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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
The Supreme Court on Friday, Nov. 3, granted Amgen’s petition for certiorari on the second of the Questions Presented in its petition...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
Welcome to the Summer edition of Benefits Litigation Update, brought to you by The ERISA Industry Committee (ERIC) and the law firm Epstein Becker & Green. With a new Administration and executive branch, we are already...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
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
A Stipulation and Scheduling Order for Trial (Order) entered on May 19, 2017 in the Amgen v. Sandoz litigation rescheduled trial for March 26, 2018 (from December 18, 2017), and pushed back other pre-trial deadlines....more
As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions: ..Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide...more
On Friday, the United States Supreme Court set oral arguments in Amgen v. Sandoz for April 26, 2017. Today, the United States Court of Appeals for the Federal Circuit announced that oral arguments in Amgen v. Hospira...more
Below is our midwinter 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