Injury In Fact Archives

Injury In Fact

Speculation of Harm Isn’t Standing: Not Every Adverse Board Decision Is Ticket to Appeal

by Keval Amin | Jun 12, 2025 | America Invents Act, Patents

After assessing whether a patent owner had standing to appeal the Patent Trial & Appeal Board’s final written decision, the US Court of Appeals for the Federal Circuit found no injury in fact to support Article III jurisdiction and dismissed the appeal. Dolby Labs. Licensing Corp. v. Unified Patents, LLC, Case No. 23-2110 (Fed. Cir. June 5, 2025) (Moore, Clevenger, Chen, JJ.)

Dolby owns a patent covering a prediction method involving an in-loop filter. Unified Patents, claiming to be the sole real party in interest (RPI), filed an inter partes review (IPR) challenging several patent claims as anticipated and obvious. Dolby contested the challenge, identifying nine additional entities it argued should have been named as RPIs (alleged RPIs). The Board declined to rule on Dolby’s inclusion, however, and proceeded with Unified as the sole RPI.

In its final written decision, the Board found that Unified failed to establish the unpatentability of any challenged claims. Consistent with the US Patent & Trademark Office’s practice, it also declined to address the RPI dispute, finding it immaterial – there was no evidence the alleged RPIs were estopped from filing their own IPRs later or that Unified had advantageously or strategically omitted them. Dolby appealed.

The Federal Circuit explained that when it reviews final Board decisions, its jurisdiction is constrained by Article III’s “Cases” and “Controversies” requirement. To establish standing, an appellant must demonstrate:

A concrete and particularized injury in fact that is actual or imminent, not speculative.
A causal link between the injury and the appellee’s challenged conduct.
A likelihood that the injury will be redressed by a favorable ruling.

Dolby asserted standing to appeal the Board’s refusal to address the RPI dispute based on three grounds:

Its statutory right to appeal as a “dissatisfied” party under 35 U.S.C. § 319.

The denial of its right to information under 35 U.S.C. § 312(a)(2).
An injury in fact arising from potential breaches of license agreements by the alleged RPIs and possible conflicts of interest involving the Board’s administrative patent judges.

The Federal Circuit rejected Dolby’s argument that it had a right to appeal based solely on dissatisfaction with the Board’s decision. The Court explained that the right to appeal a Board decision under the America Invents Act (AIA) requires Article III standing. The Court also dismissed Dolby’s argument for a statutory right to RPI information, finding that the AIA does not create an informational right. The Court explained that unlike statutes such as the Federal Advisory Committee Act or the Federal Election Campaign Act, which expressly grant public access to information, the AIA lacks a public access provision and explicitly limits judicial review of IPR-related determinations, including RPI disclosures.

As to Dolby’s right to appeal the Board decision, the Federal Circuit found Dolby’s argument too speculative to establish standing, citing four key deficiencies:

Dolby failed to assert that any alleged RPIs were party to license agreements, undermining its claim of potential breach.

Dolby provided no evidence of conflicts of [...]

Continue Reading

No Article III Appellate Standing Under the Sun

by Anisa Noorassa | May 15, 2025 | Patents

The US Court of Appeals for the Federal Circuit dismissed Incyte’s appeal of a Patent Trial & Appeal Board decision, holding that a disappointed validity challenger lacked appellate standing to challenge the Board’s final written decision. Incyte Corp. v. Sun Pharmaceuticals Industries, Inc., Case No. 23-1300 (Fed. Cir. May 7, 2025) (Moore, C.J.; Hughes, Cunningham, JJ.) (Hughes, J., concurring).

After the Board upheld the validity of challenged claims of a patent owned by Sun Pharmaceuticals in a post-grant review proceeding (PGR), Incyte appealed and sought a determination that the claims were unpatentable. Sun Pharmaceuticals challenged whether Incyte had Article III standing to support an appeal to the Federal Circuit based on a lack of injury-in-fact.

The Federal Circuit focused on its jurisdiction to hear the appeal as a threshold issue and whether Incyte, as the party seeking review, met its burden of establishing Article III standing at the time it filed its appeal.

As context, the Federal Circuit noted that standing requires a concrete, actual, or imminent injury that is traceable to the challenged conduct and likely to be redressed by the court’s decision. Incyte asserted it had standing to appeal based on potential infringement liability and under the competitor standing doctrine.

Addressing potential infringement liability, the Federal Circuit noted Incyte’s reliance on a supplemental declaration from an in-house business development leader submitted during briefing. Noting that Incyte’s Article III standing was “not self-evident,” the Court ruled that Incyte should have presented evidence prior to its reply brief and declined to consider the supplemental evidence. Incyte was on notice that its appellate standing was challenged, and that evidence of its standing should have been submitted at the earliest possible opportunity. Finding no good cause for the delay, the Court declined to exercise its discretion to consider Incyte’s supplemental evidence and, based only on earlier submitted evidence, found that Incyte failed to establish that it had “concrete plans for future activity” that would create a “substantial risk of future infringement.”

In its discussion of the competitor standing doctrine, which allows competitors to challenge patents that could harm their competitive position, the Federal Circuit found the doctrine inapplicable because Incyte failed to show it would suffer economic harm from the Board’s ruling on patent validity. Rather, the Board’s ruling upholding specific patent claims “does not, by the operation of ordinary economic forces, naturally harm a [challenger] just because it is a competitor in the same market as the beneficiary of the government action (the patentee).” As the Court explained, “it is not enough to show a benefit to a competitor to establish injury in fact; the party seeking to establish standing must show a concrete injury to itself.”

The Federal Circuit held that because Incyte had not shown it was currently engaged in or had non-speculative plans to engage in conduct covered by the challenged patent, it was unable to establish injury-in-fact.

In his concurrence, Judge Hughes stated that while Incyte lacked Article III standing, he believed that Federal Circuit precedent was [...]

Continue Reading

Blurred Vision: Appeal Dismissed for Lack of Standing

by Lillian Spetrino | Aug 29, 2024 | Patents

The US Court of Appeals for the Federal Circuit dismissed a patent challenger’s appeal in an inter partes review (IPR) because the challenger could not meet the injury-in-fact requirement for Article III standing. Platinum Optics Tech. Inc. v. Viavi Solutions Inc., Case No. 23-1227 (Fed. Cir. Aug. 16, 2024) (Moore, Taranto, JJ.; Checchi, Dist. J, sitting by designation).

Viavi Solutions owns a patent directed to optical filters that include layers of hydrogenated silicon and to sensor systems comprising such optical filters. Platinum Optics Technology (PTOT) petitioned for IPR. The Patent Trial & Appeal Board found that PTOT had failed to establish that the challenged claims were unpatentable. PTOT appealed.

The Federal Circuit dismissed the appeal, finding that PTOT did not have Article III standing. The Court explained that while Article III standing is not required to appear before an administrative agency (such as the US Patent & Trademark Office), such standing is required once a party seeks judicial review in an Article III federal court. PTOT argued it had standing because of potential infringement liability due to its continued distribution of a product previously accused of infringing the patent and its development of new models of the previously accused product. The Court rejected both arguments.

First, PTOT asserted that it suffered an injury in fact because there was a likelihood that Viavi would sue again. PTOT relied on a letter from Viavi stating that it did not believe PTOT could fulfill its supply agreements with noninfringing products. The Federal Circuit disagreed with PTOT’s assertion, concluding that mere speculation about the possibility of suit, without more, is insufficient to confer Article III standing. Moreover, the Court noted that Viavi’s letter was sent prior to the patent infringement suits, which were dismissed with prejudice. Thus, the Court found that PTOT had not established an injury in fact based on potential infringement liability due to its continued distribution of a previously accused product.

Second, PTOT asserted that it suffered an injury in fact based on its development of new models of the previously accused product. PTOT’s argument was supported by a declaration from a Deputy Director of Operation Management at PTOT and the same letter from Viavi threatening future suit. The Federal Circuit did not find the declaration testimony compelling. It explained that the declaration, which generally alleged that PTOT continued to develop new models of the previously accused product, did not identify any specific concrete plans for PTOT to develop a product that might implicate the patent. The declaration did not explain the particulars of these new models or how the models might relate to the patent. The Court found that the declaration was insufficient to establish that PTOT’s development activities created a substantial risk of infringement or were likely to cause Viavi to assert infringement. The Court noted that the letter from Viavi did not specifically address models in development or foreclose PTOT’s ability to develop a noninfringing product.

Thus, the Federal Circuit concluded that PTOT failed to establish an injury [...]

Continue Reading

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 [...]

Continue Reading

Speculative Injury from Rulemaking Petition Denial Doesn’t Confer Standing

by Cecilia Choy, Ph.D. and Hannah Hurley | 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 [...]

Continue Reading

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.).

(more…)