News & Analysis as of

Federal Rule 12(b)(6) Biosimilars

McDonnell Boehnen Hulbert & Berghoff LLP

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2).  While recognizing that this...more

Akin Gump Strauss Hauer & Feld LLP

Prosecution History Estoppel Bars Amgen’s Infringement Claim Under the Doctrine of Equivalents

The Federal Circuit affirmed a district court decision barring Amgen from asserting an infringement claim under the doctrine of equivalents against Coherus Biosciences because Amgen disclaimed all combinations not identified...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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