IPR2015-02776 (US 7,582,621B2)
Final Written Decision
February 23, 2017
Brief Summary: Board found CAD had shown invalidity for obviousness of the ‘621 claims by a preponderance of the evidence.
Summary: CAD petitioned for IPR of Anacor’s US 7,582,621 B2 on obviousness grounds (all claims (1-2) based on a combination of Austin (WO 95/33754) and Brehove (US 2002/0165121A1), and/or Austin and Freeman (WO 03/009689A1)). The ‘621 patent relates to the methods “of treating infection in an animal…comprising administering to the animal a therapeutically effective amount of” a boron-containing compound (tavaborole) “sufficient to treat said infection” (Kerydin® for treating toenail fungus, the OB listing for which includes five other patents (US 7,767,657B2 (IPR2015-01780 an -85, Final Written Decisions 2/23/17 both finding claims 1-24 unpatentable; US 9,549,948; US 9,566,289; US 9,566,290). The Board first concluded that “the cited prior art is representative of the level of ordinary skill in the art” and there is no need for testimony on this point (Okajima, FC 2001; Litton Indus., FC 1985). Under the broadest reasonable construction (37 CFR § 100(b); Cuozzo, US 2016), the claimed chemical compound was construed and referred to in the Decision as tavaborole. A “therapeutically effective amount” of taraborole was construed to mean “the amount of drug needed to effect the desired therapeutic result” (the “specification defines the phrase with clarity, deliberateness, and precision” (In re Paulsen, FC 1994)). The Board was not persuaded by Anacor’s arguments that CAD’s declarants were “not qualified to opine from the perspective of a person of ordinary skill in the art” since both have advanced degrees and experience in pharmaceutics including drug delivery through the nail for one of the two (“[W]e do not agree…that a person of ordinary skill in the art is required to have expertise in mycology or clinical dermatology.”)
The Decision explained that obviousness is determined as outlined by KSR (US 2007) including consideration of the Graham factors (Graham, US 1966) (e.g., “[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art…[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine elements in the way the claimed new invention does” with “a reasonable expectation of success” (Par, FC 2014)). The Decision reviewed the content of the Austin and Brehove references and Anacor’s argument that Austin was not analogous art. Anacor argued Austin was not analogous because it is related to industrial biocides and “the requirements for a useful biocide are different from the requirements for a useful drug”. But the Board concluded Austin is “reasonably pertinent to the particular problem the inventors sought to solve” and therefore analogous (Unwired Planet, FC 2016; In re ICON, FC 2007 (“logically wold have commended itself to the inventor’s attention”); Scientific Plastics, FC 2014). Anacor also argued “there is no basis to conclude” tavaborole would have been “selected…from among the millions of componds disclosed in Austin” but the Board disagreed because, e.g., “Austin discloses tavaboroloe…as a preferred fungicide” and CAD’s declarant testified that the reference “discloses test results for only sixteen compounds identified as ‘preferred compounds’”. The Board was also unpersuaded by Anacor’s arguments that neither Austin or Brehove discloses administration of a “therapeutically effective amount” (“Patent Owner attacks each reference separately and does not acknowledge what the art fairly teaches in combination. In re Merck, FC 1986). The Board also agreed with CAD’s declarant testimonies regarding a motivation to combine the references (e.g., “Austin discloses boron-based compounds that have lower molecular weight than the successful componds of Brehove and are therefore likely to effectively penetrate the nail barrier…” and a review article by the ‘621 inventors states that “boron is not an inherently toxic element.”) A reasonable expectation of success was also found since, e.g., “conclusive proof of efficacy is not required” (Hoffman-La Roche, FC 2014). The Board was also unconvinced by Anacor’s arguments regarding secondary considerations (e.g., declarant “does not provide a sufficient explanation as to how this selectivity represents an alleged unexpected result” (Kao, FC 2006)). Thus, the Board concluded CAD had shown obviousness by a preponderance of the evidence. The same conclusion based on similar reasoning was reached regarding the combination of Austin and Freeman. The Board also rejected Anacor’s motion to exclude certain exhibits as it did not rely on those in its decision.