Sanofi Seeks IPR of Cabilly Patent

30 July 2015 PharmaPatents Blog

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?

The Cabilly Patent Challenges

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.

Not Quite Parallel Litigation

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.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services

Insights