Form 8-K UNITED THERAPEUTICS Corp For: Sep 29

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15 (d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  September 29, 2015

United Therapeutics Corporation

(Exact Name of Registrant as Specified in its Charter)

Registrant’s telephone number, including area code: (301) 608-9292

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01. Entry into a Material Definitive Agreement.

On September 29, 2015, United Therapeutics Corporation (the “Company”) and Sandoz Inc. (“Sandoz”) entered into a Settlement Agreement (the “Settlement Agreement”) to settle their ongoing litigation concerning certain patents relating to Remodulin® (treprostinil) Injection (“Remodulin”) and Sandoz’s Abbreviated New Drug Application (“ANDA”) seeking approval by the U.S. Food and Drug Administration (“FDA”) to market a generic version of Remodulin.

The Settlement Agreement relates to three lawsuits filed by the Company against Sandoz alleging infringement of certain patents. The trial for the first two lawsuits (the “Sandoz I Litigation”), involved U.S. Patent No. 6,765,117, which expires in October 2017 and U.S. Patent No. 7,999,007, which expires in March 2029. That trial occurred in May and June 2014, and the Court issued its decision in August 2014. In that decision, with respect to U.S. Patent No. 6,765,117, the Court ruled that the patent is valid and infringed upon by Sandoz, and enjoined Sandoz from marketing its generic product until the expiration of that patent in October 2017. With respect to U.S. Patent No. 7,999,007, the Court ruled that the patent is valid, but that it would not be infringed upon by Sandoz’s generic product. Sandoz has appealed the ruling that U.S. Patent No. 6,765,117 is valid and would be infringed upon, and that U.S. Patent No. 7,999,007 is valid. The Company filed a cross-appeal challenging the Court’s ruling that U.S. Patent No. 7,999,007 would not be infringed upon by Sandoz’s generic version of Remodulin. Both appeals are pending before the United States Court of Appeals for the Federal Circuit.

The Settlement Agreement also relates to a separate, pending lawsuit (the “Sandoz II Litigation”) filed by the Company against Sandoz in the U.S. District Court for the District of New Jersey for patent infringement with respect to U.S. Patent No. 8,497,393, which expires in December 2028. These actions are described in further detail in Part II, Item 1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, filed with the U.S. Securities and Exchange Commission (“SEC”) on July 28, 2015.

Under the Settlement Agreement, the Company grants Sandoz a non-exclusive license to manufacture and commercialize in the United States the generic version of Remodulin described in Sandoz’ ANDA filing beginning on June 26, 2018, although Sandoz may be permitted to enter the market earlier under certain circumstances. The Settlement Agreement does not grant Sandoz a license to manufacture a generic version of any other Company product, such as Tyvaso® (treprostinil) Inhalation Solution or Orenitram® (treprostinil) Extended-Release Tablets, nor does it grant any rights with respect to any technology associated with the Remodulin Implantable System being developed by the Company and Medtronic Inc., or the pre-filled semi-disposable pump system being developed by the Company and DEKA Research & Development Corp. The Settlement Agreement does not grant Sandoz any rights other than those required to launch Sandoz’s generic version of Remodulin.

In accordance with the terms of the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. They will also take certain procedural steps to terminate the appeal in the Sandoz I Litigation and dismiss with prejudice their respective claims in the Sandoz II Litigation.

The foregoing description of the Settlement Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Settlement Agreement, which will be filed, with certain confidential terms redacted, with the SEC as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2015.

Item 9.01. Exhibits

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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Exhibit 99.1

Contact: James Edgemond

Phone: (301) 608-9292

E-mail: [email protected]

UNITED THERAPEUTICS ANNOUNCES

SETTLEMENT OF PATENT LITIGATION WITH SANDOZ INC.

Silver Spring, MD and Research Triangle Park, NC, September 30, 2015 — United Therapeutics Corporation (NASDAQ: UTHR) announced today that it has entered into a Settlement Agreement with Sandoz Inc. (“Sandoz”) relating to ongoing litigation concerning certain patents relating to United Therapeutics’ product, Remodulin® (treprostinil) Injection, and Sandoz’s Abbreviated New Drug Application (“ANDA”) seeking approval by the U.S. Food and Drug Administration to market a generic version of Remodulin.

Under the Settlement Agreement, United Therapeutics granted to Sandoz a non-exclusive license to manufacture and commercialize the generic version of Remodulin described in its ANDA filing in the United States beginning on June 26, 2018, although Sandoz may be permitted to enter the market earlier under certain circumstances. The license included in the Settlement Agreement does not permit Sandoz the right to manufacture a generic version of any other United Therapeutics product, such as Tyvaso® (treprostinil) Inhalation Solution or Orenitram® (treprostinil) Extended-Release Tablets, nor does it grant any rights with respect to any technology associated with the Remodulin Implantable System being developed by the Company and Medtronic Inc., or the pre-filled semi-disposable pump system being developed by the Company and DEKA Research & Development Corp. The Settlement Agreement does not grant Sandoz any rights other than those required to launch Sandoz’s generic version of Remodulin.

In accordance with the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

The pending litigation with Sandoz consists of a pending appeal by Sandoz of the August 2014 ruling by the U.S. District Court for the District of New Jersey finding that U.S. Patent No. 6,765,117 is valid and enforceable against Sandoz, and an appeal by United Therapeutics with respect to the District Court’s finding that U.S. Patent No. 7,999,007 would not be infringed upon by Sandoz’s generic product. Pending litigation between the parties also includes a separate lawsuit filed in September 2014 by United Therapeutics against Sandoz in the same U.S. District Court, alleging infringement of U.S. Patent No. 8,497,393. Pursuant to the Settlement Agreement, the parties will terminate all currently pending litigation.

About United Therapeutics

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer. [uthr-g]

Forward-Looking Statements

Statements included in this press release concerning the Settlement Agreement are “forward-looking statements” within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K, which could cause actual results to differ materially from anticipated results. We are providing this information as of September 30, 2015, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

ORENITRAM, REMODULIN and TYVASO are registered trademarks of United Therapeutics Corporation.