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. […]

District Court Orders Defendant to Disclose Indefiniteness Arguments to PTAB in IPR

The complex interactions between an Inter Partes Review (“IPR”) before the patent office and a patent infringement action in Federal District Court require a patent challenger to think strategically about the approach they take to challenge a patent. Judge James Donato’s recent holding in IpLearn-Focus, LLC v. Microsoft Corp. highlighted the effect that District Court […]

PTAB’s First Inter Partes Review Of Pharma Patents Is Against Generic Challenger

Last week the Patent Trial and Appeal Board found Supernus Pharmaceuticals Inc.’s three patents covering the drug Oracea® (doxycycline, USP 30 mg immediate release & 10 mg delayed release beads) valid in the first ever defense of pharmaceutical patents before the Patent Trial and Appeal Board. Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-00368, -00371, […]

Carve-Out Of Patented Uses In Hikma’s Mitigare™ Label Avoids Induced Infringement

In Takeda Pharmaceuticals USA, Inc. v. West-Ward Pharmaceutical Corp., Judge Sue L. Robinson of Delaware denied Takeda’s motion for a preliminary injunction, finding no likelihood of success on its claim that Hikma induces infringement of Takeda’s method patents under 35 U.S.C. § 271(b). The five patents-in-suit cover methods of treating acute gout flare with colchicine […]

Federal Circuit limits application of inherency doctrine in obviousness cases

This week the Federal Circuit vacated and remanded a district court judgment of invalidity because the district court had incorrectly applied the inherency doctrine in the obviousness analysis. The case, between Par and Twi, involved methods of use of nanosized formulations of the drug megestrol acetate. Par Pharm., Inc. v. TWi Pharms., Inc., No. 1:11-cv-02466 […]

Another Court Denies Attempts of Biosimilar Manufacturer to Expedite Resolution of Patent Disputes

In the decision in Celltrion Healthcare v. Kennedy Trust for Rheumatology Research  issued earlier this week, Judge Cotty of the Southern District of New York declined to exercise declaratory judgment jurisdiction in a case that would have permitted Celltrion Healthcare to expedite the patent challenges that stand in the way of the launch of its […]

Federal Circuit Affirms Invalidity of Warner Chilcott Patents for Osteoporosis Drug Actonel

A three judge panel of the Federal Circuit on November 18, 2014 affirmed the District of Delaware’s summary judgment decision that Warner Chilcott’s patents covering the osteoporosis drug Actonel were invalid for obviousness. Despite some uncertainty in the prior art regarding effective dosing of the drug, the Federal Circuit affirmed, stating that obviousness does not […]