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When Size Matters, SBA Has Final Say

Client Alert | less than 1 min read | 05.18.10

In DynaLantic Corp., GAO denied a protest based on an allegation that the awardee in a small business set-aside procurement proposed a flight training device simulator that did not comply with the nonmanufacturer rule because the awardee procured the simulators from another country. GAO explained that the protester had concurrently filed a size protest with SBA, which determined that the awardee did comply with the nonmanufacturer rule because it transformed the simulators from a COTS product to a specific product solicited, and that SBA's decision was binding on GAO because SBA has "conclusive authority" to determine the size status of offerors.

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Client Alert | 3 min read | 05.26.26

pH, Prosecution History Estoppel, and Patent Scope: Three Lessons from the Federal Circuit's Latest Hatch-Waxman Ruling

On May 13, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed a district court judgment of no infringement in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 24-1641. The decision offers important guidance for patent holders and generic manufacturers on the role of industry standards in interpreting scientific terminology during claim construction, prosecution history estoppel, and the disclosure-dedication rule....