Celltrion has filed two additional petitions for inter partes review of Genentech patents related to trastuzumab: IPR2017-01139, challenging U.S. Patent 6,627,196, and IPR2017-01140, challenging U.S. Patent 7,371,379. According to the Petitions, the patents are drawn to methods for treating cancer by administering trastuzumab and a chemotherapeutic agent. Trastuzumab is sold…
Celltrion has filed petitions for inter partes review of two patents related to Genentech’s trastuzumab: IPR2017-01121, challenging U.S. Patent 7,846,441, and IPR2017-01122, challenging U.S. Patent 7,892,549. According to the petitions, these two patents claim methods of treating patients with a sub-type of breast cancer with trastuzumab. These filings follow Celltrion’s…
During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU for their ABP 980 biosimilar (trastuzumab). Mr. Meline also indicated that Amgen is looking to file for…
Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As part of the settlement, Mylan agreed to withdraw its IPR challenges to U.S. Pat. Nos. 6,407,213 and 6,331,415….
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…
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…
On December 16, 2016, Genentech filed preliminary responses in IPR2016-01693 and IPR2016-01694. Mylan filed both IPR petitions in August against patent 6,407,213, which covers humanized antibody polypeptides and methods for their preparation and use. The patent does not focus on any particular therapy, but Genentech notes that the approach was used to develop Herceptin®,…
Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American Medical Association (JAMA), titled Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2…