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…
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,…
We have considered before [see here, and here] how U.S. courts are handling reverse payment cases in the wake of FTC v. Actavis, 133 S. Ct. 2223 (June 17, 2013). Now, for the first time, a federal jury has weighed in on one of these cases. On Dec. 5, 2014, in In re Nexium (Esomeprazole)…
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…
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…
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…
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…
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…
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…
Last week, the Supreme Court held arguments in the closely watched case of Teva v. Sandoz. Teva won at the district court level based on claim construction arguments. The Federal Circuit reversed, affording no deference to the district courts factual findings underlying claim construction. In March, the Supreme Court granted certiorari to answer one lone…