No. 21-757
`
`In the
`Supreme Court of the United States
`________________
`AMGEN INC., AMGEN MANUFACTURING LIMITED, and
`AMGEN USA, INC.,
`
`Petitioners,
`
`v.
`SANOFI, AVENTISUB LLC,
`REGENERON PHARMACEUTICALS INC., and
`SANOFI-AVENTIS U.S., LLC,
`Respondents.
`
`________________
`On Petition for Writ of Certiorari to the
`United States Court of Appeals
`for the Federal Circuit
`________________
`BRIEF IN OPPOSITION
`________________
`MATTHEW M. WOLF
`GEORGE W. HICKS, JR.
`VICTORIA L. REINES
` Counsel of Record
`ARNOLD & PORTER
`NATHAN S. MAMMEN
` KAYE SCHOLER LLP
`KIRKLAND & ELLIS LLP
`601 Massachusetts Ave., NW
`1301 Pennsylvania Ave., NW
`Washington, DC 20001
`Washington, DC 20004
`(202) 942-5000
`(202) 389-5000
`george.hicks@kirkland.com
`(Additional counsel listed on inside cover)
`Counsel for Respondents
`
`March 14, 2022
`
`
`
`
`
`
`
`In the
`Supreme Court of the United States
`________________
`AMGEN INC., AMGEN MANUFACTURING LIMITED, and
`AMGEN USA, INC.,
`
`Petitioners,
`
`v.
`SANOFI, AVENTISUB LLC,
`REGENERON PHARMACEUTICALS INC., and
`SANOFI-AVENTIS U.S., LLC,
`Respondents.
`
`________________
`On Petition for Writ of Certiorari to the
`United States Court of Appeals
`for the Federal Circuit
`________________
`BRIEF IN OPPOSITION
`________________
`MATTHEW M. WOLF
`GEORGE W. HICKS, JR.
`VICTORIA L. REINES
` Counsel of Record
`ARNOLD & PORTER
`NATHAN S. MAMMEN
` KAYE SCHOLER LLP
`KIRKLAND & ELLIS LLP
`601 Massachusetts Ave., NW
`1301 Pennsylvania Ave., NW
`Washington, DC 20001
`Washington, DC 20004
`(202) 942-5000
`(202) 389-5000
`george.hicks@kirkland.com
`(Additional counsel listed on inside cover)
`Counsel for Respondents
`
`March 14, 2022
`
`
`
`
`
`
`
`DAVID K. BARR
`DANIEL L. REISNER
`ARNOLD & PORTER
` KAYE SCHOLER LLP
`250 W. 55th Street
`New York, NY 10019
`
`
`
`DEBORAH FISHMAN
`ARNOLD & PORTER
` KAYE SCHOLER LLP
`3000 El Camino Real
`Five Palo Alto Square, Ste 500
`Palo Alto, CA 94306
`
`
`
`
`
`QUESTIONS PRESENTED
`1. Whether enablement, an issue of patent
`validity, is a question of law based on underlying
`findings of fact, as the Federal Circuit holds and this
`Court has consistently held with respect to issues of
`patent validity.
`2. Whether the lower court erred in applying long-
`established Federal Circuit law to the undisputed
`relevant evidence in this case in determining that no
`reasonable jury could conclude that the patents are
`enabled.
`
`
`
`
`
`ii
`
`CORPORATE DISCLOSURE STATEMENT
`Respondent Sanofi has no parent corporation, and
`no publicly held company owns 10% or more of its
`stock. Sanofi is the indirect parent corporation of
`Respondents sanofi-aventis U.S. LLC and Aventisub
`LLC.
`Respondent Regeneron Pharmaceuticals, Inc. has
`no parent corporation, and no publicly held company
`owns 10% or more of its stock.
`
`
`
`
`
`
`
`iii
`
`TABLE OF CONTENTS
`QUESTIONS PRESENTED........................................ i
`CORPORATE DISCLOSURE STATEMENT ............ ii
`TABLE OF AUTHORITIES ....................................... v
`INTRODUCTION ....................................................... 1
`STATEMENT OF THE CASE ................................... 3
`A. Factual Background ..................................... 3
`B. The Patents-In-Suit ...................................... 4
`C. Proceedings Below ........................................ 5
`1. First Trial and Appeal .......................... 6
`2. Second Trial ........................................... 7
`3. The Second Appeal .............................. 11
`REASONS FOR DENYING THE PETITION ......... 14
`I. The First Question Presented Does Not
`Warrant This Court’s Review ........................... 14
`A. The Federal Circuit’s Treatment of
`Enablement Is Consistent With This
`Court’s Precedents ...................................... 14
`B. The Question Presented Is of Insufficient
`Importance to Warrant Certiorari ............. 20
`C. This Case Is an Exceptionally Poor
`Vehicle
`to Address
`the Question
`Presented .................................................... 24
`II. The Second Question Presented Does Not
`Warrant This Court’s Review ........................... 29
`A. The Federal Circuit Did Not “Create[] a
`Special Test”
`for Enablement
`of
`Functional Genus Claims........................... 29
`
`
`
`iv
`
`B. The Question Presented Is of Insufficient
`Importance to Warrant Certiorari, and
`this Case Is a Poor Vehicle ......................... 33
`CONCLUSION ......................................................... 36
`
`
`
`v
`
`TABLE OF AUTHORITIES
`
`Cases
`Amgen Inc. v. Sanofi,
`872 F.3d 1367 (Fed. Cir. 2017) ...................... passim
`Battin v. Taggert,
`58 U.S. (17 How.) 74 (1854) ................................... 17
`Baxalta Inc. v. Genentech, Inc.,
`2022 WL 420479 (D. Del. Jan. 13, 2022) .............. 35
`Béné v. Jeantet,
`129 U.S. 683 (1889) ................................................ 32
`Carter-Wallace, Inc. v. Otte,
`474 F.2d 529 (2d Cir. 1972) ................................... 18
`Consol. Elec. Light Co.
`v. McKeesport Light Co.,
`159 U.S. 465 (1895) ................................................ 31
`Crown Operations, Int’l, Ltd. v. Solutia Inc.,
`289 F.3d 1367 (Fed. Cir. 2002) .............................. 30
`Enzo Life Scis., Inc.
`v. Roche Molecular Sys., Inc.,
`928 F.3d 1340 (Fed. Cir. 2019) .............................. 36
`Evans v. Eaton,
`20 U.S. (7 Wheat.) 356 (1822) ............................... 17
`Ex Parte Beall,
`2021 WL 1208966 (P.T.A.B. Mar. 26, 2021) ......... 35
`Festo Corp.
`v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) ................................................ 15
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) .................................................... 15
`
`
`
`vi
`
`Gray v. James,
`10 F.Cas. 1015 (C.C.D. Pa. 1817) .......................... 17
`Hepner v. United States,
`213 U.S. 103 (1909) ................................................ 22
`Hogg v. Emerson,
`52 U.S. (11 How.) 587 (1850) ................................. 17
`Holland Furniture Co. v. Perkins Glue Co.,
`277 U.S. 245 (1928) ................................................ 31
`Hologic, Inc. v. Minerva Surgical, Inc.,
`957 F.3d 1256 (Fed. Cir. 2020) .............................. 20
`Idenix Pharms. LLC v. Gilead Scis. Inc.,
`941 F.3d 1149 (Fed. Cir. 2019) ........................ 15, 27
`Idenix Pharms. LLC v. Gilead Scis., Inc.,
`141 S.Ct. 1234 (2021) ............................................. 21
`In re Brandstadter,
`484 F.2d 1395 (C.C.P.A. 1973) .............................. 15
`In re Hogan,
`559 F.2d 595 (C.C.P.A. 1977) ................................ 19
`In re Hyatt,
`708 F.2d 712 (Fed. Cir. 1983) ................................ 30
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988) .............. 10, 15, 17, 30
`Johnson v. I/O Concepts, Inc.,
`537 U.S. 1066 (2002) .............................................. 21
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .......................................... 14, 22
`Lowell v. Lewis,
`15 F.Cas. 1018 (C.C.D. Mass. 1817) ...................... 17
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) ................................................ 16
`
`
`
`vii
`
`Martek Biosciences Corp. v. Nutrinova Inc.,
`520 F. Supp.2d 557 (D. Del. 2007) ........................ 24
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009) .............................. 24
`McRO, Inc.
`v. Bandai Namco Games Am. Inc.,
`959 F.3d 1091 (Fed. Cir. 2020) ...................... passim
`Microsoft Corp. v. i4i Ltd. Partnership,
`564 U.S. 91 (2011) ............................................ 14, 15
`Minerals Separation Ltd. v. Hyde,
` 242 U.S. 261 (1916) ............................................... 32
`Minn. Mining & Mfg., Inc. v. Carborundum,
`155 F.2d 746 (3d Cir. 1946) ................................... 18
`Musco Corp. v. Qualite, Inc.,
`522 U.S. 814 (1997) ................................................ 21
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`572 U.S. 898 (2014) ................................................ 32
`O’Reilly v. Morse,
`56 U.S. (15 How.) 62 (1853) ............................. 32, 35
`Oil States Energy Servs., LLC
`v. Greene’s Energy Grp., LLC,
`138 S.Ct. 1365 (2018) ............................................. 25
`Peter v. Nantkwest, Inc.,
`140 S.Ct. 365 (2019) ............................................... 20
`Pullman-Standard v. Swint,
`456 U.S. 273 (1982) ................................................ 26
`Raytheon Co. v. Roper Corp.,
`724 F.2d 951 (Fed. Cir. 1983) ................................ 19
`Relford v. Commandant,
`401 U.S. 355 (1971) ................................................ 27
`
`
`
`viii
`
`Rita v. United States,
`551 U.S. 338 (2007) ................................................ 25
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) ................................................ 14
`Seymour v. Osborne,
`78 U.S. (11 Wall.) 516 (1870) ................................. 18
`Transocean Offshore Deepwater Drilling, Inc.
`v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) .............................. 24
`Vasudevan Software, Inc.
`v. MicroStrategy, Inc.,
`782 F.3d 671 (Fed. Cir. 2015) ................................ 24
`Watson v. Bersworth,
`251 F.2d 898 (D.C. Cir. 1958) ................................ 18
`Weisgram v. Marley Co.,
`528 U.S. 440 (2000) ................................................ 22
`Wood v. Underhill,
`46 U.S. (5 How.) 1 (1846) ................................. 16, 22
`Zivotofsky ex rel. Zivotofsky v. Clinton,
`566 U.S. 189 (2012) ................................................ 25
`Statutes
`35 U.S.C. §102 .......................................................... 18
`35 U.S.C. §103 .......................................................... 18
`35 U.S.C. §112 .......................................... 6, 15, 29, 30
`35 U.S.C. §282(b)(3)(A) ............................................. 15
`Pub. L. No. 112-99 (2011) ........................................... 6
`Other Authorities
`BIO, Idenix Pharms. LLC v. Gilead Scis. Inc.,
`No. 20-380 (U.S. filed Dec. 16, 2020) .................... 21
`
`
`
`ix
`
`Jane Byrne, Amgen v Sanofi ruling: It is
`time to kiss goodbye to broad, functional
`patent claims for antibodies, BioPharma-
`Reporter.com (Mar. 25, 2021),
`https://bit.ly/3bZUVnp ........................................... 35
`Paul R. Gugliuzza, Law, Fact, and
`Patent Validity, 106 Iowa L. Rev. 607
`(2021) .................................................... 15, 16, 19, 26
`Adam Houldsworth, The CAFC’s Amgen v.
`Sanofi Decision Spells Trouble for Broad
`Functional Patent Claims (Feb. 16, 2021),
`https://bit.ly/3tf5k4Q ............................................. 34
`Dani Kass, Biologics Face Tougher Patent
`Scrutiny After Amgen Ruling, Law360
`(Feb. 18, 2021), https://bit.ly/2Q5fvKM ................ 34
`Dmitry Karshtedt, et al., The Death of
`the Genus Claim, 35 Harv. J.L. & Tech. 1
`(2021) ................................................................ 28, 34
`Peter Loftus, FDA Authorizes Use of New
`Eli Lilly Covid-19 Antibody Treatment,
`Wall St. J. (Feb. 11, 2022),
`https://on.wsj.com/3oZ3jtG .................................... 34
`Pet., Idenix Pharms. LLC v. Gilead Scis. Inc.,
`No. 20-380 (U.S. filed Sept. 21, 2020) ................... 35
`Reply Br., Oil States Energy Servs., LLC
`v. Greene's Energy Grp., LLC, No. 16-712
`(U.S. filed May 15, 2017) ....................................... 25
`Ed Silverman, A U.S. Court Ruling May
`Force Biologics Makers To Review Patent
`Protections, Stat (Feb. 25, 2021),
`https://bit.ly/3uzmzhD ........................................... 34
`
`
`
`x
`
`U.S. Patent No. 8,030,457 .......................................... 4
`U.S. Patent No. 8,062,640 .......................................... 3
`U.S. Patent No. 8,829,165 .......................................... 4
`U.S. Patent No. 8,859,741 .......................................... 4
`
`
`
`
`
`
`INTRODUCTION
`This case is a patent dispute between innovators
`who independently developed antibody drugs that
`reduce low-density lipoprotein (“LDL”) cholesterol.
`The antibodies bind to a protein, PCSK9, thus
`preventing the destruction of receptors that extract
`cholesterol from the bloodstream.
` Respondents
`developed Praluent, the first FDA-approved PCSK9
`antibody, and Amgen developed Repatha. These
`antibodies differ in amino acid sequence and where
`they bind to PCSK9. Both are used to treat tens of
`thousands of patients.
`Respondents patented Praluent by its amino acid
`sequence. Amgen likewise initially patented Repatha
`by its amino acid sequence. But years later, in a
`blatant attempt to corner the market on PCSK9
`inhibitors—and
`after Respondents
`developed
`Praluent—Amgen obtained additional patents that
`broadly claim all antibodies that bind to certain amino
`acids on PCSK9 and block its binding to receptors.
`Amgen then asserted
`its new patents’ broad,
`functionally
`defined
`genus
`claims
`against
`Respondents, arguing that Praluent infringes the
`claims, and it sought damages and an injunction
`removing Praluent from the market.
`The Federal Circuit rightly rejected this gambit,
`holding that Amgen’s broad functional claims are not
`enabled and thereby invalid under 35 U.S.C. §112.
`That decision does not warrant further review by this
`Court. In its unanimous decision, the panel merely
`applied well-established
`law to the undisputed
`relevant facts and determined that Amgen’s broad
`functional claims require undue experimentation and
`
`
`
`2
`
`thus are not enabled by the particular specification in
`Amgen’s patents. Accordingly, this case presents
`nothing more than a classic case of factbound error
`correction
`that does not merit
`the Court’s
`intervention.
`Amgen nevertheless manufactures two questions
`presented in an effort to obtain certiorari. Neither
`provides a valid basis for review. In its first question,
`Amgen contends that the Federal Circuit treats
`enablement as a “question of law” while this Court
`treats enablement as a “question of fact.” But this
`Court has consistently held that patent validity issues
`like enablement are questions of law based on
`underlying findings of fact, and the Federal Circuit
`holds
`the same with respect
`to enablement
`specifically. In its second question, Amgen contends
`that the decision below created a special test
`applicable to functional genus claims. But the panel
`repeatedly disclaimed any bright-line rules or tests;
`its holding was simply the result of applying factors
`that the Federal Circuit has
`long used when
`evaluating enablement to the undisputed relevant
`evidence in this case, and that approach is consistent
`with the statutory text and this Court’s precedents.
`Both questions presented, moreover, do not implicate
`any current differences of federal law within the lower
`courts, are of insufficient importance to warrant
`certiorari, and are the subject of recently denied
`petitions, and this case suffers from multiple vehicle
`problems regardless. The petition should be denied.
`
`
`
`3
`
`STATEMENT OF THE CASE
`A. Factual Background
`High levels of LDL cholesterol can lead to
`cardiovascular disease, heart attacks, and strokes.
`See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1371 (Fed.
`Cir. 2017). The human body normally relies on LDL
`receptors in the liver to remove LDL cholesterol from
`the bloodstream. Pet.App.3a. In the early 2000s,
`academic researchers discovered that a naturally
`occurring protein called PCSK9 binds to and causes
`the destruction of those LDL receptors, leading to
`higher levels of LDL cholesterol in the blood.
`Pet.App.3a; C.A.App.3681.
` Building on
`that
`knowledge,
`pharmaceutical
`companies
`began
`developing antibodies that would bind to PCSK9,
`inhibiting it from binding to LDL receptors and so
`leaving those receptors free to continue removing LDL
`cholesterol from the bloodstream. C.A.App.3681;
`C.A.App.3766.
`Respondents began work on a PCSK9-inhibiting
`antibody in 2007. Amgen, 872 F.3d at 1372. In
`November 2011, the Patent and Trademark Office
`issued Respondents a patent on an anti-PCSK9
`antibody described by its amino acid sequence—the
`long-accepted way to claim a protein. Id.; see U.S.
`Patent No. 8,062,640. In July 2015, the Food and
`Drug Administration approved this antibody for the
`treatment of high cholesterol under the trade name
`Praluent, making it the first PCSK9 inhibitor on the
`market. 872 F.3d at 1372.
`While Respondents were developing Praluent,
`Amgen was independently pursuing its own PCSK9
`inhibitor. Amgen ultimately isolated an antibody and,
`
`
`
`4
`
`in October 2011, it obtained a patent on that antibody
`by claiming its amino acid sequence—a sequence
`different from Praluent’s amino acid sequence. See
`U.S. Patent No. 8,030,457. In August 2015, the FDA
`approved that antibody for the treatment of high
`cholesterol under the trade name Repatha. Amgen,
`872 F.3d at 1371.
`B. The Patents-In-Suit
`This case does not involve Amgen’s patent
`claiming Repatha by its amino acid sequence. It is
`undisputed that Praluent does not infringe that
`patent. Instead, this case involves two additional
`patents obtained by Amgen three years later, after
`Respondents developed Praluent. Unlike Amgen’s
`earlier patent, which claimed an antibody by amino
`acid sequence, Amgen’s new patents included broad
`claims that purported to “cover the entire genus of
`antibodies that bind to specific amino acid residues on
`PCSK9 and block PCSK9 from binding to” LDL
`receptors. Amgen, 872 F.3d at 1372; see Pet.App.4a-
`5a; U.S. Patent Nos. 8,829,165 (“’165 patent”),
`8,859,741 (“’741 patent”).1 In other words, Amgen’s
`new patents claimed any antibody with the function of
`binding to particular residues and blocking PCSK9
`from binding to LDL receptors.
`For instance, claim 1 and dependent claim 19 of
`the ’165 patent claim:
`1. An isolated monoclonal antibody, wherein,
`when bound to PCSK9, the monoclonal
`antibody binds to at least one of the following
`
`1 A “residue” is a particular amino acid in the amino acid
`sequence forming a protein. Amgen, 872 F.3d at 1372 n.3.
`
`
`
`5
`
`residues [followed by a list of 15 amino acid
`residues], and wherein the monoclonal
`antibody blocks binding of PCSK9 to [LDL
`receptors].
`19. The isolated monoclonal antibody of claim
`1 wherein the isolated monoclonal antibody
`binds to at least two of the following residues
`[followed by the same list of 15 amino acid
`residues as in claim 1].
`Pet.App.4a. By its terms, claim 19, which was asserted
`in this litigation, covers any isolated monoclonal
`antibody that binds to at least two of the identified
`amino acid residues on PCSK9 and blocks PCSK9
`from binding to LDL receptors.
`The two Amgen patents at issue in this case share
`a common specification, which describes the “trial-
`and-error process [Amgen] used to generate and
`screen antibodies that bind to PCSK9 and block
`PCSK9 from binding to” LDL receptors. Amgen, 872
`F.3d at 1372; Pet.App.3a. The specification discloses
`that Amgen identified 3,000 antibodies that bind to
`PCSK9, which Amgen narrowed down to 85 that
`blocked the interaction between PCSK9 and LDL
`receptors by 90% or more. Amgen, 872 F.3d at 1372.
`The specification only discloses the amino acid
`sequences of roughly two dozen antibodies purported
`to be within the scope of the claims. Id. And of those
`antibodies, the specification provides the three-
`dimensional structure of all of two antibodies. Id.
`C. Proceedings Below
`In October 2014, mere days after obtaining the
`’165 and ’741 patents, Amgen sued Respondents for
`infringement, asserting that Praluent fell within the
`
`
`
`6
`
`broad class of antibodies those patents claimed.
`Pet.App.5a. Respondents stipulated to infringement,
`but, as relevant here, claimed that the ’165 and ’741
`patents are invalid for failure to satisfy the Patent
`Act’s
`enablement
`and written
`description
`requirements. Pet.App.5a; Amgen, 872 F.3d at 1372;
`see 35 U.S.C. §112(a) (requiring every patent to
`include a specification that contains “a written
`description of the invention, and of 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, or with which it
`is most nearly connected, to make and use the same”).2
`1. First Trial and Appeal
`A jury ruled for Amgen, and the district court
`granted a permanent injunction removing Praluent
`from the market. Amgen, 872 F.3d at 1372-73. The
`Federal Circuit stayed the injunction pending appeal.
`Id. at 1373.
`On appeal, Respondents argued that the district
`court erroneously excluded evidence showing that
`even after Amgen filed its priority application for the
`patents, it continued its trial-and-error search for
`antibodies within the genus; such post-priority-date
`evidence, Respondents contended, was relevant to
`both
`the enablement and written description
`requirements. Id. Respondents also contended that
`the court had erroneously instructed the jury that it
`could find adequate written description if Amgen’s
`
`2 Section 112 was amended by the America Invents Act, Pub.
`L. No. 112-99 (2011). The pre-AIA statute applies to the patents
`at issue in this case.
`
`
`
`7
`
`characterized
`“newly
`specification disclosed a
`antigen,” rather than properties of the claimed
`antibodies. Id. at 1376.
`The Federal Circuit unanimously agreed with
`these arguments and vacated the jury verdict and
`permanent injunction. Id. at 1371. It held that the
`exclusion of post-priority-date evidence was erroneous
`because such evidence was relevant to determining
`whether the patents satisfied the enablement and
`written description requirements. Id. at 1374-75. And
`it held that the “newly characterized antigen” test
`embodied in the challenged jury instruction “flout[ed]
`basic legal principles of the written description
`requirement.” Id. at 1378-79. The Federal Circuit
`remanded for a new trial on enablement and written
`description. Id. at 1381-82.
`2. Second Trial
`On remand, the case was reassigned to a new
`district judge given the previous judge’s retirement.
`Before trial, Amgen again sought to exclude some of
`the same evidence that Respondents raised in the first
`appeal—including some of the same documents that
`had previously been excluded. As before, this evidence
`showed that, for years after the priority date, Amgen
`continued to look for certain desirable antibodies
`known to fall within the scope of the claims but was
`unsuccessful, despite having the ’165 and ’741 patents
`in hand—thus demonstrating the patents’ lack of
`enablement and written description. The court
`nevertheless
`prohibited
`Respondents
`from
`introducing this evidence for any purpose—even to
`impeach Amgen’s lead inventor, whose testimony was
`flatly contrary to the excluded evidence.
` See
`
`
`
`8
`
`C.A.App.3686-3687, 3807-3808, 3869-3870, 5248-
`5431.
`Despite being hamstrung by the evidentiary
`rulings, Respondents presented undisputed evidence
`demonstrating that the asserted claims are not
`enabled. For example, as to the breadth of the claims,
`Respondents’ expert testified that the patents
`“cover … a vast scope of possible antibodies,” reaching
`“millions” if not “an astronomically large number” of
`antibodies. C.A.App.3750, 3688, 3759. Amgen’s
`witnesses did not disagree; they were unable even to
`estimate the number of antibodies within the claims’
`scope. One “d[id]n’t know a specific number,”
`C.A.App.3869, and the other said he couldn’t “give …
`a number” and agreed that following the patents’
`teaching would generate “millions and millions of
`antibodies,” C.A.App.3902.
`Furthermore, Amgen’s witnesses conceded that
`given the unpredictability of antibody science, a
`skilled person would have to test every single antibody
`generated by Amgen’s disclosed methods to determine
`whether it had the necessary functional properties
`and thus was encompassed by the claims. As one
`Amgen expert admitted, knowing “the amino acid
`sequence of an antibody” does not “tell you the
`property of where it binds,” so to determine if
`generated antibodies actually “bind and block” and
`thus fall within the claims’ scope, “you’d have to test”
`each of them. C.A.App.3914-3918. Another Amgen
`expert acknowledged that “[c]hanging a single amino
`acid in an antibody’s sequence can change that
`antibody’s function,” so to determine an antibody’s
`functionality after changing “a single amino acid,” a
`
`
`
`9
`
`skilled person “would test.” C.A.App.3891. And an
`Amgen inventor conceded that even “conservative
`substitutions”—i.e., changing one amino acid of an
`antibody disclosed in the patent—are unpredictable,
`because “sometimes what you think is a conservative
`mutation is not conservative at all … in terms of the
`protein function”; thus, the “only way to know” if an
`antibody resulting from a “conservative mutation”
`falls within the claims’ scope “is to test
`it.”
`C.A.App.3768-3769.
`Given the vastness of the claims’ scope, the
`unpredictability of the art, and the need to test every
`generated antibody to determine if it falls within the
`claims’ scope, Amgen’s experts admitted that the
`amount of experimentation necessary to make and use
`(i.e., enable) the claimed antibodies was “an enormous
`amount of work” and not “practical”; no “antibody
`scientist would
`even
`contemplate doing”
`it.
`C.A.App.3902, 3914.
`In addition to this non-enablement evidence,
`Respondents also presented undisputed evidence that
`Amgen’s patents lacked sufficient written description
`because the antibodies disclosed in the patents were
`not representative of or structurally similar even to
`four antibodies discovered by Amgen’s competitors
`and known to fall within the claims—much less to the
`millions of additional antibodies that the claims
`encompassed. For example, Respondents showed that
`those four antibodies bound to PCSK9 at more (and
`markedly different) residues than Amgen’s disclosed
`antibodies, as shown in the following table:
`
`
`
`10
`
`
`C.A.App.4283. The jury found two of the five asserted
`claims invalid for lack of adequate written description
`but found the three remaining claims valid.
`Respondents moved for judgment as a matter of
`law that the patents are invalid due to lack of
`enablement and written description. The district
`court granted Respondents’ motion as to enablement,
`concluding that, under the Federal Circuit’s long-
`established multi-factor
`test
`for
`evaluating
`enablement, see In re Wands, 858 F.2d 731 (Fed. Cir.
`1988),
`Amgen’s
`patents
`require
`undue
`experimentation and
`thus are not
`enabled.
`Pet.App.27a-44a.
` Among
`other
`things—and
`repeatedly noting testimony from Amgen’s own
`witnesses—the court determined that “there is not a
`genuine material dispute of fact as to the breadth of
`the claims, and a reasonable factfinder could only
`conclude on this factual record that the scope of the
`claims is vast,” Pet.App.34a; “a reasonable factfinder
`
`
`
`11
`
`could only find that the art is unpredictable,”
`Pet.App.35a-38a; “any reasonable factfinder would
`conclude” that the patent “do[es] not teach a person of
`ordinary skill in the art how to predict from an
`antibody’s sequence whether it will bind to specific
`PCSK9 residues,” Pet.App.38a, 40a; and “a reasonable
`factfinder could only have determined that the
`experimentation necessary to enable the full scope of
`the claims would take a substantial amount of time
`and effort,” Pet.App.42a-43a.
` Accordingly, “any
`reasonable factfinder would find that practicing the
`claims’ full scope” would require “substantial” and
`“undue experimentation.” Pet.App.43a-44a.
`3. The Second Appeal
`Amgen appealed to the Federal Circuit, arguing
`that the district court had erred in its application of
`the multi-factor Wands test. See Amgen.C.A.Br.26
`(contending that “[t]his Court’s seminal enablement
`decision, Wands, demonstrates that Amgen’s patents
`are enabled”); Amgen.C.A.Br.28 (contending that the
`district court’s “Wands analysis” was “flawed”);
`Pet.App.8a (noting that “Amgen contends that, under
`a proper analysis of the Wands factors, the claims at
`issue were enabled”).
`The Federal Circuit unanimously affirmed.
`Pet.App.1a-15a.
` The court first observed that
`enablement is “a question of law … review[ed] without
`deference, although the determination may be based
`on underlying factual findings, which we review for
`clear error.” Pet.App.6a.
`The court next explained that “[w]hile functional
`claim limitations are not necessarily precluded in
`claims that meet the enablement requirements,” such
`
`
`
`12
`
`limitations “pose high hurdles in fulfilling the
`enablement requirement.” Pet.App.12a. It then held
`that,
`under
`the Wands
`factors,
`“undue
`experimentation” was necessary to enable the “full
`scope”
`of Amgen’s
`“double-function
`claims.”
`Pet.App.12a. The court remarked that the claims
`“were indisputably broad,” and “far broader in
`functional diversity than the disclosed examples.”
`Pet.App.12a-13a. The court also observed—citing
`Amgen’s own witnesses—that the “field of science”
`was “unpredictable,” and it noted “the conspicuous
`absence of nonconclusory evidence that the full scope
`of the broad claims can predictably be generated by
`the described methods.” Pet.App.13a. Next, the court
`concluded that, even after giving Amgen the benefit of
`the evidence, “any reasonable factfinder would
`conclude that the patent does not provide significant
`guidance or direction to a person of ordinary skill in
`the art for the full scope of the claims.” Pet.App.14a.
`“[U]nder these facts,” the court explained, “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.
`Thus, “weighing the Wands factors,” the court
`concluded, “undue experimentation would be required
`to practice
`the
`full scope of
`these claims.”
`Pet.App.15a.
`Amgen sought rehearing en banc. The Federal
`Circuit denied rehearing without any call for a vote.
`Pet.App.60a-61a.
` The panel issued an opinion
`respecting the denial of rehearing. Pet.App.62a-68a.
`The panel devoted the vast majority of that opinion to
`rejecting Amgen’s argument that it had “created a new
`test for enablement.” Pet.App.62a. The panel
`
`
`
`13
`
`explained that the opinion had merely “examined the
`relevant Wands factors and their interaction in a case-
`specific manner” and that what was “new” was “not
`the law, but generic claims to biological materials that
`are not fully enabled.” Pet.App.63a, 64a-65a. As the
`panel explained, “[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, hence
`that
`it has been enabled.”
`Pet.App.66a. The enablement requirement precludes
`obtaining a patent “for inventions broader than are
`disclosed or enabled, and that were apparently not
`invented by the applicant.” Pet.App.64a. Allowing
`such overly broad genus claims where an inventor has
`not done the work of filling in the gaps, the panel
`observed, “discourages invention by others.” Id.
`When “properly supported,” however, “[g]enus claims,
`to any type of invention … are alive and well.”
`Pet.App.63a.
`The panel also briefly addressed Amgen’s
`argument in its rehearing petition that the court
`should overrule its precedent treating enablement as
`a question of law based on underlying factual findings.
`Pet.App.66a-67a. The panel observed that this Court
`has “made clear that interpretation of claim scope, a
`question inexorably intertwined with enablement, is a
`question of law”; thus, “it is no surprise that
`enablement, which
`involves
`interpreting
`the
`specification and the scope of the claims, is also a
`question of law, if one that accommodates underlying
`factual inquiries where applicable.” Pet.App.68a.
`
`
`
`14
`
`I.
`
`REASONS FOR DENYING THE PETITION
`The First Question Presented Does Not
`Warrant This Court’s Review.
`A. The Federal Circuit’s Treatment of
`Enablement Is Consistent With This
`Court’s Precedents.
`“[w]hether
`asks
`Amgen’s
`first
`question
`enablement is a question of fact to be determined by
`the jury … or a question of law that the court reviews
`without deference.”
` Pet.i (alterations omitted).
`Amgen contends that the Federal Circuit has adopted
`a “contrary rule” that diverges from this Court’s
`caselaw and that certiorari is warranted to correct the
`Federal Circuit’s “opposite” approach. Pet.12, 13, 24.
`Amgen is incorrect. The Federal Circuit’s treatment
`of enablement
`is consistent with this Court’s
`treatment of patent validity issues.
`This Court has long held that patent validity is a
`question of law with underlying factual questions.
`Thus, the Court held in Microsoft Corp. v. i4i Ltd.
`Partnership, 564 U.S. 91 (2011), that “the ultimate
`question of patent validity is one of law,” with “the
`same factual questions under
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