POTTERS BAR, England and PITTSBURGH, April 17, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced the United States Court of Appeals for the Federal Circuit upheld the validity and infringement of all four patents asserted by Mylan Specialty, L.P. protecting its Perforomist® (formoterol fumarate) Inhalation Solution. The Court summarily affirmed the previous decision by the district court against Teva.
Today's decision prevents Teva from receiving final approval of its ANDA from the U.S. Food and Drug Administration (FDA) prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645. Those patents cover Perforomist® until they expire in June 2021.
Mylan CEO Heather Bresch commented: "The court's decision today again recognizes the validity of the patents covering Mylan's Perforomist® Inhalation Solution, reaffirming the strength of our intellectual property on this product. 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 the outcome of legal proceedings, product approvals, sales of products, future operations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, and competition. 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 appellate decision; risks inherent in legal and regulatory processes; the ability to protect intellectual property and preserve intellectual property rights; impacts of competition; uncertainties and matters beyond the control of management, 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 healthcare. 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 around 1,400 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 about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com
SOURCE Mylan N.V.