PTAB Grants Rare Request for Additional Discovery In IPR

26 October 2017 PTAB Trial Insights Blog
Authors: Stephen B. Maebius

In Mylan v. Allergan (IPR2016-00127, Paper No. 73), the PTAB granted a rare request for discovery filed be Petitioner in response to summaries of data presented in a Patent Owner Response used to rebut obviousness.  In particular, the PTAB found that the Garmin factors for analyzing discovery requests weighed in favor of granting Petitioner’s motion.  However, the decision only granted the requested discovery in part, and the PTAB’s reasoning as to what it granted and what it denied may be instructive in other situations.

The Patent Owner had submitted certain figures that visually depicted pharmacokinetic data designed to show the benefits of the invention so as to rebut obviousness.  Certain of the figures submitted by Patent Owner lacked mean value and standard error rates, and so the Petitioner requested discovery of the underlying pharmacokinetic data so that it could properly evaluate the significance of the figures.

The PTAB granted the request for discovery of that data as to those figures.  However, the Petitioner had also requested underlying pharmacokinetic data for figures in a publication submitted by Patent Owner which did contain mean value and standard error bars.  In this latter case, the PTAB denied Petitioner’s request for discovery, reasoning that the information presented was already sufficient to enable an assessment by Petitioner of whether the results were “significant.”

The PTAB has identified five factors (“the Garmin factors”) for determining whether additional discovery is in the interests of justice as required by 37 CFR 42.51(b)(2).  See Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, Case IPR2012-00001, slip op. at 6–7 (PTAB Mar. 5, 2013) (Paper 26) (informative).  These factors are: (1) more than a possibility and mere allegation that something useful will be discovered; (2) requests that do not seek other party’s litigation positions and the underlying basis for those positions; (3) ability to generate equivalent information by other means; (4) easily understandable instructions; and (5) requests that are not overly burdensome to answer.

This case illustrates one of the rare situations where a request for additional discovery may be granted – namely, a summary of data that does not contain sufficient information to allow a party to confirm its statistical significance.

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