STORER v. CLARK: Enablement from a Provisional Application Must Be Supported by the Disclosure and Not Require Undue Experimentation by a Person Having Ordinary Skill in the Art
STORER v. CLARK: June 21, 2017. Before Prost, Newman, and Dyk.
In order for a non-provisional patent application to be enabled by the provisional patent application from which it takes priority, the disclosure in the provisional patent application must enable one having ordinary skill to produce the claimed chemical compound without undue experimentation.
Storer appealed a PTAB decision in an interference proceeding that the claims in Storer’s patent were not enabled from the provisional patent application from which it takes priority, and thus the claims in the patent could not claim priority to the provisional patent application. The CAFC affirmed the PTAB’s decision.
Enablement: The CAFC affirmed a PTAB decision in an interference proceeding that the claims in Storer’s patent were not enabled from the provisional patent application from which it takes priority. The interference proceeding involved two patents related to the treatment of hepatitis C by administering compounds with a specific chemical and stereochemical structure. Clark moved to deny Storer the priority date of a related provisional patent application in order to invalidate the claims in Storer’s patent, arguing that the provisional patent application did not enable one having ordinary skill in the art to produce compounds having the requisite 2´F (down) substituent. The CAFC ruled that the enablement requirement can be met when one skilled in the art could practice the invention upon reading the specification without undue experimentation. In its holding, the CAFC relied on the eight enablement factors enumerated in In re Wands, 858 F.2d 731 (Fed. Cir. 1988). The CAFC confirmed the PTAB’s finding that the synthetic schemes in Storer’s provisional patent application did not teach or suggest conversion of any precursor into the 2´F (down) structure, and that knowledge of synthesis from a well-known precursor compound did not enable a person having ordinary skill in the art to produce the target compounds without undue experimentation. The CAFC ruled that, based on the disclosure in the provisional patent application, the Storer claims subject to the interference proceeding were not enabled because an undue amount of experimentation was needed in order to synthesize the compound claimed in the non-provisional patent.