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. […]
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 […]
Last week, Carlson Caspers’ attorneys Caroline Marsili presented a CLE at the 2018 Midwest IP Institute addressing (1) subject matter eligibility under 35 U.S.C. § 101, (2) biosimilar applicants’ use of IPR proceedings and their standing to appeal PTAB decisions, and (3) the CRISPR patent battles. Slides from this presentation summarizing the state of the […]
Last week, the U.S. Food & Drug Administration (“FDA”) released a Biosimilars Action Plan (“BAP”) with the objective of promoting innovation, competition and affordability of biologics and biosimilar products. Characterizing the BAP as “an important piece of the Administration’s bold Blueprint to Lower Drug Prices,” the FDA underscored the need for a competitive market for […]
Yesterday in Sandoz Inc. v. Amgen Inc., et al., the Supreme Court ruled that biosimilar makers may give 180-day notice of sales before product approval, and that the failure of a biosimilar maker to provide its application and manufacturing information to the RLD drug maker under the Biologics Price Competition and Innovation Act (“BPCIA”) is […]
In the decision in Celltrion Healthcare v. Kennedy Trust for Rheumatology Research issued earlier this week, Judge Cotty of the Southern District of New York declined to exercise declaratory judgment jurisdiction in a case that would have permitted Celltrion Healthcare to expedite the patent challenges that stand in the way of the launch of its […]