Reply Brief — Amgen Inc., et al., Petitioners v. Sanofi, et al.
Supreme Court briefMar 6, 2023
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No. 21-757
IN THE
Supreme Court of the United States
————
AMGEN INC., ET AL.,
Petitioners,
v.
SANOFI, ET AL.,
Respondents.
————
On Writ of Certiorari
to the United States Court of Appeals
for the Federal Circuit
————
REPLY BRIEF FOR PETITIONERS
————
JONATHAN P. GRAHAM
STUART L. WATT
WENDY A. WHITEFORD
STEVEN D. TANG
EMILY C. JOHNSON
AMGEN INC.
One Amgen Center Drive
Thousand Oaks, CA 91320
(805) 447-1000
JEFFREY A. LAMKEN
Counsel of Record
MICHAEL G. PATTILLO, JR.
SARAH J. NEWMAN
WALTER H HAWES IV
MOLOLAMKEN LLP
The Watergate, Suite 500
600 New Hampshire Ave., N.W.
Washington, D.C. 20037
(202) 556-2000
jlamken@mololamken.com
Counsel for Petitioners
(Additional Counsel Listed on Inside Cover)
KEITH R. HUMMEL
ANDREI HARASYMIAK
CRAVATH, SWAINE &
MOORE LLP
Worldwide Plaza
825 Eighth Avenue
New York, NY 10019
(212) 474-1000
WILLIAM G. GAEDE, III
MCDERMOTT WILL &
EMERY LLP
415 Mission Street
Suite 5600
San Francisco, CA 94105
(650) 815-7435
CHRISTIAN B. RONALD
MOLOLAMKEN LLP
430 Park Avenue
New York, NY 10022
(212) 607-8160
SARAH C. COLUMBIA
MCDERMOTT WILL &
EMERY LLP
200 Clarendon Street, Floor 58
Boston, MA 02116
(617) 535-4074
Counsel for Petitioners
TABLE OF CONTENTS
Introduction ..................................................................
Argument ......................................................................
I.
The Federal Circuit Applied a Reachthe-Full-Scope Enablement Test ..................
II. The Court Should Restore the
Statutory “Make and Use” Standard
for Enablement ................................................
A. Section 112 Provides a Practical
Standard of Reasonableness ..................
B. Sanofi-Regeneron’s “Specific
Undisclosed Embodiments”
Standard Is Unsupported .......................
C. Sanofi-Regeneron Cannot
Prevail Under Its Own Test ...................
III. The Government’s Arguments Fail ..............
IV. Genus Claims Promote, Rather Than
Stifle, Innovation .............................................
Conclusion .....................................................................
(i)
Page
1
3
3
6
6
9
11
15
21
24
ii
TABLE OF AUTHORITIES
Page(s)
CASES
Amgen Inc. v. Sanofi,
143 S. Ct. 399 (2022) ...........................................
3
Amgen Inc. v. Sanofi,
872 F.3d 1367 (Fed. Cir. 2017) ......................... 14
AstraZeneca AB v. Mylan Pharms. Inc.,
No. 1:18CV193, 2022 WL 16857400
(N.D. W. Va. Nov. 9, 2022) ................................
5
Atlas Powder Co. v. E.I. du Pont De
Nemours & Co., 750 F.2d 1569
(Fed. Cir. 1984) ...................................................
9
Auto. Techs. Int’l, Inc. v. BMW of N. Am.,
Inc., 501 F.3d 1274 (Fed. Cir. 2007) ................
8
Baxalta Inc. v. Genentech, Inc.,
579 F. Supp. 3d 595 (D. Del. 2022) ...................
5
Beidler v. United States,
253 U.S. 447 (1920) .............................................
8
Béné v. Jeantet,
129 U.S. 683 (1889) .............................................
9
Carver v. Braintree Mfg. Co.,
5 F. Cas. 235 (C.C.D. Mass. 1843)....................
8
Consol. Elec. Light Co. v.
McKeesport Light Co.,
159 U.S. 465 (1895) ............................... 8, 10, 18, 21
Cont’l Paper Bag Co. v. E. Paper
Bag Co., 210 U.S. 405 (1908) .............................
6
Diamond v. Chakrabarty,
447 U.S. 303 (1980) ............................................. 18
eBay Inc. v. MercExchange, L.L.C.,
547 U.S. 388 (2006) ............................................. 23
iii
TABLE OF AUTHORITIES—Continued
Page(s)
Holland Furniture Co. v. Perkins
Glue Co., 277 U.S. 245 (1928).................... 9, 17, 18
Human Power of N Co. v. Heartbeet Ltd.,
No. PGR2021-00110, 2022 WL 683124
(P.T.A.B. Feb. 25, 2022) ....................................
5
Lockheed Martin Corp. v. Space Sys./Loral,
Inc., 324 F.3d 1308 (Fed. Cir. 2003) ................ 22
McRO, Inc. v. Bandai Namco Games
Am. Inc., 959 F.3d 1091
(Fed. Cir. 2020) ...................................................
3
Microsoft Corp. v. i4i Ltd. P’ship,
564 U.S. 91 (2011) ............................................ 11, 16
Minerals Separation, Ltd. v.
Hyde, 242 U.S. 261 (1916) ............... 2, 6, 7, 10, 15,
16, 19, 20
Mowry v. Whitney,
81 U.S. (14 Wall.) 620 (1872) ............................. 7, 8
Neilson v. Harford (1841)
151 Eng. Rep. 1266 (Exch.) .............................. 18
O’Reilly v. Morse,
56 U.S. (15 How.) 62 (1854) ............................... 23
Pfaff v. Wells Elecs., Inc.,
525 U.S. 55 (1998) ............................................... 21
Schriber-Schroth Co. v. Cleveland
Tr. Co., 305 U.S. 47 (1938).................................
6
Smith v. Snow,
294 U.S. 1 (1935) ................................................. 16
Teva Pharms. Int’l GmbH v. Eli Lilly & Co.,
No. 18-cv-12029, 2022 WL 4824318
(D. Mass. Oct. 3, 2022) ....................................... 22
iv
TABLE OF AUTHORITIES—Continued
Page(s)
In re Wands,
858 F.2d 731 (Fed. Cir. 1988) ................... 5, 19, 21
Westinghouse v. Boyden Power Brake
Co., 170 U.S. 537 (1898) ..................................... 23
Wood v. Underhill,
46 U.S. (5 How.) 1 (1846) ...................................
8
STATUTES
21 U.S.C. § 355(j)..................................................... 23
35 U.S.C. § 112 ...................................... 1, 2, 6, 7, 9, 23
35 U.S.C. § 112(a) .............................................. 6, 9, 17
42 U.S.C. § 262(k) .................................................... 23
OTHER AUTHORITIES
2021 Annual Report Report,
Novo Nordisk (Feb. 2, 2022),
https://bit.ly/3y9JsvQ.........................................
FDA Approves Novartis Leqvio®
(Inclisiran), First-in-Class siRNA To
Lower Cholesterol and Keep It Low
with Two Doses a Year, Novartis
(Dec. 22, 2021), https://bit.ly/3EWJevV ..........
D. Karshtedt et al., The Death of
the Genus Claim, 35 Harv. J.L.
& Tech. 1 (2021) ..................................................
M. Lemley & J. Sherkow, The Antibody
Patent Paradox, 132 Yale L.J. 994
(2023)....................................................................
24
24
22
5
v
TABLE OF AUTHORITIES—Continued
Page(s)
A. Mossoff & M. Dowd, Fearmongering
Obscures the Historical, ProInnovation Role of Genus Claims,
Westlaw Today (Mar. 1, 2023),
https://bit.ly/3KWxaPo ............................ 18, 22-24
G. Quinn, Will the Supreme Court Save
Biopharma from CAFC Enablement
Insanity?, IPWatchdog (Mar. 1, 2023),
https://bit.ly/3ZJdDGd ...................................... 21
2 W. Robinson, The Law of Patents for
Useful Inventions (1890) ................................ 7, 16
9B Wright & Miller, Federal Practice
& Procedure (3d ed.).......................................... 11
IN THE
Supreme Court of the United States
————
NO. 21-757
AMGEN INC., ET AL.,
Petitioners,
v.
SANOFI, ET AL.,
Respondents.
————
On Writ of Certiorari
to the United States Court of Appeals
for the Federal Circuit
————
REPLY BRIEF FOR PETITIONERS
————
INTRODUCTION
Sanofi-Regeneron abandons the Federal Circuit’s view
that enablement depends on the cumulative time and
effort to “reach the full scope” of an invention’s embodiments. It does not contend that the effort required to find
all embodiments is even relevant. The government concedes “such a test has no foundation in the text [of § 112]
or this Court’s precedent.” U.S. Br. 29.
It was Sanofi-Regeneron, however, that pressed the
find-all-embodiments test on the Federal Circuit. Abandoning that test, Sanofi-Regeneron now makes up another: A patent with functional elements is not enabled, it
says, if there are “specific undisclosed embodiments of the
2
claimed invention” skilled artisans “cannot predictably
produce.” Resp. Br. 44. That test has no more basis in
§ 112’s text or this Court’s precedent than the reach-thefull-scope test Sanofi-Regeneron repudiates.
There is only one test for enablement—§ 112’s “make
and use” standard. That requires a practical inquiry into
what skilled artisans can do using the patent’s disclosures.
If those disclosures are “sufficiently definite to guide those
skilled in the art to” the “successful application” of “the
invention,” the patent is enabled. Minerals Separation,
Ltd. v. Hyde, 242 U.S. 261, 271 (1916). The standard is the
same whether there are 5 embodiments of the invention or
5,000. Where there are meaningfully distinct types of embodiments within the claims, the patent must “reasonabl[y]” enable skilled artisans to make and use “variation[s]”
across the claims’ scope, without subject-matter gaps skilled artisans would consider significant with due “regard to
[the patent’s] subject-matter.” Id. at 270.
Sanofi-Regeneron obfuscates with false narratives
about issues (like inventiveness) with no relevance to enablement. While Sanofi-Regeneron and its amici attempt
to manufacture factual disputes over whether skilled artisans can “make and use” the invention across the “full
scope,” e.g., U.S. Br. 22-28, the jury was instructed on that
standard, C.A. App. 2906-2907, and found for Amgen,
C.A. App. 3630-3632. Sanofi-Regeneron’s and the government’s contrary arguments operate in an evidence- and
law-free zone, divorced from the trial record and a standard of review they cannot overcome.
Sanofi-Regeneron and its amici decry the idea of genus
claims. Yet Sanofi, Regeneron, and amici (from Genentech to Sir Gregory Paul Winter) protect their own inventions through broad genus claims. If someone invents and
enables a pioneering advance, the “patent bargain” enti-
3
tles her to a patent covering the genus. The Court should
not distort enablement law to serve those who would prefer a patent system different from the one Congress enacted.
ARGUMENT
I. THE FEDERAL CIRCUIT APPLIED A REACH-THEFULL-SCOPE ENABLEMENT TEST
A. Rather than defend the Federal Circuit’s reachthe-full-scope standard, Sanofi-Regeneron denies the
Federal Circuit “relies on any such cumulative-effort
standard.” Resp. Br. 32; see U.S. Br. 29. Sanofi-Regeneron made the same argument to oppose certiorari. Br. in.
Opp. 29. This Court nonetheless granted certiorari on the
petition’s “Question 2,” Amgen Inc. v. Sanofi, 143 S. Ct.
399 (2022), which addresses the reach-the-full-scope
standard, Pet. i. Amgen thus properly addresses that issue “[f]rom its Question Presented to the last page.”
Resp. Br. 32.
The Federal Circuit’s opinion plainly turns on the effort
required to identify and make all or nearly all the antibodies within Amgen’s patent claims. The court invoked its
heightened enablement standard for “ ‘claims that state
certain structural requirements and also require performance of some function.’ ” Pet. App. 11a (quoting McRO,
Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091,
1100 n.2 (Fed. Cir. 2020)). That test “consider[s] the quantity of experimentation that would be required to make
and use, not only the limited number of embodiments that
the patent discloses, but also the full scope of the claim.”
Ibid. (emphasis added). In doing so, courts ask whether
“ ‘identifying’ ” which of the “ ‘many’ ” potential embodiments “ ‘satisfy’ ” the genus’s “ ‘requirement[s]’ ” would necessitate “ ‘undue experimentation.’ ” Pet. App. 11a-12a
(quoting McRO, 959 F.3d at 1100 n.2) (emphasis added).
4
Applying that cumulative-effort standard, the Federal
Circuit posited that Amgen’s “claims encompass[ ] millions
of candidate[ ]” antibodies, and that “it would be necessary
to first generate and then screen each candidate antibody”
to determine whether those antibodies fell within the
claims. Pet. App. 15a (emphasis added). That is an inquiry
into the effort to find all antibodies within the claims—
Sanofi-Regeneron cannot explain what else that would be.
And the court found that “no reasonable jury could conclude * * * that anything but ‘substantial time and effort’
would be required to reach the full scope of claimed
embodiments,” Pet. App. 14a (emphasis added), and that
“undue experimentation would be required to practice the
full scope of these claims,” Pet. App. 15a (emphasis added).
B. While Sanofi-Regeneron downplays the “cumulative-effort standard” as a “straw man,” Resp. Br. 31-32, it
was Sanofi-Regeneron that pressed that standard below.
It repeatedly argued that “the number of potential antibodies over the full scope of the claims that artisans would
have to make and test” was “ ‘millions.’ ” Resp. C.A. Br. 36;
see Resp. Br. 1-2, 17-18, 22-25, 27-29, 34-35, 37-40. “Someone instructed to * * * dig[ ] for gold,” Sanofi-Regeneron
thus urged, “might eventually find all the gold in the
world, but not without extraordinary trial-and-error efforts.” Resp. C.A. Br. 43 (emphasis added).
Three times in its Federal Circuit brief, Sanofi-Regeneron invoked its expert’s assertion that Amgen’s claims
were non-enabled because “ ‘you could be immunizing
mice for a hundred years’ and not find all of the claimed
antibodies.” Resp. C.A. Br. 22 (emphasis added); Resp.
C.A. Br. 36 (“all of the claimed antibodies”), 43-44 (similar).
That looks to the cumulative effort to find all antibodies
within the claim. Sanofi-Regeneron now recharacterizes
its expert as testifying that “a skilled artisan ‘could be im-
5
munizing mice for a hundred years’ and still not create a
particular desired antibody.” Resp. Br. 14 (emphasis added). That blatant switch gives away the game. SanofiRegeneron cannot pretend the cumulative-effort standard
it pressed is a figment of Amgen’s imagination.
The PTO’s Patent Trial and Appeal Board understands
the decision below as assessing the “effort required to
screen and identify all” antibodies within the claims.
Human Power of N Co. v. Heartbeet Ltd., No. PGR202100110, 2022 WL 683124, at *9 (P.T.A.B. Feb. 25, 2022) (emphasis added). District courts likewise read it to impose
“ ‘high hurdles in fulfilling the enablement requirement,’ ”
Baxalta Inc. v. Genentech, Inc., 579 F. Supp. 3d 595, 616
(D. Del. 2022) (quoting Pet. App. 12a), striking down genus
claims “given [their] breadth,” id. at 619; see also AstraZeneca AB v. Mylan Pharms. Inc., No. 1:18CV193, 2022
WL 16857400, at *8 (N.D. W. Va. Nov. 9, 2022). Commentators recognize the Federal Circuit “imposes a new requirement” for enablement “that a patentee teach [skilled
artisans] how to identify every working [embodiment] in a
genus.” M. Lemley & J. Sherkow, The Antibody Patent
Paradox, 132 Yale L.J. 994, 1031 (2023) (emphasis added).
Amici agree. E.g., NYIPLA. Br. 16; Diversified. Rschrs.
Br. 5.
C. The government says the court’s “reach the full
scope” language “appears to mean” only that skilled artisans must be able to “ ‘make and use’ embodiments beyond” the specification’s “exemplars.” U.S. Br. 30. The
Federal Circuit never suggested that making and using individual embodiments beyond Amgen’s 26 examples
“ ‘would require undue experimentation.’ ” Resp. Br. 28
(quoting In re Wands, 858 F.2d 731, 736-737 (Fed. Cir.
1988)); see U.S. Br. 26-27; pp. 15-17, infra. Instead, the
Federal Circuit varied the Wands factors by asking
6
whether there would be “ ‘undue experimentation in identifying,’ ” from “millions of ” potential embodiments, those
that “ ‘satisfy’ ” the genus’s “ ‘requirement[s],’ ” Pet. App.
11a-12a, 15a, i.e., the effort to “reach the full scope,” Pet.
App. 14a; see Pet. Br. 24-25.
Sanofi-Regeneron invokes the Federal Circuit’s assertion that “ ‘the effort required to exhaust a genus’ ” is not
“ ‘dispositive.’ ” Resp. Br. 32 (quoting Pet. App. 14a). But it
was here. Besides, the court held that the effort required
to generate and test all candidates is an “appropriate,”
Pet. App. 14a, and “important,” Pet. App. 11a, consideration. Sanofi-Regeneron and the government do not defend
that consideration as even relevant.
II. THE COURT SHOULD RESTORE THE STATUTORY
“MAKE AND USE” STANDARD FOR ENABLEMENT
A. Section 112 Provides a Practical Standard of
Reasonableness
1. Section 112(a) is clear: The specification must “enable any person skilled in the art * * * to make and use”
“the invention.” 35 U.S.C. § 112(a). That is a practical test,
focused on the ability of skilled artisans to do something
concrete—to make the invention and to use it. The requirement’s purpose is similarly practical. Section 112’s
“object * * * is to require the patentee to describe his invention so that others may construct and use it after the
expiration of the patent.” Schriber-Schroth Co. v. Cleveland Tr. Co., 305 U.S. 47, 57 (1938). Patent disclosures
thus “satisf[y] the law” if they are “sufficiently definite to
guide” skilled artisans to “successful application” of “the
invention.” Minerals Separation, 242 U.S. at 271.
The standard does not change where “the modes of ”
the claimed invention’s “embodiment * * * may be numerous and * * * different from each other.” Cont’l Paper Bag
Co. v. E. Paper Bag Co., 210 U.S. 405, 418-419 (1908). The
7
“certainty which the law requires” for enabling “variation[s]” of the invention “is not greater than is reasonable,
having regard to [the patent’s] subject-matter.” Minerals
Separation, 242 U.S. at 270. The government agrees that
enablement “generally depend[s] 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.” U.S. Br. 14.
Contrary to Sanofi-Regeneron’s accusation, Resp. Br.
37, Amgen agrees patents “must reasonably enable the entire scope of the claim,” Pet. Br. 28. Where an invention
has many embodiments, the patent enables the invention’s
“full scope” if skilled artisans can “reasonabl[y]” make and
use “variation[s],” without gaps in subject matter skilled
artisans would consider significant with “regard to [the
patent’s] subject-matter.” Minerals Separation, 242 U.S.
at 270. If the patent’s instructions are “sufficiently definite to guide” skilled artisans to “successful application”
across the scope of the “invention,” the claims are enabled.
Id. at 271; see Pet. Br. 41-42. In such cases, the “enabling
disclosure” is “ ‘commensurate with the scope of the
claims.’ ” Resp. Br. 30; see U.S. Br. 7 . But cataloging every embodiment is a task for “the mechanic, not the inventor.” 2 W. Robinson, The Law of Patents for Useful Inventions § 485 (1890).
2. Sanofi-Regeneron characterizes that standard’s
origin as “entirely unclear.” Resp. Br. 37. But it comes
from § 112’s text and the cases Sanofi-Regeneron discusses. Resp. Br. 37-42. In Mowry v. Whitney, 81 U.S. (14
Wall.) 620 (1872), for example, the patent claimed a method for manufacturing railway wheels. It was “[p]lainly
* * * impossible to describe” the specific timing and temperature parameters for every type of wheel skilled artisans might make. Id. at 645. But the patent was enabled
8
because, “in following” the specification’s “directions,”
skilled artisans “would be taught by [their] practical
knowledge” how to apply the method to any wheel in the
course of their work. Id. at 646. In Wood v. Underhill, 46
U.S. (5 How.) 1 (1846), there were “exceptions” where the
formula for mixing clay and coal dust to make bricks needed variation, but those “peculiarit[ies]” did not defeat enablement where it “appear[ed]” artisans would be able to
apply the formula to most types of clay. Id. at 5-6; see also
Carver v. Braintree Mfg. Co., 5 F. Cas. 235, 237 (C.C.D.
Mass. 1843) (patent enabled where “a skilful mechanic
could from [the patent’s] description make a proper rib for
any particular kind of cotton”). Those cases show that, if
skilled artisans can reasonably employ the invention
across the relevant field, the claim is enabled. See Pet.
Br. 30-36.1
3. There are various ways defendants can disprove
enablement. Skilled artisans may be unable to make the
invention at all. Beidler v. United States, 253 U.S. 447, 453
(1920). Defendants can show a distinct category of embodiments within the claim’s scope cannot be made following
the patent’s disclosures. Auto. Techs. Int’l, Inc. v. BMW
of N. Am., Inc., 501 F.3d 1274, 1285 (Fed. Cir. 2007). Or
they can demonstrate that the patent’s teachings force
skilled artisans on a labor-intensive hunt for working embodiments that exceeds what skilled artisans typically do,
like searching for a working needle in a haystack of failures. See Pet. Br. 45-47 (discussing Consol. Elec. Light Co.
Sanofi-Regeneron attacks Amgen’s use of the phrase “as needed.”
Resp. Br. 36-44. But saying skilled artisans must be able to make
“versions of the invention as needed” merely distinguishes the effort
to make individual embodiments from making “every possible
variation of the invention in succession,” as the reach-the-full-scope
test requires. Pet. Br. 28.
1
9
v. McKeesport Light Co., 159 U.S. 465, 472-475 (1895); Béné v. Jeantet, 129 U.S. 683, 684-686 (1889); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 250-251, 257
(1928)). That precedent amply addresses any concerns
about patentees claiming more than they enable. See
Pet. Br. 44-48.
B. Sanofi-Regeneron’s “Specific Undisclosed Embodiments” Standard Is Unsupported
1. Abandoning the cumulative-effort standard it pressed below, Sanofi-Regeneron proposes another bespoke
test: It argues a patent is not enabled “when skilled artisans cannot predictably produce specific undisclosed embodiments of the claimed invention.” Resp. Br. 44 (emphasis added). Section 112, however, refers only to “enabl[ing]” skilled artisans to “make and use” the “invention.”
35 U.S.C. § 112(a). It does not mention “embodiments,”
“specific” or “undisclosed.” It imposes no requirement
that every “specific embodiment” one can hypothesize be
“predictably produced.”
Sanofi-Regeneron identifies no case holding that a patent must enable skilled artisans to easily make all hypothetical variations of the invention. Defendants can always theorize about specific embodiments that do not
work or cannot be made. But the law recognizes that “inoperative embodiments” within a genus do not alone invalidate a claim. See Atlas Powder Co. v. E.I. du Pont De
Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984). Only
when “the number of inoperative combinations becomes
significant, and in effect forces” skilled artisans “to experiment unduly” to find ones that do exist or operate, does
that suggest “the claims might indeed be invalid.” Id. at
1576-1577. Thus, in Consolidated Electric, the defendant
prevailed by presenting clear-and-convincing evidence
that months of experimentation, with thousands of mate-
10
rials, was necessary to find one fiber (bamboo) that would
function as claimed. 159 U.S. at 472-474; Pet. Br. 45-46.
Such evidence is absent here.
Nor can Sanofi-Regeneron’s “specific undisclosed embodiments” standard be squared with a standard of “reasonable[ness]” in view of the patent’s “subject-matter.”
Minerals Separation, 242 U.S. at 270. Sanofi-Regeneron
abandons a practical focus on whether the specification
“guide[s] those skilled in the art to” the “successful application” of “the invention,” id. at 271, for a fixation on speculative outliers skilled artisans may never want or need.
2. This case illustrates the folly of Sanofi-Regeneron’s
“specific undisclosed embodiments” test. Suggesting certain antibodies within Amgen’s claims are more “desirable,” Resp. Br. 13, or “coveted,” Resp. Br. 51, Sanofi-Regeneron insinuates that, if an antibody binds at more
points in PCSK9’s sweet spot, it is more “medically effective,” Resp. Br. 43; see Resp. Br. 15, 21-22, 49, 51. That insinuation is unsupported by any evidence. Sanofi-Regeneron’s own expert said the opposite, testifying that
“there’s no correlation between the number of amino
acids that are bound and the [antibody’s] blocking” of
PCSK9’s interaction with LDL receptors. C.A. App. 3787
(462:1-15) (emphasis added). The undisputed testimony
was that, “if an antibody has a structure that allows it to
bind to one or more residues on the sweet spot”—no matter which ones or how many—“it will block” PCSK9’s interaction with LDL receptors. C.A. App. 3876 (629:10-18).
Sanofi-Regeneron states that “only Praluent is FDAapproved in a low-dose version.” Resp. Br. 1, 8-9, 21, 47.
But there is nothing about the Praluent antibody that
makes it amenable to a “low dose.” Praluent is the only
FDA-approved antibody for a low dose because only Sanofi-Regeneron sought FDA approval for both a full dose
11
and a “low” dose with half the amount of antibodies in the
container. And Sanofi-Regeneron failed to prove Praluent
would not be made by following the roadmap in Amgen’s
patents.
C. Sanofi-Regeneron Cannot Prevail Under Its
Own Test
Sanofi-Regeneron’s invocation of a “specific undisclosed embodiments” standard is ironic: Neither Sanofi-Regeneron nor the Federal Circuit identified any actual antibody that could not be made following the patents’ teachings. Pet. Br. 49; see Pet. Br. 19, 25. Sanofi-Regeneron
tried to convince the jury that Amgen’s patents were not
enabled by arguing that the roadmap in Amgen’s patents
would not produce four specific competitor antibodies—
Sanofi-Regeneron’s Praluent, Pfizer’s J16, and Merck’s
1D05 and AX132 antibodies, C.A. App. 3681 (191:2-21),
3989-3990 (912:21-913:7)—but the jury rejected that contention, and Sanofi-Regeneron never challenged that rejection on appeal or in its brief in opposition here.
1. Without mentioning those failures, Sanofi-Regeneron reprises its failed factual argument here. Resp. Br.
51. But Sanofi-Regeneron bore the burden of proving
non-enablement by clear-and-convincing evidence. Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 95 (2011). To
overturn the jury’s verdict, it must show that every reasonable juror would be compelled to find it proved nonenablement by clear-and-convincing proof. See Pet. Br.
48 (citing 9B Wright & Miller, Federal Practice & Procedure § 2535 (3d ed.)). Sanofi-Regeneron does not come
close to meeting that standard for any of its “specific undisclosed embodiments.”
While Amgen disclosed 26 example antibodies by amino-acid sequence, the patents disclosed that Amgen had
made 384 antibodies within the claims using just two pan-
12
els of mice. C.A. App. 234 (Tbl. 3), 237 (80:22-23); see pp.
19-20, infra. Amgen’s expert explained how the four competitor antibodies Sanofi-Regeneron identified would be
made following Amgen’s roadmap.2 Sanofi-Regeneron
never rebutted that testimony, and Sanofi-Regeneron
never argued on appeal that the jury could not credit it.
See Pet. C.A. Reply. Br. 3. Sanofi-Regeneron now makes
the unexplained assertion that Amgen’s expert’s testimony was “conclusory,” Resp. Br. 51 n.9, a meaningless assertion from the party that bears a clear-and-convincing burden.
Sanofi-Regeneron cites a footnote in the Federal Circuit’s decision, Resp. Br. 51, but that footnote merely compares the claims with certain “disclosed examples” in Amgen’s patents, Pet. App. 13a n.1. The Federal Circuit did
not posit, much less identify evidence, that the antibodies
identified in Sanofi-Regeneron’s chart would not be generated using the patents’ roadmap. Amgen explained that,
Pet. Br. 51 n.6, and Sanofi-Regeneron has no response.
The Federal Circuit theorized that there might be “far
corners of the claimed landscape” that might be “inaccessible,” Pet. App. 65a, but that fails to identify a “specific
undisclosed embodiment”—it is generalized speculation.
2. Sanofi-Regeneron’s argument that Amgen failed to
make a single antibody within a class variously called
“EGFa mimics,” “middle binders,” or “the missing epiAmgen’s expert testified that Praluent (“alirocumab”) could be made
“follow[ing] the road map” because the transgenic mouse system
contained “the gene pieces that are put together to make alirocumab.”
C.A. App. 3908 (757:12-758:18). He testified that Praluent likely was
among 384 antibodies Amgen initially produced, C.A. App. 39183919 (798:25-799:5), and that Pfizer’s and Merck’s antibodies could be
made following the roadmap too, C.A. App. 3908-3909 (758:19-760:21,
762:10-20).
2
13
tope,” see Resp. Br. 51, is frivolous. The documents Sanofi-Regeneron cites in support, see ibid., were excluded
from evidence at trial, see Resp. Br. 13; see also Winter
Br. 13 n.9 (quoting excluded document), or never even
offered as evidence, see Pet. C.A. Reply. Br. 32 n.13. Sanofi-Regeneron argued that the documents showed Amgen
had unsuccessfully attempted to make EGFa mimics,
Resp. C.A. Br. 42-43, 59-60, but the district court refuted
the argument, finding that the documents “did not actually
show that,” Pet. App. 47a.
The documents actually show Amgen’s initial set of 384
antibodies included at least 20 such “middle binders.” See
C.A. App. 9529-9534; C.A. Oral. Arg. 32:28-34:10 (discussing excluded documents). The jury saw data showing that
Amgen antibody 9C9 binds in the middle of the sweet spot,
antibody 21B12 binds a residue right in the middle of the
sweet spot, and antibody 1A12 sits on PCSK9 almost indistinguishably from the competitor antibodies. See D. Ct.
Dkt. 866 at 932:6-933:22; D. Ct. Dkt. 1059-1 at 148-150 (demonstratives).
3. Sanofi-Regeneron and the Federal Circuit hypothesized there might be “millions of ” potential “candidates”
for antibodies within Amgen’s claims. Pet. App. 15a. They
theorized that, applying the well-established technique
called “conservative substitution” to each of the patents’
26 example antibodies, scientists could produce “millions”
of variants. See Pet. C.A. Br. 42-43. But all those structures are disclosed in the patents. See C.A. App. 51116 (Figs. 2A-3JJJ) (26 antibodies), 211 (Tbl. 1) (listing
amino-acid substitutions). The “millions” is relevant only
under the reach-the-full-scope test Sanofi-Regeneron
abandoned—it is undisputed that making individual variants was routine. And there is no needle-in-the-haystack
problem. The patents disclose conservative substitutions
14
that “retain a similar biological activity” as the reference
antibody. C.A. App. 211 (27:60-62, 28:1-3, Tbl. 1); Pet. Br.
14-15. Sanofi-Regeneron concedes it did not identify even
one example of a conservative substitution to a disclosed
antibody that stopped the antibody from binding to
PCSK9 and blocking LDL receptors, Resp. Br. 52—failing
its own “specific undisclosed embodiment” test.
4. Sanofi-Regeneron changes the topic from enablement to false narratives. Implying Amgen did nothing innovative, it urges that Amgen was “[s]purred by” a November 2006 article proposing that antibodies could prevent PCSK9 from destroying LDL receptors. Resp. Br. 7.
But the record shows Amgen’s research started nearly
two years earlier and had already generated PCSK9 antibodies before that article appeared. See C.A. App. 3795
(494:2-6); D. Ct. Dkt. 342 at 261:1-18, 264:6-265:8. SanofiRegeneron’s contention that Amgen’s invention was
obvious in light of the prior art, Resp. Br. 35, was thus
rejected by the courts long ago, Amgen Inc. v. Sanofi, 872
F.3d 1367, 1379-1380 (Fed. Cir. 2017).
Using a misleading timeline that mixes publication
dates with invention dates, Sanofi-Regeneron implies it
discovered Praluent before Amgen applied for its patent.
Resp. Br. 8-9, 46-47 n.7. But Amgen filed its patent application in August 2007, C.A. App. 3800 (514:3-18), over a
year before Sanofi-Regeneron filed its first provisional application on Praluent in December 2008, Resp. Br. 8.3 Amgen generated PCSK9 antibodies before Regeneron genThe government’s timeline likewise erroneously describes Amgen as
“fil[ing]” for its patents on dates (U.S. Br. 4-5) that are actually when
the PTO issued the patents. Those patents “relate back to” (U.S.
Br. 4), at the latest, the January 9, 2008 priority date of Amgen’s third
provisional patent application, which Sanofi-Regeneron did not
dispute. See Amgen, 872 F.3d at 1371-1372; C.A. App. 3801 (520:2-4).
3
15
erated anything. Compare D. Ct. Dkt. 342 at 261:1-18,
264:6-265:8, with C.A. App. 3766 (379:1-9). Regeneron also sought genus claims, but was a year too late. See Prov.
Appl. No. 61/122,482 (claims 1-5). It concededly used Amgen’s anchor antibodies to confirm that Praluent binds
PCSK9’s sweet spot. Pet. Br. 15 & n.3; Resp. Br. 46-47 n.7.
Sanofi-Regeneron’s accusation that Amgen “attempt[ed] to corner the market” by adding genus claims “after
Sanofi/Regeneron developed Praluent,” Resp. Br. 1; see
Resp. Br. 10, 46, is also false. Amgen’s provisional applications from August and December 2007 included genus
claims of similar scope that likewise encompassed Praluent. See Prov. Appl. Nos. 60/957,668 (claims 68, 70-71), and
61/008,965 (claims 77, 88-89). That Sanofi-Regeneron devotes so much of its brief to (untrue) assertions having
nothing to do with enablement speaks volumes.
III. THE GOVERNMENT’S ARGUMENTS FAIL
The government agrees to the standard of “ ‘reasonable[ness], having regard to [the patent’s] subject-matter.’ ”
U.S. Br. 16 (quoting Minerals Separation, 242 U.S. at
270). But it then (U.S. Br. 22-28) departs from that standard—and from the record and the rules of procedure and
evidence. Contrast Pet. Br. 48-51.
A. Even though its own PTO issued Amgen’s patents,
the government argues they are not enabled because they
cover more antibodies than the “exemplars” in the specification. U.S. Br. 22. It urges that, because Amgen disclosed “only 26 antibodies,” the Court should “infer[ ]” that
Amgen did “not know how to produce * * * additional” antibodies. U.S. Br. 27. The patents refute that: They disclose that Amgen generated hundreds of PCSK9-blocking
antibodies. C.A. App. 237 (80:22-37). A century of law refutes any such inference: “[H]aving one [patent] embodiment before them, the public are presumed to be able to
16
construct such others as they may desire.” 2 Robinson
§ 485 (emphasis added). That presumption of enablement
can be overcome only through clear-and-convincing evidence. See i4i, 564 U.S. at 95. A patent’s teachings may
“guide” skilled artisans to the “successful application” of a
nearly “infinite[ ]” number of embodiments beyond those
disclosed in the specification. Minerals Separation, 242
U.S. at 271; see Pet. Br. 29-32. The government ignores
the rule that it is “not necessary to * * * describe in the
specification[ ] all possible forms in which the claimed principle may be reduced to practice.” Smith v. Snow, 294 U.S.
1, 11 (1935).
The government asserts that Amgen’s 26 example antibodies “do not capture even the degree of structural
variation in their competitors’ antibodies.” U.S. Br. 27.
But the question is what Amgen’s patents enable, not what
the 26 examples look like. Here, the evidence showed that
the disclosures in Amgen’s patents enable skilled artisans
to make and use the full scope of claimed antibodies,
including the competitor antibodies. See pp. 10-14, supra.
Moreover, presented with the same argument that the
competitor antibodies were distinct because they “bind to
a greater number” of PCSK9’s sweet-spot residues,
U.S. Br. 27; see Resp. Br. 15, 51 n.9, the jury rejected it.
And rightfully so, as the number of residues an antibody
binds has no effect on its function. See p. 10, supra. The
jury found Amgen’s examples “representative of the
structural diversity of the genus,” and the district court
upheld that finding as supported by “substantial evidence.” Pet. App. 25a-27a.
The government dismisses that as pertaining only to
sufficiency of the patents’ “written description.” U.S. Br.
28. But whether the examples are “representative” of the
genus’s “structural diversity” is no different for enable-
17
ment (which derives from the same sentence of § 112(a) as
the “written description” requirement, see Pet. Br. 6 n.1).
The jury’s factual finding on that issue having not been
overturned, the government cannot assert the opposite.
And the government appears to concede that, if the 26
example antibodies—which it concedes can readily be
made—are structurally representative of the full genus,
Amgen has enabled the “full scope” of its claims. U.S. Br.
26-27.
The government erroneously urges that supposedly
“obvious gaps in the structural representativeness of petitioners’ examples” cannot be ignored “on the theory that
all the undiscovered antibodies in the class are likely to be
fungible.” U.S. Br. 28. But it proves no gaps—and the antibodies are fungible. The government’s assertion that it
does not understand Amgen to “suggest that every
PCSK9 antibody that binds the sweet spot blocks LDL receptors,” U.S. Br. 23, shows the government does not understand the record. Both parties’ experts testified that,
“if an antibody has a structure that allows it to bind to one
or more residues on the sweet spot, it will block” PCSK9’s
interaction with LDL receptors. C.A. App. 3876 (629:1018) (Amgen’s expert); C.A. App. 3787 (462:16-22) (SanofiRegeneron’s expert) (similar). And there is no evidence
any antibody or category of antibodies blocks “better” or
“differently” than the 26 examples in Amgen’s patents,
better reduces cholesterol, or is better tolerated by patients. P. 10, supra. They all operate by the same mechanism: By parking on PCSK9’s sweet spot, they block that
spot and prevent it from binding to LDL receptors.
B. The government urges that Consolidated Electric
and Holland Furniture “establish that, when a patent
claims a broad class or ‘genus’ of products, * * * the specification must describe ‘some general quality, running
18
through the whole’ genus that ‘distinguishe[s]’ the products from all others.” U.S. Br. 21 (quoting Consol. Elec.,
159 U.S. at 475). “That general quality,” it urges, must be
described in “structural” terms. Ibid. (citing Holland
Furniture, 277 U.S. at 256).
While describing a structure may be one way to enable
a genus, the Court has never held it is the only way,
regardless of the nature of the art. The patent to Neilson’s
improved forge was enabled, even though it did not
identify a common structure for the “receptacle” at the
invention’s core, instead stating that any “size” or “shape”
would do. Neilson v. Harford (1841) 151 Eng. Rep. 1266,
1273-1274 (Exch.). In biological arts, inventions may be
implemented by biological generation—not structural
assembly—even when described by function. See Diamond v. Chakrabarty, 447 U.S. 303, 305-306 (1980). This
Court’s recognition of such claims laid the foundation for
the Nation’s biotech industry. See A. Mossoff & M. Dowd,
Fearmongering Obscures the Historical, Pro-Innovation
Role of Genus Claims, Westlaw Today (Mar. 1, 2023),
https://bit.ly/3KWxaPo.
Regardless, Amgen’s patents provide the relevant
“structural” requirement common to each embodiment
within the genus: a “monoclonal antibody” with the necessary physical shape and electrochemical properties to
“bind[ ] to at least one” of the residues in PCSK9’s sweet
spot. Pet. App. 4a.4
The claim term “binds to [residues on PCSK9],” C.A. App. 411
(427:47-52), conveys to skilled artisans a genus of antibody structures
that complement, and thereby bind, the sweet spot’s three-dimensional structure, see, e.g., C.A. App. 3876 (629:25-630:13). Sanofi-Regeneron’s expert agreed that “structure” and “bind[ing]” are inseparably
intertwined. C.A. App. 3789 (470:17-471:2), 3787 (462:20-22).
4
19
The government demands that Amgen’s patents “identif [y] a particular chain of amino acids that every antibody that blocks and binds will share.” U.S. Br. 24 (emphasis
added). That demand lacks “regard to [the patents’] subject-matter.” Minerals Separation, 242 U.S. at 270. The
jury heard expert testimony that amino-acid sequence is
not the metric antibody scientists use for comparing antibodies or predicting their functions. See Pet. C.A. Br. 5455; Pet. App. 25a-27a. And the tools of antibody science do
not require particular amino-acid sequences to create the
claimed antibodies. See Wands, 858 F.2d at 740. Amgen’s
patents disclose two “anchor” antibodies that, together,
bind across PCSK9’s entire sweet spot. See Pet. Br. 12.
Amgen’s expert testified that, following Amgen’s roadmap, scientists can use established means (like transgenic
mice) with those anchor antibodies as tools for identifying
“all” other antibodies that bind anywhere on the sweet
spot, and thus fall within the claims. C.A. App. 3909
(762:10-21), 3908 (757:12-14); see Pet. Br. 13-14.
C. Sanofi-Regeneron, the government, and amici,
see, e.g., Resp. Br. 35; Winter. Br. 27, flatly err in dismissing the roadmap in Amgen’s patents as “little different
from petitioners’ initial research plan,” U.S. Br. 25. The
government does not bother discussing the roadmap itself,
instead referring to the district court’s decision. Ibid. (citing Pet. App. 40a). But the district court’s analysis was so
clearly wrong that Sanofi-Regeneron did not defend it in
its Federal Circuit brief. See Pet. Br. 45 n.5. Nor did the
Federal Circuit adopt it.
Far from requiring skilled artisans to “retrace” Amgen’s “research steps,” U.S. Br. 16, the patents allow them
to start where Amgen’s research ended. Amgen’s patents
provide a wealth of previously unknown shortcuts and
techniques. Among other things, the patents disclose:
20
The region of PCSK9 that binds LDL receptors—
the sweet spot—and its precise three-dimensional
structure and biochemical properties. C.A. App.
180 (Fig. 21D), 249 (Ex. 31).
That the sweet spot is antigenic, meaning one can
generate an antibody that binds there. C.A. App.
3798 (505:21-506:3).
The first antibodies that bind there: Amgen disclosed that it had found 384 antibodies that block
the interaction between PCSK9 and LDL receptors “well,” C.A. App. 237 (80:22-23), 3798 (505:1012), characterizing 26 by amino-acid sequence,
C.A. App. 51-116.
Two anchor antibodies that—because they together cover the entire sweet spot—allow skilled artisans to identify any antibody that binds anywhere
on PCSK9’s sweet spot. Pet. Br. 45 n.5; see also
Pet. Br. 12-14; Pet. C.A. Br. 62-63.
Super-immunization protocols to produce robust
responses in transgenic mice. Pet. C.A. Br. 14.
Assays to identify antibodies that bind the sweet
spot. Pet. Br. 14; see also C.A. App. 236-238 (Ex. 3);
Pet. C.A. Br. 14-15.
Proof the antibodies reduce LDL cholesterol in live
animals. C.A. App. 242-244 (Exs. 13-16).
The government simply ignores those foundational teachings.
The effort to dismiss Amgen’s roadmap as a “trial-anderror process,” U.S. Br. 14, 24; Resp. Br. 49, has no “regard
to” the field of antibody science, Minerals Separation, 242
U.S. at 270. This is not a case, like Consolidated Electric,
where skilled artisans had to flail blindly, randomly test-
21
ing plants in hopes of discovering a “fibrous * * * material”
suitable “for incandescent conductors” in electric lamps.
159 U.S. at 472. They can make Amgen’s 26 examples.
And using Amgen’s roadmap, skilled artisans know they
will succeed in making more: They can produce a pool of
antibodies from immunized mice, and then use assays
taught by Amgen’s patents to filter down to antibodies
that “compete” with one of Amgen’s anchor antibodies and
thus bind PCSK9’s sweet spot. See Pet. Br. 13-14. That
“screen[ing]” is not trial and error, but something antibody scientists “are prepared to” perform in the ordinary
course. Wands, 858 F.2d at 740.
D. Insofar as the government invokes the “Federal
Circuit’s application of the Wands factors,” U.S. Br. 26, the
Federal Circuit did not identify any class of antibodies
that could not be made using Amgen’s patents, Pet. Br. 2527. The court’s Wands analysis turned on “the amount of
effort” that “would be required to reach the full scope of
claimed embodiments,” Pet. App. 14a—a cumulative-effort approach the government concedes is improper,
U.S. Br. 29.
IV. GENUS CLAIMS PROMOTE, RATHER THAN STIFLE,
INNOVATION
No one defends the Federal Circuit’s reach-the-full
scope test for enablement of genus claims as consistent
with the patent “bargain.” Pfaff v. Wells Elecs., Inc., 525
U.S. 55, 63 (1998). Sanofi-Regeneron and amici decry the
idea of genus claims with functional elements. E.g.,
Resp. Br. 44-48; Eli. Lilly. Br. 7-17. But Sanofi, Regeneron, and amici have protected their own inventions
through claims as broad or broader than Amgen’s. See,
e.g., U.S. Patent Nos. 8,329,669 (Sanofi); 8,298,532 (Regeneron); 6,331,415 (Genentech); 8,236,931 (Winter); see G.
Quinn, Will the Supreme Court Save Biopharma from
22
CAFC Enablement Insanity?, IPWatchdog (Mar. 1,
2023), https://bit.ly/3ZJdDGd.
A. Sanofi-Regeneron suggests that patenting an individual “antibody by amino-acid sequence” is a “longaccepted way to claim a biological discovery.” Resp. Br. 1.
But genus claims are long-accepted, too. See GSK. Br. 58; Lemley. Br. 2-7; Mossoff, supra. They are “ ‘critical to
protecting and advancing innovation,’ especially in the
chemical, pharmaceutical, and biotechnological industries.” GSK. Br. 5; see D. Karshtedt et al., The Death of
the Genus Claim, 35 Harv. J.L. & Tech. 1, 1 (2021).
Patenting specific antibody sequences offers virtually
no “protection,” for “the fruits of [an innovator’s] investment.” Pet. App. 65a. Armed with Amgen’s patents, it is
easy to make myriad antibodies beyond the disclosed examples. The doctrine of equivalents hardly “address[es]
th[e] risk” of copyists avoiding infringement by making
minor changes to amino-acid sequences. Resp. Br. 45-46;
see U.S. Br. 11, 32. That doctrine does not apply where
“even one limitation of a claim * * * is not present in the
accused [product].” Lockheed Martin Corp. v. Space
Sys./Loral, Inc., 324 F.3d 1308, 1321 (Fed. Cir. 2003).
Courts thus have refused to apply “the equivalence argument” because it “would read the amino acid sequence
limitation out of ” the claim and “effectively expand” the
claim’s scope to encompass any “antibody that has the
[claimed] effect.” Teva Pharms. Int’l GmbH v. Eli Lilly
& Co., No. 18-cv-12029, 2022 WL 4824318, at *19 (D. Mass.
Oct. 3, 2022). No company would invest billions in researching and developing new antibodies in hopes that the
doctrine of equivalents will prevent competitors from
evading an amino-acid-sequence claim.
Speculative concerns about hypothetical antibodies in
the “far corners of the claimed landscape,” Pet. App. 65a,
23
cannot meet the clear-and-convincing standard required
for invalidity. And this Court’s precedent provides the
answer to any such concerns: If some “different” antibody
in a remote corner “has so far changed the principle of the”
patent claim that it no longer “represent[s]” the invention
in Amgen’s patents, the antibody can be deemed outside
the claims’ scope (even if it “literally” falls within the
class). Westinghouse v. Boyden Power Brake Co., 170
U.S. 537, 568 (1898). The answer is not to rewrite the
longstanding enablement standard and the patent bargain
itself.
B. Sanofi-Regeneron errs in urging that many “important medical treatments will never reach the market.”
Resp. Br. 47. The prospect of an improvement patent provides an incentive to pursue innovation within a genus.
See Pet. Br. 38; Mossoff, supra. If someone did invent a
particular species more efficacious and beneficial to the
public—Sanofi-Regeneron has identified none—courts
would have ample discretion to ensure it is not kept off the
market through an injunction. See eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006). And Congress
has created processes for allowing generics and biosimilars at low costs. See 21 U.S.C. § 355(j) (Hatch-Waxman
Act); 42 U.S.C. § 262(k) (Biologics Price Competition and
Innovation Act). The Court need not distort enablement
law under § 112 to protect those interests.
C. Amici suggest that allowing claims with functional
elements would permit Amgen to monopolize “all PCSK9
antibody therapeutics.” Eli. Lilly. Br. 4 (emphasis added);
see Winter. Br. 23. Not so. This is nothing like Samuel
Morse’s effort to claim “ ‘the use of * * * electro-magnetism, however developed, for making or printing intelligible characters * * * at any distances.’ ” O’Reilly v.
Morse, 56 U.S. (15 How.) 62, 112 (1854) (emphasis added);
24
see Mossoff, supra. Amgen’s claims cover only antibodies
that block the interaction between PCSK9 and LDL
receptors by binding PCSK9’s sweet spot. Pet. App. 4a.
Merck and Novartis developed cholesterol-reducing antibodies that, binding elsewhere, function through different
mechanisms.5 Novartis developed a non-antibody, siRNAbased therapeutic that inhibits PCSK9 production and
lowers LDL cholesterol.6 And Novo Nordisk is developing
small-molecule PCSK9 inhibitors.7 That is the type of
innovation the patent system should promote—encouraging companies to develop diverse therapies, not minor
variations of antibodies performing the same function in
the same way. Upholding genus claims for pioneering
inventions accelerates the progress of science as inventors
seek their own breakthroughs instead of developing “metoo” products (like Sanofi-Regeneron did here).
CONCLUSION
The court of appeals’ judgment should be reversed.
See PCT. Appl. WO 2008/057,458 (Merck); PCT. Appl. WO 2008/125,623
(Novartis).
6
FDA Approves Novartis Leqvio® (Inclisiran), First-in-Class
siRNA To Lower Cholesterol and Keep It Low with Two Doses a Year,
Novartis (Dec. 22, 2021), https://bit.ly/3EWJevV.
7
See, e.g., 2021 Annual Report at 26, Novo Nordisk (Feb. 2, 2022),
https://bit.ly/3y9JsvQ.
5
Respectfully submitted.
JONATHAN P. GRAHAM
STUART L. WATT
WENDY A. WHITEFORD
STEVEN D. TANG
EMILY C. JOHNSON
AMGEN INC.
One Amgen Center Drive
Thousand Oaks, CA 91320
(805) 447-1000
KEITH R. HUMMEL
ANDREI HARASYMIAK
CRAVATH, SWAINE & MOORE
LLP
Worldwide Plaza
825 Eighth Avenue
New York, NY 10019
(212) 474-1000
WILLIAM G. GAEDE, III
MCDERMOTT WILL &
EMERY LLP
415 Mission Street
Suite 5600
San Francisco, CA 94105
(650) 815-7435
JEFFREY A. LAMKEN
Counsel of Record
MICHAEL G. PATTILLO, JR.
SARAH J. NEWMAN
WALTER H HAWES IV
MOLOLAMKEN LLP
The Watergate, Suite 500
600 New Hampshire Ave., N.W.
Washington, D.C. 20037
(202) 556-2000
jlamken@mololamken.com
CHRISTIAN B. RONALD
MOLOLAMKEN LLP
430 Park Avenue
New York, NY 10022
(212) 607-8160
SARAH C. COLUMBIA
MCDERMOTT WILL &
EMERY LLP
200 Clarendon Street, Floor 58
Boston, MA 02116
(617) 535-4074
Counsel for Petitioners
MARCH 2023
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.