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…
As we previously reported, last month AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira (adalimumab) product. Yesterday, BI filed an answer to AbbVie’s complaint, which includes counterclaims against AbbVie for declarations of patent invalidity and non-infringement. In support…
Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of cancer. Mvasi® is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic…
This morning, the district court in Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, entered a pretrial scheduling order. The scheduling order calls for, among other things, fact discovery to close on August 30, 2018, expert discovery to close on January 31, 2019, and any dispositive motions…
At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab). First, Amgen presented Phase 3 study data on ABP980, which it is co-developing with Allergan plc, comparing the safety…
According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced that the FDA has accepted its aBLA for its proposed biosimilar of Neupogen® (filgrastim), which is indicated for, among other things, the treatment of neutropenia-related…