Last week the Office of the Solicitor General (“SG”) filed an amicus brief on behalf of the United States in support of Sandoz’s position with respect to the BPCIA’s notice of commercial marketing requirement and patent dance provisions. You may recall that the SG also filed a brief in support of…
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 will be held on April 3, 2017. Stay tuned to Big Molecule Watch for further updates. For…
The Patent Trial and Appeal Board has granted Apotex’s petition for inter partes review of Amgen’s U.S. Patent 8,952,138, finding that Apotex has a reasonable likelihood in prevailing in its assertions that claims 1-24 are obvious over the prior art. According to the parties’ filings, the patent covers methods of folding…
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 (Summer 2016, Fall 2016).
As we previously reported, a jury trial in the ongoing infliximab biosimilar litigation, Janssen v. Celltrion (D. Mass., J. Wolf), was scheduled to begin on February 13, 2017. The district court, however, recently cancelled the originally scheduled trial date and is now scheduled to hold a hearing to address damages…
Big Molecule Watch frequently posts on BPCIA litigation, a recent summary of which can be found here. As our readers know, the interpretation of various provisions of the BPCIA is currently before the Supreme Court in Sandoz v. Amgen, which we most recently covered when cert was granted, the briefing…
Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim), for filing through the 351(k) pathway. Mylan stated that the FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9,…
Sandoz filed its opening brief to the Supreme Court on Friday, February 10, 2017. The dispute focuses on the notice marketing provision and the information exchange or “patent dance” procedures of the Biologics Price Competition and Innovation Act (BPCIA). Sandoz’s opening brief addressed: Whether notice of commercial marketing given before…
The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in September 2016 the District Court for the Southern District of Florida ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not…
According to BioPharma-reporter, Pfizer will close the Australian plant at which Pfizer manufactures API for HSP-130, a biosimilar version of Amgen’s Neulasta, by 2021. Pfizer will move production of the API to Croatia in an effort to consolidate manufacturing. HSP130 is currently in clinical trials. Stay tuned to the Big…