When Every Day Counts: United Therapeutics/Supernus Fight for Lost Patent Term

By: Gideon Eckhouse & Andreas Baltatzis  |   May 17, 2016

United Therapeutics knows how a smart patent strategy can add value. Patent term adjustment is a powerful tool that can be worth millions to patent holders, especially to pharmaceutical companies. In this case, an additional 646 days of patent protection for Orenitram® could generate $215M in revenue for United Therapeutics.

On March 28, 2016 Supernus Pharmaceuticals, Inc., and their licensee, United Therapeutics Corporation, filed a complaint in the Eastern District Court of Virginia. Supernus and United Therapeutics allege that the PTO improperly calculated the adjustment of the term of U.S. Patent Number 8,747,897 (“the ’897 patent”). Supernus and United Therapeutics argue that the improper term amounted to a violation of the 5th Amendment’s Takings Clause.

Under 35 U.S.C. § 154 a patent applicant may be entitled to an adjustment of the term of a patent after it issues. Adjustments are calculated by adding the total delay caused by the PTO and subtracting the delay caused by the applicant. Other types of delay include delay caused when seeking regulatory approval for a product covered by the patent and the related clinical testing. Delays include when the PTO fails to timely issue an office action or fails to issue a patent within three years of the time of filing.

Supernus and United Therapeutics petitioned the PTO for an adjustment of the term of the ’897 patent after it issued in 2014. The applicants calculated a total PTO delay of 2,272 days based on the issuance of office actions on the application and also based on the issuance of the granted patent. The applicant delay included time to respond to office actions totaling 242 days. Therefore, Supernus and United Therapeutics originally petitioned for an adjustment of 2,030 days.

The PTO granted an adjustment of 1,386 days. However, Suprenus and United Therapeutics argue that the PTO improperly counted an applicant delay of 646 days. The disputed time relates to an Information Disclosure Statement (IDS) filed in 2012, and whether that filing constituted delay by the applicant. In particular, Supernus and United Therapeutics argue that since the IDS, which was filed after a Request for Continued Examination (RCE), was triggered by a communication from a foreign patent office, that there was a grace period of 30 days to file. According to the complaint, “at most” there was a delay of 49 days after receiving a communication from the European Patent Office, and not the total of 646 days between the filing of the RCE and the filing of the IDS. Therefore, Supernus and United Therapeutics are asking for a total of 2,032 days of adjustment. If successful, the suit will significantly extend the term of the ’897 patent, which covers the extended release tablets marketed under the name ORENITRAM.