Tavaborole – USA

Tavaborole – USA

Anacor Pharmaceuticals, Inc. v. Lupin Limited et al

Case : 18-1606

Judge:  Judge Richard G. Andrews

Court: District of Delaware



This is a Hatch-Waxman case. Plaintiff, Anacor Pharmaceuticals, Inc. markets Kerydin® (tavaborole), a topical solution indicated for the treatment of toenail fungus. Anacor is the assignee of U.S. Patent Nos. 9,549,938, 9,566,289, 9,566,290, and 9,572,823 (collectively, the “patents-in-suit”). The patents-in-suit claim methods and formulations for treating fungal infections in humans. Each patent contains at least one dependent claim that recites treatment with a formulation comprising 5% tavaborole. In November 2017, FlatWing petitioned for inter partes review of the patents-in-suit. The PTAB instituted review of all claims of all four patents-in-suit in June 2018. On September 7, 2018, while the IPRs were pending, FlatWing filed an ANDA seeking to market a generic version of Kerydin®. On October 17, 2018, Plaintiff filed this action against FlatWing and two other generic drug manufacturers that had also filed ANDAs. Three months later, on June 5, 2019, the PTAB issued its Final Written Decisions, which concluded that the claims of each of the four patents-in-suit were obvious.


Anacor appealed the PTAB’s decision. On August 27, 2020, the Federal Circuit affirmed the PTAB’s decision. On October 26, 2020, FlatWing filed the pending motion for fees. FlatWing wants Anacor to pay it $687,295.04, which includes $584,276.00 in fees incurred by FlatWing in connection with the IPRs, $93,973.75 in fees related to this action, and $9,045.29 in expenses.


Section 285 of the Patent Act provides that “[t]he court in exceptional cases may award reasonable attorney fees to the prevailing party.” 35 U.S.C. § 285. Court said that it cannot conclude based on the record before itthat the substantive positions taken by Anacor were out of the ordinary or that the manner in which it litigated this case was unreasonable. Court has reviewed Anacor’s non-obviousness argument and, although it was ultimately unsuccessful, it did not think that it was objectively unreasonable or that it was so weak as to render it out of the ordinary. Rather, the record indicates that the parties submitted conflicting expert testimony, and the PTAB made factual findings—including crediting the testimony of FlatWing’s expert—in reaching its conclusion. Of course, Anacor lost the IPR. But losing is not an unusual occurrence—someone loses in every case—and it certainly does not by itself entitle the winner to fees.


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