Alert October 11, 2022

Issue 38: PTAB Trial Tracker

FATE OF FINTIV

As discussed in our Client Alert, “Fintiv 2.0: USPTO Director Issues Guidance Softening Risk of Discretionary Denial,” USPTO Director Kathi Vidal issued a set of interim procedures clarifying how the PTAB should apply its Fintiv decision going forward.

The impact of this interim guidance has already played out in a number of proceedings. For example, the PTAB granted institution of Samsung’s IPRs challenging patents owned by Staton Techiya. See Samsung Electronics Co., Ltd. et al v. Staton Techiya, LLC, IPR2022-00302, Paper 13 at 9-10 (PTAB July 11, 2013);  IPR2022-00302, Paper 13 at 9-10 (PTAB July 11, 2022); IPR2022-00324, Paper 13 at 9-10 (PTAB July 11, 2022).

The patents Samsung challenged are being asserted in parallel district court proceedings in the Eastern District of Texas. While the jury trial was scheduled to take place several weeks before the deadline for the Board’s final written decision, the Board reasoned, “The Interim Fintiv Guidance states that . . . scheduled trial dates are unreliable and often change, and thus [a] court’s scheduled trial date . . . is not by itself a good indicator of whether the district court trial will occur before the statutory deadline for a final written decision.” Id. (internal quotations omitted). Per the interim guidance, the Board noted that recent statistics suggests that the median time-to-trial in the relevant district is 24.2 months, making a more realistic trial date several months later than the deadline for the Board’s final written decision. As a result, the Board concluded that Fintiv factor 2 weighed against exercising discretion to deny institution. Id.

The Board also applied the interim guidance in a denial of post-grant review in Daichii Sankyo, INC. and Astrazeneca Pharmaceuticals, LP. v. Seagen, Inc. PGR2021-00030, Paper 31 at 7 (PTAB July 15, 2022). The Board noted that the district court has “substantially completed its review” of issues that were also presented in the PGR, and a jury has determined that the claims do not lack enablement. The Board reasoned that, in light of the district court proceedings, it “cannot conclude that Petitioner’s enablement case is compelling.” The Board agreed with Patent Owner that “[c]ontinuing with this proceeding would result in duplicative efforts and potentially conflicting results between the district court and the Board.” Id. The Board concluded that the circumstances “compel[ed]” the denial of institution.

The interim guidance highlights the PTAB’s efforts to further develop and clarify its application of the Fintiv factors. The Board also produced a PTAB litigation study to analyze the trends and data pertaining to Fintiv denials. Although the rules regarding discretionary denials are still evolving, the PTAB’s recent application of Director Vidal’s interim guidance provides some clarity on how the Board will apply these rules.

DIRECTOR VIDAL ACTIVE IN DIRECTOR REVIEWS

Since taking on her new role, Director Vidal has played an active role in reviewing Board decisions. A few of the notable decisions resulting from her Director Reviews are noted below.

OpenSky Industries LLC v. VLSI Technology LLC, IPR2021-01064 and Patent Quality Assurance LLC v. VLSI Technology LLC, IPR2021-01229

Director Vidal issued her opinion after reviewing the panel’s institution of two IPR petitions challenging VLSI Technology LLC’s (“VLSI”) patents. The challenges came after VLSI won a verdict of over $2 billion against Intel in litigation.  Petitioner OpenSky was formed shortly after the verdict, and critics alleged that the company’s sole purpose was to disrupt the adverse judgment through abuse of the IPR process. In the course of her review, Director Vidal ordered the parties to provide extensive documentation related to the formation of the company. Director Vidal also invited amicus briefs in the case — a first since Director Review procedures were implemented —and fourteen amici curiae briefs were filed.

In her opinion, Director Vidal reprimanded OpenSky for violating her discovery order, citing that OpenSky produced “a minimal number of documents” and that it failed to produce a privilege log. Accordingly, Director Vidal drew multiple negative inferences against OpenSky, including that it brought suit solely to extort money from both VLSI and Intel. Because of the abuse, OpenSky and its counsel are precluded from participating in the underlying proceeding, and OpenSky was ordered to show cause as to why it should not be ordered to pay compensatory damages to VLSI. Director Vidal also suggested that OpenSky’s attorneys’ conduct “also rise to the level of an ethical violation under the rules of their respective bars.”

Ultimately, Director Vidal’s decision remanded the proceeding back to the panel to determine whether, in light of the evidence available at the time of institution, there was a compelling, meritorious challenge to the patent, and to take appropriate action to terminate or maintain the proceeding in light of its determination.

Nested Bean, Inc. v. Big Beings USA Pty Ltd. and LB Online & Export Pty Ltd. d/b/a Love to Deam Online and Exports, IPR2020-01234

Director Vidal granted Big Beings USA Pty Ltd.’s request for director review, stating that it raised a question about whether the Board erred in Nested Bean Inc.’s challenge to its patent for baby swaddles. Director Vidal also stated that Big Beings also raised a question about the proper interpretation of Section 112 of the Patent Act, and invited further briefing in the case to address that matter.

Specifically, in its final written decision, the Board invalidated claims 2-16 but said claims 1, 17 and 18 were not shown to be unpatentable. Love to Dream sought director review, arguing that it should not have invalidated claims 3-16 because they depend from either valid independent claim 1 or invalidated independent claim 2. The Board reasoned that the dependent claims are invalid if either version of the claims — the version that depends on claim 1 or the version that depends on claim 2 — “is described by the prior art.” Love to Dream claimed that the Board’s interpretation is “an incorrect statement of the law” and said the Board was required under Section 112 of the Patent Act to consider the patentability of the dependent claims in relation to each independent claim separately, and issue separate findings. In the order granting director review, Vidal invited further briefing, asking for authority “specifically addressing and resolving the interpretation issue presented" in relation to Section 112. The Parties have fully briefed the issue and are awaiting a decision.

Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research Foundation, PGR2022-00021

Director Vidal revived Boehringer’s unsuccessful challenge to a Kansas State University pig vaccine patent by announcing she will review the PTAB’s decision not to institute a challenge to the patent’s validity. Director Vidal sua sponte initiated the director review of the decision, noting that “this case raises issues of particular importance to the office and the patent community.” The decision marked the first time a USPTO director has used the agency’s review powers to look at the denial of a PTAB petition rather than a grant or subsequent decision in the case. Such reviews are incredibly rare since courts have repeatedly held that institution decisions cannot be appealed, and the USPTO has said that includes appeals to the director. Any review must, therefore, arise from sua sponte action by the Director. 

Med-El v. Advanced Bionics AG, IPR2020-01016

Director Vidal vacated a decision where the Board found that the Petitioner had improperly relied on applicant admitted prior art (“AAPA”) in its arguments. AAPA refers to prior art that has been identified in the written description of the patent itself. In its decision, the Board relied on the 2020 PTAB Guidance, issued by former Director Iancu, which stated that AAPA cannot by itself be considered prior art. Director Vidal in her decision, however, noted that the updated 2022 PTAB Guidance superseded the version the Board relied on because it reflects recent changes in law. Notably, in February, the Federal Circuit held in Qualcomm v. Apple that AAPA could be relied on to illuminate the knowledge of skilled artisans at the time of the invention. Therefore, in light of the updated precedent and Guidance, Director Vidal clarified that AAPA must be considered by the panel when the petitioner relied on them in combination with some other non-AAPA prior art.

Code200 UAB v. Bright Data Ltd., IPR2022-00861 and IPR2022-00862

Director Vidal initiated a sua sponte director review vacating decisions denying institution and remanding those cases for further proceedings. In her decision, Director Vidal clarified the application of the General Plastics factors used to assess whether to deny institution under 35 U.S.C. § 314(a) in view of serial petitions challenging the same patent. In vacating the institution decisions, Vidal stated that the Board incorrectly applied the factors, noting that Factors 1-3 must be read in conjunction. When done so, Director Vidal noted, these factors only weigh in favor of discretionary denial when there are “road-mapping” concerns. That is, where a petitioner strategically stages their arguments in multiple sequential petitions whereby guidance from previous PTAB decisions are used as a roadmap to improve upon subsequent petitions until institution is granted. Acknowledging that the Board had found no evidence of road mapping in its decision denying institution, along with the fact that the Board had never substantively addressed the merits of the arguments, Director Vidal found that the Patent Owner’s concerns of fairness were outweighed by the benefits to the patent system of reviewing the merits of challenges in petitions which have not been previously addressed.

NXP USA, Inc. v. Impinij, Inc., IPR2021-01556

Director Vidal sua sponte affirmed a PTAB decision that denied NXP USA Inc.’s bid for rehearing of a Board decision that declined to institute review of a patent owned by Impinj Inc.

The Board found that it would not rethink its decision not institute review, citing Fintiv and the ongoing parallel litigation between the parties. NXP attempted to avoid the application of Fintiv by stipulating that it would not raise the same arguments based on prior art references used in the IPR at trial, but did so only after institution of the IPR was denied. In her decision, Director Vidal agreed with the panel “that a stipulation, offered by a petitioner for the first time after a decision denying institution, is not a proper basis for granting rehearing of the decision on institution.” Director Vidal further stated that, in cases involving upcoming district court trials, stipulations are intended to avoid “conflicting decisions and duplicative efforts,” so “permitting a petitioner to wait and see if the board denies institution under Fintiv, and then offer such a stipulation for the first time on rehearing, frustrates these goals and would open the door to gamesmanship.”

FEDERAL CIRCUIT RULES PTAB DENIALS DO NOT NEED DIRECTOR REVIEW

In In re: Palo Alto Networks, Inc., Palo Alto filed a petition to the Federal Circuit arguing that since the U.S. Supreme Court held that the USPTO director must be able to review the PTAB’s final decisions in order for them to comply with the Constitution, the same review is required for the Board’s decisions on institution. The Federal Circuit denied the Palo Alto’s request, holding that the Board’s refusal to consider requests for director review of institution denials does not violate the U.S. Constitution. The court stated that the director has the final say on institution decisions and there is no constitutional violation in not permitting review requests. The court further stated that “[a]lthough the director delegated that authority to the board…the director plainly has the authority to revoke the delegation or to exercise her review authority in individual cases despite the delegation.”

CERTAIN INVENTOR DISCLOSURES CAN OPERATE TO REMOVE REFERENCES FROM CONSIDERATION AS PRIOR ART

In Incyte Corp. v. Concert Pharmaceuticals, Inc., PGR2021-00006, Paper 68, at 15, 60 (P.T.A.B. May 11, 2022) the Board held that the challenged patent was not invalid because the central disclosures of a key reference relied upon by the Petitioner did not qualify as prior art under 35 U.S.C. § 102(b)(1). Under § 102(b)(1), which has not been applied previously, certain disclosures do not qualify as prior art if they are made one year or less before the effective filing date from an inventor of the claimed invention. Id. at 40.

In arriving at its decision, the Board first concluded that the challenged patent was entitled to the priority date of its associated provisional application. Second, the Board determined whether the inventor who authored the central disclosures of the key reference was in fact an inventor of the challenged claims. The Board held that the inventor was properly listed as such because of the presumption of inventorship, the signed oath of inventorship, and deposition testimony by the inventor explaining her role in developing and supervising experiments that lead to issuance of the challenged patent. Id. at 35. Third, the Board determined that the § 102(b)(1) exception applied to the relevant disclosures of the prior art because the disclosures — which were contained in a declaration submitted during prosecution of the key reference — became public when that key reference was published, which was less than a year before the priority date of the challenged patent. Id. at 39. Lastly, the Board found that the scope of the disclosures extended to properties of the compounds falling within the genus of the challenged patent. Id. at 42. Therefore, the Board concluded that the knowledge of the enhanced properties of the prior art compounds cannot be considered within the knowledge of a person of ordinary skill in the art.

As a result, the Board held that a person of ordinary skill in the art would not have had a motivation to combine the prior art as petitioner suggested, and as such the challenged patent was not invalid. Id. at 59-60.

Takeaway: Patent practitioners should carefully consider whether inventors of challenged patents have made any disclosures that would result in certain portions of prior art references to be excluded as prior art under the inventor disclosure exceptions to 35 U.S.C. § 102(a).

SUBsTITUTED expert MAY sign onto DECEASED EXPERT’s identiCal report

In Alzheon Inc. v Risen Shuzhou Pharma Tech Co., LTD., IPR2021-00347, Paper 53 at 16 PTAB (July 12, 2022), the Board considered the proper weight to give a substituted expert who signed onto a deceased expert’s identical report.

Dr. Steven Wagner, who submitted a declaration in support of Patent Owner, had been too ill to sit for a deposition and died before the proceeding concluded. At Risen’s request, the Board permitted patent owner to have a substitute expert, Dr. S. David Kimball, submit the identical report, with his signature. The report was submitted “[w]ith no changes to its content except for the relevant biographical details.” Id. at 3.

Petitioner attempted to attack Dr. Kimball’s credibility, pointing to his deposition testimony that he spent a total of only “three or four hours” looking at that report. The Board dismissed Petitioner’s arguments, stating: “We have explained the unusual circumstances by which Dr. Kimball ‘stepped into the shoes’ of patent owner’s prior declarant, the late Dr. Wagner… the board is capable of weighing Dr. Kimball's testimony in view of these circumstances." Id at 16.

Takeaway: Parties should appreciate that the Board will consider the evidence in the light the circumstances. Here, where an expert who has submitted a declaration was no longer able to participate in the action, the Board rejected attempts by the opposing party to benefit from circumstances outside their control.

EDWARDS LIFESCIENCES HIGHLIGHTS TWO PRACTICAL TIPS

In Edwards Lifesciences Corp. et al v. Cardiovalve Ltd. et al, IPR2021-00383, Paper 60, at 1 (PTAB July 18, 2022), the Board rejected Petitioner’s argument that a proposed amendment to the claims did not respond to a ground of unpatentability. The Board clarified that under Rule 42.121, the requirement is for the amendment to be responsive to ‘a ground of unpatentability,’ and there is no requirement that the response be “adequate” for it to be responsive. Id. Therefore, the Board found that the motion to amend was responsive.

Additionally, the Board denied in part Petitioner’s motion to strike certain exhibits filed with Patent Owner’s Sur-reply as untimely new evidence. Id. at 87. The exhibits at issue were used during cross-examination of Petitioner’s expert after submission of a reply declaration. The Board allowed these exhibits to come into evidence for the limited purpose of allowing the Board to understand the context of the cross-examinations. Id. The Board found that the Petitioner was not prejudiced because its expert had an opportunity to respond to the exhibits during the deposition. Id.

Takeaways: Under Rule 42.121, an amendment must be responsive to a ground of unpatentability, but there is no minimum threshold of adequacy that a response must meet in order satisfy the rule.

Exhibits used solely during cross-examination of a reply expert witness may be allowed into evidence for the limited purpose of allowing the Board to understand the context of the examination provided that the expert had the opportunity to respond to the exhibits. Notably, however, new evidence is typically not permitted with a sur-reply.

Special thank you to 2022 Summer Associates Daniel Farraye and Seth Manilove for their contributions to this edition.