Adjusting Patent Term Adjustment (PTA). Fed. Cir. Makes Additional PTA Possible.

Author:Mr Charles Vorndran
Profession:Smith Gambrell & Russell LLP

On January 23, 2019, the Court of Appeals for the Federal Circuit significantly altered the rules concerning the possible amount of PTA available to patentees. In Supernus Pharmaceuticals, Inc. v. Iancu, WL 286925 (Fed. Cir, 2019), the Federal Circuit held that the United States Patent and Trademark Office (USPTO) exceeded its rulemaking authority by assessing a PTA reduction that exceeded the statutory limitations. PTA is calculated by adding delay in prosecution attributable to the USPTO and subtracting delay attributed to the applicant. The net number of days is awarded as PTA to the granted patent.

Supernus Pharmaceuticals, Inc. ("Supernus") is the owner of US Patent No. 8747897 ("the '897 patent") claiming oral osmotic pharmaceutical dosage forms of treprostinil. When the '897 patent granted, the USPTO awarded 1,260 days of PTA to the patent which included a reduction of 646 days due to Applicant delay. Supernus filed a Request for Reconsideration of PTA which was rejected by the USPTO. Supernus appealed to the U.S. District Court for the Eastern District of Virginia and filed a motion for summary judgment on the grounds that 37 C.F.R. § 1.704(c)(8) is arbitrary, capricious, and contrary to the PTA statute. In the appeal Supernus conceded that it was responsible for 100 days of delay but was not responsible for the remaining 546 days of delay. The district court granted judgment in favor of the USPTO. Supernus timely appealed to the Federal Circuit.

At issue in the calculation of the PTA is whether Applicant's delay during prosecution in filing an Information Disclosure Statement containing references cited in a counterpart European application was the result of the Supernus's failure to undertake reasonable efforts under the terms of 35 U.S.C. § 154(b)(2)(C)(i). This section of the statute requires that the period of adjustment...

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