Not a Lexis Advance subscriber? Try it out for free.

Amgen Inc. v. Sanofi

United States Court of Appeals for the Federal Circuit

October 5, 2017, Decided

2017-1480

Opinion

 [*1371]  [***1356]   Prost, Chief Judge.

Appellants Sanofi, Aventisub LLC, Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S., LLC (collectively, "Appellants") appeal from a final judgment [**3]  of the district court holding U.S. Patent Nos. 8,829,165 ("'165 patent") and 8,859,741 ("'741 patent") not invalid and granting a permanent injunction enjoining sales of Appellants' Praluent® alirocumab ("Praluent").1 In particular, Appellants argue that the district court improperly excluded evidence regarding written description and enablement, improperly instructed the jury on written description, improperly denied Appellants' motion seeking JMOL of no written description and no enablement, improperly granted Appellees' motion seeking JMOL of non-obviousness, and improperly issued the permanent injunction. Appellants' Br. 1. Because we conclude that the district court (i) erred by excluding Appellants' evidence regarding written description and enablement, and (ii) improperly instructed the jury on written description, we reverse-in-part and remand for a new trial on written description and enablement. We also conclude that Appellants are not entitled to JMOL of no written description and no enablement. We affirm the district court's grant of Appellees' JMOL of non-obviousness. Finally, we vacate the district court's permanent injunction.

The patents at issue generally relate to antibodies that help reduce low-density lipoprotein cholesterol (LDL-C), [**4]  or "bad cholesterol." High levels of LDL-C in the bloodstream can cause heart attacks, strokes, and cardiovascular disease. Typically, high LDL-C is treated using small molecules called statins. In some cases, however, statins have adverse side effects or cannot reduce a patient's LDL-C to a healthy level, requiring alternative treatment. One such alternative treatment is a PCSK9 inhibitor—the medicine claimed by the patents at issue. PCSK9 is a naturally occurring protein that binds to and causes the destruction of liver cell receptors (LDL receptors, or LDL-Rs) that are responsible for extracting LDL-C from the bloodstream.

Appellees Amgen Inc., Amgen Manufacturing, Ltd., and Amgen USA, Inc. (collectively, "Appellees") first began studying PCSK9 in early 2005. This research resulted in the development of Appellees' drug Repatha™ which uses the active ingredient "evolocumab." Evolocumab is a monoclonal antibody that targets PCSK9 to prevent it from destroying LDL-R proteins. Appellees filed for FDA approval on August 27, 2014. The FDA approved Repatha in August 2015.

Read The Full CaseNot a Lexis Advance subscriber? Try it out for free.

Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.

872 F.3d 1367 *; 2017 U.S. App. LEXIS 19416 **; 124 U.S.P.Q.2D (BNA) 1354 ***; 2017 WL 4413412

AMGEN INC., AMGEN MANUFACTURING LIMITED, AMGEN USA, INC., Plaintiffs-Appellees v. SANOFI, AVENTISUB LLC, REGENERON PHARMACEUTICALS INC., SANOFI-AVENTIS U.S., LLC, Defendants-Appellants

Subsequent History: Later proceeding at Amgen, Inc. v. Sanofi, Inc., 2018 U.S. Dist. LEXIS 131358 (D. Del., Aug. 1, 2018)

US Supreme Court certiorari denied by Amgen Inc. v. Sanofi, 2019 U.S. LEXIS 86 (U.S., Jan. 7, 2019)

Prior History:  [**1] Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-01317-SLR, 1:14-cv-01349-SLR, 1:14-cv-01393-SLR, 1:14-cv-01414-SLR, Judge Sue L. Robinson.

Amgen Inc. v. Sanofi, 2016 U.S. Dist. LEXIS 34245 (D. Del., Mar. 16, 2016)Amgen Inc. v. Sanofi, 2017 U.S. Dist. LEXIS 1351 (D. Del., Jan. 5, 2017)Amgen Inc. v. Sanofi, 227 F. Supp. 3d 333, 2017 U.S. Dist. LEXIS 192 (D. Del., Jan. 3, 2017)Amgen Inc. v. Sanofi, 2016 U.S. Dist. LEXIS 19525 (D. Del., Feb. 18, 2016)

Disposition: REVERSED IN PART, AFFIRMED IN PART, VACATED IN PART, AND REMANDED.

CORE TERMS

antibodies, patent, written description, district court, genus, antigen, invention, binding, post-priority-date, species, disclose, permanent injunction, protein, Guidelines, prior art, specification, infringement, provisional, skill, state of the art, amino acid, non-obviousness, proffered, patentee, newly, monoclonal antibody, public interest, illuminate, injunction, enabled

Patent Law, Specifications, Description Requirement, Standards & Tests, Claims & Specifications, Description Requirement, Evidence, Relevance, Relevant Evidence, Proof, Enablement Requirement, Written Description Versus Enablement, Judicial Notice, Adjudicative Facts, Facts Generally Known, Verifiable Facts, Civil Procedure, Trials, Judgment as Matter of Law, Jurisdiction & Review, Standards of Review, Substantial Evidence, Remedies, Injunctions, Permanent Injunctions, Equitable Relief, Injunctions