EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial...more
As previously reported, Amgen sought leave to appeal a decision of the Federal Court of Appeal (2020 FCA 188) affirming Justice Southcott’s decision that the relevant claims of its filgrastim (NEUPOGEN) patent were invalid...more
About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation. Allergan USA, Inc. v. Prollenium US Inc. 1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware...more
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...more
As we previously reported, Mylan recently filed a motion for judgment on the pleadings regarding Amgen’s assertion of the ’707 Patent, which covers methods related to producing the biosimilar pegfilgrastim. Mylan’s motion...more
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Neupogen® (filgrastim) and/or Neulasta® (pegfilgrastim). Amgen v. Adello (filgrastim) - As we previously reported, in March,...more
Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Below is a summary of these developments....more
On Friday, Amgen filed a complaint for patent infringement under the BPCIA against yet another developer of a biosimilar of Neulasta® (pegfilgrastim). Amgen has sued Mylan in the Western District of Pennsylvania for...more
On October 14, 2016, Mylan Pharmaceuticals and the Biosimilars Council, a subsidiary of the Generic Pharmaceuticals Association (GPhA), filed amicus briefs in support of granting review in Apotex v. Amgen, No. 16-332. As...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astellas Pharma Inc. et al. v. Apotex Inc. et al. 1:15-cv-00857; filed September 22, 2015 in the District Court of...more