Kaken Pharm. Co., Inc., Bausch Health Cos. Inc. v. USPTO
Docket No. 2018-2232 (IPR2017-00190, -01429)
NEWMAN, O’MALLEY, TARANTO
March 13, 2020
Brief Summary: IPR obviousness decision reversed based on erroneous claim construction in method of treatment claim.
Summary: Kaken appealed PTAB (“Board”) IPR decision finding all claims of US 7,214,506 directed to a method for treating…onychomycosis” by “topically administering” and antifungal agent (the azole agent KP-103) to the nail (e.g., toenail) of a subject. Acrux filed the IPR petition alleging obviousness based on multiple prior art references (JP ‘639, U.S. Pat. No. 5,391,367, and the non-patent references “Hay” and the “Kaken Abstracts”). The FC panel opinion explains that the ‘506 patent states as an “object of the patent to provide a topical treatment that is effective more quickly than oral medications”, the traditional treatment that “required long treatment periods and could cause gastrointestinal disorders”. The Board determined that “‘treating onychomycosis’ includes treating ‘superficial mycosis that involves disease of the skin or visible mucosa’”, rejecting Kaken’s argument that the term refers to “the keratinized nail plate and underlying nail bed”. The FC panel found the Board’s “broadest reasonable interpretation” of this term to be “unreasonable” “in light of the specification and prosecution history”, and that it should be defined as Kaken argued. While the definition of “nail” in the specification “includes skin structures surrounding the nail plate”, the FC panel found that “the Board drew an unwarranted inference from that broad definition” and that “[a]s a matter of ordinary meaning…when the specification says that ‘onchomycosis’ is a disease involving invasion of the ‘nail’, it does not compel a conclusion that the disease can invade any part of the defined ‘nail’” (e.g., “this language alone does not support the Board’s conclusion”; similar discussion regarding the meaning of “superficial mycosis”; “Other parts of the specification, which explain that an effective topical treatment would need to penetrate the nail plate, support Kaken’s construction.”; In re Power Int., FC 2018). The prosecution history was also found to support Kaken’s position, including statements in response to double-patenting rejection that “[o]nchomycosis is a condition that specifically affects the nail plate” and “that the ‘present invention shows the unexpected ability of an azolylamine derivate to penetrate the nail and be retained by the nail” which led to withdrawal of the rejection (“This exchange would leave a skilled artisan with no reasonable uncertainty about the scope of the claim language in the respect at issue here.”; citing Phillips (FC 2005), Hynix (FC 2011), Standard Oil (FC 1985), Microsoft (FC 2015); see FN2 explaining that “[t]he intrinsic evidence in this case is decisive, making it unnecessary to review the expert evidence” (SIPCO, FC 2019)). And “[t]he Board relied on its erroneous claims construction throughout its consideration of facts that were part of its obviousness analysis”, and therefore reversed the Board’s decision without “prejudge[ing] the effect the withdrawal of Acrux has on how the Board should proceed on remand.”