It has been a busy few days for Director Vidal and the USPTO, with the Bureau providing updated guidance on how the PTAB will apply its discretion under Fintiv when reviewing post-grant petitions and separately issuing updated guidance on the Interim Director’s review process.
On 22 June 2022, the Office published a note setting out the current thinking of Director Vidal and the Office on
Fintiv and the ability of the PTAB to discretionarily deny post-grant proceeding given the status of parallel litigation. Specifically, the Office has explained that it will not refuse the imposition of an IPR or RMP under Fintiv:(1) where a petition presents compelling evidence of non-patentability; (2) where a request for refusal under Fintiv is based on a parallel procedure of the ITC; or (3) where a petitioner directs not to pursue in a parallel district court the same grounds as those presented in the petition or any grounds that could reasonably have been raised in the petition (that’s to say, a sotera-style stipulation). As for Fintiv factor two, which examines the proximity of the District Court trial date to the Board’s statutory deadline for a written final decision, the Bureau’s updated guidance makes it clear that the PTAB will be looking at the median deadline for trial for a given district rather than specific case schedules. Ultimately, these updated guidelines don’t stop Fintiv practical, but they certainly diminish the general applicability of Fintiv, which seemed to be withering on the vine anyway. However, for the respondents before the ITC, Fintiv seems to have reached its end.
The Office has also published a study examining the impact of PTAB denials of post-grant requests where there is a parallel proceeding in a district court concerning the same patent. The study covers the second quarter of fiscal year 2019 through the first quarter of fiscal year 2022. As we stated above, the study showed that there was a strong overall decline in
Fintiv refusal, in addition to the following:
- After Fintiv was designated as a precedent, the status of parallel litigation was raised in approximately 40% of all cases.
- Fintiv denials peaked in the second quarter of fiscal 2021 and declined significantly thereafter.
- The PTAB has not issued any Fintiv denials based on parallel litigation in the Western District of Texas since August 2021.
- USPTO guidelines on the use of stipulations appear to have led to an increase in stipulation filings and a significant decrease in the Fintiv denies.
- The PTAB denied the institution on the basis of Fintiv of only three total AIA petitions challenging drug patents: two amber listed patents and one biologic drug patent.
Updated Guidance on the Acting Director’s Review Process
Just a day before the desktop update Fintivguidelines, the USPTO has issued additional guidelines regarding the Acting Director Review process. The new guidelines can be found on the USPTO Director’s Review Web page under Section 10. In particular, the Bureau updated its guidance on how parties should focus and prioritize issues when seeking Director’s review by (1) identifying any issues first impression; (2) provide a list of issues raised in order of priority; and (3) provide a brief explanation of the issues and a brief explanation of the rationale for prioritizing the issues.
As previously mentioned in our April 22 post, issues that may warrant Director’s Review include: issues that involve an interim change in law or USPTO procedures or guidelines, material errors of fact or law , issues that the PTAB has misinterpreted or overlooked, new issues of law or policy, issues on which the PTAB Panel’s rulings are divided, issues of particular importance to the Board or the patents, or inconsistencies with Office procedures, guidance or decisions. For example, Director Vidal recently granted a request for Director’s Review based on the patentee’s argument that the PTAB misapplied the law regarding multiple dependent claims and the ability of the Commission to cancel dependent claims if one, but not both, establishes independent claims. are unpatentable. See Nested Bean, Inc. v. Big Beings USA Pty LtdIPR2020-01234, Document 36 (June 17, 2022).
Along the same lines, Director Vidal noted that there are three areas where she can personally be involved in reviewing PTAB decisions: where an error of fact or law by the board should be corrected, when new issues arise for which the USPTO has no guidance, and when clarification is needed about how the law will be interpreted and applied.
In anticipation of a request for comment regarding the Director’s Review process, the USPTO is accepting preliminary public comments at [email protected] through July 11, 2022.
The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.