March 31, 2014

Mylan Comments on U.S. Supreme Court's Consideration of the Standard of Review of Patent Claim Construction

PITTSBURGH, March 31, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) announced that today the Supreme Court of the United States granted certiorari in Mylan's patent litigation against Teva relating to Mylan's Abbreviated New Drug Application (ANDA) for glatiramer acetate (Copaxone).  In July of 2013, the Court of Appeals for the Federal Circuit ruled that Teva's U.S. Patent No. 5,800,808 ("the '808 patent"), along with other patents, was invalid as indefinite. 

The Supreme Court will consider the issue of the standard of review that appellate courts should apply when considering appeals relating to the construction of a patent claim.  Specifically, the Supreme Court has agreed to consider a question proposed by Teva:  whether a district court's factual finding in support of its construction of a patent claim term may be reviewed for legal error, as the Federal Circuit requires, or only for clear factual error.  Mylan continues to believe that Teva's '808 patent is invalid for indefiniteness.

At this time, Mylan confirms its adjusted diluted earnings per share guidance range for the full year 2014, and its expectation that first quarter adjusted diluted earnings per share will be approximately equal to first quarter 2013 adjusted diluted earnings per share, all as previously stated on the quarterly earnings conference call held on February 27, 2014.

This press release includes statements that constitute "forward-looking statements," including with regard to litigation and the Company's future earnings.  These often may be identified by the use of words such as "may," "believe," "anticipate," "expect," "plan," "estimate," "target" and variations of these words or comparable words. Because forward-looking 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: risks inherent in legal and regulatory processes; our expected or targeted future financial and operating performance and results; and uncertainties and matters beyond the control of management.  For more detailed information on the risks and uncertainties associated with our business activities, see the Company's Annual Report on Form 10-K for the year ended December 31, 2013 and its other filings with the Securities and Exchange Commission ("SEC"). You can access our Form 10-K and other filings with the SEC through the SEC website at www.sec.gov, and we strongly encourage you to do so. The Company undertakes no obligation to update statements herein 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.

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