News & Analysis as of

Generic Drugs Patent Infringement

Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited

by Knobbe Martens on

Federal Circuit Summaries - Before Prost, Lourie and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: When another patent for a drug issues after an ANDA is filed, there can...more

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

China Announces New Initiatives to Level the Playing Field for Innovative and Generic Drugs

by Ropes & Gray LLP on

China’s Government will launch several incentives to enhance accessibility of innovative drugs, especially imported oncology drugs. The State Council, China’s cabinet, has decided not to apply any tariff on imported drugs,...more

Ophthalmic Solution Claims Not Invalid, Not Infringed

by McDermott Will & Emery on

In a patent infringement suit related to the generic version of the drug Combigan®, the US Court of Appeals for the Federal Circuit held that claims asserted by Allergan Sales, LLC, were not invalid but not infringed....more

Innovation In Hatch-Waxman And ANDA Litigation

by Seyfarth Shaw LLP on

The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through...more

Top Developments in Hatch-Waxman Litigation for March 2018

by Morrison & Foerster LLP on

This month, we highlight several significant decisions including The Medicines Company v. Hospira, Inc. and Index Pharmaceuticals, LLC v. Gilead Sciences, Inc. and the Trump administration’s legislative proposal to increase...more

PTAB Holds Indian Tribes Don’t Offer an Out from IPR

In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal Board rejected tribal sovereign immunity to IPRs. The PTAB’s decision also...more

Rx IP Update - February 2018

by Smart & Biggar on

Federal Court of Appeal dismisses Teva’s levofloxacin damages appeal - On February 8, 2018, the Federal Court of Appeal issued public reasons for its decision dismissing Teva’s appeal relating to the damages and costs...more

Orexigen Therapeutics, Inc. v. Actavis Laboratories Fl, Inc.

by Robins Kaplan LLP on

Case Name: Orexigen Therapeutics, Inc. v. Actavis Laboratories Fl, Inc., Civ. No. 15-451-RGA, 2017 U.S. Dist. LEXIS 169570 (D. Del. Oct. 13, 2017) (Andrews, J.)....more

Sanofi v. Lupin Atl. Holdings S.A.

by Robins Kaplan LLP on

Case Name: Sanofi v. Lupin Atl. Holdings S.A., Civ. No. 15-415-RGA (consol.), 2017 U.S. Dist. LEXIS 174931 (D. Del. Oct. 23, 2017) (Andrews, J.)....more

Allergan Sales, LLC v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan Sales, LLC v. Teva Pharms. USA, Inc., Civ. No. 2:15-cv-1471-JRG-RSP (Lead), 2017 U.S. Dist. LEXIS 176262 (E.D. Tex. Oct. 24, 2017) (Gilstrap, J.)....more

Otsuka Pharm. Co. v. Mylan Inc.

by Robins Kaplan LLP on

Case Name: Otsuka Pharm. Co. v. Mylan Inc., Civ. No. 14-4508 (JBS-KMW), 2017 U.S. Dist. LEXIS 184160 (D.N.J. Nov. 7, 2017) (Simandle, J.)....more

Galderma Labs., L.P. v. Teva Pharms USA, Inc.

by Robins Kaplan LLP on

Case Name: Galderma Labs., L.P. v. Teva Pharms USA, Inc., Civ. No. 3:17-cv-01076-M (N.D. Tex. Nov. 11, 2017) (Lynn, J.). Drug Product and Patent(s)-in-Suit: Soolantra® (ivermectin); U.S. Patents Nos. 8,815,816 (“the ’816...more

Brigham & Women’s Hospital, Inc. v. Perrigo Co.

by Robins Kaplan LLP on

Case Name: Brigham & Women’s Hospital, Inc. v. Perrigo Co., Civ. No. 13-11640-RWZ, 2017 U.S. Dist. LEXIS 190604 (D. Mass. Nov. 17, 2017) (Zobel, S.J.)....more

Eli Lilly & Co. v. Dr. Reddy’s Labs., Ltd.

by Robins Kaplan LLP on

Case Name: Eli Lilly & Co. v. Dr. Reddy’s Labs., Ltd., Civ. No. 1:16-cv-00308-TWP-MPB, 2017 U.S. Dist. LEXIS 205578 (S.D. Ind. Dec. 14, 2017) (Pratt, J.)....more

Novartis Pharms. Corp. v. West-Ward Pharms. Int’l Ltd.

by Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. West-Ward Pharms. Int’l Ltd., 15-cv-474-RGA, 2017 U.S. Dist. Lexis 205600 (D. Del. Dec. 14, 2017) (Andrews, J.)....more

Hogan Lovells Moscow Life Sciences team secures major win in a precedent patent case for Novartis against a generic producer in...

by Hogan Lovells on

Led by partner Natalia Gulyaeva, the Hogan Lovells Moscow team represented Novartis in a precedent case for pharma business proving that one can obtain an injunction using patent rights against a generic in Russia before the...more

Amgen Inc. v. Alkem Labs. Ltd.

by Robins Kaplan LLP on

Case Name: Amgen Inc. v. Alkem Labs. Ltd., Civ. No. 17-cv-815-GMS, -817-GMS, 2017 U.S. Dist. LEXIS 208124 (D. Del. Dec. 19, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Sensipar® (cinacalcet HCl); U.S. Patent...more

Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, No. 2016-2583, 2017 U.S. App. LEXIS 20441 (Fed. Cir. Oct. 19, 2017) (Circuit Judges Dyk, Linn, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D....more

New Reverse-Payment Decision Sheds Further Light on Plaintiffs’ Causation Burden

by Holland & Knight LLP on

As post-Actavis antitrust litigation over so-called “reverse payment” patent settlements proceeds, courts continue to provide further illumination about what evidence a private plaintiff would need to offer to survive summary...more

Merck Sharp & Dohme Corp. v. Hospira, Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Hospira, Inc. 874 F.3d 724, No. 17-1115, 2017 U.S. App. LEXIS 21201 (Fed. Cir. Oct. 26, 2017) (Circuit Judges Newman, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by...more

Bayer Pharma AG v. Watson Labs., Inc.

by Robins Kaplan LLP on

Case Name: Bayer Pharma AG v. Watson Labs., Inc., 874 F.3d 1316, No. 2016-2169, 2017 U.S. App. LEXIS 21705 (Fed. Cir. Nov. 1, 2017) (Circuit Judges Lourie, Moore, and O’Malley presiding; Opinion by Moore, J.) (Appeal from D....more

Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

by Hogan Lovells on

The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic...more

Sanofi v. Watson Labs. Inc.

by Robins Kaplan LLP on

Case Name: Sanofi v. Watson Labs. Inc., Nos. 875 F.3d 636, Nos. 2016-2722, 2016-2726, 2017 U.S. App. LEXIS 22438 (Fed. Cir. Nov. 9, 2017) (Circuit Judges Prost, Wallach, and Taranto presiding; Opinion by Taranto, J.) (Appeal...more

Eli Lilly and Co. v. Perrigo Co.

by Robins Kaplan LLP on

Case Name: Eli Lilly and Co. v. Perrigo Co., No. 2016-2555, -2614, 2017 U.S. App. LEXIS 23624 (Fed. Cir. Nov. 22, 2017) (Circuit judges Chen, Plager, and Hughes presiding; Opinion by Chen, J.) (Appeal from S.D. Ind., Barker,...more

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