Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware holding claims covering two Amgen-owned patents invalid for lack of enablement under 35 U.S.C. § 112. Amgen Inc., v. Sanofi, 2021 U.S. App. LEXIS 3952 (Fed. Cir. 2021). The patents at issue are directed to antibodies that bind […]
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 […]
Last week, in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., the Federal Circuit held that venue based on “acts of infringement” in Hatch-Waxman cases must be predicated “on past acts of infringement—i.e., acts that occurred before the action alleging infringement was filed.” In ANDA cases, “those acts occur only in districts where actions […]
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 […]
A district court recently compelled production of numerous documents over a party’s privilege and work product claims. Although the case is not specific to Hatch-Waxman litigation, it serves as an important reminder of the standards necessary to establish privilege and work product protections. The case also highlights how transactional work, tangential to a litigation, may […]
Judge Stark of the District of Delaware invalidated three Noven patents directed to its Minivelle estrogen therapy patch under § 112, finding that each claim failed to enable and provide written description support for the full scope of the claim. Noven Pharms., Inc. v. Amneal Pharms. LLC, No. 18-699 (D. Del. 2020). Noven’s Minivelle product, […]
The Federal Circuit recently dismissed an appeal of an adverse IPR decision by a generic pharmaceutical company for lack of Article III standing, finding that the company—which had yet to file an ANDA—had not suffered an injury-in-fact. The underlying IPR, originally filed by Apotex, involved U.S. Patent No. 9,187,405 (directed to methods of treating multiple […]
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 […]