Federal Circuit Affirms Invalidity of Pharmaceutical Patent

May 17, 2018

Merchant & Gould is pleased to announce that the Federal Circuit in Anacor Pharmaceuticals, Inc. v. Iancu affirmed the invalidity of a patent covering tavaborole (Kerydin®), which is a drug used to treat onychomycosis. 

The appeal arose from three successful inter partes review (IPR) trials that Merchant & Gould handled for its client, Coalition for Affordable Drugs X LLC, where the Patent Trial and Appeals Board (PTAB) held every claim of the two Orange Book patents covering Kerydin® to be invalid.  In a rare practice, the Director of U.S. Patent and Trademark Patent Office intervened in, and defended the appeal through its Office of the Solicitor. 

The patent owner argued on appeal that tavaborole was not structurally similar, and therefore non-obvious to other boron-based compounds in the prior art.   The issue of structural similarity often arises in ANDA cases involving an attempt to invalidate a new compound that is structurally similar to an old compound.  Merchant & Gould used a different strategy at trial to invalidate the claims.  Rather, the compound at issue was known in the prior art.  The issue was new use of an old compound, and Merchant & Gould argued that its structural similarity to other prior art compounds that performed the claimed function made it obvious to try the old compound with the claimed function (i.e., treatment of onychomycosis).  The Federal Circuit agreed with Merchant & Gould’s arguments at trial.

The opinion also addresses an issue that commonly arises in IPRs -- the scope of what is new evidence and proper reply.  The Federal Circuit gave leeway to introducing so-called new evidence that was either first cited by the patent owner, or the subject of cross-examination or redirect of the experts during their depositions.

The successful trial team crossed several Merchant & Gould offices and included lead trial counsel Peter Gergely, managing partner of the New York office; Kathleen E. Ott, partner in the Denver office; Ryan J. Fletcher, Ph.D, senior associate in the Denver office; Brent E. Routman, partner in the Minneapolis office; and Jeffrey D. Blake, partner in the Atlanta office.

“We are happy for our client and the outcome of this case, which addresses several important IPR issues impacting the pharmaceutical industry” said Gergely.