On October 8, the Institute for Clinical and Economic Review (ICER) published their first report of Unsupported Price Increases (UPIs), aimed at identifying drug price increases that ICER…
On October 8, the Institute for Clinical and Economic Review (ICER) published their first report of Unsupported Price Increases (UPIs), aimed at identifying drug price increases that ICER…
As we previously reported, earlier this year Kashiv Biosciences filed two inter partes review (IPR) petitions challenging certain claims of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997, which…
On September 20, 2019, the District Court for the District of Delaware endorsed a joint stipulation of the parties to dismiss all claims and counterclaims in the Genentech v. Pfizer…
As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a…
On September 17, 2019, the U.S. District Court for the Western District of Pennsylvania endorsed the parties’ stipulation and proposed order of non-infringement of U.S. Patent No. 9,643,997…
Last week, several briefs were filed in Federal Circuit appeals relating to trastuzumab biosimilars: Trastuzumab IPR Appeals On September 3, 2019, the USPTO submitted responsive appellate briefs…
On August 28, 2019, the District Court for the District of Delaware issued an opinion related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741)…
In February of this year, Amgen filed three petitions for inter partes review (IPR) of Alexion Pharmaceuticals’ U.S. Patent Nos. 9,725,504 (IPR2019-00739), 9,718,880 (IPR2019-00740), and 9,732,149…
Goodwin Releases 2025-2026 Update to Guide to Biosimilars Litigation and Regulation in the U.S. First launched in 2019, the Guide is the industry’s first and leading compendium of the laws…
As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the…