News & Analysis as of

ANDA Patents

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

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

NJ Court Grants Exceptional Case Fees Based on Speculative Infringement Suit

by McDermott Will & Emery on

The US District Court for the District of New Jersey awarded Luitpold more than $210,000 in fees and costs under 35 USC § 285 after granting its motion for judgment on the pleading under Fed. R. Civ. P. 12(c) (ANDA Update,...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

Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. 2017)

The Federal Circuit reversed a finding of non-obviousness on Friday based on clear error by the District Court on factual underpinnings of its obviousness determination, in Bayer Pharma AG v. Watson Laboratories, Inc. Such...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

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

Federal Circuit Splits on Approach to Analyzing Graham Factors

by BakerHostetler on

In Merck Sharp & Dohme Corp. v. Hospira, Inc., the Federal Circuit affirmed the lower court’s ruling that the asserted claims of Merck’s U.S. Patent No. 6,486,150 (the ’150 patent) were obvious despite evidence of commercial...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

Spotlight on Upcoming Oral Arguments – November 2017

In this appeal, the Federal Circuit will consider whether it has jurisdiction to review a PTAB decision to terminate an IPR and enter an adverse judgment against the patent owner. Arthrex argues that the Court has...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

Process Discoverable by “Merely Ordinary Experimentation” Rendered Obvious

In Merck Sharp & Dohme Corp. v. Hospira, Inc., No. 2017-1115 (Fed. Cir. Oct. 26, 2017), a divided Federal Circuit panel affirmed the district court’s finding that a claimed process for making a chemical compound was obvious....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

Merck Sharp & Dohme Corp. v. Hospira, Inc. (Fed. Cir. 2017)

The Federal Circuit continues its explication of the law of obviousness post-KSR Int'l. v. Teleflex Inc. (and Judge Pauline Newman continues to disagree with her brethren in some regards) in a decision handed down last...more

Missouri Senator Introduces Bill to Abrogate Native American Sovereignty for Inter Partes Review Petitions

by Orrick - IP Landscape on

S.1948 – A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents. Allergan, Inc. and The Saint Regis Mohawk Tribe v. Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals,...more

Chief Judge Stark Denies Prevailing Party’s Motion For Attorneys’ Fees And Expenses In ANDA Action

by Fox Rothschild LLP on

By Memorandum Order entered by The Honorable Leonard P. Stark in Reckitt Benckiser LLC v. Aurobindo Pharma Limited et al., Civil Action No. 14-1203-LP (D.Del. October 16, 2017), the Court denied Defendants motion for...more

District Court Allows Mohawk Tribe to Join ANDA Litigation, Finds Patents at Issue Invalid

In something of an anticlimax, Federal Circuit Judge William Bryson, sitting by designation on the bench of the U.S. District Court for the Eastern District of Texas, granted Allergan's motion to join the St. Regis Mohawk...more

Venue Over An ANDA Defendant: D. Del. Weighs In

by Fish & Richardson on

In light of the Supreme Court’s TC Heartland decision, courts around the country have been grappling with venue-related challenges in patent cases. Under the patent venue statute, 28 U.S.C. § 1400(b), venue is proper “where...more

Recent Court Decisions on Venue Challenges Following TC Heartland

by Knobbe Martens on

The U.S. District Court for the District of Delaware recently handed down two important decisions on motions to transfer for improper venue. Judge Stark presided over both cases, transferring one case and ordering further...more

District of Delaware “Clips”- Off Venue-Discovery for Medical Device Company but Allows It for Pharmaceutical Company

by Orrick - IP Landscape on

Boston Sci. Corp. v. Cook Grp., Inc., No. 15-980-LPS-CJB, 2017 U.S. Dist. LEXIS 146126, at *2 (D. Del. Sep. 11, 2017); Bristol-Myers Squibb Co. v. Mylan Pharm., Inc., No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372, at *3 (D....more

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