District Court Upholds Mylan's U.S. Patents on Perforomist® Inhalation
PITTSBURGH, March 24, 2014
PITTSBURGH, March 24, 2014 /PRNewswire/ --Mylan Inc. (Nasdaq: 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.
Contact: Nina Devlin (Media), 724.514.1968, Kris King (Investors),
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