Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today the
U.S. District Court for the Southern District of New York has found in
favor of Teva in the Company's patent infringement lawsuit against
Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories
Inc./Natco Pharmaceuticals regarding Teva's relapsing-remitting multiple
sclerosis (RRMS) product, COPAXONE®. Teva filed suit against
Momenta/Sandoz and Mylan/Natco for infringement of multiple patents
covering the chemical composition of COPAXONE®, methods of using the
product and processes for manufacturing the product. This decision
covers several patents, the last of which expires on September 1, 2015.
The judge rejected Momenta/Sandoz and Mylan/Natco's claims that the
COPAXONE® patents are invalid and unenforceable and found that the
purported generic versions of COPAXONE® for which Momenta/Sandoz and
Mylan/Natco seek Food and Drug Administration (FDA) approval infringe
those patents. This ruling should prevent the FDA from approving, and
the defendants from selling their purported generic versions of
COPAXONE® in the U.S. until the Orange Book patents expire on May 24,
2014. As a result of this ruling, Teva also believes that the defendants
will be enjoined from selling their products until the process patent
expires on September 1, 2015. Furthermore, any purported generic version
of COPAXONE® would need to obtain FDA approval prior to being made
available to the public. At this point, it is unclear what the
requirements would be for approval of a purported generic synthetic
peptide.
Dr. Jeremy Levin, Teva's President and Chief Executive Officer stated,
"Teva is confident COPAXONE® will remain a proprietary, global market
leading product for the reduction of relapses in patients with RRMS over
the product's lifecycle given the strength of its intellectual property
(IP) rights."
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