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BTG INTERN. LTD. v. AMNEAL PHARMACEUTICALS LLC

2019-1147 2019-1148 2019-1323 2019-1324 2019-1325.

923 F.3d 1063 (2019)

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.

United States Court of Appeals, Federal Circuit.

Decided: May 14, 2019.

Attorney(s) appearing for the Case

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.

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...

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