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…
Last month, the Federal Circuit affirmed per curium U.S. District Judge Colm F. Connolly’s order denying Genentech’s request for either a temporary restraining order or a preliminary injunction. Genentech sought a preliminary injunction to prevent Amgen from selling a generic version of Genentech’s blockbuster cancer drug, Herceptin®. Amgen launched on the same day the district court…
On June 18, 2019, the FDA announced plans to expand its Paragraph IV Patent Certifications List, a database used to list information about applications for generic drug approval. The changes are part of the FDA’s on-going efforts “to provide the industry with greater transparency in order to provide greater certainty around timing of market entry…
The PTAB recently denied a petitioner’s request for inter partes review of a competitor’s surgical device patent, stating that the petitioner failed to provide a claim construction necessary to meet its burden to show a reasonable likelihood that at least one claim is unpatentable. OrthoPediatrics Corp. v. K2M, Inc., IPR2018-01548, Paper 9 (P.T.A.B. March 1,…