Last week, Judge Andrews from the District of Delaware granted Defendant Hikma’s motion to dismiss Plaintiff Amarin’s induced infringement claims related to the drug Vascepa®. Amarin Pharma, Inc. v. Hikma Pharm. USA Inc. Amarin sells Vascepa® for two indications: severe hypertriglyceridemia (the “SH indication”) and cardiovascular risk reduction (the “CV indication”). Hikma received FDA approval […]
Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (“Amarin”) sued ANDA-holder Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals PLC (“Hikma”) and health insurance provider Health Net, LLC (“Health Net”) for induced infringement of three patents covering methods of use for Amarin’s drug Vascepa®. Notably, the complaint asserts a novel theory of induced infringement against Health Net. […]
As predicted in our October 29th post, Teva sought rehearing en banc of the Federal Circuit’s re-instatement of a $235 million jury verdict against it for induced infringement despite its “skinny label” carve out of the patented use. In the original ruling the Federal Circuit held that Teva was liable for damages during a period […]
On October 9th, we wrote about a potentially significant Federal Circuit decision concerning “skinny” labels in GSK v. Teva. Today we write to discuss another important facet of this decision: guidance concerning the availability of lost profits in the generic drug context. This case involved GlaxoSmithKline’s (“GSK’s”) patent covering the use of carvedilol (sold as […]
Last Friday (GSK v. Teva), a split panel of the Federal Circuit (“CAFC”) may have drastically limited the effectiveness of Section viii carve-outs when it reinstated a $235 million jury verdict against Teva, concluding that substantial evidence supported the jury’s finding of induced infringement. Patent owner GlaxoSmithKline (“GSK”) sued Teva in the District of Delaware […]
Judge Du of the District of Nevada recently issued findings of facts and conclusions of law in a patent trial related to the drug Vascepa®. Amarin Pharma, Inc. v. Hikma Pharma. USA Inc. The court ultimately held that the asserted claims were all invalid as obvious. But first it held that defendants proposed labels would […]
This month the Federal Circuit held that Breckenridge’s proposed labeling for a generic colonoscopy prep kit would induce infringement of Braintree’s patent covering SUPREP. Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 16-1731 (Fed. Cir. May 5, 2017). In doing so, the Federal Circuit clarified when proposed labeling amounts to an affirmative intent to induce […]
Shire has petitioned the Federal Circuit to rehear en banc its decision in Shire v. Amneal, where the Federal Circuit declined to hold an API manufacturer liable as an indirect infringer. Shire asked the court to address the question of whether a non-ANDA filer can be liable for future infringement under 35 U.S.C. § 271(e)(2) […]
The Ruling. In a 6-2 decision issued Tuesday, the Supreme Court once again disagreed with the Federal Circuit and held that a defendant’s good-faith (but incorrect) belief that a patent is invalid is not a defense to an induced infringement claim. Commil USA, LLC v. Cisco Sys., Inc., No. 13-896. The Court also affirmed that induced […]
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 […]