The PTAB has granted Celltrion’s petition for inter partes review of Biogen’s U.S. Patent 7,820,161. (IPR2016-01614) The patent is drawn to methods of treating rheumatoid arthritis by administration of rituximab. Rituximab is sold by Biogen and Genentech under the trade-name Rituxan®. Rituxan is FDA approved to treat non-Hodgkin’s lymphoma, chronic…
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…
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…
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).
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…
Yesterday, Hospira filed two petitions for inter partes review of Genentech’s U.S. Patent 7,371,379 (IPR2017-00805) and U.S. Patent 6,627,196 (IPR2017-00804). According to the petitions, these patents are directed to methods of treating certain cancers with trastuzumab, sold under the name Herceptin®. These petitions follow closely on the heels of three…
On Friday, Hospira filed the following petitions – IPR2017-00731 (U.S. Patent No. 7,846,441), and IPR2017-00737 and IPR2017-00739 (both for U.S. Patent No. 7,892,549). According to these petitions, the patents are drawn to methods of using trastuzumab in combination with certain other agents for the treatment of cancers. Trastuzumab is the active…
As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its Mylan-Biocon’s aBLA. This is Mylan and Biocon’s first U.S. regulatory submission through the 351(k) pathway. The anticipated…
Merck Sharp & Dohme filed two petitions for inter partes review of Genentech’s U.S. Patent 6,331,415, one of the “Cabilly Patent,” which claims processes and materials broadly applicable to recombinant antibody manufacturing. Today, the PTAB granted one of those and denied the other. IPR2017-00047 was filed along with a motion…