News & Analysis as of

Generic Drugs Pharmaceutical Patents

GlaxoSmithKline LLC v. Teva Pharma. USA, Inc.

by Robins Kaplan LLP on

Case Name: GlaxoSmithKline LLC v. Teva Pharma. USA, Inc., No. 14-878, 2018 U.S. Dist. LEXIS 51169 (D. Del. Mar. 28, 2018) (Stark, J.). Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S. Patent No. RE40,000 (“the...more

Aptalis Pharmatech, Inc. v. Apotex Inc.

by Robins Kaplan LLP on

Case Name: Aptalis Pharmatech, Inc. v. Apotex Inc., No. 2017-1344 (Fed. Cir. Jan. 4, 2018) (Circuit Judges Reyna, Wallach, and Stoll presiding; Opinion by Stoll, J.) (Appeal from D. Del., Robinson, J.)....more

The Medicines Co. v. Hospira, Inc.

by Robins Kaplan LLP on

Case Name: The Medicines Co. v. Hospira, Inc., 2014-1469, 2014-1504 (Fed. Cir. Feb. 6, 2018) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D. Del., Andrews, J.)....more

Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, 881 F.3d 1376 (Fed. Cir. 2018) (Circuit Judges Taranto, Clevenger, and Stoll presiding; Opinion by Stoll, J.) (Appeal from D. Del., Robinson, J.)....more

Sumitomo Dainippon Pharma Co. v. Emcure Pharmaceuticals

by Knobbe Martens on

Before Moore, Mayer, and Stoll. Appeal from the United States District Court for the District of New Jersey. Summary: Plain claim language will not be narrowed based on a patent’s specification unless the patentee clearly...more

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

Hatch-Waxman goes to Taiwan

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms. The amended Act is expected to come into effect in late 2018 or early 2019....more

Federal Circuit Review - March 2018

by Knobbe Martens on

Distribution Agreements Can Constitute Offers for Sale Under Section 102(b) - In The Medicines Company v. Hospira, Inc., Appeal Nos. 2014-1469, 2014-1504, the Federal Circuit held that a distribution agreement qualified as...more

Recent Biosimilar Industry Coverage

by Goodwin on

A number of media sources have covered new developments in the biosimilars space. Here is a round-up of some highlights from this month....more

Patent IPRs and Allergan’s Sovereign Immunity Defense

In an age of rising healthcare costs, pharmaceutical companies can be an easy target in calls for patent reform. Patent protection helps drug manufacturers recoup their investment in developing the new drug,. It also...more

AAM Publishes White Paper on Need for Increased Access to Biosimilars

by Goodwin on

A recent white paper from the Association for Accessible Medicines (AAM) highlighted the continued need to lower prescription drug prices. According to the paper, up to half of all patients fail to adhere to their medication...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

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

The Medicines Company v. Hospira, Inc.

by Knobbe Martens on

Federal Circuit Summaries - Before Dyk, Wallach, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: A distribution agreement qualifies as an invalidating “offer for sale”...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

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