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LITIGATION
6 Months Ended
Jun. 30, 2018
LITIGATION  
LITIGATION

 

NOTE 9: - LITIGATION

 

a.On May 31, 2017, United Therapeutics Corporation (“United Therapeutics”) 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 Therapeutics, which expires in December 2028 and covers a method of making treprostinil, the active pharmaceutical ingredient in United Therapeutics’ 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. The Appellate Court heard oral arguments from the parties on November 7, 2017. On November 14, the Court of Appeals upheld the PTAB ruling in our favor without issuing an opinion. On February 9, 2018, United Therapeutics filed a writ of certiorari with the U.S. Supreme Court asking for a review of the appellate ruling in view of another case pending before the Supreme Court challenging the constitutionality of IPR proceedings. On April 24, 2018, the Supreme Court ruled that IPRs are constitutional in the above pending case, and United Therapeutics has told the Company that it will withdraw the petition.

 

b.The Company has a commercial dispute with one of its suppliers as a result of the Company’s termination of a development agreement in 2017, whereby the supplier alleges wrongful termination and certain breaches of the agreement by the Company. As of June 30, 2018, the Company believes that the claims have no merit and the dispute is in its early stages.

 

c.Three plaintiffs, Richard Scarantino, Australia A. Hoover and Donald Skinner, have filed separate putative class action lawsuits on June 27, 2018, June 27, 2018 and June 29, 2018, respectively, each in the United States District Court for the Northern District of California, each purportedly on behalf of the shareholders of SteadyMed, against SteadyMed and its directors and each alleging, among other things, violations of sections 14(a) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 14a-9 thereunder. The complaints in these actions each seek, among other things, to enjoin the defendants from completing the previously announced proposed merger transaction by which SteadyMed will become a wholly-owned subsidiary of United Therapeutics Corporation (the “Merger”).  On July 6, 2018, plaintiff Hoover filed a motion for preliminary injunction, seeking to enjoin the Merger from proceeding until certain disclosures were made to shareholders in addition to those included in the proxy statement issued in connection with the merger (the “Proxy Statement”).  On July 16, 2018, SteadyMed provided certain additional disclosures in a supplement to the Proxy Statement filed with the SEC (the “Supplemental Disclosures”).  On July 19, 2018 and July 20, 2018, respectively, plantiffs Skinner and Hoover filed notices of voluntary dismissal of their actions without prejudice as moot, Counsel for plantiff Scarantino has confirmed that the Supplemental Disclosures moot their claims in that action and that it will likewise be dismissed. As stated in the Supplemental Disclosures, the Supplemental Disclosures should not be taken to indicate that SteadyMed or its affiliates, officers, directors or other representatives, or any recipient of this information, considered the information contained in the Supplemental Disclosures to be material; rather, SteadyMed believes that the Proxy Statement disclosed all required material information.