News & Analysis as of

Generic Drugs Pharmaceutical Industry

CMS Releases CY 2019 Proposed Rule for Medicare Advantage and Part D

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the...more

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

In re Sebela Patent Litigation

by Robins Kaplan LLP on

Case Name: In re Sebela Patent Litigation, 14-6414 (CCC) (MF), 2017 U.S. Dist. Lexis 128258 (D.N.J. Aug. 11, 2017) (Cecchi, J.). Drug Product and Patents-in-Suit: Brisdelle® (paroxetine mesylate); U.S. Patents Nos....more

Sale of Generic Drug to Physician With “Extensive Information” on the Label May Induce Infringement

In Sanofi v. Watson, No. 2016-2722, the Federal Circuit affirmed the district court’s decision, upholding induced infringement and validity of Sanofi’s patents covering compositions of, uses for, and methods for administering...more

Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc.

by Robins Kaplan LLP on

Case Name: Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc., 11-2317 (MLC) (DEA), 2017 U.S. Dist. LEXIS 107707 (D.N.J. July 12, 2017) (Cooper, J.). Drug Product and Patent(s)-in-Suit: Vimovo® (naproxen / esomeprazole...more

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

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

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

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

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

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

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