to make and use the same.” 35 U.S.C.

112(a). The questions presented are as follows:

1. Whether the court of appeals gave insufficient

weight to the jury’s verdict in affirming the district

court’s grant of judgment as a matter of law based on

lack of enablement.

2. Whether the court of appeals correctly

determined that the challenged claims are not

adequately enabled.

(I)

TABLE OF CONTENTS

Page

Interest of the United States....................................................... 1

Statement ...................................................................................... 1

Discussion ...................................................................................... 8

A. Petitioners’ argument that enablement is a jury

question does not warrant further review .................... 9

B. Petitioners’ challenge to the court of appeals’

enablement holding does not warrant further

review .............................................................................. 16

Conclusion ................................................................................... 22

TABLE OF AUTHORITIES

Cases:

Amgen Inc. v. Sanofi,

872 F.3d 1367 (Fed. Cir. 2017), cert. denied,

139 S. Ct. 787 (2019) ..................................................... 3, 4, 5

Battin v. Taggert, 58 U.S. (17 How.) 74 (1854) ............. 12, 14

Chandris, Inc. v. Latsis, 515 U.S. 347 (1995) ..................... 10

Consolidated Elec. Light Co. v.

McKeesport Light Co., 159 U.S. 465 (1895)................ 16, 17

Crown Operations Int’l, Ltd. v. Solutia Inc.,

289 F.3d 1367 (Fed. Cir. 2002) ............................................. 6

Erfindergemeinschaft UroPep GbR v.

Eli Lilly & Co., 276 F. Supp. 3d 629

(E.D. Tex. 2017), aff ’ d, 739 Fed. Appx. 643

(Fed. Cir. 2018), cert. denied,

140 S. Ct. 449 (2019) ........................................................... 21

Google LLC v. Oracle Am., Inc.,

141 S. Ct. 1183 (2021) ......................................................... 12

Hana Fin., Inc. v. Hana Bank,

574 U.S. 418 (2015)........................................................ 11, 13

(III)

IV

Cases—Continued:

Page

Holland Furniture Co. v. Perkins Glue Co.,

277 U.S. 245 (1928).............................................................. 17

Idenix Pharm. LLC v. Gilead Scis. Inc.,

941 F.3d 1149 (Fed. Cir. 2019), cert. denied,

141 S. Ct. 1234 (2021) ......................................................... 15

J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred

Int’l, Inc., 534 U.S. 124 (2001) ............................................. 2

Markman v. Westview Instruments, Inc.,

517 U.S. 370 (1996)........................................................ 11, 12

Martek Biosciences Corp. v. Nutrinova Inc.:

520 F. Supp. 2d 537 (D. Del. 2007),

aff ’ d in part and rev’d in part,

579 F.3d 1363 (Fed. Cir. 2009) ................................. 15

579 F.3d 1363 (Fed. Cir. 2009) ....................................... 15

McRO, Inc. v. Bandai Namco Games Am. Inc.,

959 F.3d 1091 (Fed. Cir. 2020) ..................................... 21, 22

Minerals Separation, Ltd. v. Hyde,

242 U.S. 261 (1916)........................................................ 19, 20

Mowry v. Whitney,

81 U.S. (14 Wall.) 620 (1872) .............................................. 20

National Recovery Techs., Inc. v.

Magnetic Separation Sys., Inc., 166 F.3d 1190

(Fed. Cir. 1999) ................................................................... 22

Neely v. Martin K. Eby Const. Co.,

386 U.S. 317 (1967).............................................................. 13

O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1854) .................... 2

Seymour v. Osborne,

78 U.S. (11 Wall.) 516 (1871) .............................................. 13

Teva Pharm. USA, Inc. v. Sandoz, Inc.,

574 U.S. 318 (2015).............................................................. 11

Trustees of Bos. Univ. v. Everlight Elecs. Co.,

896 F.3d 1357 (Fed. Cir. 2018) ........................................... 15

United States v. Gaudin, 515 U.S. 506 (1995) .................... 11

V

Cases—Continued:

Page

Wands, In re, 858 F.2d 731

(Fed. Cir. 1988) ..........................................2, 3, 10, 11, 17, 18

Will of Bingham, In re, 325 U.S. 365 (1945) ....................... 10

Wood v. Underhill,

46 U.S. (5 How.) 1 (1846) ...............................2, 10, 13, 14, 20

Wyeth & Cordis Corp. v. Abbott Labs.,

720 F.3d 1380 (Fed. Cir. 2013) ........................................... 21

Constitution, statutes, and rule:

U.S. Const. Art. I, § 8, Cl. 8 .................................................... 1

Patent Act of 1952, 35 U.S.C. 1 et seq. ................................... 1

35 U.S.C. 112(a) ................................................. 2, 9, 10, 16

35 U.S.C. 112(b) ........................................................... 2, 11

Fed. R. Civ. P. 50(a)(1) ...................................................... 6, 13

Miscellaneous:

U.S. Patent:

No. 8,030,457 (filed Oct. 4, 2011) ...................................... 3

No. 8,062,640 (filed Nov. 22, 2011) ................................... 3

No. 8,829,165 (filed Sept. 9, 2014) .................................... 4

No. 8,859,741 (filed Oct. 14, 2014) .................................... 4

In the Supreme Court of the United States

No. 21-757

AMGEN INC., ET AL., PETITIONERS

v.

SANOFI, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF FOR THE UNITED STATES AS AMICUS CURIAE

INTEREST OF THE UNITED STATES

This brief is submitted in response to the Court’s

order inviting the Solicitor General to express the views

of the United States. In the view of the United States,

the petition for a writ of certiorari should be denied.

STATEMENT

1. The Constitution authorizes Congress “[t]o promote the Progress of Science and useful Arts, by securing for limited Times to * * * Inventors the exclusive

Right to their * * * Discoveries.” U.S. Const. Art. I,

§ 8, Cl. 8. The Patent Act of 1952 (Patent Act) specifies

patentable subject matter, conditions for patentability,

and the requirements for a patent application. See 35

U.S.C. 1 et seq.

Among other things, a patent application must contain a “specification” that includes “one or more claims

(1)

2

particularly pointing out and distinctly claiming the

subject matter which the inventor or a joint inventor regards as the invention.” 35 U.S.C. 112(b). The specification must also describe “the invention, and * * * the

manner and process of making and using it, in such full,

clear, concise, and exact terms as to enable any person

skilled in the art to which it pertains * * * to make and

use the same.” 35 U.S.C. 112(a).

The enablement requirement ensures that a patentee “can lawfully claim only what he has invented

and described.” O’Reilly v. Morse, 56 U.S. (15 How.)

62, 121 (1854). It also ensures that the public will be

able to use the invention after the patentee’s term of exclusivity expires. See J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124, 142 (2001) (“The

disclosure required by the Patent Act is ‘the quid pro

quo of the right to exclude.’ ”) (citation omitted).

In assessing whether a claim is properly enabled,

this Court has asked whether a person “skilled” in the

relevant art, acting with the benefit of the patent’s specification, would need to conduct “experiments of his

own” to make and use the invention. Wood v. Underhill,

46 U.S. (5 How.) 1, 4 (1846). The Federal Circuit has

further elaborated that a patent claim is invalid for lack

of enablement when it requires “undue experimentation,” a standard that involves “weighing many factual

considerations.” In re Wands, 858 F.2d 731, 737 (1988).

The Wands court articulated various factors to inform

such determinations: (1) “the quantity of experimentation necessary,” (2) “the amount of direction or guidance presented,” (3) “the presence or absence of working examples,” (4) “the nature of the invention,” (5) “the

state of the prior art,” (6) “the relative skill of those in

3

the art,” (7) “the predictability or unpredictability of the

art,” and (8) “the breadth of the claims.” Ibid.

2. The patents at issue in this case cover medications

that help control blood levels of low-density lipoprotein

(LDL) cholesterol, which contributes to plaque buildup

on the walls of blood vessels and increases the risk of

heart disease and stroke. See Pet. App. 3a; Pet. 7. Receptors on the liver are responsible for removing LDL

cholesterol from the bloodstream. Ibid. But a naturally

occurring protein called proprotein convertase subtilisin/kexin type 9, or PCSK9, can disrupt this process by

binding to LDL receptors, causing their eventual destruction. Ibid.; see, e.g., C.A. App. 3681.

Like all proteins, PCSK9 is composed of amino acids

(i.e., “residues”), and a particular region of PCSK9’s

amino-acid structure is responsible for binding to LDL

receptors. See Pet. App. 27a & n.6; C.A. App. 3795. Another type of protein, an antibody, may also bind to that

region on PCSK9. When it does, the antibody may prevent PCSK9 from binding to LDL receptors, thereby

“allowing LDL receptors to continue regulating the

amount of circulating LDL cholesterol.” Pet. App. 3a;

Pet. 7.

In October 2011, petitioners obtained a patent covering the amino-acid sequence of a specific antibody that

binds to the relevant region of PCSK9 and prevents it

from binding to LDL receptors. See U.S. Patent No.

8,030,457, fig. 3JJ (filed Oct. 4, 2011). One month later,

respondents obtained a patent covering a different antibody, also identified by its amino-acid sequence, that

performs a similar function. See U.S. Patent No.

8,062,640 (filed Nov. 22, 2011); Amgen Inc. v. Sanofi,

872 F.3d 1367, 1372 (Fed. Cir. 2017), cert. denied, 139

S. Ct. 787 (2019). Petitioners and respondents later

4

began marketing their respective antibodies. See

Amgen Inc., 872 F.3d at 1371-1372.

This case does not involve petitioners’ patent for a

specific antibody. Instead, it involves patents that petitioners obtained in 2014 claiming any antibody that performs a particular function. At issue are Claims 19 and

29 of U.S. Patent No. 8,829,165 (filed Sept. 9, 2014) (’165

patent) and Claim 7 of U.S. Patent No. 8,859,741 (filed

Oct. 14, 2014) (’741 patent). See Pet. App. 19a-20a. Together, they “claim antibodies that bind to one or more

of ” the specified residues in the key region “of the

PCSK9 protein and block PCSK9 from binding to LDL

receptors.” Id. at 4a.

The two patents share a common specification, which

discloses the amino-acid sequences of 26 antibodies and

depicts the three-dimensional structure of two of them.

Pet. App. 4a; Amgen Inc., 872 F.3d at 1371-1372. The

patents also describe processes that can be used to identify other antibodies that perform the claimed functions. A practitioner could generate a random pool of

antibodies (such as by injecting mice with PCSK9), then

test those antibodies to determine whether they bind to

PCSK9 and block its interaction with LDL receptors.

See Pets. C.A. Br. 13-16. Alternatively, a practitioner

could selectively replace the amino acids in one of the

antibodies identified in the patent with other amino acids exhibiting common properties—a process known as

“conservative substitution[ ]”—then test whether the

resulting antibody still achieves the desired functions.

Id. at 16-17; see Pet. App. 15a, 36a, 39a.

3. Petitioners sued respondents for infringement of

the ’165 and ’741 patents. Pet. App. 5a. The parties

stipulated to infringement of the relevant claims but

disputed the claims’ validity. Ibid.

5

a. Before trial, the district court excluded certain

evidence (concerning antibodies developed after the

priority date of petitioners’ patents) that respondents

asserted was relevant to enablement. Amgen Inc., 872

F.3d at 1373. At the close of trial, the jury determined

that the relevant claims had not been shown to be invalid for lack of enablement. Id. at 1372-1374.

On appeal, the Federal Circuit reversed and remanded for a new trial. Amgen Inc., 872 F.3d at 1381.

The court of appeals held that the district court had

erred in excluding respondents’ post-priority-date evidence, explaining that the evidence was relevant to enablement because it might “show[ ] that [petitioners] engaged in lengthy and potentially undue experimentation

to enable the full scope of the claims.” Id. at 1375.

b. On remand, the district court again excluded, as

irrelevant and potentially confusing, certain evidence

about antibodies developed after the priority date. See

C.A. App. 5428-5431. The parties then tried the question of enablement to a second jury. Pet. App. 18a. The

court instructed the jury on the Wands factors and on

the ultimate enablement determination—namely,

whether “a person having ordinary skill would need to

experiment unduly to make and use the full scope of the

claimed invention.” D. Ct. Doc. 812, at 12 (Feb. 25,

2019). The jury again upheld the claims. Pet. App. 18a;

see D. Ct. Doc. 818, at 2-3 (Feb. 26, 2019) (verdict form

finding each claim properly enabled).

Respondents moved for judgment as a matter of law

(JMOL) on enablement. Pet. App. 19a. The district

court stated that “[e]nablement is a legal question

based on underlying factual determinations.” Id. at 28a

(citation omitted). It explained that JMOL “is appropriate if ‘the court finds that a reasonable jury would

6

not have a legally sufficient evidentiary basis to find for

[a] party’ on an issue.” Id. at 20a (quoting Fed. R. Civ.

P. 50(a)(1)) (brackets in original). The court further

noted that it must “view[ ] the evidence in the light most

favorable to the nonmovant.” Ibid. (citation omitted).

Applying that standard, the district court determined that “there does not appear to be a genuine dispute between the parties” that “millions” of antibodies

“would need to be tested to determine whether they fell

within the claims.” Pet. App. 33a. It noted that both

parties had acknowledged substantial uncertainty in

the art, id. at 34a-38a, and that the patents lack “guidance on how to predict whether an antibody will bind,”

id. at 38a. The court observed that petitioners’ own experts had testified that “the experimentation necessary

to enable the full scope of the claims would take a substantial amount of time and effort.” Id. at 42a. The

court concluded that “a reasonable factfinder could not

fail to find that the experimentation required is ‘undue.’ ” Id. at 43a.

c. The court of appeals affirmed. Pet. App. 1a-15a.

The court characterized enablement as “a question of

law that we review without deference, although the determination may be based on underlying factual findings, which we review for clear error.” Id. at 6a. The

court reaffirmed that a patent claim is invalid for lack

of enablement if “a person of ordinary skill in the art

would not be able to practice the claimed invention without ‘undue experimentation,’ ” as determined in light of

the Wands factors. Id. at 7a (citation omitted). And it

noted that a patent’s disclosure “must be ‘at least commensurate with the scope of the claims.’ ” Ibid. (quoting

Crown Operations Int’l, Ltd. v. Solutia Inc., 289 F.3d

1367, 1378-1379 (Fed. Cir. 2002)).

7

The court of appeals observed that the claims at issue here are “defined, not by structure, but by meeting

functional limitations.” Pet. App. 12a. It concluded

“that the claims are far broader in functional diversity

than the disclosed examples,” citing evidence that,

“although the claims include antibodies that bind up to

sixteen residues, none of [petitioners’] examples binds

more than nine,” and “there are three claimed residues

to which not one disclosed example binds.” Id. at 13a &

n.1. The court noted “the conspicuous absence of nonconclusory evidence that the full scope of the broad

claims can predictably be generated by the described

methods,” and determined that “no reasonable factfinder could conclude that there was adequate guidance

beyond the narrow scope of the working examples.” Id.

at 13a-14a. The court observed that “it would be necessary to first generate and then screen” “millions” of

“candidate antibod[ies]” “to determine whether [they]

meet[ ] the double-function claim limitations.” Id. at

15a. While declining to hold “that the effort required to

exhaust a genus is dispositive,” the court determined

that “no reasonable jury could conclude under these

facts that anything but ‘substantial time and effort’

would be required to reach the full scope of claimed embodiments.” Id. at 14a. In light of those considerations,

the court affirmed “that undue experimentation would

be required.” Id. at 15a.

d. The court of appeals denied rehearing en banc

with no recorded dissents. Pet. App. 60a-61a. The panel

issued a separate opinion denying panel rehearing. Id.

at 62a-68a. It observed that “properly supported”

“[g]enus claims” are valid because “all that the enablement requirement precludes is obtaining protection for

inventions broader than are disclosed or enabled.” Id.

8

at 63a-64a. But the panel made clear that “[d]rawing a

broad fence around subject matter, without filling in the

holes, is not inventing the genus.” Id. at 64a. In the

case at bar, “[t]he problem was not simply that * * * it

would take a long time to collect the full set of each and

every embodiment,” but that the “far corners of the

claimed landscape that were particularly inaccessible or

uncertain to make” were unenabled given “the narrow

and limited guidance in the specification.” Id. at 65a.

The panel also saw no basis to disturb longstanding circuit precedent describing enablement as “a question of

law, albeit based on underlying factual findings.” Id. at

66a-67a.

DISCUSSION

Petitioners contend that the court of appeals erred

by treating enablement as a question of law and by examining the full scope of the claims in assessing

whether they are fully enabled. Those arguments lack

merit and further review is not warranted.

A. The enablement inquiry includes both legal and

factual components. Disputes about the meaning of the

statutory language present classic questions of law,

whereas the Wands factors require factual inquiries. In

determining whether a mixed question of fact and law

like enablement is properly resolved by the jury or the

court, this Court examines history, precedent, and functional considerations.

Here, the district court submitted enablement to the

jury, and neither party challenges its decision to do so.

Petitioners instead claim that the courts below usurped

the jury’s role by overturning its verdict as a matter of

law. But petitioners concede that a court may resolve a

question initially decided by the jury on a motion for

JMOL, and that is what the courts below did here.

9

Petitioners complain about the formulation the court of

appeals used in articulating the standard of review, but

they do not identify any practical implications flowing

from that disagreement.

B. Petitioners contend that the degree of experimentation required to implement the full scope of a patent’s

claims is irrelevant to the enablement inquiry. That is

incorrect. The Patent Act requires a patent to enable

the “invention.” 35 U.S.C. 112(a). Thus, where a patentee purports to invent an entire genus, it must enable the entire genus.

In the alternative, petitioners argue that the court of

appeals’ enablement determination was wrong on the

facts. That case-specific contention does not warrant

this Court’s review. In any event, the decision below

was reasonable in light of the evidence, and this case

would be a poor vehicle for considering such a challenge

given unresolved disputes over the scope of the record.

Nor have petitioners shown that the Federal Circuit

imposes a heightened enablement standard for genus

claims. Because a patent’s disclosure must be commensurate with the scope of its claims, broad claims naturally require more extensive enablement.

A. Petitioners’ Argument That Enablement Is A Jury

Question Does Not Warrant Further Review

1. A patent must describe “the manner and process

of making and using” “the invention” “in such full, clear,

concise, and exact terms as to enable any person skilled

in the art * * * to make and use the same.” 35 U.S.C.

112(a). Petitioners contend (Pet. 14) that “[e]nablement

is a factual determination for a jury,” but that characterization is overly simplistic. The determination

whether an invention is adequately enabled includes

both legal and factual components.

10

a. Construing the Patent Act is a quintessential legal task committed to the court, not the jury. See, e.g.,

Chandris, Inc. v. Latsis, 515 U.S. 347, 369 (1995) (“Because statutory terms are at issue, their interpretation

is a question of law and it is the court’s duty to define

the appropriate standard.”); In re Will of Bingham, 325

U.S. 365, 371 (1945) (holding that the “meaning of the

words of ” a statute is a “question[ ] of law”). Accordingly, both this Court and the Federal Circuit have

treated the interpretation of the statutory enablement

standard as a legal question. In Wood v. Underhill, 46

U.S. (5 How.) 1 (1846), the Court observed that “[t]he

degree of certainty which the law requires is set forth

in the act of Congress,” and it construed the statute to

require an assessment of the extent to which one skilled

in the art would have to conduct “experiments of his

own” in order “to compound and use” the invention. Id.

at 4. The Federal Circuit has further elucidated that

standard by inquiring whether the degree of experimentation needed is “undue.” In re Wands, 858 F.2d

731, 737 (Fed. Cir. 1988).

Petitioners effectively concede that the meaning of

the statutory enablement requirement is a question of

law. In their second question presented, petitioners

contend that the court of appeals formulated a legal

standard for enablement that is “ ‘inconsistent with the

[Patent] Act’s text’ ” and “this Court’s precedents.” Pet.

24 (citation omitted); see Pet. 25. Petitioners’ request

that this Court clarify the governing enablement standard belies their claim that enablement turns exclusively

on “factual determination[s].” Pet. 14.

Enablement also depends on other legal judgments.

Because a patent must enable those skilled in the art to

practice “the invention,” 35 U.S.C. 112(a), which is

11

defined by the patent’s “claims,” 35 U.S.C. 112(b), the

“interpretation of claim scope” is “inexorably intertwined with enablement,” Pet. App. 68a. And this Court

has held that the construction of patent claims “is exclusively within the province of the court.” Markman v.

Westview Instruments, Inc., 517 U.S. 370, 372 (1996).

At the same time, enablement also depends on “underlying factual findings.” Pet. App. 6a. The inquiries

necessitated by the Wands factors—including, for example, the quantity of experimentation necessary, the

relative skill of those in the art, and the predictability of

the art, see Wands, 858 F.2d at 737—are fact-intensive

and often require the evaluation of witness credibility

or the weighing of competing evidence.

b. As the above discussion illustrates, the ultimate

determination of whether a patent satisfies the legal

test for enablement presents a mixed question of law

and fact. “[T]he application-of-legal-standard-to-fact

sort of question . . . , commonly called a ‘mixed question

of law and fact,’ has typically been resolved by juries.”

Hana Fin., Inc. v. Hana Bank, 574 U.S. 418, 423-424

(2015) (quoting United States v. Gaudin, 515 U.S. 506,

512 (1995)); see id. at 424 (explaining that the court can

assist the jury in “apply[ing] the relevant legal standard” by “craft[ing] careful jury instructions that make

that standard clear”); Gaudin, 515 U.S. at 514 (describing the jury’s responsibility to “draw the ultimate conclusion” in criminal cases).

But that is not a categorical rule. In the patent context, for example, claim construction is performed exclusively by the court, even when it turns on “testimony

requiring credibility determinations,” Markman, 517

U.S. at 389, or the resolution of “underlying factual disputes,” Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S.

12

318, 325 (2015). Ultimately, in determining whether a

particular issue is for the judge or jury, this Court looks

to history, precedent, and functional considerations

such as comparative expertise. See Markman, 517 U.S.

at 378-391; see also Google LLC v. Oracle Am., Inc., 141

S. Ct. 1183, 1199-1200 (2021).

2. a. In this case, the district judge submitted the

enablement question to the jury, instructing that “you

must make your decision whether or not the degree of

experimentation required is undue based upon all of the

evidence presented to you.” D. Ct. Doc. 812, at 11-12.

That was consistent with this Court’s observation that

it is “the right of the jury to determine, from the facts

in the case, whether the specifications, including the

claim, were so precise as to enable any person skilled in

the [art] to make the one described.” Battin v. Taggert,

58 U.S. (17 How.) 74, 85 (1854). The jury then returned

a verdict finding each claim properly enabled. See D. Ct.

Doc. 818, at 2-3.

This case does not present an appropriate vehicle to

determine whether the district court erred in submitting enablement to the jury, as neither party challenges

that decision. Instead, petitioners contend (Pet. 22-23)

that the court of appeals usurped the jury’s role by

overturning its verdict as a matter of law. Petitioners

emphasize the court’s statement that enablement “is a

question of law that we review without deference,” Pet.

App. 6a, and its reference to “weighing the Wands factors,” id. at 15a. See Pet. 17; Cert. Reply Br. 6. Petitioners’ contention does not warrant this Court’s review.

Even when a particular determination would otherwise be made by a jury, the court may resolve the “question on a motion for summary judgment or for judgment

13

as a matter of law.” Hana Fin., Inc., 574 U.S. at 423;

see Neely v. Martin K. Eby Const. Co., 386 U.S. 317, 321

(1967). Petitioners correctly concede that enablement

“can be decided on summary judgment or JMOL where

warranted,” Cert. Reply Br. 3, and this Court’s decisions confirm that understanding, see Wood, 46 U.S.

(5 How.) at 5 (observing that, “when the specification of

a new composition of matter gives only the names of the

substances which are to be mixed together, without

stating any relative proportion, undoubtedly it would be

the duty of the court to declare the patent to be void”);

Seymour v. Osborne, 78 U.S. (11 Wall.) 516, 540 (1871).

Here, the district court addressed the sufficiency of

the patents’ enablement only on respondents’ motion

for JMOL, which contended that “no reasonable jury

could conclude that the asserted claims were enabled.”

Pet. App. 27a. After reciting the legal standard for

JMOL, see id. at 20a-21a (discussing Fed. R. Civ. P.

50(a)(1)), the court asked whether “a reasonable factfinder could only conclude on this factual record” that

each Wands factor favored petitioners or respondents,

id. at 34a; see, e.g., id. at 38a, 43a, and “whether a reasonable factfinder could not fail to find that the experimentation required is ‘undue,’ ” id. at 43a.

The court of appeals’ analysis followed the same

framework. The court framed the question before it as

what a “reasonable factfinder” or a “reasonable jury”

could find. Pet. App. 14a. And the court declined to

resolve contested “dispute[s]” between the parties, instead relying on what was “clear” from the record and

the “absence of nonconclusory evidence.” Id. at 12a13a. “[A]fter weighing the Wands factors,” the court of

appeals determined that the district “court did not err

in concluding that undue experimentation would be

14

required to practice the full scope of these claims.” Id.

at 15a.

Taken in isolation, the court of appeals’ statement

that enablement presents a “question of law,” Pet. App.

6a, might suggest a departure from the JMOL standard. But petitioners conspicuously omit (e.g., Pet. i) the

court’s statement in the same sentence of its opinion

that “the determination may be based on underlying

factual findings, which we review for clear error,” Pet.

App. 6a. Moreover, petitioners do not grapple with the

fact that the district court reached the question of enablement only in the context of a motion for JMOL, id. at

27a, or that both lower courts described the issue before

them as whether a “reasonable jury” could have found

for petitioners on enablement, e.g., id. at 14a.

Those aspects of the litigation easily distinguish this

case from the decisions on which petitioners rely. In

Wood, the trial court told the jury that “the specification

was too vague and uncertain to support the patent.” 46

U.S. (5 How.) at 6. Similarly in Battin, the trial court

instructed the jury “that [its] verdict * * * must be for

the defendants.” 58 U.S. (17 How.) at 85. Those decisions, unlike this case, addressed scenarios where the

courts “took from the jury facts which it was their province to examine and determine.” Ibid.

In short, petitioners have failed to show that their

semantic disagreement with the court of appeals carries

any practical significance. That is particularly true

given that, at the least, both lower courts unambiguously applied the correct JMOL standard to the individual Wands factors. See Pet. App. 14a, 32a, 38a, 40a, 43a.

The lower courts’ finding of no enablement followed

naturally from their conclusions as to the Wands factors, including that “no reasonable factfinder could

15

conclude that there was adequate guidance beyond the

narrow scope of the working examples” or “that anything but ‘substantial time and effort’ would be required

to reach the full scope of claimed embodiments.” Id. at

14a. Petitioners do not contend that they could prevail

on enablement despite the individual Wands factors

having been resolved against them.

b. Petitioners contend (Pet. 17-24) that the Federal

Circuit has systematically usurped the jury’s role by

characterizing enablement as a question of law. In support of that assertion, however, they point to only a

handful of cases in which courts purportedly “substitute[d] their judgments” for those of a jury. Pet. 20.

The cited Federal Circuit decisions do not support

petitioners’ charge of judicial overreaching because the

court in those cases deemed JMOL appropriate only after determining that “a reasonable jury would not have

had a legally sufficient basis to find” the claims enabled

without “undue experimentation.” Idenix Pharm. LLC

v. Gilead Scis. Inc., 941 F.3d 1149, 1156 (2019), cert. denied, 141 S. Ct. 1234 (2021); see Trustees of Bos. Univ.

v. Everlight Elecs. Co., 896 F.3d 1357, 1364 (2018) (“Although we review the evidence in the light most favorable to BU, the jury’s verdict on enablement here cannot

be sustained.”). Petitioners also cite a district court decision setting aside a jury verdict, Martek Biosciences

Corp. v. Nutrinova Inc., 520 F. Supp. 2d 537 (D. Del.

2007). But the Federal Circuit reversed that judgment

in relevant part, holding that “the evidence support[ed]

the jury’s implicit finding that one need not perform undue experimentation to practice” the invention, “as well

as the jury’s ultimate conclusion that [the defendant]

failed to prove invalidity.” Martek Biosciences Corp. v.

Nutrinova, Inc., 579 F.3d 1363, 1379 (2009).

16

B. Petitioners’ Challenge To The Court Of Appeals’ Enablement Holding Does Not Warrant Further Review

1. The Federal Circuit held that the patent claims at

issue here are invalid because “undue experimentation”

would be required to enable their “full scope.” Pet. App.

12a. Petitioners contend that the amount of “ ‘time and

effort’ * * * required to reach the full scope of claimed

embodiments” is irrelevant to the enablement analysis.

Pet. 26 (quoting Pet. App. 14a). In their view, the “Federal Circuit’s novel reach-the-full-scope test is” both

“atextual” and “foreclose[d]” by this Court’s precedent.

Ibid.

Petitioners are incorrect. Under the Patent Act’s

plain terms, a patent must describe “the manner and

process of making and using” “the invention” in sufficiently precise terms “to enable any person skilled in

the art to which it pertains * * * to make and use the

same.” 35 U.S.C. 112(a) (emphases added). When, as

here, a patent claims an entire genus based on its function, the patent must enable that entire genus.

This Court’s decisions confirm that the full scope of

the claims must be considered in assessing enablement.

In Consolidated Electric Light Co. v. McKeesport Light

Co., 159 U.S. 465 (1895), the inventors disclosed carbonized paper and wood carbon filaments and obtained a

patent covering filaments composed of any “carbonized

fibrous or textile material.” Id. at 467-468. But the patent specification did not identify “some general quality,

running through the whole fibrous and textile kingdom,

which distinguished it from every other, and gave it a

peculiar fitness for the particular purpose.” Id. at 475.

As a result, “the most careful and painstaking experimentation” would have been necessary “for a person to

know what fibrous or textile material was adapted to the

17

purpose of an incandescent conductor.” Ibid. In those

circumstances, the Court rejected the proposition “that

one, who had discovered that a certain fibrous or textile

material answered the required purpose, should obtain

the right to exclude everybody from the whole domain

of fibrous and textile materials.” Id. at 476. Similarly

in Holland Furniture Co. v. Perkins Glue Co., 277 U.S.

245 (1928), the Court held that the disclosure of “a particular starch glue” with a certain function did not enable a claim for “all starch glues” with that function,

given that “[o]ne attempting to use or avoid the use of

[the] discovery as so claimed and described functionally

could do so only after elaborate experimentation,” id. at

256-257. The Court explained that “[a] claim so broad”

would improperly “extend[ ]” the “patent monopoly”

“beyond the discovery” by permitting “the inventor who

has discovered that a defined type of starch answers the

required purpose to exclude others from all other types

of starch.” Id. at 257.

In a variation on their principal argument, petitioners suggest that even if the court of appeals permissibly

considered the “ ‘substantial time and effort’ * * * required to reach the full scope of claimed embodiments,”

it erred in treating that consideration as dispositive.

Pet. 27 (quoting Pet. App. 14a) (emphasis omitted). But

the court considered the degree of experimentation required to reach the full scope of the claims as merely

one of the Wands factors, not the sum total of the analysis. See Pet. App. 12a-15a; see also id. at 41a-43a;

Wands, 858 F.2d at 737 (identifying “the quantity of experimentation necessary” as one factor relevant to the

enablement inquiry). And in the very same breath, the

court emphasized that it was not “hold[ing] that the

18

effort required to exhaust a genus is dispositive.” Pet.

App. 14a.

In any event, this case would be a poor vehicle for

taking up petitioners’ legal arguments. The court of appeals’ emphasis on the full scope of the claims flowed

naturally from the Wands factors, which include both

“the quantity of experimentation necessary” and “the

breadth of the claims.” 858 F.2d at 737. In this Court,

petitioners do not dispute that the Wands factors provide an appropriate framework for resolving questions

of enablement and undue experimentation. Nor do petitioners propose an alternative standard for determining whether a patent adequately enables the claimed invention. As a result, the scope and nature of petitioners’

argument—including the extent to which it would displace longstanding Federal Circuit precedent—are unclear.

2. Petitioners contend that, even apart from the purported legal errors discussed above, the court of appeals erred in analyzing the facts of this particular controversy. See Pet. 29; see also, e.g., Pet. 22-23 (disputing the court’s purported resolution of “hotly contested

fact issues”). That case-specific argument does not warrant this Court’s review.

In any event, the court of appeals’ enablement determination was reasonable on the record before it. The

court explained that “the claims are far broader in functional diversity than the disclosed examples,” noting

that “there are three claimed residues to which not one

disclosed example binds” and that, “although the claims

include antibodies that bind up to sixteen residues, none

of [the] examples binds more than nine.” Pet. App. 13a

& n.1; see C.A. App. 4283 (listing “competitor antibodies”

that bind more and different residues) (capitalization

19

omitted). In addition, “there [wa]s no testimony from

any expert that the structure-function relationship” of

antibodies “would eliminate the need for testing newlycreated antibodies to determine whether they had the

functions of blocking and binding,” since even conservative substitution could potentially introduce unpredictable variations in function. Pet. App. 37a; see id. at 12a,

13a, 15a, 36a. Using the patents’ disclosure, a practitioner thus would need to generate and test “millions of

candidates.” Id. at 15a.

Petitioners assert that the challenged claims here

“are very narrow,” Pet. 23 (citation omitted), but they

do not even estimate the number of antibodies a person

of ordinary skill would need to generate and test to enable the full scope of the claims. Petitioners also contend (Pet. 32-33) “that, by following the patents’

roadmap, skilled artisans would generate antibodies

within the claims every time.” But disclosing how to

produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all

such antibodies—and it is the latter that petitioners

claim as their invention.

This Court has found a lack of enablement in similar

circumstances. See pp. 16-17, supra (discussing Consolidated Electric Light Co. and Holland Furniture

Co.). Petitioners rely heavily (Pet. 26) on Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916), where the

Court upheld patent claims for separating metallic from

nonmetallic material in ore by agitating the ore in a solution of water and oil. Id. at 265-266. The Court

acknowledged “that when different ores are treated

preliminary tests must be made to determine the

amount of oil and the extent of agitation necessary in

order to obtain the best results.” Id. at 270. But it

20

nevertheless found the invention adequately enabled

because “the range of treatment within the terms of the

claims, while leaving something to the skill of persons

applying the invention, is clearly sufficiently definite to

guide those skilled in the art to its successful application.” Id. at 271.

Minerals Separation thus stands for the proposition

that the need to tweak an invention to accommodate differing circumstances—without changing the basic principles on which the invention operates—does not render

a patent claim invalid for lack of enablement. The other

decisions petitioners cite (Pet. 27) follow a similar pattern. See Wood, 46 U.S. (5 How.) at 5 (explaining that

“the general rule is given with entire exactness,” and

that “the notice of the variations” accounts for clay that

is “more or less hard to burn than the kind ordinarily

employed”); Mowry v. Whitney, 81 U.S. (14 Wall.) 620,

645 (1872) (observing that “no particular science or

skill” was required to make the necessary adjustments

in light of “the object of the process”).

In this case, by contrast, the district court determined that a “person of ordinary skill in the art” using

the random-generation method and “attempting to obtain a claimed antibody that is not disclosed” “ ‘would

have to do essentially the same amount of work as the

inventors of the patents-in-suit.’ ” Pet. App. 40a (citation omitted). The court observed that “even conservative substitutions may have unexpected results,” and it

highlighted the absence of testimony “that every antibody within the scope of the claims could be made

through intelligent substitution.” Id. at 32a, 44a; see id.

at 14a, 36a & n.10.

Finally, this case presents a poor vehicle for error

correction given the parties’ unresolved evidentiary

21

disputes. Respondents argued below that, if the invalidity judgment were reversed, a new trial would be

warranted because the district court had improperly excluded evidence showing petitioners’ “unsuccessful

post-priority-date efforts to discover” antibodies that

“indisputably fall within the claims’ scope.” Resps. C.A.

Br. 59. In respondents’ view, this evidence demonstrates that, “as of the priority date, [petitioners] did

not * * * enable the claims’ full scope.” Id. at 60. The

court of appeals had no occasion to consider that argument in light of its affirmance. A retrial therefore might

be necessary if this Court ruled for petitioners on the

present record.

3. Petitioners assert that the court of appeals’ standard is “ ‘impossible’ to satisfy any time a genus claim covers a ‘nontrivial’ number of embodiments.” Pet. 30 (citation omitted). That concern is overstated. In recent

years, the Federal Circuit has repeatedly rejected enablement challenges to genus claims. See, e.g., McRO,

Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091,

1099 (2020); Erfindergemeinschaft UroPep GbR v. Eli

Lilly & Co., 276 F. Supp. 3d 629, 662-663 (E.D. Tex.

2017), aff ’d, 739 Fed. Appx. 643 (Fed. Cir. 2018), cert.

denied, 140 S. Ct. 449 (2019); see also Pet. App. 63a

(“Genus claims, to any type of invention, when properly

supported, are alive and well.”). The court has explained that the specification need not “describe how to

make and use every possible variant of the claimed invention,” Pet. App. 8a (citation omitted), and that

“[e]ven ‘a considerable amount of experimentation is

permissible,’ ” Wyeth & Cordis Corp. v. Abbott Labs.,

720 F.3d 1380, 1386 (Fed. Cir. 2013) (citation omitted).

Nor does the Federal Circuit apply “a different,”

more stringent “enablement test for genus claims” than

22

for other types of claims. Pet. 25. The key decision that

petitioners cite (Pet. 22) for the proposition that the

Federal Circuit applies a lower enablement threshold to

non-genus claims, see McRO, Inc., 959 F.3d at 1100, itself involved a genus claim, id. at 1096. And here, although the court of appeals observed that the use of

broad functional claiming “pose[s] high hurdles,” Pet.

App. 12a, and “raises the bar for enablement,” id. at

13a, those comments simply reflect the fact that a disclosure must be “commensurate with the scope of the

claims,” National Recovery Techs., Inc. v. Magnetic

Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir.

1999).

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.

ELIZABETH B. PRELOGAR

Solicitor General

BRIAN M. BOYNTON

Principal Deputy Assistant

Attorney General

MALCOLM L. STEWART

Deputy Solicitor General

AUSTIN L. RAYNOR

Assistant to the Solicitor

General

DANIEL TENNY

BRIAN J. SPRINGER

Attorneys

SEPTEMBER 2022