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Kaken Pharm. Co. v. Iancu

United States Court of Appeals for the Federal Circuit

March 13, 2020, Decided

2018-2232

Opinion

 [*1347]  Taranto, Circuit Judge.

U.S. Patent No. 7,214,506 describes and claims methods for topically treating fungal infections in human nails. The parties here treat Kaken Pharmaceutical Co. and  [*1348]  Bausch Health Companies Inc. (together, Kaken) as the patent owner. Acrux Limited and Acrux DDS Pty. Ltd. (together, Acrux), which no longer are parties to this proceeding, successfully sought an inter partes review of all claims of the '506 patent under 35 U.S.C. § 311-319. The Patent Trial and Appeal Board of the Patent and Trademark Office [**2]  ultimately determined that all claims of the '506 patent are unpatentable for obviousness. Acrux DDS PTY Ltd. v. Kaken Pharm. Co., Ltd., No. IPR2017-00190, 2018 Pat. App. LEXIS 7331, 2018 WL 2761408 (P.T.A.B. June 6, 2018).

Kaken appeals. The Director of the Patent and Trademark Office, who intervened after Acrux withdrew, defends the Board's decision. We agree with Kaken on its principal contention—that the Board erred in its claim construction of one claim limitation. Because the Board's obviousness analysis materially relied on its erroneous claim construction, we cannot affirm the Board's unpatentability determination. We reverse the claim construction, vacate the Board's decision, and remand the matter to the Board.

The '506 patent, titled "Method For Treating Onychomycosis, provides a series of interlocking definitions. The patent states that "[o]nychomycosis" is a class of "superficial mycosis" that affects the "nail of [a] human or an animal." '506 patent, col. 9, lines 32-35. The umbrella term, "superficial mycosis," encompasses infections that attack tissues of the "skin or visible mucosa." Id., col. 5, lines 20-26. According to the patent, "skin" is "a tissue including the three layers being epidermis, de[r]mis and subcutaneous tissue, accompanied by pilus (hair), nail, [**3]  [and various glandulae] as appendages." Id., col. 4, lines 54-57. In turn, 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." Id., col. 4, lines 65-67.

Each of these structures is labeled in the following diagram:

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952 F.3d 1346 *; 2020 U.S. App. LEXIS 8018 **; 2020 U.S.P.Q.2D (BNA) 10164; 2020 WL 1222728

KAKEN PHARMACEUTICAL CO., LTD., BAUSCH HEALTH COMPANIES INC., Appellants v. ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor

Prior History:  [**1] Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2017-00190, IPR2017-01429.

ACRUX DDS PTY LTD., ACRUX LIMITED, and ARGENTUM PHARMACEUTICALS LLC,, 2018 Pat. App. LEXIS 7331 (P.T.A.B., June 6, 2018)

Disposition: REVERSED IN PART, VACATED, AND REMANDED.

CORE TERMS

nail, onychomycosis, lines, patent, plate, mycosis, skin, treating, infection, disease, superficial, tissue, compound, nail bed, specification, unguium, tinea, references, includes, characterization, antifungal, effective, invention, formula, penetrate, invades, atom, subcutaneous, artisan, keratin

Patent Law, Infringement Actions, Claim Interpretation, Jurisdiction & Review, Standards of Review, De Novo Review, Substantial Evidence, Claim Interpretation, Aids & Extrinsic Evidence