Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, Appeal No. 2022-1706 (Fed. Cir. Nov. 7, 2023)

In this week’s Case of the Week, the Federal Circuit dismissed appellant Allgenesis’s appeal of an inter partes review decision that upheld claims of Cloudbreak’s U.S. Patent No. 10,149,820 as patentable, finding that Allgenesis had failed to demonstrate a “case or controversy” under Article III sufficient to confer standing to maintain its appeal.  The opinion serves as a reminder that while Article III standing is not required to initiate inter partes review proceedings before the U.S. Patent Office, it is required to maintain an appeal from such proceedings in the federal courts, and provides additional guidance on when that showing can be made.

The ’820 patent claims methods of treating pterygium, an eye condition involving tumor-like growths, with nintedanib, a multikinase inhibitor that reduces new blood vessel growth in the cornea.  The Patent Trial and Appeal Board found that Allgenesis failed to show the challenged claims were obvious over the prior art, including, inter alia, because they were entitled to priority to the ’820 patent’s provisional application, which predated Allgenesis’s own PCT application directed to similar subject matter.  On review, the Federal Circuit found that Allgenesis failed to demonstrate Article III standing sufficient to maintain its appeal.

The Court first rejected Allgenesis’s argument that it had standing based on potential infringement liability, which requires “that [the appellant] has concrete plans for future activity that creates a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement.”  While Allgenesis had conducted Phase II clinical testing of a nintedanib-based pterygium treatment in 2020, its appeal was supported by a declaration from its Vice President stating only that, for example, Allgenesis “is continuing to devote resources to the development of this project” and “continues to invest in and pursue this project.”  The Federal Circuit found such “generic” averments to be insufficient to establish any “concrete plans” to develop and commercialize a potentially infringing treatment.  The Court similarly rejected Allgenesis’s argument that the parties’ settlement discussions incident to the IPR had failed to foreclose the possibility of future litigation, finding such conversations did not in themselves show a substantial risk of infringement, “especially given that Allgenesis has made no assertion that Cloudbreak has sued or threatened to sue Allgenesis if it brings a nintedanib product to market.”

The Federal Circuit also rejected Allgenesis’s argument that it suffered an “injury in fact” based on the PTAB’s priority determination vis-à-vis Allgenesis’s PCT application.  The Court disagreed that Allgenesis faced any preclusive or collateral estoppel effects from the PTAB’s decision, noting that because collateral estoppel does not attach to non-appealable judgments, “[i]f the examiner were to reach the same priority determination during prosecution of Allgenesis’ pending application, Allgenesis can challenge that determination in a separate appeal.”  Otherwise, the Court found that Allgenesis’s “quite vague allegations” failed to demonstrate any particular injury from the Board’s priority determination with respect to its own patent rights.

The opinion can be found here.

By Jason A. Wrubleski



Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., Appeal No. 2022-1889 (Fed. Cir. Nov. 6, 2023)

In an appeal from a district court stipulated judgment of infringement, the Federal Circuit reversed, remanding for further consideration of the underlying claim construction.  The term at issue is “a pH of 13 or higher.”  At issue was the number of significant digits relevant to the number “13.”  Both parties relied on portions of the intrinsic record.  Three textbooks were also submitted.  The district court considered the intrinsic evidence, but rejected consideration of extrinsic evidence.  The Court of Appeals held that the intrinsic evidence was insufficient to answer the question, and remanded for the district court to consider the extrinsic record, noting “[i]t is not for this court to make those findings in the first instance. … [w]e leave those and other relevant factual questions that might arise based on the extrinsic evidence, including the three textbooks, for the district court to address in the first instance.”

The opinion can be found here.

By Nika Aldrich

This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.

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