Richard Storer et al. v. Jeremy Clark and United States (intervenor)

Docket No. 2015-1802 (appeal from PTAB No. 105,981)

June 21, 2017

Brief Summary: Board interference decision that Storer’s (Idenix’s) provisional application was not enabled for the claims affirmed because, e.g., “the art, at least with respect to fluoridation of tertiary alcohols to produce a tertiary fluorine in the 2’ ‘down’ position, was highly unpredictable.” Priority was therefore awarded to Clark’s (Gilead’s) application.

Summary: Storer (senior party) appealed from PTAB interference decision that the provisional application to which Idenix’s US 7,608,600 claims priority was not enabled for treatment of hepatitis C virus infection by administering to infected individuals compounds “having the 2’F(down) substituent” of the claims. The intereference was declared with Clark’s Ser. No. 11/854,218 (assigned to Gilead). Storer argued the claimed 2’F(down) compounds “were generically disclosed…and were readily obtained based on the disclosure and the prior art.” The PTAB disagreed the provisional enabled the 2’F(down) compound because “undue experimentation would be required to produce” the structure (“when the issue is priority based on the content of the specification, ‘[t]he earlier application must contain a written description of the subject matter of the interference, and must meet the enablement requirement” (35 USC § 112, para. 1 (now 112(a)); Hyatt, FC 1998)). Storer did not “dispute that the…provisional contains no specific examples of synthesis of compounds having the” 2’F(down) structure (3rd Wands factor (“presence or absence of working examples”)), that it had not been synthesized as of the provisional application filing date (4th Wands factor (“nature of the invention”)), the prior art did not teach, or explicitly suggest the use” a particular precursor (“DAST”) relied on by Storer to make the compound and the 2’F(down) substituent was not suggested by the prior art (5th Wands factor (“the state of the prior art”)), and level of skill in the art was very high (6th Wands factor). The PTAB also found “the art, at least with respect to fluoridation of tertiary alcohols to produce a tertiary fluorine in the 2’ ‘down’ position, was highly unpredictable.” Storer argued a prior art reference (“Matsuda”) showing a methyl group at the 2’ position and the provisional specification enabled the 2’F(down) compound (“Matsuda provides any necessary information not in the…provisional”) but the PTAB disagreed because, e.g., as Clark argued, the provisional does not show conversion of any of the compounds therein to Matsuda’s compound and the synthetic schemes thereof include the “wrong stereochemistry”. The FC panel opinion explained that while “[k]knowledge of the prior art is presumed” and “[t]he specification need not recite textbook science”, “it must be more than an invitation for further research” (Genentech, FC 1997 (“the specification, not the knowledge of one skilled in the art…must supply the novel aspects of the invention in order to constitute adequate enablement”)). The FC panel agreed with the PTAB, finding “Wands factor 7, the predictability of the art…to be particularly relevant” (pointing to expert testimony) but also the “undue” nature of the experimentation required (“at least two years of a high priority experimentation”, exemplified by Idenix’s own efforts). Thus, the Board decision was affirmed.

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