A recent Federal Circuit decision, Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, provides some interesting insights into patent challenge strategies, and their consequences, when a potentially infringing product is not yet on the market.

Allgenesis, which has been developing a pterygium treatment product using nintedanib, filed an inter partes review (IPR) petition to try to invalidate one of Cloudbreak’s patents relating to pterygium treatment. Allgenesis lost at the Patent Trial and Appeal Board (PTAB), which issued a final written decision upholding the patentability of the challenged claims. The PTAB’s decision included a finding that Allgenesis’s own patent application, on which Allgenesis based a number of its invalidity arguments, was not prior art to the Cloudbreak patent.

Allgenesis appealed to the Federal Circuit, which dismissed the appeal, finding that, although the IPR statute permitted Allgenesis to file the IPR, the law governing appeals to the Federal Circuit (which is an Article III court) did not permit Allgenesis to appeal the PTAB’s IPR decision, because Allgenesis did not have standing.…