On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira® (adalimumab). We previously discussed Boehringer Ingelheim’s Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”). The
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”). The Citizen Petition is available on regulations.gov under docket number: FDA-2020-P-2247. Boehringer Ingelheim seeks an interpretation of “strength” to
We previously wrote about Genentech’s U.S. Patent No. 6,407,213 (“the ’213 patent”) to Carter, first in October 2017, and more recently in March 2018. At the time of our last update, the ’213 patent had been at issue in six district court litigations, and had been the subject of ten filed IPR petitions,
The August 2018 Update to the PTAB Trial Practice Guide added guidance regarding the Patent Trial and Appeal Board’s (“the Board”) discretion under 35 U.S.C. § 325(d) to deny institution of an AIA trial when the same or substantially the same prior art or arguments were previously presented to the United States Patent and Trademark
U.S. Patent No. 8,329,172 (“the ’172 patent”), a Biogen-owned patent covering a treatment regime for low-grade B-cell non-Hodgkin’s lymphoma, has been a relatively frequent subject of our posts. We first wrote about it in March of 2017, reporting on the filing of Celltrion’s IPR petition against the patent, then again that May, reporting
Earlier this month, Celltrion, Inc. (“Celltrion”) filed a copycat IPR petition directed against U.S. Patent No. 7,976,838 (“the ʼ838 patent”) that is essentially identical to a petition filed by Pfizer, Inc. (“Pfizer”). The PTAB recently instituted review of the ʼ838 patent based on Pfizer’s petition in IPR2017-01923. Celltrion’s copycat petition was accompanied by a motion
In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to Carter. The ’213 patent, “Method for making humanized antibodies,” which Genentech has stated in SEC filings covers technology used in developing the breast cancer drug Herceptin® (trastuzumab), has since been asserted or is otherwise
As we previously reported, Pfizer filed three IPR petitions against Biogen-owned patents claiming methods of treatment with rituximab in April 2017. The three proceedings are: IPR2017-01166, regarding U.S. Patent No. 8,329,172 (“the ’172 patent”); IPR2017-01167, regarding U.S. Patent No. 8,557,244 (“the ’244 patent”); and IPR2017-01168, regarding U.S. Patent No. 8,821,873 (“the ’873 patent”). Institution
On November 6, 2017, Sandoz, Inc. filed its eighth inter partes review (“IPR”) against AbbVie Biotechnology Ltd. (“AbbVie”), challenging yet another patent from the Humira® patent portfolio. Humira®, used for the treatment of autoimmune diseases such as rheumatoid arthritis and Crohn’s disease, continues to be the number one selling drug in the world.[i] With
Samsung Bioepis (“Bioepis”) has joined a growing list of challengers to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) issued to Carter, et al. by filing two new petitions for inter partes review (“IPR”). The ʼ213 patent, entitled “Method for Making Humanized Antibodies,” is generally directed to antibodies with humanized variable domains comprising non-human complementarity