SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. - United Therapeutics Corporation announced in a press release that the US Patent and Trademark's Office (USPTO) Patent Trial and Appeal Board (PTAB) issued a Final Written Decision in connection with the inter partes review (IPR) of United Therapeutics' US Patent No. 8,497,393 (the '393 patent). The PTAB found that all claims of the '393 patent are not patentable. United Therapeutics is evaluating its options, including the possibility of immediately exercising its right of appeal to the US Court of Appeals for the Federal Circuit or first requesting a rehearing before the PTAB. The '393 patent remains valid and enforceable until appeals have been exhausted.
By way of background, the '393 patent claims, among other things, treprostinil produced using an improved method and is listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations publication, also known as the Orange Book, for Remodulin® (treprostinil) Injection, Tyvaso® (treprostinil) Inhalation Solution, and Orenitram® (treprostinil) Extended-Release Tablets. United Therapeutics is currently asserting the '393 patent (along with several other patents) against Watson Laboratories, Inc. and Actavis Laboratories FL, Inc. in connection with their efforts to obtain approval to market generic copies of Tyvaso and Orenitram, respectively. The Watson and Actavis cases are scheduled for trial in September 2017 and February 2018, respectively.
SteadyMed Ltd. initiated the IPR in October 2015, and has reported plans to file for FDA approval of its Trevyent® treprostinil product in the second quarter of 2017.
United Therapeutics intends to continue vigorously defending the '393 patent, but even if the ultimate result is unfavorable, United Therapeutics has other patents claiming subject matter similar to the '393 patent and with the same expiration date (December 2028). Specifically, in the last month, the USPTO awarded United Therapeutics two additional patents related to the '393 patent, US Patent Nos. 9,593,066 and 9,604,901. United Therapeutics prosecuted the applications that resulted in these new patents in parallel with the '393 patent IPR and presented claims addressing the invalidity arguments raised by SteadyMed in the IPR and Watson and Actavis in the ongoing litigations. The USPTO allowed the new patent claims with full knowledge of the IPR, the invalidity arguments presented therein, and the invalidity arguments raised by Watson and Actavis in connection with the '393 patent. Thus, United Therapeutics anticipates that these new patents should be less susceptible to challenge than the '393 patent. United Therapeutics has listed both these new patents in the Orange Book for Remodulin, Tyvaso, and Orenitram.