District Court Upholds Mylan's U.S. Patents on Perforomist® Inhalation Solution

PITTSBURGH, March 24, 2014 /PRNewswire/ -- Mylan Inc. MYL today announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist® (formoterol fumarate) Inhalation Solution. Mylan previously sued Teva alleging that Teva's Abbreviated New Drug Application (ANDA) for this product infringed four Mylan patents covering Perforomist.  After a full trial, the Court entered a judgment finding infringement of the patents-in-suit, rejecting Teva's defenses, and enjoining Teva from making, using, offering to sell, selling or importing the inhalation product described in Teva's ANDA. The Court's decision also prevents Teva's ANDA, which has yet to receive a tentative approval from the U.S. Food and Drug Administration (FDA), from receiving final approval prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.

Mylan CEO Heather Bresch commented: "The court's decision to recognize the validity of the patents covering Mylan's Perforomist® Inhalation Solution not only affirms the strength of our intellectual property on this product, but also our broader respiratory portfolio, including Mylan's combination product currently in development. We are excited about the growth of our respiratory franchise and look forward to continuing to meet unmet needs in this increasingly important space."

This press release includes statements that constitute "forward-looking statements," including with regard to market composition as a result of litigation and sales of the product. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.