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 previously reported, Genentech filed a complaint against Amgen in the District of Delaware seeking declaratory judgment that Amgen has violated the patent dance provisions of the BPCIA in connection with its proposed biosimilar version of Genentech’s Avastin® product by failing to provide manufacturing information beyond its aBLA and…
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…
The PTAB has denied institution of IPR2016-01608, in which Bioeq IP AG sought review of Genentech’s U.S. Patent 6,716,602. That patent is directed to methods for increasing the yield of a heterologous recombinant protein produced by recombinant host cells. This decision and other important PTAB filings on biologic patents are posted…
Celltrion has filed a petition for inter partes review (IPR2017-00959) of Genentech’s U.S. Patent 8,591,897. According to the petition, the patent is directed to methods of treating a sub-type of breast cancer with a regimen that includes trastuzumab. Trastuzumab is marketed by Genentech under the trade-name Herceptin®. This petition and other…
As we reported last November, the NOR-SWITCH Phase IV study concluded that patients could be safely and effectively switched from originator infliximab (Remicade®) to Celltrion’s biosimilar product CT-P13 (Remsima®). On February 17, Celltrion Healthcare and Pfizer released primary outcome data at the 12th Congress of the European Crohn’s and Colitis…
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…