News & Analysis as of

Hatch-Waxman

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Federal Circuit Clarifies the “Reasonable Expectation of Success” Required in Hatch-Waxman Obviousness Challenges

by Dechert LLP on

The U.S. Federal Circuit recently clarified the standard that patent challengers must satisfy when attempting to invalidate patented inventions directed to new uses for known drugs. Although designated as a nonprecedential...more

Bolar Exemptions in North America

Bolar Exemptions in the U.S. Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more

Global Patent Prosecution Newsletter - December 2017

Worldwide Bolar Exemptions - Many countries have exemptions for patent infringement for a product and/or process that is not being used for direct commercialization and profit. For biopharmaceuticals, this exemption,...more

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation

by Morgan Lewis on

There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more

Hatch-Waxman Venue: The New Narrow?

by Robins Kaplan LLP on

The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party...more

Rx IP Update - November 2017

by Smart & Biggar on

Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman - The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for...more

Federal Circuit Clarifies Probative Value of Patent Dance Statements

by Jones Day on

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...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

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

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

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

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

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

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

327 Results
|
View per page
Page: of 14
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.