EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astellas Pharma Inc. et al. v. Apotex Inc. et al. 1:15-cv-00857; filed September 22, 2015 in the District Court of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC - 2:15-cv-01697; filed September 3, 2015 in the...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
Case Name: AstraZeneca AB v. Apotex Corp., 2014-1221, 2015 U.S. App. LEXIS 5543 (Fed. Cir. Apr. 7, 2015) (Circuit Judges O’Malley, Clevenger, and Bryson presiding; Opinion by Bryson, J.) (Appeal from S.D.N.Y., Cote, J.) - ...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., et al. 1:15-cv-00438; filed May 29, 2015 in the District Court...more
Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more
Addressing the issue of subject matter jurisdiction in Hatch-Waxman litigation, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s dismissal for lack of case or controversy of an action seeking...more
Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more