Last week, Sandoz announced new data reportedly showing that its proposed adalimumab biosimilar matches the safety and efficacy profile of Humira®. The data was obtained from a long term study of patients with moderate-to-severe chronic plaque psoriasis. As we reported here, Sandoz has filed a Marketing Authorisation Application (MAA) with the…
Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017. Among other things,…
Today, Pfizer filed an antitrust lawsuit against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade® (infliximab) product. The complaint alleges that “[w]hen Pfizer introduced its competing biologic Inflectra (infliximab-dyyb) in 2016, J&J…
A hearing on summary judgment on infringement of claim 1 of U.S. Patent No. 8,722,631 for the biosimilar version of etanercept has been set for next month before Judge Claire C. Cecchi. Stay tuned to Big Molecule Watch for updates.
On September 15, Boehringer Ingelheim (BI) and Samsung Bioepis each issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding a biosimilar product for which the company is seeking European marketing approval. BI’s…
As we previously reported, Immunex sued Sanofi and Regeneron earlier this year in the Central District of California alleging that the sale of Sanofi and Regeneron’s FDA-approved Dupixent® (dupilumab) product would infringe Immunex’s U.S. Patent 8,679,487. Today, the defendants in the case filed a motion to file a first amended…
The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights: On August 29, Pfizer filed two petitions for IPR of Genentech’s U.S. patents related to formulations of Herceptin® (trastuzumab): IPR2017-02019 on U.S. Patent 6,339,142 and IPR2017-02020 on U.S. Patent 9,249,218….
We reported earlier this week that the district court in Amgen v. Hospira denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) and granted-in-part and denied-in-part the parties’ respective motions for exclusion of expert testimony. The district court also ruled this week on several motions in limine…
Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s disclosure provisions are preempted by federal law under both field preemption and conflict preemption. The brief is…
Goodwin’s Intellectual Property and Life Sciences teams won three awards, and were shortlisted in 10 categories for over 10 awards, at the 2017 LMG Life Sciences Awards hosted in New York City on September 13. The awards recognized and honored the leading attorneys, firms and in-house counsel teams who have…