Injury In Fact Archives

See Here: No Standing Based on Vague Future Plans or Adverse Priority Findings

by Sarah J. Fischer | Nov 16, 2023 | Patents

The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact. Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, Case No. 22-1706 (Fed. Cir. Nov. 7, 2023) (Moore, Stoll, Cunningham, JJ.)

Allgenesis Biotherapeutics filed an IPR petition challenging a patent owned by Cloudbreak Therapeutics. The challenged patent discloses compositions and methods for treating the eye condition pterygium. During the IPR proceeding, Cloudbreak disclaimed all but two of the claims. The Patent Trial & Appeal Board issued a final written decision finding that Allgenesis failed to show that the remaining two claims were unpatentable. As part of its decision, the Board made a priority decision that a Patent Cooperation Treaty (PCT) application belonging to Allgenesis was not prior art to Cloudbreak’s patent. Allgenesis appealed.

Article III of the US Constitution limits the Federal Circuit’s jurisdiction to adjudication of “cases” or “controversies,” which means the appellant must have (1) suffered an injury in fact (2) that is fairly traceable to the challenged conduct of the defendant and (3) likely to be redressed by a favorable judicial decision.

Allgenesis attempted to establish Article III standing based on two separate arguments. First, Allgenesis argued that it had standing based on potential infringement liability. To support that argument, Allgenesis offered a declaration by its vice president of finance that included information about a Phase II trial completed three years prior and a related 2020 publication. That declaration, however, did not identify any specific plan to conduct a Phase III trial or to seek US Food and Drug Administration (FDA) approval, and instead only contained generic statements that the project was not abandoned. While Allgenesis’s briefing and oral argument included statements that it planned to engage in a Phase III trial, the Federal Circuit determined that there was no record support for this claim. The Court found that the evidence before it did not constitute the necessary concrete plans to convey standing to appeal the final written decision. Allgenesis also attempted to rely on its own failed attempts at seeking a settlement from Cloudbreak, but the Court concluded that this was insufficient to show a substantial risk of infringement.

Allgenesis’s second argument was that the Board’s priority decision created an injury in fact. Allgenesis argued that the Board’s determination about the priority date of Cloudbreak’s patent affected Allgenesis’s patent rights because it would have a preclusive effect on Allgenesis’s pending applications. The Federal Circuit was unpersuaded and explained that collateral estoppel does not attach to a non-appeal priority decision from an IPR decision. To the extent that an examiner did reach the same conclusion as the Board, Allgenesis would be free to appeal that decision.

Practice Note: For Board petitioners seeking to establish standing to appeal unfavorable final written decisions, it is necessary to develop sufficient support to show standing in fact. For life sciences companies working in drug development, declarations [...]

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Speculative Injury from Rulemaking Petition Denial Doesn’t Confer Standing

by Cecilia Choy, Ph.D. | Jul 20, 2023 | America Invents Act, Patents

The US District Court for the District of Columbia affirmed the dismissal of a case alleging that the US Patent & Trademark Office (PTO) violated the Administrative Procedure Act (APA) by denying the plaintiffs’ rulemaking petition. The district court found that the plaintiffs’ alleged injury was too speculative to confer Article III standing. US Inventor, Inc. v. US Patent and Trademark Office, Case No. 22-2218 (D.D.C. July 12, 2023) (Bates, J.)

Under the America Invents Act (AIA), the Patent Trial & Appeal Board may hear challenges to the validity of patents through inter partes review (IPR) and post-grant review (PGR). The decision to initiate a review is made at the discretion of the PTO on a case-by-case basis. US Inventor, Inc., and National Small Business United (collectively, NSBU) filed a rulemaking petition with the PTO, arguing that the PTO unlawfully designated cases as precedential or informative without putting those considerations through notice-and-comment rulemaking, as required by the APA. NSBU expressed the same position in a previous lawsuit filed in the Eastern District of Texas that was dismissed for lack of standing—a decision upheld by the US Court of Appeals for the Fifth Circuit. NSBU subsequently filed a lawsuit in the District of Columbia. The PTO filed a motion to dismiss for lack of standing.

In a motion to dismiss, a court will accept facts alleged in the complaint as true but will not assume the truth of legal conclusions. The District of Columbia noted that not every denial of a rulemaking petition confers standing on the petitioner. Standing is established by claiming an injury in fact that can be traced to the defendant’s actions and is likely to be redressed by the court. Therefore, a plaintiff must show that the denial of the petition caused a concrete injury in fact. Injury in fact must be concrete, particularized and not conjectural or hypothetical. Standing can be established via associational standing or organizational standing. Here, the court found that NSBU could establish neither.

In finding no associational standing, the District of Columbia agreed with the PTO that NSBU’s theory of injury was too speculative and not concrete. NSBU proposed an “uncertain series of events” that could lead to an alleged injury, but the court rejected the claim as attenuated conjecture based on the actions of independent third parties (similar to the fact pattern in the Supreme Court’s 2013 decision in Clapper v. Amnesty Int’l USA.)

The District of Columbia heavily criticized the first step of NSBU’s proposed series of events, which was that a valid IPR or PGR would have to be filed on behalf of a patent held by a member of NSBU’s organizations. The court found that identifying potential members that might face IPR or PGR proceedings if a third party decided to bring a claim against them was too hypothetical and relied entirely on the actions of a third party.

The District of Columbia also disagreed with NSBU’s reliance on statistics. NSBU argued that patent cancellation is more likely [...]

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Article III Standing Required to Appeal Final Decisions by the PTAB

by Mandy H. Kim | May 7, 2020 | Patents

Addressing the issue of Article III standing in an appeal of an inter partes review (IPR) decision, the US Court of Appeals for the Federal Circuit dismissed the appeal because the party appealing failed to establish an injury sufficient to confer standing. Argentum Pharms. LLC v. Novartis Pharms. Corp., Case No. 18-2273 (Fed. Cir. Apr. 23, 2020) (Moore, J.).

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