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Amgen Inc. V. Sanofi, No No. 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 a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit ———— PETITION FOR A WRIT OF CERTIORARI ———— STUART L. WATT JEFFREY A. LAMKEN WENDY A. WHITEFORD Counsel of Record ERICA S. OLSON MICHAEL G. PATTILLO, JR. EMILY C. JOHNSON SARAH J. NEWMAN AMGEN INC. MOLOLAMKEN LLP One Amgen Center Drive The Watergate, Suite 660 Thousand Oaks, CA 91320 600 New Hampshire Ave., NW (805) 447-1000 Washington, D.C. 20037 (202) 556-2000 [email protected] Counsel for Petitioners :,/621(3(635,17,1*&2,1&± ±:$6+,1*721'& QUESTION PRESENTED The 1952 Patent Act requires patents to “contain a written description of the invention, and of the manner and process of making and using it.” 35 U.S.C. §112(a). The “written description” must be “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.” Ibid. “The object of the statute 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). The Federal Circuit has construed §112(a) as impos- ing separate “written description” and “enablement” re- quirements subject to different standards. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010) (en banc). The Federal Circuit holds that the standard in §112(a)—“in such full, clear, concise, and exact terms as to enable” skilled artisans “to make and use” the invention—does not govern written descrip- tion of the invention; it applies only to the “enablement” requirement (“the manner and process of making and using”). Ibid. For “written description of the invention,” the Federal Circuit applies its own standard: The patent disclosure must demonstrate that the inventor “‘had pos- session’” of the invention “‘as of the filing date.’” App., infra, 7a (quoting Ariad, 598 F.3d at 1350). The Federal Circuit has announced (and then modified or rescinded) various specialized “possession” sub-tests, as well as the evidence relevant to “possession.” The question present- ed is: Whether the standard for determining the adequacy of the “written description of the invention” should be as the statute says—that the description must be “in such (i) ii full, clear, concise, and exact terms as to enable any per- son skilled in the art to which it pertains * * * to make and use the same”—or whether court-created standards should control instead. iii PARTIES TO THE PROCEEDINGS BELOW Petitioners Amgen Inc., Amgen Manufacturing Limit- ed, and Amgen USA, Inc., were plaintiffs in the district court and appellees in the court of appeals. Respondents Sanofi, Aventisub LLC, Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S., LLC, were defendants in the district court and appellants in the court of appeals. iv CORPORATE DISCLOSURE STATEMENT Pursuant to this Court’s Rule 29.6, petitioner Amgen Inc. states that it has no parent corporation and that no publicly held company owns 10% or more of its stock. Petitioners Amgen Manufacturing Limited and Amgen USA, Inc., state that they are fully owned by Amgen Inc. TABLE OF CONTENTS Page Opinions Below ............................................................. 1 Statement of Jurisdiction ........................................... 1 Statutory Provisions Involved ................................... 2 Introduction .................................................................. 2 Statement ...................................................................... 5 I. Statutory Framework ..................................... 5 A. The Written-Description Requirement .............................................. 5 B. The Federal Circuit’s Written- Description Precedent .............................. 8 II.Proceedings Below .......................................... 11 A. Amgen Invents and Patents Antibodies That Can Lower Cholesterol by Binding to PCSK9’s “Sweet Spot” .............................................. 11 B. Proceedings Before the District Court ........................................................... 13 C. Proceedings Before the Federal Circuit ......................................................... 15 Reasons for Granting the Petition ............................ 16 I. The Federal Circuit’s “Possession” Standard Defies Text, History, and Precedent .......................................................... 18 A. The Federal Circuit’s Approach Contradicts §112(a)’s Text ....................... 19 B. The Federal Circuit’s “Inventor- Had-Possession” Standard Has No Statutory Basis .......................................... 23 (v) vi TABLE OF CONTENTS—Continued Page C. The Federal Circuit’s Approach Defies History and This Court’s Precedent .................................................... 24 II.The Issue Is Exceptionally Important ......... 27 A. The Federal Circuit’s Ever- Changing “Possession” Tests Impede Innovation .................................... 27 B. This Case Exemplifies the Federal Circuit’s Destabilizing Approach ............ 29 C. The “Possession” Standard Has a Disparate Impact on Biotechnology ....... 32 III. Review Is Warranted Here ........................... 33 Conclusion ..................................................................... 34 Appendix A – Court of Appeals Opinion (Oct. 5, 2017) ............................................................ 1a Appendix B – District Court Order on Post- Trial Motions (Jan. 3, 2017) ................................... 26a Appendix C – District Court Final Judgment (Jan. 3, 2017) ............................................................ 56a Appendix D – District Court Order on Evidentiary Issues (Feb. 18, 2016) ....................... 58a Appendix E – District Court Order on Motion for Reargument (Mar. 2, 2016) ................ 64a Appendix F – Court of Appeals Order Denying Rehearing En Banc (Feb. 23, 2018) ......................................................... 69a Appendix G – Relevant Statutory Provisions .......... 71a vii TABLE OF AUTHORITIES Page(s) CASES AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc.,759 F.3d 1285 (Fed. Cir. 2014) ................................................ 28, 29 Anascape, Ltd. v. Nintendo of Am., Inc., 601 F.3d 1333 (Fed. Cir. 2010) ......................... 28 Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc) ........................................................ passim In re Barker, 559 F.2d 588 (C.C.P.A. 1977) ......................... 21, 27 Bilski v. Kappos, 561 U.S. 593 (2010) .................. 23 Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011) ........... 15, 30 Christianson v. Colt Indus. Operating Corp., 486 U.S. 800 (1988) ................................. 29 Ex Parte Dickson, No. 2007-4125, 2007 WL 5108541 (B.P.A.I. Nov. 5, 2007) ....... 30 Donner v. Am. Sheet & Tin Plate Co., 165 F. 199 (3d Cir. 1908).................................... 26 Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) ................... 9, 26, 30 In re Gay, 309 F.2d 769 (C.C.P.A. 1962) ............. 26 In re Hogan, 559 F.2d 595 (C.C.P.A. 1977) ................................................ 14, 31 Ill. Tool Works, Inc. v. Foster Grant Co., 547 F.2d 1300 (7th Cir. 1976) ............................ 26 Int’l Primate Prot. League v. Adm’rs of Tulane Educ. Fund, 500 U.S. 72 (1991) ......... 20 Le Roy v. Tatham, 63 U.S. 132 (1860) ......... 8, 24, 25 viii TABLE OF AUTHORITIES—Continued Page(s) LizardTech, Inc. v. Earth Res. Mapping, Inc., 433 F.3d 1373 (Fed. Cir. 2006) ................ 9 Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) ........................................... 6, 25 Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306 (Fed. Cir. 2003) ....................... 9, 32 Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004) ................................................... 30 Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013) ......................................... 11, 28, 29 Pfaff v. Wells Elecs., Inc., 525 U.S. 55 (1998) ............................................... 5 Philip A. Hunt Co. v. Mallinckrodt Chem. Works, 177 F.2d 583 (2d Cir. 1949) .................. 26 Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) ............ 9, 11 In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967) ................................................... 8 SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348 (2018) ......................................... 19 Schriber-Schroth Co. v. Cleveland Tr. Co., 305 U.S. 47 (1938) ........................... passim The Telephone Cases, 126 U.S. 1 (1888) ............ 23, 25 United Carbon Co. v. Binney & Smith Co., 317 U.S. 228 (1942) ............................................. 31 Universal Oil Prods. Co. v. Globe Oil & Ref. Co., 322 U.S. 471 (1944) ........................... 5, 25 Univ. of Rochester v. G.D. Searle & Co., 375 F.3d 1303 (Fed. Cir. 2004) ....................... 9, 27 ix TABLE OF AUTHORITIES—Continued Page(s) U.S. Steel Corp. v. Phillips Petrol. Co., 865 F.2d 1247 (Fed. Cir. 1989) ......................... 31 Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991) ......................... 9 In
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