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.