post-grant review PGR Archives

post-grant review PGR

Delay Is Okay: Final Written Decisions Can Be Issued After Statutory Deadline

by Jake B. Vallen | Nov 30, 2023 | America Invents Act, Patents

In a matter of first impression, the US Court of Appeals for the Federal Circuit concluded that the Patent Trial & Appeal Board has the authority to issue a final written decision (FWD) in a post-grant review (PGR) proceeding after the statutory deadline has passed. Purdue Pharma L.P. v. Collegium Pharm., Inc., Case No. 22-1482 (Fed. Cir. Nov. 21, 2023) (Dyk, Hughes, Stoll, JJ.)

Purdue owns a patent directed to a pharmaceutical formulation meant to prevent or deter the abuse of opioid analgesics through the use of an aversive agent. On March 13, 2018, Collegium filed a PGR petition asserting that the patent claims were invalid. On September 24, 2019, Purdue filed a notice of bankruptcy and imposition of automatic stay, after which the Board stayed the PGR proceeding. The Board’s one-year deadline to issue an FWD under 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) expired on October 4, 2019. After the bankruptcy court lifted the stay on the PGR proceeding on September 1, 2020, Purdue argued that the Board no longer had the authority to issue an FWD because the 18-month statutory deadline to do so had passed. The Board disagreed and issued an FWD finding the challenged claims unpatentable. Purdue appealed.

Purdue argued that the Board did not have authority to issue an FWD after the deadline established by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) had passed. Purdue advanced four arguments in favor of its proposed interpretation of § 326(a)(11):

The use of “shall” and “requiring” deprives the Board of the authority to issue an FWD.
The “negative words” of “not later than 1 year” and “by not more than 6 months” indicate a loss of authority.
The statutory language in § 326(a)(11) requires PGR proceedings to be conducted “in accordance with” the Board’s jurisdictional grant in 35 U.S.C. § 6, and therefore the Board’s jurisdiction expires when the deadline in § 326(a)(11) expires.
The exceptions in § 326(a)(11) for “good cause” and “joinder” demonstrate that those are the only limited instances where the Board may issue an FWD after the statutory deadline.

None of Purdue’s arguments persuaded the Federal Circuit. The Court reasoned that § 328(a) plainly requires the issuance of an FWD and that “[h]ad Congress meant to deprive the agency of power in § 326(a)(11), it knew how to do it” vis-à-vis the use of specific language, like the language it used in other sections of the America Invents Act (AIA), such as 35 U.S.C. § 315(b) and 35 U.S.C. § 321(c), both of which specifically deny agency power after a temporal deadline.

The Federal Circuit also considered the legislative history of § 316(a)(11), recognizing that Congress created PGR and inter partes review (IPR) proceedings when enacting the AIA to, among other things, replace the “lengthy and inefficient” reexamination proceeding. The Court reasoned that prohibiting an FWD after the statutory deadline would “force” parties to commence district court litigation—an act contrary to the purpose of the AIA, which [...]

Continue Reading

Status Quo Has Few Defenders at PREVAIL Act Senate Subcommittee Hearing

by Christopher M. Bruno and Ian Howard | Nov 16, 2023 | America Invents Act, Patents

On November 8, 2023, the US Senate Judiciary Subcommittee on Intellectual Property heard testimony from four witnesses on the proposed Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. Although the PREVAIL Act includes several provisions regarding transparency and independence, its thrust is its dramatic alteration of Patent Trial & Appeal Board post-grant review (PGR) and inter partes review (IPR) proceedings, including their relationship to co-pending district court litigation, with the goal of incentivizing innovation by reducing costs and making such challenges less likely to be successful.

We previously reported on the provisions of the proposed PREVAIL Act when it was introduced. The biggest changes under consideration include the introduction of a standing requirement, a heightened burden of proof from preponderance-of-the-evidence to clear-and-convincing evidence, a stronger estoppel to thwart costly and unnecessary co-pending actions in court and at the Board, and the separation of the Board’s institution and decision-making functions.

Three witnesses spoke in favor of the PREVAIL Act before the subcommittee, emphasizing that the Board failed to live up to the purposes and intentions of the America Invents Act (AIA). These witnesses were Representative Lamar Smith, a co-sponsor of the AIA; Michelle Armond, co-founder of the law firm Armond Wilson LLP and a practitioner before the Board; and Joseph Kiani, founder of Masimo Industries.

Smith testified that Congress enacted the AIA because it recognized the potential for Board proceedings to be abused, and according to Smith, that is exactly what has happened. Each of the three witnesses testified that well-funded litigants have exploited Board procedures to overwhelm small businesses by forcing them into expensive duplicative proceedings in multiple forums. For example, Kiani posited that the Board posed an existential threat to startups, attributing findings of invalidity against his company’s patents to the AIA’s invalidation-friendly procedures.

Armond explained to the subcommittee how the PREVAIL Act would streamline Board proceedings and harmonize them with district court and International Trade Commission (ITC) litigation. According to Armond, in the wake of the AIA, both the Board and district courts have failed to offer uniform standards for deciding whether to stay a proceeding in their forum pending resolution of a parallel proceeding in the other. The PREVAIL Act would resolve this problem by requiring litigants to select only one forum in which they may raise their invalidity arguments. Armond argued that using the same clear-and-convincing-evidence standard in Board review proceedings and other litigation would harmonize the Board with district courts and the ITC by ensuring that different forums reach the same invalidity decision.

Joseph Matal, former US Patent & Trademark Office interim director and acting solicitor, and current principal of Clear IP, LLC, was the lone dissenting witness at the hearing. According to Matal, the PREVAIL Act’s proposal to require a clear-and-convincing-evidence standard in Board review proceedings is misguided because Board judges possess the requisite agency expertise to second-guess patent examination decisions. Additionally, Board judges often have more time to evaluate the patents and more information than the examiner. According to Matal, [...]

Continue Reading

PTO Requests Comments on Revisions to AIA Trial Proceedings

by Amol Parikh | Apr 27, 2023 | America Invents Act, Patents

On April 21, 2023, the US Patent & Trademark Office (PTO) announced that it is seeking public input on proposed modifications to the rules of practice for inter partes reviews (IPRs) and post grant reviews (PGRs) before the Patent Trial & Appeal Board to better align the practices with the PTO’s mission to promote and protect innovation and investment in the same and to provide a less expensive alternative to district court litigation to resolve certain patentability issues while also protecting against patentee harassment.

The PTO is considering promulgating rules that the Director—and, by delegation, the Board—will use to do the following:

Exercise the Director’s discretion to institute IPRs and PGRs
Provide a procedure for separate briefing on discretionary denial that will allow parties to address relevant issues for discretionary denial without encroaching on the page limit to address the merits of a case
Give petitioners the ability to pay additional fees for a higher word-count limit
Clarify that all settlement agreements, including pre-institution settlement agreements, are required to be filed with the Board.

To create clear, predictable rules where possible, as opposed to balancing tests that decrease certainty, the PTO is considering changes that would provide for discretionary denials of petitions in the following categories, subject to certain conditions and circumstances as discussed further in the Official Notice:

Petitions filed by certain for-profit entities
Petitions challenging under-resourced patent owner patents where the patentee has brought or is attempting to bring products to market
Petitions challenging patent claims previously subject to a final adjudication upholding the patent claims against patentability challenges in district court or in post-grant proceedings before the PTO
Serial petitions
Petitions raising previously addressed prior art or arguments
Parallel petitions
Petitions challenging patents subject to ongoing parallel litigation in district court.

The PTO also seeks comments on proposed threshold definitions that apply to one or more of these categories of petitions subject to discretionary denials. Those definitions set forth the criteria used to determine the following:

What constitutes a “substantial relationship” between entities sufficient to trigger or avoid discretionary denial
When claim sets are deemed to have “substantial overlap” with challenged claims
What constitutes “compelling merits” sufficient to trigger an exception to discretionary denial.

For example, one proposal with respect to the “substantial relationship” is a requirement that a patent owner and petitioner disclose anyone with an ownership interest in the patent owner or petitioner, any government funding related to the patent, any third-party litigation funding support, and any stake any party has in the outcome of the America Invents Act (AIA) proceeding or any parallel proceedings on the challenged claims.

Additional changes being considered by the PTO include the following:

Absent exceptional circumstances, requiring petitioners to file a stipulation that neither they nor their privy or real parties in interest have filed prior post-grant proceedings (PGRs, IPRs, covered business methods or ex parte reexaminations) on the challenged claims
If petitioners’ post-grant proceeding is instituted, requiring that [...]

Continue Reading

Not “Use It or Lose It”: Even if Unexercised, Director’s Authority over Institution Decisions Remains

by Christopher M. Bruno | Aug 25, 2022 | Patents

The US Court of Appeals for the Federal Circuit denied mandamus relief, finding that a party is not entitled to petition the director for review of a Patent Trial & Appeal Board (Board) decision denying institution of an inter partes review (IPR) or post-grant review (PGR) proceeding. This ruling reflects the Court’s ongoing consideration of the Supreme Court’s decision in United States v. Arthrex, Inc., which held that Board judges cannot constitutionally render final decisions in IPRs without US Patent & Trademark Office (PTO) Director oversight. Click here for our discussion of the case on remand, for which the Federal Circuit just denied en banc rehearing. In re Palo Alto Networks, Inc., Case No. 22-145 (Fed. Cir. Aug. 16, 2022) (Dyk, Chen, JJ.) (Reyna, J., concurring).

After being sued by Centripetal Systems for patent infringement, Palo Alto Networks filed petitions for IPR and PGR of some of the asserted patents. The Board denied institution, and Palo Alto Networks filed requests for Director rehearing. Although the PTO acknowledged receipt of the request, it informed Palo Alto Networks that the Director was not considering requests for rehearing of institution decisions “at this time.” Thereafter, Palo Alto Networks sought a writ of mandamus from the Federal Circuit. Between the request for mandamus and the Court’s decision, the PTO issued guidance explaining that although the PTO was not considering requests for rehearing, “the Director has always retained and continues to retain the authority to review such decisions sua sponte after issuance (at the Director’s discretion),” and indeed, exercised its authority to initiate sua sponte review since.

The Federal Circuit rejected Palo Alto Networks’ claim that the Director’s refusal to consider petitions for rehearing of institution decisions amounted to an abdication of authority prohibited by the Appointments Clause. Even assuming that institution decisions were “final decisions on how to exercise executive power” implicating the Appointments Clause, the Court found that the Director maintains statutory and regulatory authority to review institution decisions (unlike in Arthrex), and that the Board renders such decisions only based on the Director’s delegation of authority (also unlike Arthrex). Accordingly, the structural authority maintained by the Director is sufficient, even if such authority goes unexercised, according to the Court.

Writing separately, Judge Reyna agreed that no Appointments Clause violation had occurred but on different grounds. Although Judge Reyna noted that a categorical rejection of requests for rehearing by the Director might raise constitutional concerns, he concluded that mandamus was inappropriate for several reasons. First, the Director’s caveat that she refused to accept requests “at this time” did not constitute a categorical refusal but rather an exercise of discretion. Second, the Director’s invocation of her sua sponte authority to review belied a lack of exercise of discretion. The Director did in fact exercise sua sponte authority to consider Palo Alto Networks’ request, even though briefing in the Federal Circuit was pending, and thus a writ of mandamus was inappropriate.

Clarification or Raising the Bar? PTO Director Issues New Guidance for Discretionary PTAB Denials

by Thomas DaMario | Jun 30, 2022 | America Invents Act, Patents

On June 21, 2022, US Patent & Trademark Office (PTO) Director Katherine K. Vidal issued a memorandum addressing interim procedures for discretionary denials in America Invents Act (AIA)-post grant proceedings at the Patent Trial & Appeal Board (Board). In 2020, in order to minimize the potential conflict between the Board and parallel district court proceedings, the PTO designated the Board’s opinion in Apple v. Fintiv as precedential. Since Fintiv, the Board has issued several discretionary denials of institution based on parallel proceedings in district (and in some cases other administrative) courts. Director Vidal’s memo seeks to provide additional guidance on the PTO’s interpretation of Fintiv and its progeny and addresses multiple factors that were previously left to individual administrative law judge (ALJ) interpretation.

The memo includes rendering an initial evaluation of the merits of the petition. In particular, the Board will not deny institution of an inter partes review (IPR) or post-grant review (PGR) under Fintiv when a petition presents compelling evidence of unpatentability. This standard is higher than the institution standard, which requires only that “there is a reasonable likelihood that petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” While the memo does not elaborate on the evidence required to meet this compelling standard, numerous decisions were cited as illustrative. (See: e.g., Illumina Inc. v. Trs. of Columbia Univ., IPR2020-00988, Paper 20 (PTAB Dec. 8, 2020); Synthego Corp. v. Agilent Techs., Inc., IPR2022-00402, Paper 11 (May 31, 2022); Samsung Elecs. Co. v. Scramoge Tech., Ltd., IPR2022-00241, Paper 10 (June 13, 2022).)

Additionally, Director Vidal confirmed that Fintiv does not apply to parallel proceedings before the International Trade Commission nor where there has been a stipulation not to pursue the same grounds in a district court proceeding. The stipulation applies to grounds that are actually raised in the petition and any grounds that could have reasonably been raised in the petition, suggesting that there may be some dispute later in the district court proceeding about what grounds “could have reasonably been raised in the petition.”

Finally, the memo clarified the second factor of the Fintiv analysis: the speed with which the district court case may go to trial and be resolved. The Board will consider not only the scheduled trial date, but also the median time-to-trial for the particular district court, number of cases before the specific district court judge and the speed and availability of other dispositions.

Practice Note: While the standard for institution has not changed, the new compelling standard effectively ups the bar for any IPR, PGR or covered business method (CBM) proceedings where there is a parallel district court case. Prior to filing a new petition, patent challengers should objectively weigh the merits of their challenge or consider stipulating not to pursue the same invalidity grounds in the parallel district court proceeding.