Court Opinion

ID: 4697198
Source: CourtListenerOpinion
Date Created: 2021-06-21 15:01:12.428471+00
Date Added: 2024-06-11T08:05:44.940308
License: Public Domain

Case: 20-1074    Document: 159     Page: 1    Filed: 06/21/2021

            NOTE: This order is nonprecedential.

    United States Court of Appeals
        for the Federal Circuit
                   ______________________

      AMGEN INC., AMGEN MANUFACTURING,
          LIMITED, AMGEN USA, INC.,
               Plaintiffs-Appellants

                              v.

     SANOFI, AVENTISUB LLC, FKA AVENTIS
     PHARMACEUTICALS INC., REGENERON
  PHARMACEUTICALS INC., SANOFI-AVENTIS U.S.
                       LLC,
               Defendants-Appellees
              ______________________

                         2020-1074
                   ______________________

     Appeal from the United States District Court for the
 District of Delaware in Nos. 1:14-cv-01317-RGA, 1:14-cv-
 01349-RGA, 1:14-cv-01393-RGA, 1:14-cv-01414-RGA,
 Judge Richard G. Andrews.
                  ______________________

     JEFFREY A. LAMKEN, MoloLamken LLP, Washington,
 DC, filed a petition for rehearing en banc for plaintiffs-ap-
 pellants. Also represented by SARAH JUSTINE NEWMAN,
 MICHAEL GREGORY PATTILLO, JR.; SARA MARGOLIS, New
 York, NY; EMILY JOHNSON, ERICA S. OLSON, STEVEN TANG,
 STUART WATT, WENDY A. WHITEFORD, Amgen Inc., Thou-
 sand Oaks, CA; KEITH HUMMEL, Cravath Swaine & Moore
 LLP, New York, NY; WILLIAM G. GAEDE, III, McDermott
Case: 20-1074   Document: 159     Page: 2    Filed: 06/21/2021

 2                                     AMGEN INC.   v. SANOFI

 Will & Emery LLP, Menlo Park, CA; CHRISTOPHER B.
 MEAD, Schertler Onorato Mead & Sears LLP, Washington,
 DC; JAMES L. HIGGINS, MELANIE K. SHARP, Young, Cona-
 way, Stargatt & Taylor, LLP, Wilmington, DE. Plaintiff-
 appellant Amgen Inc. also represented by SARAH CHAPIN
 COLUMBIA, McDermott, Will & Emery LLP, Boston, MA;
 LAUREN MARTIN, Quinn Emanuel Urquhart & Sullivan
 LLP, Boston, MA.

     MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP,
 Washington, DC, filed a response for defendants-appellees.
 Also represented by VICTORIA REINES; DAVID K. BARR,
 DANIEL REISNER, New York, NY; DEBORAH E. FISHMAN,
 Palo Alto, CA; GEORGE W. HICKS, JR., NATHAN S. MAMMEN,
 CALVIN ALEXANDER SHANK, Kirkland & Ellis LLP, Wash-
 ington, DC. Defendants-appellees Sanofi, Aventisub LLC,
 Sanofi-Aventis U.S. LLC also represented by STEPHANIE
 DONAHUE, Sanofi, Bridgewater, NJ. Defendant-appellee
 Regeneron Pharmaceuticals Inc. also represented by LARRY
 A. COURY, LYNDA NGUYEN, Regeneron Pharmaceuticals
 Inc., Tarrytown, NY.

     MARK A. LEMLEY, Stanford Law School, Stanford, CA,
 for amici curiae Ann Bartow, Timothy Richard Holbrook,
 Mark David Janis, Dmitry Karshtedt, Mark A. Lemley,
 Stephen McJohn, Robert P. Merges, Sean B. Seymore.

     JEFFREY PAUL KUSHAN, Sidley Austin LLP, Washing-
 ton, DC, for amici curiae Biogen Inc., Bristol-Myers Squibb
 Company, Corning Incorporated, Merck Sharp & Dohme
 Corp. Also represented by STEVEN J. HOROWITZ, Chicago,
 IL; SUE WANG, San Francisco, CA.

     JOHN M. DESMARAIS, Desmarais LLP, New York, NY,
 for amicus curiae GlaxoSmithKline PLC. Also represented
 by ELIYAHU BALSAM, TODD LAWRENCE KRAUSE.
                  ______________________
Case: 20-1074     Document: 159     Page: 3    Filed: 06/21/2021

 AMGEN INC.   v. SANOFI                                         3

         ON PETITION FOR REHEARING EN BANC
                  ______________________

    Before MOORE, Chief Judge*, NEWMAN, LOURIE, DYK,
  PROST**, O’MALLEY, REYNA, TARANTO, CHEN, HUGHES, and
                 STOLL, Circuit Judges.***

   LOURIE, Circuit Judge, with whom PROST and HUGHES,
   Circuit Judges, join, authored a separate opinion on the
          denial of the petition for panel rehearing.

 PER CURIAM.

                          ORDER
     Amgen Inc., Amgen Manufacturing, Limited, and
 Amgen USA, Inc. filed a petition for rehearing en banc. A
 response to the petition was invited by the court and filed
 by Sanofi, Aventisub LLC, Sanofi-Aventis U.S. LLC, and
 Regeneron Pharmaceuticals Inc. A group of intellectual
 property professors; GlaxoSmithKline plc; and Biogen Inc.,
 Bristol-Myers Squibb Company, Corning Incorporated,
 and Merck Sharp & Dohme Corp. requested leave to file
 briefs as amici curiae, which the court granted. The peti-
 tion was first referred as a petition for rehearing to the
 panel that heard the appeal, and thereafter the petition for
 rehearing en banc was referred to the circuit judges who
 are in regular active service.
     Upon consideration thereof,
     IT IS ORDERED THAT:

     ________________________
     *    Chief Judge Kimberly A. Moore assumed the posi-
 tion of Chief Judge on May 22, 2021.
     **   Circuit Judge Sharon Prost vacated the position of
 Chief Judge on May 21, 2021.
     *** Circuit Judge Evan J. Wallach assumed senior sta-

 tus on May 31, 2021, and did not participate in the decision
 on the petition for rehearing en banc.
Case: 20-1074     Document: 159   Page: 4    Filed: 06/21/2021

 4                                      AMGEN INC.   v. SANOFI

     The petition for panel rehearing is denied.
     The petition for rehearing en banc is denied.
     The mandate of the court will issue on June 28, 2021.

                                   FOR THE COURT

  June 21, 2021                    /s/ Peter R. Marksteiner
     Date                          Peter R. Marksteiner
                                   Clerk of Court
Case: 20-1074   Document: 159     Page: 5   Filed: 06/21/2021

         NOTE: This disposition is nonprecedential.

    United States Court of Appeals
        for the Federal Circuit
                  ______________________

      AMGEN INC., AMGEN MANUFACTURING,
          LIMITED, AMGEN USA, INC.,
               Plaintiffs-Appellants

                             v.

     SANOFI, AVENTISUB LLC, FKA AVENTIS
     PHARMACEUTICALS INC., REGENERON
  PHARMACEUTICALS INC., SANOFI-AVENTIS U.S.
                       LLC,
               Defendants-Appellees
              ______________________

                        2020-1074
                  ______________________

     Appeal from the United States District Court for the
 District of Delaware in Nos. 1:14-cv-01317-RGA, 1:14-cv-
 01349-RGA, 1:14-cv-01393-RGA, 1:14-cv-01414-RGA,
 Judge Richard G. Andrews.
                  ______________________

 LOURIE, Circuit Judge, with whom PROST and HUGHES,
 Circuit Judges, join, authoring a separate opinion on the
 denial of the petition for panel rehearing.
     Amgen has petitioned for panel rehearing. The peti-
 tion is denied.
Case: 20-1074    Document: 159     Page: 6    Filed: 06/21/2021

 2                                       AMGEN INC.   v. SANOFI

     Amgen argues that we have created a new test for en-
 ablement. That is incorrect. It has always been, or at least
 has been since the Patent Act of 1870, that a patent appli-
 cant must enable one’s invention, whatever the invention
 is. See Section 26, Patent Act of 1870, 16 Stat. 198 (1870),
 (R.S. § 4888). A composition of matter, whether a chemical
 compound or biological material, accordingly, must be ena-
 bled, as must other types of inventions.
     If the invention is a group of compositions, defined as a
 genus, that group is enabled by a disclosure commensurate
 with the scope of the genus. For years, before biological
 materials were often claimed, chemical genus claims were
 enabled by actual or constructive (often called prophetic)
 examples. Chemical patent specifications were filled with
 examples of compounds that had been prepared, generally
 shown by use of the past tense to describe the procedures,
 with melting points or other physical constants obtained by
 actual reductions to practice. Constructive examples were
 described in the present tense, with starting materials and
 process details resulting in named compounds within the
 scope of the claims. Whether actual or constructive, those
 examples enabled the full scope of the claims. Such well-
 supported generic claims do not lack for enablement, or
 written description. Amici and others bemoaning the so-
 called death of generic claims are therefore off-base. Genus
 claims, to any type of invention, when properly supported,
 are alive and well.
      What is new today is not the law, but generic claims to
 biological materials that are not fully enabled. Enable-
 ment is required, even for generic claims to biological ma-
 terials. But, as with genus claims to chemical compounds,
 if they encompass more subject matter than just a few spe-
 cies, they need to be enabled accordingly. Biological com-
 positions not actually prepared need to be described
 constructively, if required to enable the full scope of the
 claims, with procedures and names of resultant composi-
 tions, as with chemical compositions.
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 AMGEN INC.   v. SANOFI                                     3

     Amgen and amici argue that requiring that broad ge-
 neric claims in the biotechnology field be supported by dis-
 closure enabling the full scope of the claims will make it
 impossible to obtain proper protection for biotechnology in-
 ventions. But all that the enablement requirement pre-
 cludes is obtaining protection for inventions broader than
 are disclosed or enabled, and that were apparently not in-
 vented by the applicant or patentee, as shown by a lack of
 enabling disclosure. If the genus had been invented by the
 time of filing, it would have been fully enabled in the pa-
 tent.
      Entitlement to broad genus claims thus requires dis-
 closure and enablement of species supportive of the genus
 that a patentee claims to have invented. That requirement
 is based on the concept that in order to have invented a
 genus, one needs to have invented species that constitute
 the genus. Drawing a broad fence around subject matter,
 without filling in the holes, is not inventing the genus. It
 in fact discourages invention by others. If one has disclosed
 or enabled only a small number of invented species, then
 one has not invented a broad genus. Invention of a genus
 means to conceive and reduce to practice a reasonable
 number and distribution of species constituting the genus.
 Mere statement of a genus does not demonstrate that one
 has invented a generic concept, without the enablement of
 constituent species.
     Amici insist that this court has recently adopted a
 “numbers-based standard” to evaluate enablement, asking
 not whether experimentation is undue but how long it
 would take to make and screen every species. IP Profes-
 sors’ Amicus Br. 7. That mischaracterizes our law, and our
 opinion specifically resisted what might be termed a simple
 “numerosity” or “exhaustion” requirement. Consistent
 with our law, the opinion examined the relevant Wands
 factors and their interaction in a case-specific manner. The
 problem was not simply that the claimed genus was nu-
 merous—it was that it was so broad, extending far beyond
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 4                                       AMGEN INC.   v. SANOFI

 the examples and guidance provided. Likewise, it was not
 that it would take a long time to collect the full set of each
 and every embodiment—it was that the narrow and limited
 guidance in the specification made far corners of the
 claimed landscape that were particularly inaccessible or
 uncertain to make unenabled.
     Amgen and its amici argue that our decisions on ena-
 blement (just as it was once argued with respect to written
 description) threaten innovation and will “devastate” the
 incentives to invest in drug discovery. It seems to them
 that the sky is falling. But enablement is part of our law,
 and for good reason. One should not gain exclusivity over
 claimed subject matter without disclosing how to make and
 use it. And if one considers that one has invented a group
 of compositions defined by a genus but does not know
 enough to fully enable that genus, one would suppress in-
 novation if one were able to claim such a broad genus, not
 enhance it. Amgen, by asserting such broad, unsupported
 claims is doing just that, by trying to control what it has
 not invented. And, contrary to assertions by amici that
 broad, unenabled claims are necessary to protect invest-
 ment, claims to materials properly supported by inventive
 work and disclosure can be protected. Amgen in fact has
 separate patent protection on the PCSK9 antibody that it
 has invented and additionally purports to cover by the ge-
 neric claim we have invalidated.         See U.S. Patent
 8,030,457. Thus, the failure to obtain unsupported, unena-
 bled claims has not deprived it of patent protection on the
 fruits of its investment.
     Additionally, if another party invents a species not de-
 scribed or enabled by a first inventor, and hence not able to
 be encompassed by a properly enabled generic claim, that
 party has promoted the progress of the useful arts. Yet if
 that compound is so close to species disclosed and claimed
 by a first entrant as to be an equivalent, there is the doc-
 trine of equivalents to protect the innovator. And, of
 course, that second comer may encounter the expensive
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 AMGEN INC.   v. SANOFI                                      5

 hurdle of having to meet its own regulatory requirements,
 if it does not qualify for ANDA or biosimilar status.
     Claims 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. In such
 cases, it is circular; enablement comes only with success,
 which depends upon enablement. It is not the law that one
 can put forth an idea, or a result or function, and claim all
 methods of achieving it; one cannot claim everything that
 works.
     This court has already considered the impact of func-
 tional means claim limitations on whether a disclosure is
 commensurate in scope with the claim. The answer is that
 single means claims claim too much. See In re Hyatt, 708
 F.2d 712, 714 (Fed. Cir. 1983) (Rich, J.) (“The proper stat-
 utory basis for the rejection of a single means claim is the
 requirement of the first paragraph of § 112 that the ena-
 bling disclosure of the specification be commensurate in
 scope with the claim under consideration. The long-recog-
 nized problem with a single means claim is that it covers
 every conceivable means for achieving the stated result,
 while the specification discloses at most only those means
 known to the inventor.”). Multiple means claims simply
 compound the problem.
     Amgen argues that we should overrule case law that
 holds that enablement is a question of law, albeit based on
 underlying factual findings. But we are bound by our prec-
 edent and decline to recommend to the court that it go en
 banc to overrule longtime precedent simply because a party
 has questioned it. One can reasonably ask, as Amgen does,
 why enablement is a question of law when written descrip-
 tion, which sits side by side with the enablement require-
 ment, is not. They both relate to the disclosure in the
 patent specification. But our precedent is long in the tooth,
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  6                                        AMGEN INC.   v. SANOFI

  dating back before the establishment of this court. See
  Raytheon Co. v. Roper Corp., 724 F.2d 951, 960 n.6 (Fed.
  Cir. 1983), cert. denied, 469 U.S. 835 (1984) (citing In re
  Hogan, 559 F.2d 595, 604 (C.C.P.A. 1977) (stating that
  “Courts should not treat the same legal question, enable-
  ment under § 112, in one manner with respect to the appli-
  cant and in a different manner with respect to the
  examiner.”) (emphasis added); In re Brandstadter, 484
  F.2d 1395, 1406 (C.C.P.A. 1973) (analyzing whether cer-
  tain affidavits could be considered when evaluating “the ul-
  timate legal question of enablement.”) (emphasis added));
  see also Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200,
  1216 (Fed. Cir. 1991), cert. denied, 502 U.S. 856 (1991) (cit-
  ing Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261,
  1268 (Fed. Cir. 1986), cert. denied, 479 U.S. 1030 (1987))
  (“We review a determination of enablement as a question
  of law.”) (emphasis added); Elan Pharms., Inc. v. Mayo
  Found. for Med. Educ. & Research, 346 F.3d 1051, 1054
  (Fed. Cir. 2003) (citing Enzo Biochem, Inc. v. Calgene, Inc.,
  188 F.3d 1362, 1369 (Fed. Cir. 1999)) (“[W]hether a disclo-
  sure is enabling . . . is a question of law . . . .”) (emphasis
  added); McRO, Inc. v. Bandai Namco Games Am., Inc., 959
  F.3d 1091, 1096 (Fed. Cir. 2020) (citing Wyeth & Cordis
  Corp. v. Abbott Labs., 720 F.3d 1380, 1384 (Fed. Cir. 2013))
  (“[W]hether a patent satisfies the enablement requirement
  is a question of law . . . .”) (emphasis added). The much-
  cited Wands case is the signature authority on the issue.
  See In re Wands, 858 F.2d 731, 735 (Fed. Cir. 1988) (ex-
  plaining that “we review enablement as a question of law.”)
  (emphasis added).
      Indeed, despite being repeatedly asked over the dec-
  ades this court has existed, the Supreme Court has not
  seen fit to take up this question. It has, however, made
  clear that interpretation of claim scope, a question inexo-
  rably intertwined with enablement, is a question of law.
  Obviousness, which involves comparing claim scope with
  the prior art, is similarly a question of law. And so it is no
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  AMGEN INC.   v. SANOFI                                     7

  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 inquir-
  ies where applicable. Thus, the principle is indelibly em-
  bodied in and consistent with our law, and we see no reason
  to change it, especially where the arguments that Amgen
  makes provide no compelling reason to introduce such a
  seismic shift.
      Accordingly, the petition for panel rehearing is denied.