Last week, the Federal Circuit denied Sandoz’s petition for an en banc rehearing of its precedential July 1st panel decision upholding two of Immunex’s patents covering Enbrel®.
As explained in the petition, Immunex was the first to make etanercept, the tumor necrosis factor (TNF) receptor fusion protein that is the active ingredient in Enbrel® (used
Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir phosphate), one of the most popular antivirals prescribed for relief from the influenza virus. The active ingredient is indicated for the treatment of acute, uncomplicated influenza A and B in patients two weeks of age or older who have
We previously reported that on January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, or unenforceable. That same day, Celltrion and Teva also filed a suit seeking declaratory
On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit against Genentech, Inc., Hoffmann-La Roche Inc., and City of Hope seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, and/or unforceable. According to Celltrion and Teva, a
Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019)
The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public meeting on Wednesday, July 12, 2017, to consider Novartis’ biologic license application (BLA 125646) for tisagenlecleucel (CTL019), an investigational chimeric antigen receptor T cell (“CAR-T”) therapy. Novartis is seeking approval of CTL019 for the treatment of patients from
On June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897 (“the ’897 patent”) related to Genentech’s Herceptin® (trastuzumab). Pfizer has a trastuzumab biosimilar in phase III development, but it has not yet announced the filing of an application for that product with the
On May 25, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”). The ‘213 patent, entitled “Method for Making Humanized Antibodies,” issued on June 18, 2002. Although the IPR petitions do not identify a particular biologic, Genentech has publicly stated that the technology
Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”) related to Genentech’s Herceptin® (trastuzumab). Celltrion has announced that it plans to submit an application for a trastuzumab biosimilar product to the FDA this year (possibly as early as next month), as reported
Over the last two weeks, Pfizer, Inc. (“Pfizer”) has filed petitions for inter partes review (“IPR”) of three additional patents related to Biogen and Genentech’s Rituxan® (rituximab) at the Patent Trial and Appeal Board (“PTAB”). The proceedings are: IPR2017-01166, filed on April 21, 2017, regarding U.S. Patent No. 8,329,172 (“the ’172 patent”); IPR2017-1167, filed on
Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in Japan. Trastuzumab is a monoclonal antibody indicated for the treatment of patients with metastactic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens. Celltrion’s Herzuma (trastuzumab) is