News & Analysis as of

Generic Drugs

Ferring Pharms. Inc. v. Par Pharm., Inc.

by Robins Kaplan LLP on

Case Name: Ferring Pharms. Inc. v. Par Pharm., Inc., Civ. No. 1:15-cv-173-RGA, 2017 U.S. Dist. LEXIS 106491 (D. Del. July 11, 2017) (Andrews, J.). Drug Product and U.S. Patent: Prepopik® (sodium picosulfate, magnesium...more

Pfizer Inc. v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more

FDA Announces New Draft REMS Guidance

by Goodwin on

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all...more

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

by Arnall Golden Gregory LLP on

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

Price-Fixing Allegations Against Generic Drug Manufacturers Broaden as State Attorneys General Seek Amended Complaint

by Arnall Golden Gregory LLP on

On October 31, 2017, the Attorneys General of forty-five states and the District of Columbia (the “State AGs”) moved to amend a December 2016 complaint alleging a broad price-fixing scheme among key players in the generic...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Sanofi v. Watson Labs., the Circuit affirms a determination of induced infringement of one patent and direct infringement of another, thus assuring Sanofi another 12 years of exclusivity as to its Multaq® atrial...more

Reckitt Benckiser LLC v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Reckitt Benckiser LLC v. Amneal Pharms. LLC, Nos. 15-2155 (RMB/JS), 15-4524 (RMB/JS), 2017 U.S. Dist. LEXIS 133998 (D.N.J. Aug. 22 2017) (Bumb, J.). Drug Product and Patent(s)-in-Suit: Mucinex® (guaifenesin);...more

Non-News: Warnings Claims For A Generic Drug Preempted (Still)

by Reed Smith on

We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it...more

California Enacts Limitations on Copayment Coupons

by Arnall Golden Gregory LLP on

As prescription drug pricing continues to dominate political headlines, state legislatures are taking action intended to lower drug prices for health plans and patients. Despite industry opposition, California has enacted a...more

Supernus Pharms., Inc. v. TWi Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Supernus Pharms., Inc. v. TWi Pharms., Inc., 15-369 (RMB/JS), 2017 U.S. Dist. LEXIS 154446 (D.N.J. Sept. 21, 2017) (Bumb, J.). Drug Product and Patent(s)-in-Suit: Oxtellar XR® (oxcarbazepine); U.S. Patents Nos....more

Dutch Supreme Court hands down landmark decision on infringement of second medical use patents

by Hogan Lovells on

On 3 November 2017, the Dutch Supreme Court (Hoge Raad) handed down a landmark decision on the infringement of second medical use patents in the Merck Sharp & Dohme Corp. (“MSD”) v. Teva Pharma B.V. and Pharmachemie B.V....more

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

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., No. 2:15-CV-1455-WCB, 2017 U.S. Dist. LEXIS 136445 (E.D. Tex. Aug. 25, 2017) (Bryson, C.J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine); U.S. Patents...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-01471-FRG-RSP, 2017 U.S. Dist. LEXIS 127886 (E.D. Tex. July 25, 2017) (Payne, M.J.). Drug Product and U.S. Patent: Delzicol® (mesalamine); U.S....more

Reckitt Benckiser Pharms., Inc. v. Dr. Reddy’s Labs. S.A.

by Robins Kaplan LLP on

Case Name: Reckitt Benckiser Pharms., Inc. v. Dr. Reddy’s Labs. S.A., No. 14-1451-RGA, 2017 U.S. Dist. LEXIS 140633 (D. Del. Aug 31, 2017) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Suboxone® (buprenorphine HCl /...more

Reverse-Payment Plaintiffs Mine Patent Litigation Record to Survive Summary Judgment

by Holland & Knight LLP on

We pointed out in a recent article that, based on recent decisions by the Courts of Appeals for the First and Third Circuits, private antitrust plaintiffs seeking damages from so-called “reverse-payment” settlement agreements...more

Tris Pharma, Inc. v. Actavis Labs. FL, Inc.

by Robins Kaplan LLP on

Case Name: Tris Pharma, Inc. v. Actavis Labs. FL, Inc., No. 14-1309-GMS, 2017 U.S. Dist. LEXIS 143299 (D. Del. Sept. 5, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Quillivant XR® (methylphenidate...more

Federal Circuit Finds Orally Disintegrating Drug Formulation Obvious

In Bayer Pharma AG v. Watson Labs., Inc., No. 2016-2169 (Fed. Cir. Nov. 1, 2017), the Federal Circuit reversed the district court’s conclusion that certain claims of Bayer’s patent covering Staxyn would not have been obvious...more

Mallinckrodt Hosp. Prods. IP Ltd. v. Praxair Distrib., Inc.

by Robins Kaplan LLP on

Case Name: Mallinckrodt Hosp. Prods. IP Ltd. v. Praxair Distrib., Inc., No. 15-170-GMS, 2017 U.S. Dist. LEXIS 142644 (D. Del. Sept. 5, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: INOmax® (nitric oxide); U.S....more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Bayer v. Watson, the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too heavily on the commercial availability of the prior art. The panel...more

Bristol-Myers Squibb Co. v. Mylan Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., Civ. No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372 (D. Del. Sept. 11, 2017) (Stark, J.)... Drug Product and U.S. Patent: Eliquis® (apixaban); U.S. Patents Nos....more

Kowa Co. Ltd. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Kowa Co. Ltd. v. Amneal Pharms. LLC, No. 14-CV-2758 (PAC), 2017 U.S. Dist. LEXIS ______ (S.D.N.Y. Sept. 19, 2017) (Crotty, J.)... Drug Product and Patent(s)-in-Suit: Livalo® (pitavastatin); U.S. Patent No....more

Invalidation Of A Claim In A Closely-Related Patent Dooms Preliminary Injunction

by Orrick - IP Landscape on

In Sebela Int’l Ltd. v. Actavis Labs., FL, Inc., Civil Action Nos. 17-4789-CCC-MF & 17-4964-CCC-MF (D.N.J. Sep. 14, 2017), plaintiffs Sebela International Limited, Sebela Ireland Limited, and Sebela Pharmaceuticals Inc....more

Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc., No. 15-cv-6075 (PGS) (DEA), 2017 U.S. Dist. LEXIS 164131 (D.N.J. Sept. 29, 2017) (Sheridan, J.)... Drug Product and Patent(s)-in-Suit: Noxafil®...more

Anticipated Acts of Infringement May Establish Venue for Hatch-Waxman

by McDermott Will & Emery on

Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware if a generic drug company has permanent and continuous presence in Delaware...more

Millennium Pharms., Inc. v. Sandoz Inc.

by Robins Kaplan LLP on

Case Name: Millennium Pharms., Inc. v. Sandoz Inc., Nos. 2015-2066, 2016-1008, -1009, -1010, -1109, -1110, -1283, -1762, 2016 U.S. App. LEXIS 12702 (Fed. Cir. July 17, 2017) (Circuit Judges Newman, Mayer, and O’Malley...more

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