Bio/Pharma IPR Challenges Nearly Double in 2015

28 July 2015 PTAB Trial Insights Blog

Newly released statistics (2015-06-30 PTAB Statistics) from the USPTO reveal that the number of bio/pharma IPR challenges almost doubled in 2015, even though fiscal year 2015 still has three months to go. Last year, there were only 66 bio/pharma IPR petitions filed. This fiscal year, so far 113 bio/pharma IPR petitions have been filed as of June 30th.

Petitioners are often challenging bio/pharma patents that have been involved in prior litigation, such as the recently filed Cabilly ‘415 patent IPR petition. Also, ANDA filers are increasingly turning to IPR to challenge bio/pharma patents, such as in Amneal v. Supernus. Parallel proceedings may increase the complexity of IPR due to the need for protective orders and motions to seal if confidential information from litigation proceedings is introduced into the IPR.

Although there has been a rapid increase in bio/pharma IPR petitions, there are still relatively few that have reached final decisions. Also, a number of them have settled before any final decision or even before institution. This makes it difficult to assess whether challengers are faring better in the PTAB than in the courts. Challengers may also be more willing to use IPR against bio/pharma patents when they have other defenses still available to use in litigation (such as non-infringement or section 112 invalidity) that will not be estopped by an unsuccessful IPR.

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.