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

Supreme Court briefFeb 10, 2023

Ask Donna

What actually matters in this document.

Text

No. 21-757

In the Supreme Court of the United States

AMGEN INC., ET AL., PETITIONERS

SANOFI, ET AL.

ON WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF FOR THE UNITED STATES AS AMICUS CURIAE

SUPPORTING RESPONDENTS

THOMAS W. KRAUSE

Solicitor

FARHEENA Y. RASHEED

Deputy Solicitor

AMY J. NELSON

Senior Counsel for Patent

Policy and Litigation

PETER J. SAWERT

MONICA B. LATEEF

Associate Solicitors

United States Patent and

Trademark Office

Alexandria, VA 22314

ELIZABETH B. PRELOGAR

Solicitor General

Counsel of Record

BRIAN M. BOYNTON

Principal Deputy Assistant

Attorney General

MALCOLM L. STEWART

Deputy Solicitor General

COLLEEN E. ROH SINZDAK

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

QUESTION 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 question presented is as follows:

Whether the court of appeals correctly held that the

patents at issue in this case do not enable the full scope

of the claimed invention.

(I)

TABLE OF CONTENTS

Page

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

Statement ...................................................................................... 2

Summary of argument ................................................................. 9

Argument:

A. Section 112(a)’s enablement requirement is not

satisfied if a person skilled in the art must

undertake undue experimentation in order to

make and use the invention .......................................... 12

B. Petitioners’ claims fail under Section 112(a)

because undue experimentation would be required

to make and use the claimed antibodies ...................... 22

C. Petitioners’ remaining arguments lack merit ............. 29

Conclusion ................................................................................... 33

TABLE OF AUTHORITIES

Cases:

Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017),

cert. denied, 139 S. Ct. 787 (2019) .................................... 4-6

Consolidated Electric Light Co. v. McKeesport Light

Co., 159 U.S. 465 (1895) ................... 13, 17-18, 21- 24, 26, 28

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

289 F.3d 1367 (Fed. Cir. 2002) ............................................. 7

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki

Co., Ltd., 535 U.S. 722 (2002) ............................................. 32

Graver Tank & Mfg. Co. v. Linde Air Prods. Co.,

339 U.S. 605 (1950).............................................................. 32

Holland Furniture Co. v. Perkins Glue Co.,

277 U.S. 245 (1928)............................................. 10, 19-26, 31

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

Inc., 534 U.S. 124 (2001) ....................................................... 2

(III)

Cases—Continued:

Page

Loom Co. v. Higgins, 105 U.S. 580 (1882) ........................... 25

Minerals Separation, Ltd. v. Hyde,

242 U.S. 261 (1916).................................................... 9, 10, 16

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

Universal Oil Prods. Co. v. Globe Oil & Ref. Co.,

322 U.S. 471 (1944)........................................................ 12, 13

Wands, In re, 858 F.2d 731 (1988) ........ 3, 9, 13, 21, 26-27, 30

Wood v. Underhill, 46 U.S. (5 How.) 1 (1846) ........... 3, 14, 15

Constitution and statutes:

U.S. Const. Art. I, § 8, Cl. 8 .................................................... 2

Act of Apr. 10, 1790, ch. 7, § 2, 1 Stat. 110-111 ................... 12

Patent Act of 1952, 35 U.S.C. 1 et seq. ................................... 2

35 U.S.C. 2(a)(1)................................................................. 1

35 U.S.C. 101 ............................................................ 2, 3, 31

35 U.S.C. 102 ................................................................ 2, 31

35 U.S.C. 103 ................................................................ 2, 31

35 U.S.C. 112 ...................................................................... 2

35 U.S.C. 112(a) ........................... 1, 2, 9, 10, 12-14, 16, 17,

21-23, 26, 28-30

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

35 U.S.C. 131 ...................................................................... 1

Rev. Stat. 4888 (1875) (35 U.S.C. 33 (1925))........................ 18

Miscellaneous:

U.S. Patent:

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

No. 8,062,640 (filed Nov. 22, 2011) ................................... 4

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

SANOFI, ET AL.

ON WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF FOR THE UNITED STATES AS AMICUS CURIAE

SUPPORTING RESPONDENTS

INTEREST OF THE UNITED STATES

This case presents the question whether petitioners’

patents “enable any person skilled in the art * * * to

make and use” the claimed invention. 35 U.S.C. 112(a).

The United States Patent and Trademark Office is responsible for examining all patent applications and for

granting and issuing patents when the applicants satisfy the statutory conditions for patentability. 35 U.S.C.

2(a)(1), 131. Several other agencies of the federal government also have significant regulatory interests in

the efficacy of the patent system. The United States

therefore has a substantial interest in the Court’s resolution of the question presented here. At the Court’s

invitation, the United States filed an amicus brief at the

petition stage of this case.

(1)

STATEMENT

1. The Intellectual Property Clause of 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), 35 U.S.C. 1 et seq., authorizes

patents to be issued for “any new and useful process,

machine, manufacture, or composition of matter, or

any new and useful improvement thereof,” 35 U.S.C.

101. The Patent Act also establishes conditions for patentability, see, e.g., 35 U.S.C. 102 (novelty), 103 (nonobviousness), and the required contents of a patent application, see 35 U.S.C. 112.

A patent application must contain a “specification”

that includes “one or more claims 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 informs competitors and the

courts about the scope of the patentee’s exclusive rights

during the period of exclusivity, and it ensures that the

public will be able to use the invention after the 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

undue-experimentation 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 the art,” (7) “the predictability or unpredictability of the art,” and (8) “the breadth of the

claims.” Ibid. The Wands factors have been widely utilized, and no party appears to dispute their applicability

in this case.

2. This case involves patents for “composition[s] of

matter,” 35 U.S.C. 101, that are used in medical treatments. The patents at issue here cover medications that

help control blood levels of low-density lipoprotein

(LDL) cholesterol using antibody technology. Pet. App.

3a-4a.

a. In the human body, receptors on liver cells “remove LDL cholesterol from the blood stream, thus regulating the amount of circulating LDL cholesterol.”

Pet. App. 3a. But a naturally occurring protein called

proprotein convertase subtilisin/kexin type 9 (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, and a particular region of PCSK9’s aminoacid structure is responsible for binding to LDL receptors. See Pet. App. 27a & n.6; C.A. App. 3795.

Sometime in the 2000s, scientists determined that it

might be possible to create another type of protein, an

antibody, that would bind to PCSK9 in the same region

that PCSK9 binds to LDL receptors, which petitioners

refer to as PCSK9’s “sweet spot.” Pet. Br. 10 (citation

omitted). By binding to the sweet spot, an antibody

might prevent PCSK9 from binding to LDL receptors,

thereby allowing the liver cells to bind and remove more

LDL from the bloodstream. See id. at 7; Pet. App. 3a.

In October 2011, petitioners obtained a patent covering a specific antibody, identified by the amino acid sequence of its binding region, which binds to the PCSK9

sweet spot and prevents PCSK9 from binding to LDL

receptors. See U.S. Patent No. 8,030,457 (filed Oct. 4,

2011). The next month, respondents obtained a patent

covering a different antibody, identified by the amino

acid sequence of its binding region, which binds to a different location on the sweet spot but also blocks PCSK9

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

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

872 F.3d 1367, 1372 (Fed. Cir. 2017) (Amgen I), cert. denied, 139 S. Ct. 787 (2019). Petitioners and respondents

both ultimately obtained FDA approval for their antibodies and began marketing them. See Amgen I, 872

F.3d at 1371-1372.

b. In 2014, petitioners obtained two additional patents that relate back to their 2011 patent. U.S. Patent

No. 8,829,165 (filed Sept. 9, 2014) (’165 patent) and U.S.

Patent No. 8,859,741 (filed Oct. 14, 2014) (’741 patent).

Claims 19 and 29 of the ’165 patent, and Claim 7 of the

’741 patent, are the subject of this suit. 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 identical specifications that

disclose the amino-acid sequences of 26 antibodies and

depict the three-dimensional structures of two of those

antibodies, including the antibody identified in petitioners’ initial 2011 patent. Pet. App. 4a; Amgen I, 872 F.3d

at 1371-1372. The specifications also describe two

methods that can be used to produce other antibodies

that perform the claimed functions of binding to the

PCSK9 sweet spot and blocking PCSK9 from binding

with LDL receptors. The specifications explain that a

practitioner could generate a random pool of antibodies

(such as by injecting mice with PCSK9); test those antibodies to determine whether they bind to PCSK9; and

then perform an additional test to determine if the antibodies that bind with the sweet spot also block its interaction with LDL receptors. See Pet. Br. 13-14.

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[]”—and then test to determine whether the resulting antibody still achieves the desired functions. Id. at

16-17 (citation omitted); see Pet. App. 15a, 36a, 39a. Petitioners have not sought or obtained a patent for either

of the two methods that the specifications identify for

producing antibodies that perform the desired functions.

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.

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 I, 872

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

that the relevant patent 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. Id. 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

jury upheld the patent claims. Ibid.; see D. Ct. Doc. 818,

at 2-3 (Feb. 26, 2019) (verdict form).

Respondents moved for judgment as a matter of law

on enablement. Pet. App. 19a. 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.” Id. at 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 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).

The court also 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, 1379 (Fed. Cir. 2002)).

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 it 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” in petitioners’ patents. Id. at 14a. In light

of those considerations, the court affirmed the district

court’s holding “that undue experimentation would be

required.” Id. at 15a.

d. The court of appeals denied panel rehearing and

rehearing en banc, with no recorded dissents. Pet. App.

60a-61a. The panel issued a separate opinion on the denial of panel rehearing, stating that it had not “created

a new test for enablement,” id. at 62a, but had simply

applied longstanding patent-law principles to the

claimed inventions here. Id. at 62a-68a.

The panel explained that, “[i]f the invention is a

group of compositions [of matter], defined as a genus,

that group is enabled by a disclosure commensurate

with the scope of the genus.” Pet. App. 63a. The panel

stated that the enablement problem with petitioners’

patents was “not simply that the claimed genus was numerous,” or “that it would take a long time to collect the

full set of each and every embodiment.” Id. at 65a. Rather, it was that the genus “was so broad, extending far

beyond the examples and guidance provided,” and that

“far corners of the claimed landscape that were particularly inaccessible” were not enabled given “the narrow

and limited guidance in the specification.” Ibid. The

panel further observed that “[c]laims defining a composition of matter by function raise special problems

because one may not know whether a species is within

the scope of a generic claim until one has made it and

one can ascertain whether it possesses the claimed function.” Id. at 66a. The panel emphasized, however, that

“well-supported generic claims do not lack for enablement,” and that “[g]enus claims, to any type of invention, when properly supported, are alive and well.” Id.

at 63a.

SUMMARY OF ARGUMENT

Section 112(a) requires a patent’s specification to

contain a “description of the invention, and of the manner and process of making and using it” sufficient to

“enable any person skilled in the art * * * to make and

use the same.” 35 U.S.C. 112(a). As the parties now

agree, a patent cannot satisfy that requirement if a person skilled in the art would be forced to undertake “undue experimentation” to produce the claimed invention.

In re Wands, 858 F.2d 731, 737 (1988). A specification

does not enable a person skilled in the art to make and

use a product if the person is compelled to engage in the

same trial-and-error process the inventor undertook to

produce her innovation in the first place.

This Court’s precedents recognize that determining

whether a specification requires undue experimentation

involves a fact-specific inquiry that takes account of the

context in which the invention arises and the nature of

the claim. The enablement requirement does not demand that a specification eliminate all need for experimentation, requiring no greater “certainty” than “is

reasonable, having regard to [the patent’s] subjectmatter.” Minerals Separation, Ltd. v. Hyde, 242 U.S.

261, 270 (1916). A claim for a process to be applied to

natural substances may, for example, contemplate some

testing on the part of a practitioner to adapt the process

to natural variations in those substances. Ibid. By contrast, the enablement requirement is not satisfied when

a patent claims a broad functionally-defined class of

products but provides insufficient structural information to enable practitioners to produce more than a

small subset of that class without engaging in “elaborate experimentation.” Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 241, 257 (1922).

Petitioners’ claims resemble the broad product

claims this Court has found invalid under the enablement requirement. With respect to 26 exemplar antibodies, petitioners’ patent specifications provide structural information sufficient to permit scientists to reverse engineer those exemplars using standard laboratory techniques. Petitioners then claim a monopoly on

all other antibodies that also function to bind to the

PCSK9 sweet spot and block PCSK9 from binding to

LDL receptors. But their roadmap for creating those

additional antibodies does little more than instruct researchers to generate a pool of PCSK9 antibodies and

then run experiments to determine which ones exhibit

the claimed functionalities. Petitioners may not evade

an undue-experimentation problem merely by baking

the need for experimentation into their roadmap.

Petitioners contend that they have satisfied Section

112(a)’s enablement requirement because their

roadmap will produce claimed antibodies every time,

and that the 26 exemplars they have already produced

are representative of the structural diversity within the

genus. Applying the Wands factors that both parties

now accept, the Federal Circuit correctly determined

that no reasonable juror could conclude that the

roadmap would produce antibodies within the full scope

of the claim without undue experimentation, and the 26

exemplars do not begin to capture the structural diversity within the class. Pet. App. 12a-15a. Indeed, petitioners’ exemplars do not even capture the structural

diversity represented among the antibodies that petitioners’ competitors have already created.

Petitioners are also wrong to assert that the Federal

Circuit announced a “reach-the-full-scope” test under

which a finding of undue experimentation turns on the

amount of time and effort required to make a complete

set of products within a claimed genus. Pet. App. 14a.

Nor will an affirmance undermine patent policy. Where

an inventor develops an innovative process that may be

applied across multiple contexts, she can protect it with

a process patent. Where she invents an innovative

product and others attempt to market that product with

insignificant alterations designed to evade an infringement suit, the inventor may use the doctrine of equivalents to enforce her patent against those copyists. But

an inventor whose novel product achieves a widelyshared research goal may not obtain a patent for the

entire genus of products that perform the same function, thereby foreclosing others from inventing potentially better products that achieve the same goal, unless

she provides the information necessary to enable others

to make and use the full range of products within the

genus.

ARGUMENT

A. Section 112(a)’s Enablement Requirement Is Not Satisfied If A Person Skilled In The Art Must Undertake Undue Experimentation In Order To Make And Use The

Invention

1. Since the first Patent Act of 1790, federal patent

law has required that every patent must contain enough

information to “enable a workman or other person

skilled in the art * * * to make * * * or use” the invention. Act of Apr. 10, 1790, ch. 7, § 2, 1 Stat. 110-111. The

current version of that requirement is codified at 35

U.S.C. 112(a). It states that each patent’s “specification

shall contain a written description * * * of 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 invention. Ibid.

By requiring every patent to describe the claimed invention in a manner that enables others skilled in the

art to make and use it, Section 112(a) implements the

basic “quid pro quo” on which the U.S. patent system is

premised. Universal Oil Prods. Co. v. Globe Oil & Ref.

Co., 322 U.S. 471, 484 (1944) (emphasis omitted). “[T]he

United States offers a [time-limited] monopoly to an inventor who refrains from keeping his invention a trade

secret,” and in exchange the inventor discloses the information necessary “to enable one skilled in the art to

practice the invention once the period of the monopoly

has expired.” Ibid. At every stage of the patent process, the enablement requirement helps to effectuate

that quid pro quo.

At the beginning of the process, when the inventor

drafts and submits her patent application, the enablement requirement deters her from broadening her

claims beyond the reach of her discovery in order to obtain an “unwarranted extension of [the] monopoly” that

the patent promises. Consolidated Electric Light Co. v.

McKeesport Light Co., 159 U.S. 465, 476 (1895). And by

requiring the inventor to provide enough information to

enable her peers to “make and use” the invention, 35

U.S.C. 112(a), the enablement requirement helps to ensure that the inventor herself has the knowledge and

capacity to create what she has claimed.

Once the inventor has secured her patent, Section

112(a) protects her exclusive rights, while allowing continued innovation to occur beyond the bounds of the protected invention. A patent specification that conforms

to Section 112(a) “apprise[s] the public of what the patentee claims as [her] own, the courts of what they are

called upon to construe, and competing manufacturers

and dealers of exactly what they are bound to avoid.”

Consolidated Electric, 159 U.S. at 474; see Universal

Oil, 322 U.S. at 484 (explaining that a patent’s specification “warn[s] the industry concerned of the precise

scope of the monopoly asserted”).

Finally, after the patent’s period of exclusivity has

run, the enablement requirement ensures that others

skilled in the art will be able to make and use any embodiment within the claimed invention. Section 112(a)

thus protects the public’s ability to enjoy the long-term

benefits that the patent laws’ incentives for innovation

are intended to produce.

2. As both parties now recognize, to satisfy Section

112(a)’s enablement requirement, a patent must provide enough information to allow a “person skilled in the

art” to reproduce the claimed invention without “undue

experimentation.” In re Wands, 858 F.2d 731, 735 (Fed.

Cir. 1988) (citing 35 U.S.C. 112(a)); see Pet. Br. 4, 25-26;

Resp. Br. 2, 27. Section 112(a)’s plain text dictates that

conclusion. A patent does not “enable any person

skilled in the art * * * to make and use” an invention

if, after gleaning all the information that the patent provides, the person must engage in a trial-and-error process akin to the one that produced the invention in the

first place. 35 U.S.C. 112(a). One would not say, for

example, that a recipe “enables” a baker to “make” a

cake if it directs her to use “some” of each ingredient,

forcing the baker to experiment with different quantities of flour, sugar, eggs, and butter until she finally

produces the intended result. Thus, almost two centuries ago, this Court held that a patent’s specification

“must be in such full, clear, and exact terms as to enable

any one skilled in the art to * * * compound and use

[the invention] without making any experiments of his

own.” Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846)

(emphasis added).

Despite the seemingly categorical nature of Wood’s

articulation of the governing rule, this Court has consistently recognized that the adequacy of the specification, and in particular the extent to which a specification

may be adequate even if some further experimentation

is required to make and use the invention, will generally

depend not on any bright-line rule but on a flexible inquiry that takes into account the nature of the claimed

invention and the field in which it arises. Recipes again

provide a useful analogy: A recipe for stew that contains an instruction to “season to taste” typically enables a cook to make a successful dish because similar

instructions are standard in recipes, and a more precise

instruction is generally impossible given natural variations in ingredients and sodium tolerances. On the

other hand, a bread recipe that instructs a baker to add

“some salt” will generally prevent her from making a

successful loaf without undue experimentation because

salt typically plays a role in leavening bread, and recipes almost invariably specify the precise quantity necessary to produce the chemical reaction that makes the

bread rise.

This Court recognized the fact-specific nature of the

undue-experimentation inquiry in Wood, which rejected

an enablement challenge to a patent that claimed a new

process for making bricks by mixing coal dust into the

clay. See 46 U.S. (5 How.) at 4. The Court observed

that a patent claiming “a new composition of matter”

would be invalid if it gave “only the names of the substances which are to be mixed together, without stating

any relative proportion,” or if “the proportions were

stated ambiguously and vaguely.” Id. at 5. The Court

explained that “in such cases it would be evident, on the

face of the specification, that no one could use the invention without first ascertaining by experiment the exact

proportion of the different ingredients required to produce the result intended to be obtained.” Ibid. The

Court concluded, however, that the patent before it did

not reflect “this degree of vagueness and uncertainty.”

Ibid. The Court observed that the patent at issue specified a proportion of coal dust and clay that should be

used as “a general rule,” and then offered two alternative proportions to be used “where the clay has some

peculiarity.” Ibid. The Court determined that the need

to articulate these “exceptions” did not prevent the patent from satisfying the enablement requirement because “some small difference in the proportions must

occasionally be required” to reflect the varieties of clay

to which the patented process would be applied. Ibid.

In Minerals Separation, Ltd. v. Hyde, 242 U.S. 261

(1916), the Court again emphasized the fact-specific nature of the undue-experimentation inquiry. In that

case, the Court rejected an enablement challenge to a

patent that claimed a process for separating metal from

mineral ores, even though a person using the process

would need to conduct some “preliminary tests” to

adapt the process to the particular ore at hand. Id. at

270. The Court held that “the certainty which the law

requires in patents is not greater than is reasonable,

having regard to [the patent’s] subject-matter.” Ibid.

Because the “composition of ores varies infinitely,” the

Court found that it was “obviously impossible to specify

in a patent the precise treatment which would be most

successful and economical in each case.” Id. at 271.

“[L]eaving something to the skill of persons applying”

the patented process did not fall afoul of the enablement

requirement because the specification was “clearly sufficiently definite to guide those skilled in the art to [the

process’s] successful application.” Ibid.

Wood and Minerals Separation establish that a patent does not violate Section 112(a)’s enablement requirement merely because its specification requires

some degree of experimentation to account for the nature of the patented invention or the field in which it

arises. But Wood and Minerals Separation also make

clear that, regardless of the subject matter, the degree

of experimentation required may not be so great as to

defeat the basic command of the enablement requirement by forcing others skilled in the art to retrace the

patentee’s research steps.

3. The patents at issue here do not claim a specific

antibody, but instead claim a class or “genus” of antibodies, defined by the functions those antibodies

perform. This Court’s precedents offer some basic principles to guide the fact-specific analysis regarding

whether a patent that claims a genus of products “enable[s] any person skilled in the art * * * to make and

use” the claimed genus without undue experimentation.

35 U.S.C. 112(a).

The Court has long recognized, for example, that a

patent generally cannot satisfy the enablement requirement when its specification references a broad class of

substances without giving a person skilled in the art a

means of discerning whether and to what extent each

substance will produce a working invention. This principle is famously illustrated in Consolidated Electric,

supra, where the inventors of an earlier, less successful

version of the lightbulb sued Thomas Edison for patent

infringement. The plaintiffs there alleged that Edison’s

invention of a lightbulb with a bamboo filament infringed their own patent, which claimed every incandescent lightbulb with a filament made from a “fibrous or

textile material.” 159 U.S. at 472. The only lightbulb

the patent holders had invented or described in their

specification involved a filament made of carbonized paper, but the patent nonetheless claimed the broad class

of lightbulbs made with fiber and wood filaments, on the

theory that carbonized paper was “the best material for

an incandescent conductor.” Ibid. Edison proved them

wrong by making the “brilliant” discovery that a form

of bamboo grown in China and Japan worked far better

as a filament than carbonized paper, and in fact provided the missing element needed to bring electric

lighting into general usage. Id. at 474. The patent holders rewarded this discovery with an infringement suit.

Id. at 471-472.

The Court in Consolidated Electric held that Edison

was not an infringer because the prior patent’s description of a lightbulb made with a fibrous or wood filament

did not enable Edison to “ ‘make, construct, compound,

and use’ ” his bamboo-filament lightbulb, “except by the

most careful and painstaking experimentation.” 159

U.S. at 474-475 (quoting Rev. Stat. 4888 (1875) (35

U.S.C. 33 (1925)). The Court explained that many fibers

and woods do not work as filaments, and that the bamboo Edison ultimately used was a “better specimen”

than the carbonized paper the patent holders had invented. Id. at 476; see id. at 475-476. Nor did the prior

patent guide Edison towards his choice of bamboo by

identifying “a quality common” to all or most woods and

fibers that “adapt[s] them peculiarly to incandescent

conductors.” Id. at 472. Edison was instead required to

experiment for months “among the different species of

vegetable growth” in order to discern the structural

properties that would make a particular wood or fiber

suitable for use in a filament, and he then spent many

more months finding the particular bamboo fibers he ultimately used. Id. at 472-474. The Court concluded

that, given this quantity of experimentation, it was not

reasonable to assert that the prior patent had enabled

Edison’s discovery. Id. at 476.

The Consolidated Electric Court emphasized that

the plaintiffs’ patent was invalid not simply because it

claimed a broad range of filaments, but rather because

it described those filaments by reference to a general

class of substances, without providing the information a

person skilled in the art would need to identify the specific substances that would make the invention succeed.

159 U.S. at 472, 475. The Court recognized, for example, that the patent might have been valid if the

inventors had identified “some general quality, running

through the whole fibrous and textile kingdom,” that

“distinguished it from every other, and gave it a peculiar fitness for the particular purpose.” Id. at 475. In

those circumstances, the patent would not have triggered the need for undue experimentation because the

description would have led Edison straight to his bamboo or its functional equivalent. But Edison’s experiments had revealed that there was immense diversity in

the class of woods and fibers, and neither the patent’s

example of carbonized paper nor anything else in the

patent had enabled Edison to identify an effective wood

or fiber except through trial and error. Id. at 475-476.

In Holland Furniture Co. v. Perkins Glue Co., 277

U.S. 245 (1928), the Court elaborated and expanded on

these principles in holding a composition-of-matter patent invalid for lack of enablement because it described

a key ingredient purely in functional, rather than structural, terms. The patent at issue in Holland Furniture

claimed a class of starch glues that had the properties

of animal glue. Id. at 247. The Court explained that

animal glue has certain properties, such as its texture

and flexibility, that make it ideal for fastening together

pieces of wood for use in wood veneering. Ibid. Perkins

Glue Company was the first to make a starch glue that

was similar enough to animal glue that it could also be

used in wood veneering. Ibid. Perkins obtained a patent claiming not just the specific starch glue the company manufactured, but also every “starch glue which,

combined with about three parts or less by weight of

water, will have substantially the same properties as animal glue.” Id. at 250-251. The patent specified that, to

make a glue falling within the broader claim, it was necessary to choose a “starch ingredient * * * possess[ing]

such qualities that when combined with three parts of

water and with alkali it would produce a product ‘as

good as’ * * * or having the properties of animal glue.”

Id. at 256.

This Court held that Perkins’s broad composition-ofmatter patent claim was invalid for lack of enablement

because the patent described the key ingredient of its

glue—the starch—“in terms of its functions” without

describing the “physical characteristics or chemical

properties” that would produce the desired results.

Holland Furniture, 277 U.S. at 256. Perkins had instructed gluemakers to choose a starch that would produce a glue with the properties of animal glue, without

specifying structural features that would identify such

a starch. Id. at 257. For that reason, the Court explained, “[o]ne attempting to use or avoid the use of

Perkins’[s] discovery as so claimed and described functionally could do so only after elaborate experimentation” to determine which starches would produce such a

glue. Ibid.

The Court in Holland Furniture therefore concluded that the only composition of matter that Perkins’s patent enabled was the specific starch glue his

company had invented. 277 U.S. at 256. The specification identified that glue’s “characteristic ingredient

with particularity” by describing one of the starch’s important structural features, its “water absorptivity” or

“degeneration.” Id. at 255. Perkins therefore was entitled to a patent on starch glues made from starch sharing the same general “water absorptivity” as the one the

patent identified, but it was not entitled to claim the

broader class of all starch glues made from a starch that

would result in a glue with the properties of animal glue.

Id. at 255-257.

Taken together, Consolidated Electric and Holland

Furniture establish that, when a patent claims a broad

class or “genus” of products, the specification cannot

satisfy Section 112(a)’s enablement requirement merely

by providing an example of the products that fall within

the class and a generalized description that captures

other products similar to the example. To ensure that a

“person skilled in the art” is able to “make and use” all

of the products the patent claims, 35 U.S.C. 112(a), the

specification must describe “some general quality, running through the whole” genus that “distinguishe[s]”

the products from all others, Consolidated Electric, 159

U.S. at 475. That general quality, moreover, may not be

defined purely in “terms of the use or function of the

product itself.” Holland Furniture, 277 U.S. at 256.

Rather, the patent must describe, with enough particularity to avoid the need for undue experimentation, the

structural features that distinguish the genus. Ibid.

4. The Federal Circuit has enumerated a set of

“Wands factors” to assist courts in applying these principles across the wide variety of contexts in which inventors claim patents and alleged infringers mount enablement defenses based on “undue experimentation.”

Wands, 858 F.2d at 736. The Wands factors instruct a

court confronted with an undue-experimentation challenge to consider, among other things, (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 the art,” (7) “the predictability or unpredictability of the art,” and (8) “the breadth of the

claims.” Id. at 737. As both parties appear to recognize,

those factors are appropriately applied to cases like this

one to assess whether Section 112(a)’s enablement requirement is met. Pet. Br. 23; Resp. Br. 31.

B. Petitioners’ Claims Fail Under Section 112(a) Because

Undue Experimentation Would Be Required To Make

And Use The Claimed Antibodies

Under the foregoing principles, the patents at issue

here are invalid because they do not satisfy Section

112(a)’s enablement requirement. The Federal Circuit

correctly determined that a person skilled in the art

could not “make and use” the full scope of the antibodies

covered by petitioners’ claims without “undue experimentation.” Pet. App. 6a, 15a.

1. a. Petitioners’ genus claims suffer from the same

defects that led this Court to invalidate the claims in

Consolidated Electric and Holland Furniture. Like the

patent holders in those cases, petitioners claim a broad

class of products, defined in functional terms to encompass every PCSK9 antibody that binds to the PCSK9

sweet spot and blocks PCSK9 from binding with LDL

receptors. And, as in Consolidated Electric and Holland Furniture, petitioners do not assert that they have

made and used all (or even any substantial percentage)

of the embodiments of the broad class they claim.

Instead, petitioners assert that they have made 26

exemplar antibodies. The patents describe those exemplars with varying degrees of structural detail. For two

of the exemplar antibodies, 21B12 and 31H4, petitioners

disclose the antibodies’ amino acid sequences, as well as

their 3-D crystal structures, showing where and how

they bind to PCSK9. For the remaining 24 exemplars,

the specifications provide only the amino acid sequences. Nonetheless, this kind of structural information is generally sufficient to permit a scientist to

“make and use” any of the exemplars she chooses

through standard laboratory techniques that allow scientists to use an antibody’s amino acid sequence to reverse-engineer additional antibodies with the same sequence. 35 U.S.C. 112(a); see Pet. Br. 13 (explaining

that a skilled artisan can “make either antibody 21B12

or 31H4 using the amino-acid sequences the patents

provide”). Accordingly, as in Consolidated Electric and

Holland Furniture, the patents at issue here likely

would satisfy Section 112(a)’s enablement requirement

if they claimed only the exemplar antibodies.

Petitioners’ patent specifications also resemble

those in Consolidated Electric and Holland Furniture

in their dearth of structural information regarding the

many compositions of matter, other than the enumerated exemplars, that their patent claims encompass.

Petitioners’ patents describe the untold number of additional antibodies within their claimed genus only in

terms of how they function: antibodies that will both

bind to the PCSK9 sweet spot and block PCSK9 from

binding to LDL receptors. Pet. App. 19a. The specifications do not assert that the two limitations necessarily

go hand in hand; petitioners do not suggest that every

PCSK9 antibody that binds to the sweet spot will block

LDL receptors, or that identifying an antibody with one

of the functional characteristics eliminates the need for

additional experimentation to determine whether the

antibody has the other feature as well. To the contrary,

petitioners’ “roadmap” for creating new antibodies

within the genus calls for a scientist to produce a pool of

PCSK9 antibodies; run one experiment to “identify the

antibodies * * * that bind to PCSK9’s sweet spot”; and

then conduct a second experiment to determine which

of the antibodies that bind to the sweet spot also block

LDL receptors.” See, e.g., Pet. Br. 13-14.

The specifications also do not identify any common

structural characteristic, “running through” the whole

class of antibodies that bind and block, that would enable scientists to distinguish those antibodies from any

others. Consolidated Electric, 159 U.S. at 475. Petitioners do not contend, for example, that they have

identified a particular chain of amino acids that every

antibody that binds and blocks will share. If petitioners

had identified such a feature, scientists might be able to

use it to identify other antibodies in the class, as scientists can do with the exemplars. See Pet. Br. 13.

Accordingly, like the patent holders in Consolidated

Electric and Holland Furniture, petitioners have succeeded in creating an example (or here, 26 examples) of

a new kind of product that other inventors have sought

to produce. That achievement entitled petitioners to

patents on the specific antibodies they created. Instead

of contenting themselves with patents on those inventions, however, petitioners sought an “unwarranted extension of [their] monopoly” to antibodies they have not

invented, and that their patents do not enable others to

produce. Consolidated Electric, 159 U.S. at 476.

b. Petitioners contend that their claims are adequately enabled because their specifications contain a

“roadmap” that “produces claimed antibodies every

time,” and because respondents have not identified any

antibody that is encompassed by the claims but could

not be produced using the process the roadmap identifies. Pet. Br. 25; see id. at 49. In stating that antibodies

with the desired functionalities can be produced “every

time,” petitioners appear simply to mean that candidate

antibodies can be produced in sufficiently large quantities to give a researcher confidence that some will have

the desired functional characteristics. See C.A. App.

3896 (testimony that, by “immuniz[ing] mice or us[ing]

non-animal approaches,” a researcher can produce

“thousands of antibodies, tens of thousands”); id. at

3897 (testimony that “it’s inevitable you’re going to get

the antibody that will, in fact, bind to an epitope on

PCSK9 that blocks the interaction and will bind to specific amino acids”). Petitioners’ contention that researchers can routinely generate some antibodies encompassed by the claims therefore says nothing about

whether their roadmap would enable a scientist to produce the full range of claimed antibodies without undue

experimentation.

Petitioners’ contention that their roadmap will produce claimed antibodies every time also appears to rely

on recharacterizing their initial research goal—finding

a PCSK9 antibody that blocks PCSK9 from binding

with LDL receptors—as a functional limitation on the

scope of the claims. By defining the class in this way,

petitioners’ specifications are able to set out a roadmap

that, according to the district court’s findings, is little

different from petitioners’ initial research plan. Pet.

App. 40a. Given that petitioners’ initial research produced their 26 exemplar antibodies, their roadmap may

produce additional claimed antibodies with the same

functions, but only because the specifications effectively

instruct scientists to engage in the sort of “independent

invention” that petitioners employed in developing their

antibodies in the first place. Loom Co. v. Higgins, 105

U.S. 580, 591 (1882). As Holland Furniture recognized,

“[a] claim so broad, if allowed, would operate to enable



Petitioners assert (Br. 45 n.5) that this finding was so weak that

respondents did not defend it on appeal. To the contrary, respondents’ counsel relied heavily on the finding at oral argument before

the Federal Circuit. See e.g, C.A. Oral Argument at 18:50-19:15.

the inventor who has discovered that a defined” substance “answers the required purpose to exclude others” from claiming additional substances that answer

the same purpose “and so foreclose efforts to discover

other and better types.” 277 U.S. at 257.

c. Petitioners also suggest that their broad claims

may be distinguished from the claims in cases like Consolidated Electric and Holland Furniture because,

while practitioners in those cases could produce additional products only through “elaborate experimentation,” Holland Furniture, 277 U.S. at 257, “[t]he basic

‘methods for obtaining and screening monoclonal antibodies’ were * * * well known” even before 1988, when

Wands was decided. Pet. Br. 49 (quoting Wands, 858

F.2d at 736). The Federal Circuit held in Wands that it

did not require undue experimentation to produce the

antibodies needed to practice the immunoassay methods claimed in the challenged patents. Pet. App. 9a-10a

(discussing Wands, supra). As the court of appeals observed in this case, however, “Wands did not proclaim

that all broad claims to antibodies are necessarily enabled.” Id. at 10a. Rather, the Wands Court rejected the

particular enablement challenge in front of it based on

the determination that the challenge was predicated on

an “erroneous” understanding of the data in the record.

858 F.2d at 739. Indeed, Wands specifically recognized

that “[n]o evidence was presented” regarding what type

or degree of antibody screening might amount to undue

experimentation. Id. at 740.

2. a. The Federal Circuit’s application of the Wands

factors in this case further confirms that petitioners’

claims are invalid for lack of enablement. As the court

of appeals recognized, petitioners’ argument that their

specifications comply with Section 112(a) rests heavily

on the premise that the 26 exemplars they have produced and identified are representative of the “full

scope” of antibodies their patents claim. Pet. App. 14a.

Relying on the Wands factors, the Federal Circuit correctly rejected that premise. The court concluded both

that the claimed genus was more diverse than the exemplars suggest, and that the specifications offer no

way for scientists to produce antibodies meaningfully

distinct from the exemplars without undue experimentation. Id. at 12a-15a.

The Federal Circuit observed, for example, that the

breadth of petitioners’ genus (which covers some subset

of antibodies that bind to one or more of 16 sites within

the PCSK9 sweet spot), in conjunction with the “unpredictable” nature of antibody science, makes it implausible that only 26 exemplars could represent the full class.

Pet. App. 13a-14a. Moreover, given petitioners’ incentive to create and disclose as broad a range of antibodies

as possible to bolster their claims, the specifications’ inclusion of only 26 antibodies suggests that petitioners

do not know how to produce and describe additional exemplars without undue experimentation. And respondents’ trial evidence demonstrated that petitioners’ examples do not capture even the degree of structural variation in their competitors’ antibodies. That evidence

showed that, although none of the exemplar antibodies

identified in petitioners’ patents bind to more than nine

residues, four antibodies produced by respondents and

third parties (including the antibody for which respondents received a patent) bind to a greater number. See

Resp. Br. 15, 51 n.9. That gap reinforces the inference

that petitioners did not know how to produce such antibodies without elaborate experimentation, and that

their patents’ specifications therefore could not have

provided information sufficient to “enable any person

skilled in the art * * * to make and use” those antibodies. 35 U.S.C. 112(a). See Pet. App. 13a-14a.

b. In contesting the Federal Circuit’s determination

that the exemplars identified in the patents are not representative of the full scope of the class, petitioners rely

(Br. 49) on the district court’s finding that the exemplars are “representative of the structural diversity of

the genus,” Pet. App. 25a. The district court made that

finding, however, in the course of considering (and rejecting) respondents’ separate challenge to the jury’s

finding that the patents at issue here satisfy Section

112(a)’s “written description” requirement. See id. at

23a-27a. Although the Federal Circuit’s ruling on enablement made it unnecessary for that court to address

the written-description issue, the district court’s conclusion that petitioners’ 26 examples are representative

is difficult to harmonize with the same court’s determination that the claims are not enabled because of the

breadth, diversity, and unpredictability of the class.

Compare, e.g., id. at 25a-26a, with id. at 43a-44a.

In any event, this Court should not overlook obvious

gaps in the structural representativeness of petitioners’

examples on the theory that all the undiscovered antibodies in the class are likely to be fungible. In Consolidated Electric, the inventors of the earlier version of

the lightbulb obtained a patent for an overly broad class

of lightbulbs based on their representation that the carbonized-paper filament they were using in their lightbulb was the “best” filament possible. See 159 U.S. at

472. Edison’s subsequent demonstration of their error,

see id. at 474, illustrates the dangers of assuming that

the products a patent holder has created are as good as

anything yet to come.

C. Petitioners’ Remaining Arguments Lack Merit

Petitioners offer several additional arguments in

support of reversal, but none has merit. The Federal

Circuit does not apply the “reach the full scope” test for

genus claims in the manner that petitioners describe.

And petitioners’ arguments based on potential policy

concerns overlook the distinct roles played by other patent-law principles in striking an appropriate balance

between robust patent protection and facilitating follow-on innovation.

1. Petitioners primarily assert (Br. 21-27) that the

Federal Circuit applies a “reach the full scope” test under which the application of Section 112(a)’s enablement

requirement to a genus claim depends on the cumulative time and effort required to create all potential embodiments of the claim. As petitioners observe, such a

test has no foundation in the text or this Court’s precedent. Under Section 112(a), the relevant question with

respect to genus claims is whether a “person skilled in

the art” can “make and use” each particular embodiment of the claim without undue experimentation. 35

U.S.C. 112(a). If the patent’s specification provides sufficient guidance to enable that to be done, the patent is

not invalid simply because considerable aggregate effort is needed to make a complete set of embodiments.

Petitioners are wrong, however, in attributing (Pet.

26-27) to the Federal Circuit the overly demanding rule

that petitioners describe. Petitioners’ argument appears to rest on a misunderstanding of a paragraph in

which the Federal Circuit discussed the difficulty that a

person skilled in the art would encounter if she wished

to make antibodies that were within the scope of petitioners’ claims but not within “the scope of the disclosed

examples and guidance.” Pet. App. 14a. Although the

Federal Circuit disavowed any holding “that the effort

to exhaust a genus is dispositive,” the court found it “appropriate * * * to look at the amount of effort needed

to obtain embodiments outside the scope of the disclosed examples and guidance.” Ibid.

Petitioners appear to agree that, if the specification’s

guidance does not enable a person skilled in the art to

“make and use” embodiments beyond the exemplars, 35

U.S.C. 112(a), then the claim is not fully enabled. See

Pet. Br. 28 (“[N]o one denies that a patent must reasonably enable the entire scope of the claim.”). The court

of appeals’ observation that “ ‘substantial time and effort’ would be required to reach the full scope of claimed

embodiments” in petitioners’ patents, Pet. App. 14a, appears to mean nothing more than that. Petitioners’ portrayal of the Federal Circuit as focused myopically on a

“reach the full scope” inquiry is also incompatible with

the remainder of the court’s decision, which cited

Wands and then considered a range of factors bearing

on the court’s enablement determination. See id. at

11a-15a. Petitioners’ characterization also ignores the

panel’s subsequent clarification that the problem with

petitioners’ patents “was not that it would take a long

time to collect the full set of each and every embodiment,” but instead that “far corners of the claimed landscape” were not enabled given “the narrow and limited

guidance in the specification.” Id. at 65a (Lourie, J., on

the denial of panel rehearing).

2. Petitioners assert (Pet. 37-41) that permitting

broad genus claims like theirs is essential to vindicating

the Patent Act’s purposes. Other established patent

principles, however, are better suited to addressing the

concerns petitioners identify, without extending a patentee’s exclusive rights beyond what she has invented.

a. Petitioners contend (Br. 39) that, unless broad genus claims like theirs can be patented, inventors will

have no protection when they “identify[] the mechanism

for producing a desired effect and mak[e] a working

version.” In fact, an inventor who devises a genuinely

innovative method of achieving a useful result may obtain a patent on the “process” or “improvement thereof”

that is used to produce the desired outcome. 35 U.S.C.

101; see 35 U.S.C. 102, 103. Petitioners, however, did

not seek to patent their roadmap for producing the

claimed antibodies, perhaps because (as respondents allege, Resp. Br. 1) the roadmap simply summarizes a

process that was already well known in the art. And if

petitioners had received a patent on a novel process for

generating antibodies that perform the desired functions, competing scientists could have sought to invent

around the patent by devising alternative methods of

generating the same or comparable antibodies. The effect of petitioners’ patents, by contrast, is to preclude

the creation, by any method, of antibodies with the desired functionality, including antibodies far afield from

the ones that petitioners have produced. Cf. Holland

Furniture, 277 U.S. at 257 (explaining that a “patentee

may not by claiming a patent on the result or function

of a machine extend his patent to devices or mechanisms

not described in the patent”); Pet. App. 66a (Lourie, J.,

on the denial of panel rehearing) (“It is not the law that

one can put forth an idea, or a result or function, and

claim all methods of achieving it.”).

b. Petitioners also contend (Br. 40) that enforcing

the enablement requirement will compel inventors to

engage in “rote identification of permutations within an

invention” merely to ensure that a competitor cannot

avoid the force of the patent by making an insignificant

change to a claimed product. But the “doctrine of equivalents” already prevents such efforts to evade the patent laws through insignificant variations on a patented

invention. Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 732 (2002). Under that wellestablished doctrine, “[t]he scope of a patent is not limited to its literal terms but instead embraces all equivalents to the claims described.” Id. at 732. A patent

holder therefore may enforce her patent against a competitor who has made “unimportant and insubstantial

changes and substitutions” in order to bring her own

conduct outside the patent’s literal coverage. Graver

Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605,

607 (1950).

Petitioners have not alleged that, under the doctrine

of equivalents, respondents’ use of their own patented

antibody infringed petitioners’ original, more limited

patents on antibody 21B12 or the other exemplars petitioners created. That may be because respondents’ antibody would be found meaningfully distinct from the

ones petitioners have produced. But petitioners’ inability to invoke the established protections that patent law

offers provides no justification for upholding petitioners’ broad genus claims against respondents’ enablement challenge.

CONCLUSION

The judgment of the court of appeals should be affirmed.

Respectfully submitted,