In a recently unsealed opinion from the District of Delaware, Judge Dyk of the Federal Circuit sitting by designation, held a patent in the “inherently unpredictable” field of antibodies invalid on summary judgment for failing to satisfy the enablement requirement. Baxalta Inc. v. Genentech Inc. Delaware Opinion, Case No. 17-cv-509-TBD (D. Del. Jan. 13, 2022). […]
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 […]
Recently, District Judge John Z. Lee of the Northern District of Illinois refused to dismiss a patent infringement suit brought under the Biosimilar Price Competition and Innovation Act (“BPCIA”) against a foreign parent company on the grounds that the domestic subsidiary was not a necessary party. See AbbVie Inc. v. Alvotech hf., No. 21-cv-02258 (N.D. […]
Recently, the Eleventh Circuit sided with Florida-based Catalyst Pharmaceuticals Inc., holding that the U.S. Food and Drug Administration’s interpretation of the Orphan Drug Act is contrary to the plain language of the statute. Catalyst Pharm., Inc. v. Becerra. The court found that the FDA unlawfully infringed on an exclusivity period it awarded to Catalyst for […]
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. […]
A Special Discovery Master in Celgene Corp. v. Hetero Labs Ltd., No. 17-3387 (D.N.J. Mar. 29, 2021)1 recently issued a Report and Recommendation requiring defendants to move to amend their invalidity contentions to add dozens of prior art references that defendants’ experts relied on, but which defendants failed to disclose in their invalidity contentions. The court […]
In a nonprecedential opinion issued on June 25, 2021, the Federal Circuit upheld the PTAB’s rule against incorporation of evidence by reference. 3M Company v. Evergreen Adhesives, Inc., No. 2020-1738 (Fed. Cir. June 25, 2021). 3M filed an IPR against Evergreen Adhesives Inc. (formerly Westech Aerosol Corp.), asserting that its aerosol adhesive patent was invalid […]
Judge Bryson, sitting in the District of Delaware invalidated four patents owned by Lipocine, Inc., finding that the patents did not meet the written description and enablement requirements of 35 U.S.C. § 112. Lipocine Inc. v. Clarus Therapeutics, Inc., No. 19-622 2021 (D. Del. 2021). Lipocine’s patents were directed to methods for treating men deficient […]
Last week, the Eastern District of Kentucky declined to stop a third-party company from importing a key pharmaceutical compound on behalf of a generic drug developer, holding that the company was protected by the Hatch-Waxman Act’s “safe harbor” provision. Although the importer itself was not developing the generic drug, its actions were “in furtherance” of […]
The District Court of New Jersey declined Plaintiffs’ Vifor (International) AG and American Regent, Inc. request for judicial correction of what they argued was an obvious error in a patent related to Injectafer®. Vifor (International) AG v. Mylan Laboratories Limited, 19-cv-13955 (D.N.J. April 26, 2021). While Vifor may still seek correction at the USPTO, the […]