BTG INTERNATIONAL LIMITED, JANSSEN BIOTECH, INC., JANSSEN ONCOLOGY, INC., JANSSEN RESEARCH & DEVELOPMENT, LLC, Plaintiffs-Appellants
AMNEAL PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY'S LABORATORIES, INC., DR. REDDY'S LABORATORIES, LTD., WOCKHARDT BIO AG, WOCKHARDT USA LLC, WOCKHARDT LTD., MYLAN PHARMACEUTICALS INC., MYLAN INC., WEST-WARD PHARMACEUTICALS CORP., NKA HIKMA PHARMACEUTICALS USA INC., HIKMA PHARMACEUTICALS LLC, TEVA PHARMACEUTICALS USA, INC., Defendants-Appellees PAR PHARMACEUTICAL, INC., PAR PHARMACEUTICAL COMPANIES, INC., RISING PHARMACEUTICALS, INC., Defendants BTG INTERNATIONAL LIMITED, JANSSEN BIOTECH, INC., JANSSEN ONCOLOGY, INC., JANSSEN RESEARCH & DEVELOPMENT, LLC, Plaintiffs-Appellants
AMERIGEN PHARMACEUTICALS, INC., AMERIGEN PHARMACEUTICALS LIMITED, Defendants-Appellees JANSSEN ONCOLOGY, INC., Appellant
AMERIGEN PHARMACEUTICALS LIMITED, ARGENTUM PHARMACEUTICALS LLC, Appellees JANSSEN ONCOLOGY, INC., Appellant
MYLAN PHARMACEUTICALS INC., AMNEAL PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY'S LABORATORIES, INC., DR. REDDY'S LABORATORIES, LTD., TEVA PHARMACEUTICALS USA, INC., WEST-WARD PHARMACEUTICAL CORPORATION, HIKMA PHARMACEUTICALS LLC, Appellees JANSSEN ONCOLOGY, INC., Appellant
WOCKHARDT BIO AG, Appellee
from the United States District Court for the District of New
Jersey in Nos. 2:15-cv-05909-KM-JBC, 2:16-cv-02449-KM-JBC,
2:17-cv-06435-KM-JBC, 2:16-cv-02449-KM-JBC Judge Kevin
from the United States Patent and Trademark Office, Patent
Trial and Appeal Board in Nos. IPR2016- 00286, IPR2016-01317,
IPR2016- 01332, IPR2017-00853, IPR2016- 01582.
Constantine L. Trela, Jr., Sidley Austin LLP, Chicago, IL,
argued for all plaintiffs-appellants. Plaintiffs-appellants
Janssen Biotech, Inc., Janssen Oncology, Inc., Janssen
Research & Development, LLC also represented by Steven J.
Horowitz, David T. Pritikin, Thomas D. Rein; Alyssa B.
Hjemdahl-Monsen, New York, NY; Ryan C. Morris, Carter Glasgow
Phillips, Paul Zegger, Washington, DC.
Anthony C. Tridico, Finnegan, Henderson, Farabow, Garrett
& Dunner, LLP, Washington, DC, for plaintiff-appellant
BTG International Limited. Also represented by Jennifer Howe
K. Kelley, Perkins Coie, LLP, Washington, DC, argued for all
defendants-appellees. Defendants-appellees Mylan Inc., Mylan
Pharmaceuticals Inc. also represented by Shannon Bloodworth,
Brandon Michael White; Dan L. Bagatell, Hanover, NH; David
Lee Anstaett, Andrew Dufresne, Madison, WI.
Charles B. Klein, Winston & Strawn LLP, Washington, DC,
for defendants-appellees Amneal Pharmaceuticals LLC, Amneal
Pharmaceuticals of New York, LLC, Dr. Red-dy's
Laboratories, Inc., Dr. Reddy's Laboratories, Ltd., Hikma
Pharmaceuticals LLC, Teva Pharmaceuticals USA, Inc.,
West-Ward Pharmaceuticals Corp. Also represented by Andrew
Curtis Nichols, Jovial Wong; Ryan Hauer, Chicago, IL.
Dennies Varughese, Sterne Kessler Goldstein & Fox, PLLC,
Washington, DC, for defendants-appellees Wock-hardt Bio AG,
Wockhardt USA LLC, Wockhardt Ltd. Also represented by Daniel
Ritterbeck, Jon Wright.
William Hare, McNeely, Hare & War, LLP, Washington, DC,
for defendants-appellees Amerigen Pharmaceuticals, Inc.,
Amerigen Pharmaceuticals Limited. Also represented by
Christopher Casieri, Princeton, NJ.
Stanek Rea, Crowell & Moring, LLP, Washington, DC, for
appellee Argentum Pharmaceuticals LLC.
W. Krause, Office of the Solicitor, United States Patent and
Trademark Office, Alexandria, VA, argued for amicus curiae
Andrei Iancu. Also represented by Frances Lynch, Joseph
Matal, Robert J. McManus, Farheena Yasmeen Rasheed; Mark R.
Freeman, Scott R. McIntosh, Jennifer Utrecht, Appellate
Staff, Civil Division, United States Department of Justice,
William M. Jay, Goodwin Procter LLP, Washington, DC, for
amicus curiae Association for Accessible Medicines. Also
represented by Joshua James Bone, Boston, MA; Jeffrey
Francer, The Association for Accessible Medicines,
Moore, Wallach, and Chen, Circuit Judges.
Wallach, Circuit Judge.
BTG International Limited et al. ("Appellants")
sued Appellees Amneal Pharmaceuticals LLC et al.
("Appellees") in the U.S. District Court for the
District of New Jersey ("District Court"),
asserting that Appellees' Abbreviated New Drug
Applications ("ANDA") for the generic version of
Appellants' abiraterone product ZYTIGA® infringes
claims 1-20 ("Asserted Claims") of U.S. Patent No.
8, 822, 438 ("the '438 patent"). Subsequently,
Appellees Amerigen Pharmaceuticals, Inc. and Amerigen
Pharmaceuticals Limited (collectively, "Amerigen");
Appellees Mylan Pharmaceuticals Inc. and Mylan Inc.
(collectively, "Mylan"); and Appellees Wockhardt
Bio AG, Wockhardt USA LLC, and Wockhardt Ltd. (collectively,
"Wockhardt") filed three, separate inter partes
review ("IPR") petitions with the U.S. Patent and
Trademark Office ("USPTO"). They alleged that the
Asserted Claims would have been obvious under 35 U.S.C.
§ 103 (2006).
three IPRs, the USPTO's Patent Trial and Appeal Board
("PTAB") issued claim construction orders adverse
to Appellants, as well as final written decisions finding the
Asserted Claims obvious. Amerigen Pharm. Ltd. v. Janssen
Oncology, Inc., No. IPR2016-00286, 2018 WL 454509, at
*20 (P.T.A.B. Jan. 17, 2018); Mylan Pharm. Inc. v.
Janssen Oncology, Inc., No. IPR2016-01332, 2018 WL
456305, at *20 (P.T.A.B. Jan. 17, 2018); Wockhardt Bio AG
v. Janssen Oncology, Inc., No. IPR2016-01582, 2018 WL
456328, at *21 (P.T.A.B. Jan. 17, 2018). Similarly, following
a bench trial, the District Court concluded that the Asserted
Claims would have been obvious in light of its claim
construction and the same combination of prior art relied on
by the PTAB. BTG Int'l Ltd. v. Amneal Pharm.
LLC, 352 F.Supp.3d 352, 384-90 (D.N.J. 2018);
see J.A. 146-48 (Final Judgment).
appeal the PTAB's Final Written Decisions and the
District Court's Final Judgment. We consolidated the
appeals. We have jurisdiction pursuant to 28 U.S.C. §
1295(a)(1) and 1295(a)(4)(A) (2012). We affirm the PTAB's
Final Written Decision in Wockhardt. Because our
affirmance renders the remaining issues on appeal moot, we
dismiss the appeals of Amerigen, Mylan, and
"Methods and Compositions for Treating Cancer," the
'438 patent teaches a method "compris[ing]
administering a 17a-hydroxylase/C17, 20-lyase
[('CYP17') inhibitor, such as abiraterone acetate
3β-acetoxy-17-(3-pyridyl)androsta-5, 16-diene), in
combination with at least one additional therapeutic agent
such as an anti-cancer agent or a steroid." '438
patent col. 1 ll. 8- 12. Specifically, the '438 patent
discloses the administration of a therapeutically effective
amount of a CYP17 inhibitor, such as abiraterone, with a
therapeutically effective amount of at least one additional
therapeutic anti-cancer agent. Id. col. 2. 1. 9-col.
3 l. 27. This combination therapy seeks to provide "more
effective ways to treat cancer such as, but not limited to,
prostate and breast cancer," id. col. 1 ll.
65-67, in addition to providing "effective anti-cancer
treatment options for patients who are not responding to
current anti-cancer treatments" and those "whose
cancer has recurred," id. col. 2 ll. 1-5. The
'438 patent defines an "anti-cancer agent" as
"any therapeutic agent that directly or indirectly kills
cancer cells or directly or indirectly prohibits[, ] stops[,
] or reduces the proliferation of cancer cells."
Id. col. 4 ll. 8-11. The '438 patent lists
acceptable forms of anti-cancer agents, including, inter
alia, prednisone. Id. col. 3 ll. 16,
claim 1 is representative and recites: "[a] method for
the treatment of a prostate cancer in a human
comprising administering to said human a therapeutically
effective amount of abiraterone acetate or a pharmaceutically
acceptable salt thereof and a therapeutically effective
amount of prednisone." Id. col. 16 ll. 16-20