Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...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, the district court granted Sandoz’s motion for summary judgment of non-infringement in the ongoing Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars....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
As we previously reported, in Amgen v. Sandoz, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment regarding non-infringement of...more
Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more
The Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court. In that decision, the Federal Circuit held that Amgen’s state law claims, based on the...more
Below is our fall 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 (Summer...more
Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. According to the press release, the data package submitted as part of...more
Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports Sandoz’s position that Amgen’s state-law claim for an injunction under...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
On July 17, 2017, in the ongoing Amgen v. Sandoz litigation regarding Sandoz’s proposed biosimilar of Neulasta® (pegfilgrastim), the magistrate judge ordered, among other things, that Amgen is entitled to discovery from...more
As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court had remanded to the Federal Circuit,...more
As we have previously reported, on June 12, 2017, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz holding that notice of commercial marketing may be given prior to FDA approval. The Court also held that no...more
On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is...more
Below is our spring 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
On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more
On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act...more
The Supreme Court has ordered a briefing schedule in Amgen v. Sandoz. Because the Court granted and consolidated Sandoz’s petition and Amgen’s conditional cross-petition, the Court has adopted a four-brief schedule,...more
On January 13, 2017, the Supreme Court granted certiorari to two related petitions brought by Amgen, Inc. and Sandoz, Inc. to resolve disputes regarding the interpretation of the Biologics Price Competition and Innovation Act...more