Anacor Pharmaceuticals, Inc. v. Flatwing Pharmaceuticals, LLC
Docket No. 2019-2264-2267 (IPR2018-00168-00171, -01358-01361)
PROST, NEWMAN (D), HUGHES
August 27, 2020 (Non-precedential)
Brief Summary: IPR decisions finding Anacor’s tavaborole (5%) (KERYDIN®) patents invalid for obviousness affirmed (e.g., “concentration is a result-effective variable”).
Summary: Anacor appealed four IPR final written decisions (FWDs) holding all the claims of Orang Book patents US 9,549,938; 9,566,289; 9,566,290; and 9,572,823 (shared specifications; previously invalidated US 7,582,621 also listed on OB (FC 2018)) relating to the treatment of fungal infections using the boron-containing compound tavaborole (5%) (KERYDIN®) invalid for obviousness in view of Austin (WO publication), Brehove (US publication), and Samour (US 6,224,887). The ‘621 patent was previously invalidated in view of Austin and Brehove which were found to disclose topical compositions of boron-containing compounds like tavaborole for treating fungal infections (e.g., “structural and functional similarities” to tavaborole). In the FWDs leading to this appeal, the Board “rejected Anacor’s argument that Samour teaches away from a 5% concentration” (“in favor a 10%-econazole composition”) and found that “Samour does not ‘criticize or otherwise discourage the use of 5% w/w of antifungal agent’”. The FC panel also rejected Anacor’s argument because “Samour’s teachings barely even suggest a ‘preference for an alternative’ approach…let alone discourage a skilled artisan from pursuing a 5%-antifungal composition, as is required for a reference to teach away” (DePuy, FC 2009; Adams, US 1966). The FC panel also found that “[t]he Board reasonably credited testimony from Flatwing’s expert that the claimed composition could have been made according to well-known formulation techniques”, “the existence of the Brehove reference describing in vivo inhibition of a common fungus with organoboron compositions…is especially damaging to Anacor’s arguments”, “the inventors evidently did not consider formulating organoborons a great challenge”, and “there is no dispute that a skilled artisan would have appreciated that concentration is a result-effective variable” (In re Aller, CCPA 1955). Thus, the DC decision was affirmed.