On Nov. 07, 2023, Federal Circuit dismissed appeal of Allgenesis Biotherapeutics because it failed to establish sufficient injury in fact.

 

Cloudbreak Therapeutics owns US 10,149,820 patent, related to compositions and methods for treating pterygium. Allgenesis petitioned for IPR of all claims of US’820. Cloudbreak disclaimed genus claims leaving only claims 4 and 5, which more narrowly claim the use of nintedanib. The Board issued a final written decision holding Allgenesis failed to show claims 4 and 5 are anticipated or obvious. Specifically, the Board determined Allgenesis’ PCT (Jun. 22, 2015) does not qualify as prior art because current claims have priority of Jun. 06, 2015 and hence does not anticipte. The Board also determined Allgenesis failed to show claims 4 and 5 would have been obvious over King and Amparo. Allgenesis appealed.

 

Federal Circuit said that Allgenesis does not meet the Article III standing requirements. Allgenesis asserts it has standing to appeal the Board’s decision based on (1) its potential infringement liability and (2) the Board’s priority determination.

With respect to potential infringement liability, Court held that Allgenesis failed to identify any specific, concrete plans to develop a nintedanib product. There is no development activities since the completion of its Phase II trial in 2020 or plans for future clinical development. Allgenesis has not identified any plans to conduct Phase III trials
or seek FDA approval. Therefore, Allgenesis has not shown its activities will create a substantial risk of infringement or will likely cause Cloudbreak to assert a claim of infringement.

With respect to priority determination, Court held that Board’s determination will not have a preclusive effect on
the scope of its pending patent application which claims priority to Allgenesis’ PCT. Allgenesis has failed to articulate with any specificity how the Board’s priority determination will impact its issued patents or pending continuation applications which claim priority to its PCT application. Allgenesis’ general and nonspecific allegations are insufficient to meet its burden of establishing standing.

 

Federal Circuit thus concluded that Allgenesis failed to establish an injury in fact sufficient to confer Article III
standing and therefore dismissed the appeal.