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…
On November 8, 2016, Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). According to the Mylan press release, this submission is Mylan’s first for a biosimilar in the United States, and may lead to the first approved trastuzumab biosimilar in the United States. Mylan…
The FDA has accepted Genentech’s BLA for a subcutaneous formulation of rituximab. The drug is indicated to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate to severe rheumatoid arthritis, Wegener’s granulomatosis and microscopic polyangiitis. According to Genentech, its formulation uses a recombinant human hyaluronidase enzyme from Halozyme, approved and marketed under…
On October 11, 2016, Merck Sharp & Dohme (MSD) filed for IPR on U.S. Patent No. 6,331,415, one of the Cabilly patents owned by Genentech. IPR2017-00047. MSD also filed a motion for joinder with Mylan’s petition for IPR on this patent (IPR2016-00710), representing that its petition is based on grounds…
Last month, researchers published results from a randomized phase I clinical trial of CT-P10, a biosimilar candidate to rituximab, comparing the pharmacokinetics parameters and safety profiles in patients with rheumatoid arthritis in the Annals of the Rheumatic Diseases. The researchers reported that in the phase I trial CT-P10 and rituximab “demonstrated equivalent pharmacokinetic and comparable…
On September 16, Hospira filed a petition for an inter partes review of Genentech’s U.S. Patent No. 7,807,799 which is directed to methods of purifying proteins, including trastuzumab. Trastuzumab is marketed by Genentech under the brand-name Herceptin®, and is indicated for the treatment of certain sub-types of breast cancer. The petition…
As we previously reported, over the past year several petitions requesting Inter Partes Review (IPR) of patents that claim foundational inventions for biologic drug production were filed. Here we discuss the scope of two of the foundational patents that are currently under consideration by the Patent Trial and Appeals Board…
On September 9, 2016, Hospira filed a petition for an IPR of U.S. Patent No. 7,622,115, owned by Genentech. The ‘115 patent claims methods of treating various cancers with bevacizumab, which is marketed by Genentech under the brand name Avastin®. Please see our IPR tracker page for all important IPR…
On September 8, 2016, the Board instituted an IPR of U.S. Patent No. 6,331,415, one of the Cabilly patents owned by Genentech. The Petitioner in IPR2016-00710 is Mylan. The ’415 patent was the subject of two other IPRS that were terminated last week following settlements between Genentech and those Petitioners, Sanofi-Aventis and…