It’s been a busy few days for Director Vidal and the USPTO, with the Office providing updated guidance on how the PTAB will apply its discretion under Fintiv when considering post-grant petitions and separately issuing updated guidance on the interim Director review process.
On June 22, 2022, the Office issued a memo providing Director Vidal’s and the Office’s current thinking on Fintiv and the PTAB’s ability to discretionarily deny a post-grant proceeding in view of the status of a parallel litigation. Specifically, the Office explained that it will not deny institution of an IPR or PGR under Fintiv:(1) when a petition presents compelling evidence of unpatentability; (2) when a request for denial under Fintiv is based on a parallel ITC proceeding; or (3) where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as presented in the petition or any grounds that could have reasonably been raised in the petition (i.e., a Sotera-style stipulation). As to Fintiv factor two, which looks at the proximity of the district court’s trial date to the Board’s projected statutory deadline for a final written decision, the Office’s updated guidance makes clear that the PTAB will look to the median time-to-trial for a given district rather than specific case schedules. At the end of the day, these updated directives do not end Fintiv practice but they certainly lessen the general applicability of Fintiv, which appeared to be withering on the vine anyway. For respondents before the ITC, however, Fintiv appears to have met its end.
The Office also released a study investigating the impact of PTAB denials of post-grant petitions when there is a parallel district court proceeding concerning the same patent. The study covers the second quarter of fiscal year 2019 through the first quarter of fiscal year 2022. As we indicated above, the study showed that there has been a sharp overall decline in Fintiv denials, in addition to the following:
- After Fintiv was designated precedential, the status of a parallel litigation was raised in about 40% of all cases.
- Fintiv denials peaked in the second quarter of fiscal year 2021 and dropped significantly afterward.
- The PTAB issued no Fintiv denials based on parallel litigation in the Western District of Texas since August 2021.
- The USPTO’s guidance on using stipulations appears to have led to an increase in stipulation filings and a significant decrease in Fintiv denials.
- The PTAB has denied institution based on Fintiv of only three total AIA petitions challenging drug patents: two Orange Book-listed patents and one biologic drug patent.
Updated Guidance on the Interim Director Review Process
Just one day prior to the Office’s updated Fintiv guidance, the USPTO posted further guidance regarding the interim Director review process. The new guidance can be found on the USPTO Director review webpage under § 10. In particular, the Office updated its guidance on how parties should focus on and prioritize issues when requesting Director review by (1) identifying any issues of first impression; (2) providing a priority-ranked list of issues being raised; and (3) providing a brief explanation of the issues and a brief explanation of the rationale for the prioritized-ranking of the issues.
As previously mentioned in our April 22 post, the issues that may warrant review by the Director include: issues that involve an intervening change in the law or USPTO procedures or guidance, material errors of fact or law, matters that the PTAB misapprehended or overlooked, novel issues of law or policy, issues on which PTAB panel decisions are split, issues of particular importance to the Office or patent community, or inconsistencies with Office procedures, guidance, or decisions. By way of example, Director Vidal just recently granted a request for Director review based on the patent owner’s argument that the PTAB misapplied the law concerning multiple-dependent claims and the Board’s ability to cancel dependent claims if one—but not both—base independent claims are found unpatentable. See Nested Bean, Inc. v. Big Beings USA Pty Ltd, IPR2020-01234, Paper 36 (June 17, 2022).
Relatedly, Director Vidal noted there are three areas where she, personally, may become involved in reviewing PTAB decisions: when an error of fact or law by the Board needs to be addressed, when new issues arise where the USPTO does not have guidance, and when clarification is needed as to how the law will be interpreted and applied.
In anticipation of a Request for Comments concerning the Director review process, the USPTO is accepting preliminary feedback from the public at [email protected] until July 11, 2022.