The Federal Circuit has long reviewed all claim construction orders “de novo” – without any deference to factual issues underlying the district court’s decision. Today, the Supreme Court overturned that longstanding precedent, ruling that findings of fact made as part of a claim construction order should be reviewed for clear error. Teva Pharmaceuticals USA Inc., et […]
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. […]
In the antitrust case of Mylan v. Celgene, pending in the District of New Jersey (Civil Action No. 14-2094), Judge Esther Salas issued an oral order, finding that Mylan had stated a claim under the Sherman Antitrust Act based on Celgene’s refusal to sell samples of certain pharmaceutical products to Mylan. In particular, Judge Salas […]
A valid reissue patent must satisfy 35 U.S.C. § 251, which requires that there be an “error” in the original patent. On December 24, 2014, the Federal Circuit clarified this “error” requirement with its decision in Fleming v. Escort Inc., 2014 U.S. App. LEXIS 24419 (Fed. Cir. 2014). In Fleming, the patentee alleged that he […]
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 […]