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Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc.

United States Court of Appeals, Federal Circuit

February 1, 2019


          Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2016-00204, IPR2016-01101, IPR2016-01242 IPR2016-01245.

          Steven William Parmelee, Wilson, Sonsini, Goodrich & Rosati, PC, Seattle, WA, argued for all appellants. Appellant Mylan Pharmaceuticals Inc. also represented by Michael T. Rosato, Jad Allen Mills; Aden M. Allen, Nicole W. Stafford, Austin, TX.

          Matthew L. Fedowitz, Buchanan Ingersoll & Rooney PC, Alexandria, VA, for appellant Breckenridge Pharmaceutical, Inc.

          Todd S. Werner, Carlson, Caspers, Vandenburgh, Lindquist & Schuman, PA, Minneapolis, MN, for appellant Alembic Pharmaceuticals Ltd. Also represented by Sarah Stensland, Patterson Thuente Pedersen, PA, Minneapolis, MN.

          Jack B. Blumenfeld, Morris, Nichols, Arsht & Tun-nell LLP, Wilmington, DE, argued for appellee. Also represented by Alexa Hansen, Covington & Burling LLP, San Francisco, CA; Jennifer L. Robbins, New York, NY; Beth S. Brinkmann, Priscilla Grace Dodson, Evan Smith Krygowski, George Frank Pappas, Washington, DC.

          Before Lourie, Bryson, and Wallach, Circuit Judges.


         Mylan Pharmaceuticals Inc. ("Mylan"), Breckenridge Pharmaceutical, Inc. ("Breckenridge"), and Alembic Pharmaceuticals, Ltd. ("Alembic") (collectively, "Appellants") appeal from the final written decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board ("the Board") in an inter partes review concluding that claims 1-13 of U.S. Reissue Patent 38, 551 ("the '551 patent") are not unpatentable. See Argentum Pharm. LLC v. Research Corp. Techs., IPR 2016-00204, 2017 WL 1096590, at *1-2 (P.T.A.B. Mar. 22, 2017) ("Decision"). For the reasons detailed below, we affirm.


         Epilepsy is a neurological disorder that affects about one percent of the human population. It is characterized by two or more unprovoked seizures occurring more than 24 hours apart. Epilepsy can be associated with conditions affecting the structure of the brain, but, for the vast majority of affected individuals, no specific cause can be identified. While there is no known cure for epilepsy, treatment can include both drug therapy and surgery, and most patients are treated via long-term administration of anticonvulsant drugs to prevent seizures. The nature and severity of seizures varies considerably across the patient population, and treatment is typically tailored for each specific patient.

         Research Corporation Technologies, Inc. ("RCT") owns the '551 patent, which discloses and claims enantiomeric compounds and pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system ("CNS") disorders. Claim 1 recites:

1. A compound in the R configuration having the formula:

         (Image Omitted))


Ar is phenyl which is unsubstituted or substituted with at least one halo group;
Q is lower alkoxy, and
Q1 is methyl.

         '551 patent col. 3811. 8-23.

         At issue here are claims 8-13.[1] Claim 8 depends from claim 1 and recites "[t]he compound according to claim 1 which is (R)-N-benzyl-2-acetamido-3- methoxypropionamide," referred to in the patent as "BAMP" and referred to herein as lacosamide:

         (Image Omitted)

         Claim 9 claims lacosamide in 90 percent or greater purity, claim 10, therapeutic compositions comprising the claimed compounds, and claims 11-13, use of the compounds for treating central nervous system disorders. Id. col. 38 ll. 39-51. Because arguments have not been made concerning the separate claims, we will consider them together, as did the Board.

         On November 23, 2015, Argentum Pharmaceuticals LLC ("Argentum") petitioned for inter partes review ("IPR") of the '551 patent. In its petition, Argentum challenged claims 1-13 on eight grounds. The Board only instituted on two grounds involving three references: (1) obviousness of claims 1-9 over Kohn 1991[2] and Silverman[3] and (2) obviousness of claims 10-13 over Kohn 1991, Silverman, and U.S. Patent 5, 378, 729 ("the '729 patent").[4] The instituted grounds appear in the petition as ground 3A and ground 3B.

         In its argument, Argentum advanced a lead compound analysis. It relied on Kohn 1991 for disclosure of compound 3l, its proffered lead compound. Kohn 1991, authored by the named inventor of the '551 patent, Dr. Harold Kohn, discloses a series of functionalized amino acids ("FAAs") with anticonvulsant activity. Dr. Kohn observed that FAA racemates with N-benzylamide moieties and acetylated amino groups provided potent protection against seizures in mice. For his research presented in the 1991 paper, Dr. Kohn began with (R, S)-2-acetamido-N-benzyl-2-methylacetamide as a lead compound and replaced the α-methyl group, denoted in the structure below as "X," with functionalized nitrogen, oxygen, and sulfur substituents:

         (Image Omitted)

         Dr. Kohn then evaluated the potency of the compounds in mice, reporting for each the effective dosage for 50 percent of ...

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