On March 18, 2019, UFCW Local 1500 Welfare Fund, a New-York based grocery union, filed a putative class-action lawsuit against AbbVie and seven adalimumab biosimilar manufacturers alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the United States….
We are excited to share a video produced in collaboration with Bristows LLP focused on the areas of biosimilars litigation and regulation in the U.S. and EU/UK. In this video , Overview of Differences Between Governing Schemes for Biosimilars, Dom Adair, Partner at Bristows and Rob Cerwinski, Partner at Goodwin…
On February 25, 2019, a jury in the District of Delaware made findings related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) covering its cholesterol-lowering drug Repatha® (evolocumab). The jury found Sanofi and Regeron failed to demonstrate that at least some claims of the…
On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. The ’997 patent relates to a method of protein purification and is in the same patent family…
On Monday, Magistrate Judge Lloret, who is visiting the U.S. District Court for the District of Delaware from the Eastern District of Pennsylvania, granted Boehringer Ingelheims’s (“BI’s”) motion to compel discovery relating to its unclean hands defense in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning BI’s aBLA for a biosimilar version of AbbVie’s…
On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s motion for summary judgment that the asserted genus claims directed to monoclonal antibodies that inhibit PCSK9 (such as Amgen’s Repatha® and Sanofi/Regeneron’s Praluent® products)…
On January 22, 2019, the Supreme Court issued its decision in Helsinn Healthcare v. Teva Pharmaceuticals USA, holding that under § 102(a), as amended by the American Invents Act (“AIA”), an inventor’s sale of an invention to a third party who is obligated to keep the invention confidential could still…
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen filed this past August alleging patent infringement based on Apotex’s filing of aBLAs for pegfilgrastim and filgrastim biosimilar…
We previously reported on discovery disputes in the adalimumab litigation between AbbVie and Boehringer Ingelheim (BI) pending before the District of Delaware. Earlier this month, Judge Lloret issued an order on additional discovery motions filed by the parties. Taking into account standards under the Federal Rules, “that the amount in controversy…
In a complaint filed yesterday, the State of California sued AbbVie, Inc. based on an alleged kickback scheme in connection with AbbVie’s Humira® (adalimumab). The complaint alleges that AbbVie violated the Insurance Frauds Prevention Act (“IFPA”) by providing kickbacks to health providers throughout California. Specifically, AbbVie allegedly indirectly paid healthcare…