Hospira, Inc. (“Hospira”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on September 9, 2016, for inter partes review (“IPR”) of U.S. Patent No. 7,622,115 (“the ’115 patent”) related to Genentech’s Avastin® (bevacizumab). Interestingly, Genentech elected not to file a preliminary response. On March 16, 2017, the PTAB issued a decision instituting review of claims 1-5 of the ’115 patent. The claims of the ’115 patent are generally directed to methods of treating cancer in a patient by administering an effective amount of bevacizumab and assessing the patient for gastrointestinal perforation during treatment.
Bevacizumab is an anti-vascular endothelial growth factor A (Anti-VEGF) specific monoclonal antibody that inhibits formation of new blood vessels and is used to slow the growth of tumors related to several types of cancers. Avastin® is indicated for treatment of conditions related to metastatic colon cancer, lung cancer, glioblastoma, ovarian cancer, and cervical cancer.
The proceeding is IPR2016-01771. The real party-in-interest identified for Petitioner is Hospira. Petitioner also identified Pfizer Inc. as a real party-in-interest who, going forward, may have control or an interest in the outcome of the proceeding. The only real party-in-interest identified for Patent Owner is Genentech, Inc. (“Genentech”).
Hospira and Genentech are also involved in several IPR proceedings concerning Genentech’s patents for trastuzumab (Herceptin®). The PTAB has instituted one of those proceedings as reported in this post and Institution decisions on Hospira’s other trastuzumab patent petitions are expected in July and August of this year. A complete list of IPRs related to trastuzumab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.
Earlier this year, Genentech filed litigation against Amgen in the United States District Court for the District of Delaware accusing Amgen of failing to comply with the disclosure requirements of section (l)(2)(A) of the BPCIA during the first step of the “patent dance” for Amgen’s proposed bevacizumab biosimilar as discussed in this post. Judge Sleet dismissed that complaint exactly two weeks after it was filed, as reported here, but the dismissal was without prejudice, permitting Genetech to file an Amended Complaint.