As we previously reported, a number of amici curiae have submitted briefs in support of each party in Sandoz v. Amgen. On March 17, Biotechnology Innovation Organization (“BIO”), a trade association representing various members of the biotechnology industry, filed an amicus brief in support of Amgen. The brief argues that…
As we posted here, here, and here, various amicus briefs have been submitted in Sandoz v. Amgen. Last week, Janssen Biotech, Inc. submitted an amicus brief in support of Amgen. Janssen’s brief emphasizes two points. First, Janssen asserts that the express statutory purpose of the 180-day notice of commercial marketing is to…
On February 17, 2016, we reported that Amgen and Sandoz had both petitioned the U.S. Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz, each seeking to advance their respective positions on whether the BPCIA patent dance is mandatory and whether/when notice of commercial launch must…
On Friday, March 10, Amgen filed its consolidated opening and responsive brief to the Supreme Court in Sandoz v. Amgen. As we covered in a previous post, Sandoz filed its opening brief in the case last month, addressing the question of whether an effective notice of commercial marketing can be given before FDA licensure of…
As we have previously reported, in April the Supreme Court will hear arguments regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions. As we reported last week, several amicus briefs in support of Sandoz were filed last week. The amicus brief, filed by…
As we covered in previous posts, the Supreme Court will hear arguments regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions in April 2017. Several amicus briefs in support of Sandoz were filed last week, including by AARP and AHIP. Mylan, Inc. (“Mylan”), Apotex…
As we have previously reported, the Supreme Court will later this year hear arguments in Sandoz v. Amgen regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions. Several amicus briefs in support of Sandoz were filed last week. One brief was filed by AARP,…
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, the Biosimilars Council filed an amicus brief in support of Sandoz’s position with respect to both issues. The brief is available here. The…
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…