Efinaconazole - USA

IPR decision (Jun. 06, 2018):

AIA Review	Filing Date	Institution Date	Petitioner	Patent No.	Final Written Decision
IPR2017-00190	11/02/2016	05/01/2017	Acrux DDS Pty Ltd.	7,214,506	Claims 1 and 2 are unpatentable
IPR2017-01429*	05/12/2017	11/13/2017	Argentum Pharmaceuticals LLC

* joined to IPR2017-00190

US 7,214,506 (expiring on Oct. 05, 2021) claims method for treating a subject having onychomycosis by topically administering to a nail a therapeutically effective amount of Efinaconazole.

USFDA approved Jublia® (Efinaconazole) topical solution Jun 6, 2014. NCE would expire on Jun 6, 2019.

Decision summary:

Claim construction:

PTAB by applying BRI standard concluded that the term, “nail” includes “nail plate, nail bed, nail matrix, further side nail wall, posterial nail wall, eponychium and hyponychium which make up a tissue around thereof.” It also concluded on this record that “onychomycosis” is not limited to infections of the nail plate and nail bed, but includes superficial mycosis that involves disease of the skin or visible mucosa.

Obviousness over the Ogura with each of JP ’639, the ’367 patent, or Hay:

PTAB found that Ogura is not prior art to the ’506 patent as Patent Owner has established that the invention was reduced to practice before Ogura was allegedly published. Therefore, PTAB concluded that the Petitioner has not shown by a preponderance of the evidence that claims 1 and 2 are unpatentable.

Obviousness over Kaken Abstracts with JP ’639, the ’367 patent, or Hay:

PTAB agreed with Petitioner that the Kaken Abstracts point to KP-103 as being known to have potent antifungal activity against T. mentagrophytes, one of the major causes of onychomycosis. The Kaken Abstracts showed that KP-103 is effective in vitro and in vivo, at least with respect to skin, in treating fungal infection. As Dr. Walters (Petitioner’s expert) notes, the question is not whether one of ordinary skill in the art would have been led to use efinaconazole because of the particular compound(s) taught by JP ’639, the ’367 patent, and Hay, but whether one of ordinary skill in the art would have been motivated by the disclosures of JP ’639, the ’367 patent, or Hay in combination with the Kaken Abstracts, as a whole, to improve the topical formulations and methods of JP ’639, the ’367 patent, or Hay by using efinaconazole, “a highly potent antifungal compound with broad spectrum activity that is not inactivated by keratin and has high retention in the horny layer, in the topical formulation and method”.

PTAB credited Dr. Walters’ and Dr. Weignberg’s testimony and found that Petitioner has shown sufficient rationale for one of ordinary skill in the art to combine the teachings of the Kaken Abstracts with the teachings of each of JP ’639, the ’367 patent, or Hay with a reasonable expectation of success. Also, because the method for Jublia®’s use is not reasonably commensurate with the claims of the challenged claims, PTAB found that Petitioner has rebutted the presumption of nexus for the secondary considerations relating to Jublia®. PTAB also concluded that the Patent Owner’s evidences of other secondary considerations are weak and insufficient to support the non-obviousness of the challenged claims.

Thus, Petitioner has shown by a preponderance of the evidence that claims 1 and 2 of the ’506 patent are obvious under 35 U.S.C. § 103(a).