MYLAN PHARMACEUTICALS INC., BRECKENRIDGE PHARMACEUTICAL, INC., ALEMBIC PHARMACEUTICALS LTD., Appellants
RESEARCH CORPORATION TECHNOLOGIES, INC., Appellee
Appeals from the United States Patent and Trademark Office,
Patent Trial and Appeal Board in Nos. IPR2016-00204,
IPR2016-01101, IPR2016-01242 IPR2016-01245.
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,
Matthew L. Fedowitz, Buchanan Ingersoll & Rooney PC,
Alexandria, VA, for appellant Breckenridge Pharmaceutical,
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.
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.
Lourie, Bryson, and Wallach, Circuit Judges.
LOURIE, CIRCUIT JUDGE.
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.
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.
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:
Ar is phenyl which is unsubstituted or substituted with at
least one halo group;
Q is lower alkoxy, and
Q1 is methyl.
patent col. 3811. 8-23.
issue here are claims 8-13. Claim 8 depends from claim 1 and
recites "[t]he compound according to claim 1 which is
referred to in the patent as "BAMP" and referred to
herein as lacosamide:
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.
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
and Silverman and (2) obviousness of claims 10-13 over
Kohn 1991, Silverman, and U.S. Patent 5, 378, 729 ("the
'729 patent"). The instituted grounds appear in the
petition as ground 3A and ground 3B.
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:
Kohn then evaluated the potency of the compounds in mice,
reporting for each the effective dosage for 50 percent of ...