EpiPen RICO Ruling Opens Door for Private AKS Enforcement
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
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more
Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s...more
After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: As we reported in January 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al. 1:15-cv-00756; filed August 27, 2015 in the District...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Purdue Pharma L.P. et al. v. Actavis Laboratories FL, Inc. 1:15-cv-00686; filed August 5, 2015 in the District Court of...more
Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more