Teva Pharmaceutical (Teva) is seeking to amend its existing complaint against Momenta Pharmaceuticals/Sandoz to include patent infringement of three additional patents related to the characterisation of Copaxone (glatiramer acetate injection).
Reportedly, the proposed updated complaint has been filed under seal with the US District Court for the Southern District of New York along with a motion requesting that the Court grant Teva leave to amend.
The company 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 characterisation of the active ingredient in Copaxone. These patents do not expire until several years after the patents currently in litigation.
The company said that the internal research at Teva has indicated that even minor changes in the synthetic process and/or molecular weight distribution of a glatiramoid (glatiramir acetate-like substance) 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, via 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 MS patients to establish safety, efficacy and immunogenicity in this patient population.
The company is defending its Copaxone intellectual property rights against infringement wherever they are challenged and intends to pursue all relevant regulatory avenues via the FDA. In September 2009, Teva has received a Paragraph IV certification notice from Mylan Pharmaceuticals /Natco Pharma relating to their ANDA containing a Paragraph IV certification for Copaxone. On October 16, 2009, Teva filed a lawsuit in the US District Court for the Southern District Court of New York with respect to Mylan’s filing. A trial date has not been set.