News & Analysis as of

Federal Rule 12(b)(6) BPCIA

Rothwell, Figg, Ernst & Manbeck, P.C.

Venue Considerations for Hatch-Waxman and BPCIA Litigation

In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent...more

Fish & Richardson

Who Can Be A Defendant In Biosimilar Patent Litigation?

Fish & Richardson on

Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food and Drug Administration approval, be sued...more

Fox Rothschild LLP

Judge Sleet Grants Amgen’s Motion To Dismiss Genetech’s Commercial Marketing Claim Without Prejudice

Fox Rothschild LLP on

By Memorandum Opinion entered by The Honorable Gregory M. Sleet in Genentech, Inc. et al. v. Amgen Inc., Civil Action No. 17-1407-GMS (D.Del. April 17, 2018), the Court granted defendant Amgen’s motion to dismiss the claim of...more

McDermott Will & Emery

ANDA Update - Volume 2, Number 2

McDermott Will & Emery on

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

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