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LITIGATION
6 Months Ended
Jun. 30, 2017
LITIGATION  
LITIGATION

 

NOTE 9: - LITIGATION

 

On May 31, 2017, United Therapeutics Corporation (“United”) filed a motion to appeal with the U.S. Court of Appeals for the Federal Circuit regarding a Final Written Decision of the Patent Trial and Appeal Board (the “PTAB”) for an IPR petition filed by the Company on October 21, 2015. The IPR petition sought to invalidate U.S. Patent No. 8,497,393 (the “‘393 Patent”) owned by United, which expires in December 2028 and covers a method of making treprostinil, the active pharmaceutical ingredient in United’s drug, Remodulin. The Final Written Decision for the IPR petition issued by the PTAB on March 31, 2017, found that all claims of the ‘393 Patent are not patentable. On June 30, 2017, the Company submitted an NDA to the FDA seeking approval of Trevyent, a single-use, pre-filled pump intended to deliver a two-day supply of treprostinil, either subcutaneously or intravenously, using its PatchPump technology. The Company will be required to make a certification with respect to the ‘393 Patent in its NDA for Trevyent.