Federal Circuit Dramatically Expands ANDA Jurisdiction

Last week, the Federal Circuit issued its panel opinion in two cases: Accorda Therapeutics Inc. and Alkermes Pharma Ireland Ltd. v. Mylan Pharmacueticals, Inc. and Mylan Inc. and AstraZeneca AB v. Mylan Pharmacueticals, Inc.  The question before the Court in both cases was whether Mylan was properly subject to jurisdiction in the District of Delaware.  […]

Mylan Loses Another Jurisdictional Challenge in Delaware: Will the Federal Circuit Weigh in?

In November, we wrote about Mylan’s attempt to dismiss an infringement action for lack of personal jurisdiction.  U.S. District of Delaware Judge Gregory M. Sleet denied that motion, finding specific jurisdiction because Mylan sent its paragraph IV certification to the NDA holder who was located in Delaware.  AstraZeneca AB v. Mylan Pharms., Inc., 2014 U.S. […]

Post-Daimler Paradigm Shift: Personal Jurisdiction in the ANDA Context

Mylan recently filed two ANDAs seeking approval to sell generic versions of AstraZeneca’s ONGLYZA® and KOMBIGLYZE™ drug products.  In response, AstraZeneca LP (“AZP”) filed a complaint in the District of Delaware for patent infringement, and Mylan moved to dismiss for lack of personal jurisdiction.  Judge Gregory M. Sleet denied the motion, finding specific jurisdiction because […]

District Court Finds Jurisdiction For Declaratory Judgment Action Involving Disclaimed Patent

The Eastern District of Virginia recently allowed a subsequent ANDA filer to proceed with a declaratory judgment action seeking a declaration of unenforceability of a patent that remained listed in the Orange Book after the patentee disclaimed it and requested its delisting from the Orange Book. Glenmark Generics Ltd. v. Ferring B.V., Civ. No. 3:14-CV-422-HEH […]

Generic’s Counterclaims for Non-Infringement are Proper Despite Covenant Not to Sue From Brand

On April 9, 2014, in Purdue Pharmaceutical Products, L.P. v. TWi Pharmaceuticals, Inc., Civ. No. 12-5311 (D.N.J.), Judge Jose L. Linares of the United States District Court for the District of New Jersey ruled that a generic drug company who is not a first-filer has standing to assert a counterclaim for non-infringement despite the issuance […]