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.
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,
Michael B. Cottler, Goodwin Procter LLP, New York, NY, for
appellant Fresenius Kabi USA, LLC.
J. Parker, Alston & Bird LLP, New York, NY, for appellant
Mylan Laboratories Limited. Also represented by Charles
Abraham Naggar, Stephen Yang.
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.
Moore, Wallach, and Hughes, Circuit Judges.
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.
'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;
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