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Amgen Inc. v. Sanofi, Aventisub LLC

United States Court of Appeals, Federal Circuit

October 5, 2017


         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.

          Daryl Joseffer, King & Spalding LLP, Washington, DC, argued for plaintiffs-appellees. Also represented by Christopher Robert Healy, Joshua Nathaniel Mitchell; Merritt Ellen McAlister, Atlanta, GA; Katherine Nicole Clouse, Sarah Chapin Columbia, McDermott, Will & Emery LLP, Boston, MA; William G. Gaede, III, Menlo Park, CA; Eric W. Hagen, Los Angeles, CA; Emily Curtis Johnson, Erica S. Olson, Dennis J. Smith, Steven D. Tang, Stuart L. Watt, Wendy A. Whiteford, Amgen Inc., Thousand Oaks, CA; Christopher Mead, London & Mead, Washington, DC; Melanie K. Sharp, Young, Conaway, Stargatt & Taylor LLP, Wilmington, DE.

          Paul D. Clement, Kirkland & Ellis LLP, Washington, DC, argued for defendants-appellants. Also represented by George W. Hicks, Jr., Nathan S. Mammen; Siew Yen Chong, Vishal C. Gupta, John J. Molenda, Steptoe & Johnson, LLP, New York, NY; Richard Praseuth, Los Angeles, CA; Kiley Ann White, Washington, DC.

          Duane Christopher Marks, Eli Lilly and Company, Indianapolis, IN, for amicus curiae Eli Lilly and Company. Also represented by Gregory Alan Cox, Gilbert Voy, Alexander Wilson.

          Barbara Anne Jones, AARP Foundation Litigation, Pasadena, CA, for amici curiae AARP and AARP Foundation.

          Dimitrios T. Drivas, White & Case LLP, New York, NY, for amicus curiae Pfizer Inc. Also represented by Eric M. Majchrzak, Amit Thakore; Jeffrey Neil Myers, Pfizer Inc., New York, NY.

          David A. Kelly, Hunton & Williams LLP, Atlanta, GA, for amicus curiae Ipsen Pharma S.A.S.

          Melissa Arbus Sherry, Latham & Watkins LLP, Washington, DC, for amicus curiae AbbVie Inc. Also represented by Michael A. Morin, Emily K. Sauter.

          William Marsillo, Boies, Schiller & Flexner, LLP, Armonk, NY, for amici curiae Luis Aparicio, M.D., W. Ross Davis, M.D., Avichai Eres, M.D., Norman Lepor, M.D., Mary McGowan, M.D., Narendra Singh, M.D., Paul

          Thompson, M.D., Rosa DeBernardo, Alina Wilson. Also represented by Michael Jay, Santa Monica, CA.

          Before Prost, Chief Judge, Taranto and Hughes, Circuit Judges.


         Appellants Sanofi, Aventisub LLC, Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S., LLC (collectively, "Appellants") appeal from a final judgment 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 ena-blement, 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), 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." Evo-locumab 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.

         The two patents at issue, both of which share the same specification, are entitled "Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PCSK9)."[2] The '165 patent issued on September 9, 2014, and the '741 patent issued on October 14, 2014. The patents have an undisputed priority date of January 9, 2008. Appellants' Br. 12. The relevant claims cover the entire genus of antibodies that bind to specific amino acid residues on PCSK9 and block PCSK9 from binding to LDL-Rs.[3] The patents do not specifically claim Repatha, or any other antibody, by amino acid sequence. Claim 1 of the '165 patent is representative. It recites:

An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDL[-]R.

'165 patent col. 427 ll. 47-53.

         The patents disclose the trial-and-error process Appellees used to generate and screen antibodies that bind to PCSK9 and block PCSK9 from binding to LDL-Rs. Id. at col. 73 l. 29-col. 124 l. 31. In particular, the specification explains that to discover the claimed antibodies, 3, 000 human monoclonal antibodies were "rescreened for binding to wild-type PCSK9 to confirm stab[ility], " id. at col. 78 ll. 4-6, which were eventually narrowed to "85 antibodies that blocked interaction between the PCSK9 . . . and the LDLR [at] greater than 90%, " id. at col. 80 ll. 35-37. The specification also discloses the three-dimensional structures, obtained via x-ray crystallography, of two antibodies known to bind to residues recited in the claims-21B12 (Repatha) and 31H4. Id. at fig. 3E, fig. 3JJ, col. 99 l. 29-col. 103 l. 60. Finally, the specification discloses the amino acid sequences of twenty-two other antibodies that "bin" with Repatha or 31H4, meaning they compete with these antibodies for binding to PCSK9. Id. at figs. 2A-2D, figs. 3A-3JJ, col. 88 l. 30-col. 89 l. 37.

         In September 2007, Appellants also started exploring antibodies targeting PCSK9. This research resulted in development of Praluent. The active ingredient in Praluent is a monoclonal antibody that targets PCSK9 to prevent it from binding to and destroying LDL-R proteins. The LDL-R proteins then extract LDL-C thereby lowering overall LDL-C levels in the bloodstream. In November 2011, the PTO issued Appellants a patent that claimed Praluent by its amino acid sequence. Appellants filed for FDA approval of Praluent in November 2014. The FDA approved Praluent in July 2015.


         In October 2014, Appellees sued Appellants, claiming that Praluent infringed the patents in suit. Appellants stipulated to infringement but challenged the patents' validity on ...

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