IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
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
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
VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS - Before Newman, O’Malley, and Taranto. Appeal from the District Court of New Jersey - Summary: Venue in Hatch-Waxman cases is proper only in districts where actions...more
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
A Complaint Identifying Infringing Products and the Patents Allegedly Infringed, Accompanied by Statements that the Products Meet All Elements of at Least One Claim of the Asserted Patents, May be Sufficient to Meet the...more
Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.) - Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos....more
Case Name: Ferring B.V. v. Actavis, Inc., Civil No. 15-4222 (SRC)(CLW), 2016 U.S. Dist. LEXIS 69328 (D.N.J. May 26, 2016) (Chesler, J.) - Drug Product and Patents-in-Suit: Lysteda® (tranexamic acid); U.S. Patent No....more
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
Fallon, M. J. Report and recommendation recommending that defendants’ motion to dismiss for lack of personal jurisdiction and failure to state a claim be denied in part and granted in part. The disputed technology in...more
Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) - Drug Product and Patent(s)-in-Suit: Coreg®...more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more