United Therapeutics Corporation (NASDAQ:UTHR) Files An 8-K Regulation FD DisclosureItem 7.01. Regulation FD Disclosure
As disclosed previously in the Quarterly Report on Form10-Q (the “10-Q”) filed by United Therapeutics Corporation (the “Company”) on July27, 2017, the Company is engaged in litigation with Watson Laboratories,Inc. (“Watson”) based on Watson’s Abbreviated New Drug Application seeking approval by the U.S. Food and Drug Administration to market a generic version of Tyvaso® (treprostinil) Inhalation Solution before the expiration of certain of the Company’s U.S. patents at various dates from November2018 through December2028. This litigation is pending in the U.S. District Court for the District of New Jersey (the “District Court”), and the Company previously disclosed that trial is scheduled for September2017.
Separately, Watson has filed petitions for inter partes review (“IPR”) with the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office, seeking to invalidate the claims of two of the Company’s patents that expire in 2028, relate to Tyvaso and are asserted in the District Court case.
On July27, 2017, the Company filed with the District Court an agreement with Watson to stay the District Court case until the PTAB resolves Watson’s petitions for IPR either through declining to institute the IPRs or by issuing a final written decision on the merits of the IPR. The agreement is subject to the District Court’s approval. If the District Court approves the agreement, trial may occur in early 2018 if the IPRs are not instituted, and the Company does not expect trial to take place before early 2019 if the IPRs are instituted. The Company does not expect Watson will launch a generic version of Tyvaso during the period that the stay of the District Court case is in effect.
The Company intends to vigorously enforce our intellectual property rights relating to Tyvaso.
For additional information regarding the Company’s litigation with Watson, please refer to Note 12 — Legal Proceedings to the financial statements contained in the 10-Q.
The information contained in this Current Report on Form8-K shall not be deemed to be “filed” for the purposes of Section18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act except as shall be expressly set forth by specific reference in such filing.
Forward-Looking Statements
Statements included in this Current Report on Form8-K that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding the Company’s ongoing litigation with Watson relating to patents relating to Tyvaso. These forward-looking statements are subject to certain risks and uncertainties, such as those described in the Company’s periodic and other reports filed with the Securities and Exchange Commission that could cause actual results to differ materially from anticipated results, and are qualified by the cautionary statements, cautionary language and risk factors set forth in the Company’s periodic reports and documents filed with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form10-K, Quarterly Reports on Form10-Q and Current Reports on Form8-K. The Company claims claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company is providing this information as of July28, 2017, and assumes no obligation to update or revise the information contained in this Current Report on Form8-K whether as a result of new information, future events or any other reason.
TYVASO is a registered trademark of United Therapeutics Corporation.
