BTG Int'l Ltd. v. Amneal Pharm. LLC

923 F.3d 1063

BTG INTERNATIONAL LIMITED, Janssen Biotech, Inc., Janssen Oncology, Inc., Janssen Research & Development, LLC, Plaintiffs-Appellants

v.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

v.Amerigen Pharmaceuticals, Inc., Amerigen Pharmaceuticals Limited, Defendants-Appellees

Janssen Oncology, Inc., Appellant

v.Amerigen Pharmaceuticals Limited, Argentum Pharmaceuticals LLC, Appellees

Janssen Oncology, Inc., Appellant

v.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

v.Wockhardt Bio AG, Appellee

2019-1147

2019-1148

2019-1323

2019-1324

2019-1325

United States Court of Appeals, Federal Circuit.

Decided: May 14, 2019

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 Roscetti.

Nathan 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. Reddy'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 Wockhardt 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.

Teresa Stanek Rea, Crowell & Moring, LLP, Washington, DC, for appellee Argentum Pharmaceuticals LLC.

Thomas 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, Washington, DC.

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, Washington, DC.

Before Moore, Wallach, and Chen, Circuit Judges.

Wallach, Circuit Judge.

Appellants 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).¹

In all 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).

Appellants 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 BTG .²

BACKGROUND

I. The ’438 Patent

Entitled "Methods and Compositions for Treating Cancer," the ’438 patent teaches a method "compris[ing] administering a 17a-hydroxylase/C_17,20-lyase [ (‘CYP17’)³ ] inhibitor, such as abiraterone acetate [ (‘abiraterone’) ] (i.e., 3ß-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. l. 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, 19.⁴

Independent 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 (emphasis added).

II. The Relevant Prior Art

A. Gerber

Gerber, G.S. & Chodak, G.W., Prostate Specific Antigen for Assessing Response to Ketoconazole and Prednisone in Patients with Hormone Refractory Metastatic Prostate Cancer , 144 J. Urology 1177–79 (1990) ("Gerber") (J.A. 23053–55) is a study that evaluates prostate specific antigen ("PSA") level changes, which Gerber identifies as a "good indicator of disease activity," with "increasing PSA levels" being associated with "evidence of progressive disease." J.A. 23053. This study evaluated PSA level changes in "[a] total of [fifteen] patients with hormone refractory metastatic prostate cancer [that were] treated with [a combination of] ketoconazole^{[5 ]} and prednisone." J.A. 23053. It defined "[u]nresponsiveness to the initial hormone therapy ... as an increasing PSA level on [two] consecutive determinations that were at least [one] month apart." J.A. 23053. Gerber explains that patients exhibiting "progressively increasing PSA levels had a decrease in PSA in response to treatment with ketoconazole and prednisone." J.A. 23055. More specifically, Gerber explains that "PSA levels may be useful to define the small subgroup of men failing standard hormonal therapy who will benefit from the combination of ketoconazole and prednisone." J.A. 23055. Therefore, Gerber concludes that "there appears to be a small subgroup of patients with progressive prostate cancer despite hormonal therapy who will derive significant benefit from the combination of ketoconazole and glucocorticoid [such as prednisone ] replacement therapy." J.A. 23055.

B. O’Donnell

O’Donnell, A., et al., Hormonal Impact of the 17a-hydroxylase/C_17,20-lyase Inhibitor Abiraterone Acetate (CB7630) in Patients with Prostate Cancer , 90 Brit. J. of Cancer 2317–25 (2004) ("O’Donnell") (J.A. 23171–79) is an article publishing the results of three clinical studies, see J.A. 23171-79, and discloses the treatment of prostate cancer with abiraterone at dosages between 500–800 milligrams ("mg"), J.A. 23171. A daily dose of abiraterone between 500–800 mg resulted in suppression of testosterone levels to the castrate range in non-castrate males. J.A. 23171....