Statutory Disclaimer Removes the District Court’s Authority to Invalidate Patent Claims

In a recent decision, the Federal Circuit held that the district court lacked authority to “disinter” and declare claims invalid where the patent owner had statutorily disclaimed the claims. Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., 933 F.3d 1367 (Fed. Cir. 2019). The case concerns the drug cabazitaxel, marketed as Jevtanta®, which is used […]

Federal Circuit Holds That a Customer Does Not Have Standing For a Declaratory Judgment

The Federal Circuit recently held that a healthcare provider did not have standing to bring a declaratory judgment action where its only interest was as a purchaser of potential generic versions of the patented drug. AIDS Healthcare Foundation v. Gilead Sciences, Inc., No. 2016-2475 (Fed. Cir. May 11, 2018).  The court held that absent direct […]

Delaware Recognizes Declaratory Judgment Action Concerning Biosimilar Applicant’s Failure to Give Notice of Commercial Marketing

The District of Delaware recently held that branded biologic companies may pursue a private cause of action to address a biosimilar applicant’s anticipated violation of the commercial marketing notice requirement under 42 U.S.C. § 262(1)(8)(A). In Amgen Inc. et al. v. Hospira, Inc., Civ. Action No. 15-839 (D. Del.), the Plaintiffs filed a patent infringement […]