The Federal Circuit today issued its formal mandate in Amgen v. Sandoz, as promised in its October 16th order denying the parties’ petitions for rehearing in the case. With the…
The Federal Circuit today issued its formal mandate in Amgen v. Sandoz, as promised in its October 16th order denying the parties’ petitions for rehearing in the case. With the…
As we reported in an earlier post, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants. Since then, several entities…
IPR2015-01514 (Amgen Inc.) (U.S. Patent No. 8,916,157) Petitioner: Amgen Inc. Patent: U.S. Patent No. 8,916,157 Patent Title: Formulation of human antibodies for treating TNF-α associated…
As discussed in earlier coverage, Amgen has now made good on its intention to seek a preliminary injunction against Apotex. Amgen looks to block Apotex from marketing its Neulasta biosimilar…
The Federal Circuit has denied the petitions for panel rehearing and for rehearing en banc in Amgen v. Sandoz. The order denying the petitions is available…
As we reported in a previous post, Amgen is the plaintiff in another suit litigating the patent information provisions of the BPCIA, this time against Hospira. Amgen’s complaint alleged…
Momenta and Baxalta have announced a global clinical trial to study the safety, efficacy and immunogenicity of M923, a biosimilar to AbbVie’s Humira (adalimumab). The trial is intended to support…
As we’ve reported previously, the parties in Amgen v. Apotex have completed the first wave of the BPCIA patent dance and are now litigating the first round of patent infringement…
On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As we previously reported, Amgen’s complaint alleged that Apotex…
Last updated: November 28, 2016 Below is a summary of the BPCIA litigations that have been filed to date. Please also read our quarterly BPCIA litigation round-up posts for additional…