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Storer v. Clark

Record Showing Unpredictable Field Sufficient to Support Non-Enablement Determination in Interference

Storer v. Clark, (Fed. Cir. June 21, 2017) (Prost, NEWMAN, Dyk) (PTAB) (2 of 5 stars)

Fed Cir affirms PTAB’s interference decision granting priority to an application by Clark (assigned to Gilead), over an application by Storer (assigned to Idenix). The Board properly determined that Storer was not entitled to the priority date of his provisional application due to a lack of enablement as to the subsequently-claimed compounds. The opinion notes that Storer had initially attempted to have the District of Delaware review the Board’s priority determination, but that case was dismissed for lack of jurisdiction under Biogen, 785 F.3d 648 (Fed. Cir. 2015). The opinion notes, “Although Storer says that Biogen was incorrectly decided, that decision is binding on this panel.” Op. at 3.

The claims related to treatment of hepatitis C and the formation of specific compounds used therein. The opinion concludes that a person of skill would have been unable to practice the invention, based on the provisional and the prior art, without undue experimentation. To assess undue experimentation, the opinion applies the eight-factor test of Wands, 858 F.2d 731 (Fed. Cir. 1988). The opinion includes detailed discussion of the chemical compounds and techniques at issue, and particularly notes the Board’s determinations that the relevant art—“fluoridation of tertiary alcohols”—was “highly unpredictable,” and significant experimentation would be necessary to reach the claimed compounds from the disclosure in Storer’s provisional. Op. at 18–20. On the whole, the record supported the Board’s determinations.

KEYWORDS: ENABLEMENT; INTERFERENCE; UNDUE EXPERIMENTATION (YES)