EpiPen RICO Ruling Opens Door for Private AKS Enforcement
We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept...more
The USPTO published Revision 07.2022 of the Ninth Edition of the Manual of Patent Examining Procedure (MPEP). A change summary is available here....more
On July 20, 2018 in Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (Dyk, Moore and Reyna JJ) held that Native American (“Indian”) Tribes do...more
Mylan Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Akron, Inc. petitioned for inter partes review (IPR) of various patents owned by Allergan, Inc., which the Board instituted. One week before the scheduled IPR...more
On July 20 in Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (Dyk, Moore and Reyna JJ) held that Native American (“Indian”) Tribes do not...more
On Friday, July 20, 2018, the Court of Appeals for the Federal Circuit addressed the controversial application of sovereign immunity for inter partes review (“IPR”) in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. In...more
In Saint Regis Mohawk Tribe et al. v. Mylan Pharmaceuticals Inc. et al., the U.S. Court of Appeals for the Federal Circuit held that Native American tribal sovereign immunity does not apply in Inter Partes Review (“IPR”)...more
On July 20, 2018, the Federal Circuit held in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals that tribal sovereign immunity does not prevent IPR on a patent assigned to a tribe asserting such immunity. The court expressly...more
Federal Circuit Rejects Use of Tribal Immunity to Shield Patents in IPR Proceedings - The Federal Circuit issued its opinion on Friday in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals, affirming the decision by the...more
We have previously discussed antitrust implications of pharmaceutical companies’ efforts to maximize patent protection for their drugs. Consumers and generic drug makers, for instance, have alleged antitrust violations based...more
The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office recently issued a Final Written Decision in an inter partes review styled Mylan Pharm. v. AstraZeneca AB affirming the patentability of all challenged...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more