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…
This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S. Patent & Trademark Office. The ’487 patent is directed to an “isolated human antibody that competes with…
Amgen announced yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases. AMGEVITA is Amgen’s first biosimilar approved by the EC. Amgen states in its press release that “AMGEVITA was approved in the United States (U.S.) by…
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…
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…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also previously reported, Janssen filed its opening appeal brief on January 26, 2017. On March 7, 2017, Celltrion filed its response brief. Celltrion argues that…
Celltrion has filed three petitions for IPR of Biogen’s patents related to rituximab: IPR2017-01093, challenging U.S. Patent 8,329,172; IPR2017-01094 challenging U.S. Patent 8,557,244; and IPR2017-01095 challenging U.S. Patent 9,296,821. Rituximab is marketed under the trade-name Rituxan® by Genentech and Biogen, and is indicated for the treatment of some cancers and…
The PTAB has instituted inter partes review of Genentech’s U.S. Patent 7,622,115, granting Hospira’s petition in IPR2016-01771. According to the institution decision, the patent is directed to methods for treating cancer in a patient comprising administering an effective amount of bevacizumab and assessing the patient for gastrointestinal (“GI”) perforation during treatment…
The PTAB has instituted IPR2016-01837, in which Hospira challenges Genentech’s U.S. Patent 7,807,799. The institution decision extends to all challenged claims, claims 1-3 and 5-11. According to the decision, the ‘799 patent relates to improved methods for conducting protein A affinity chromatography, and the specification includes an example using trastuzumab….