Momenta Pharmaceuticals Announces District Court Decision to Invalidate Teva Pharmaceuticals Patents in COPAXONE ® (glatiramer acetate injection) 40 mg/mL Litigation

CAMBRIDGE, Mass., Jan. 31, 2017  -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today announced that the United States District Court for the District of Delaware has found each of Teva Pharmaceutical’s U.S. Patent Nos. 8,232,250; 8,399,413; 8,969,302; and 9,155,776  invalid as obvious over the prior art.

 

“We are very pleased with the District Court’s decision to invalidate the four method of use patents litigated by Teva to block Sandoz’s potential launch of our Glatopa® 40 mg product,” said Craig Wheeler, President and Chief Executive Officer of Momenta. “Today’s favorable ruling further bolsters our confidence in the potential for us to offer multiple sclerosis patients a more affordable generic version of COPAXONE 40 mg following regulatory approval.”

In 2016, the Patent Trial and Appeal Board (PTAB) declared U.S. Patent Nos. 8,232,250, 8,399,413 and 8,969,302 invalid due to obviousness through an Inter Partes Review (IPR) proceeding. Today’s decision confirms that of the PTAB and finds U.S. 9,155,776 invalid on similar grounds. Both the PTAB’s and today’s District Court decision are appealable to the Federal Circuit. In November 2016, Mylan filed a petition asking the PTAB to institute an IPR proceeding against U.S. 9,155,776 patent. A decision on whether that challenge is instituted is due from the PTAB in April 2017.

 

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural and functional analysis of complex drugs and is headquartered in Cambridge, MA.  Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications.

 

To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release. The company’s logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

 

Forward Looking Statements

Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to its beliefs and intentions related to the approval and launch of our Glatopa product and the invalidity of Teva’s patents, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "hope," "target," "project," "goals," "potential," "predict," "might," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the Company's Quarterly Report on Form 10-Q for the month ended September 30, 2016 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

COPAXONE is a registered trademark of Teva Pharmaceuticals. Glatopa is a registered trademark of Novartis AG.

 

 

 

Investor Relations:

Sarah Carmody

Momenta Pharmaceuticals

1-617-395-5189

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Media Relations:

Karen Sharma

MacDougall Biomedical Communications

1-781-235-3060          

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