On July 27, 2015, Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. filed a petition for Inter Partes Review (IPR) of the “Cabilly II” patent, U.S. Patent No. 6,331,415. The Cabilly II patent granted shortly after I started my career as an attorney, and has stayed in the news almost ever since. Will this IPR make its final headlines?
When the Cabilly II patent issued in 2001 with claims to recombinant methods for producing immunoglobulin molecules (e.g., antibodies) comprising heavy and light chains in a single host cell, after a settled interference and with a priority date back to 1983, it drew a lot of attention from the biotechnology industry. Since then, the patent has survived a reexamination proceeding and several (settled) district court challenges, including two settled earlier this year (Eli Lilly and Co. v. Genentech, Inc., CACD-2-13-cv-07248 and Bristol-Myers Squibb Co. v. Genentech, Inc., CACD-2-13-cv-05400). Now Sanofi-aventis and Regeneron are seeking to have claims 1-4, 9, 11, 12, 14-20 and 33 canceled in an IPR Proceeding.
Will the USPTO Patent Trial and Appeal Board finally put an end to Cabilly II disputes, or will the patent withstand what could be one of its final challenges?
In researching this article I came across this 2009 article by Kevin Noonan. His comments about a “statute of repose” for patents seem even more relevant today.
Sanofi-aventis and Regeneron also are seeking a declaratory judgment of invalidity and non-infringement of the Cabilly III patent, U.S. Patent No. 7,923,221. As set forth in the Complaint filed July 27, 2015 in the U.S. District Court for the Central District of California, declaratory judgment jurisdiction is based on “the cloud created by the imminent threat of a lawsuit” alleging that their recently approved Praluent® (alirocumab) product infringes the Cabilly III patent. Praluent® is a human monoclonal antibody approved to treat “adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart problems.” The Complaint states that the Cabilly II patent is not at issue in that case, but also alleges that Genentech has asserted “the Cabilly patents” against others who have made and/or sold recombinantly produced antibodies.
For additional insight on the growing popularity of IPRs in the pharmaceutical and biotechnology industries, don’t miss this article by my partner Steve Maebius on Foley’s PTAB Trial Insights blog.