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
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
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...more
AbbVie filed its opening claim construction brief in its litigation with Boehringer Ingelheim (BI). AbbVie asserted eight patents against BI. ...more
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more
As we previously reported, last month AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira...more
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more
Today, Boehringer Ingelheim received FDA approval for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic...more
Today, AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira (adalimumab) product. The complaint...more
The UK Patents Court recently issued a judgement which referred four questions to the CJEU in the case Actavis Group v Boehringer Ingelheim that aim to clarify how the SPC Regulation ought to be interpreted in respect of...more