Generic drug maker Teva Pharmaceutical Industries Ltd. (TEVA) said Tuesday that it is seeking to amend its existing complaint against Momenta Pharmaceuticals, Inc./Sandoz Inc. to include patent infringement of three additional patents related to the characterization of multiple sclerosis therapy Copaxone, or glatiramer acetate injection.
The proposed updated complaint has been filed under seal with the U.S. District Court for the Southern District of New York along with a motion requesting that the Court grant Teva leave to amend.
Teva originally filed suit against Momenta/Sandoz in August 2008 for infringement of multiple patents covering the chemical composition of Copaxone, pharmaceutical compositions containing it and methods of using it. Teva seeks leave to amend its complaint to include the additional patents related to the characterization of the active ingredient in Copaxone. These patents do not expire until several years after the patents currently in litigation.
According to Teva, Copaxone is a highly-complicated product to develop and manufacture, and given the inability to fully characterize its active ingredients, Teva has serious doubts about any generic applicant's ability to demonstrate conclusively that the composition of its product is identical to that of Copaxone. Internal research at Teva has indicated that even minor changes in the synthetic process and/or molecular weight distribution of a glatiramoid can have severe ramifications on the safety and mechanism of action of the product.
Teva contends that any company that files an application for any glatiramoid, through an ANDA or 505(b)(2) application, should conduct pre-clinical testing as well as full-scale, placebo-controlled clinical trials with measured clinical endpoints in multiple sclerosis patients to establish safety, efficacy and immunogenicity in this patient population.
Teva said it remains committed to vigorously defending its Copaxone intellectual property rights against infringement wherever they are challenged and intends to pursue all relevant regulatory avenues via the U.S. Food and Drug Administration.
In September, Teva received a Paragraph IV certification notice from Mylan Pharmaceuticals Inc./Natco Pharma Ltd. relating to their ANDA containing a Paragraph IV certification for Copaxone. On October 16, 2009, Teva filed a lawsuit in the U.S. District Court for the Southern District Court of New York with respect to Mylan's filing. A trial date has not been set.
TEVA closed Monday's regular trade at $53.20, up from the previous close of $52.03, on 5.57 million shares.
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