As we covered in a previous post, in April the Supreme Court will hear arguments regarding the BPCIA’s notice of commercial marketing requirement and patent dance provisions. Last week,…
As we covered in a previous post, in April the Supreme Court will hear arguments regarding the BPCIA’s notice of commercial marketing requirement and patent dance provisions. Last week,…
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…
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…
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…
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…
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…
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…
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®…
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”…
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…