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Neptune Generics, LLC v. Eli Lilly & Co.

United States Court of Appeals, Federal Circuit

April 26, 2019

NEPTUNE GENERICS, LLC, FRESENIUS KABI USA, LLC, Appellants
v.
ELI LILLY & COMPANY, Appellee MYLAN LABORATORIES LIMITED, FRESENIUS KABI USA, LLC, Appellants
v.
ELI LILLY & COMPANY, Appellee

          Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2016-00237, IPR2016-00240, IPR2016-01190, IPR2016-01191, IPR2016-01335, IPR2016-01337, IPR2016-01341, IPR2016-01343, IPR2016-00318, IPR2016-01340, IPR2016-01393, IPR2016-01429.

          Sarah Elizabeth Spires, Skiermont Derby LLP, Dallas, TX, argued for all appellants. Appellant Neptune Ge-nerics, LLC also represented by Paul Skiermont; Mieke K. Malmberg, Los Angeles, CA; Joshua Harlan Harris, Neptune Generics, LLC, Chicago, IL.

          Michael B. Cottler, Goodwin Procter LLP, New York, NY, for appellant Fresenius Kabi USA, LLC.

          Thomas J. Parker, Alston & Bird LLP, New York, NY, for appellant Mylan Laboratories Limited. Also represented by Charles Abraham Naggar, Stephen Yang.

          Adam Lawrence Perlman, Williams & Connolly LLP, Washington, DC, argued for appellee. Also represented by Galina I. Fomenkova, Dov Philip Grossman, David M. Krinsky, Andrew P. Lemens, Charles McCloud; James Patrick Leeds, Eli Lilly and Company, Indianapolis, IN.

          Before Moore, Wallach, and Hughes, Circuit Judges.

          Moore, Circuit Judge.

         Neptune Generics, LLC, Fresenius Kabi USA, LLC, and Mylan Laboratories Ltd. ("Petitioners") appeal the Patent Trial and Appeals Board's inter partes review ("IPR") decisions holding Petitioners did not establish that claims 1-22 of U.S. Patent No. 7, 772, 209 are unpatentable for obviousness. Because the Board did not err in its obviousness analysis, substantial evidence supports its underlying fact findings, and subject matter eligibility is not properly before the court in an appeal from an IPR decision, we affirm.

         Background

         The '209 patent is owned by Eli Lilly & Co. and relates to administering folic acid and a methylmalonic acid ("MMA") lowering agent, such as vitamin B12, before administering pemetrexed disodium, a chemotherapy agent, in order to reduce the toxic effects of pemetrexed, an antifolate. '209 patent at 1:19-21, 57-61. Antifolates inhibit enzymes used in making the components of DNA and RNA, slowing the ability of cells to divide. Id. at 1:36-38. However, antifolates have toxic effects, which can be life threatening. E.g., id. at 1:11-12; 1:62-2:4.

         The two independent claims in the patent are method of treatment claims. They recite:

1. A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein
the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.
12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein ...

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