Teva files suit against Momenta/Sandoz over Copaxone, OK for generic Prevacid in USA for Teva and Mylan

Israel's Teva Pharmaceutical Industries says it is seeking to amend its existing complaint against Momenta Pharmaceutical and Swiss drug major Novartis' US Sandoz unit to include patent infringement of three additional patents related to the characterization of its multiple sclerosis drug Copaxone (glatiramer acetate injection). 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.

Teva originally filed suit against Momenta/Sandoz in August 2008 for infringement of multiple patents (seven in the Orange Book which extend through May 24, 2014), covering the chemical composition of Copaxone, pharmaceutical compositions containing it and methods of using it. The Israeli firm seeks leave to amend its complaint to include the additional patents related to the characterization of the active ingredient in the drug. These patents do not expire until several years after the patents currently in litigation.

Teva claims that Copaxone is a "highly-complicated product to develop and manufacture", and that even small changes in the chemical makeup can be dangerous, reports the local Globs newspaper As a result, says Teva, any firm producing a generic version should conduct extensive clinical trials first.

On October 16, Teva filed a law suit against pharmaceutical firm Mylan regarding the latter's request for certification of its generic version of Copaxone.

Meantime, the US Food and Drug Administration has granted final approval for Teva's Abbreviated New Drug Application (ANDA) to market its generic version of Japanese drug major Takeda subsidiary Tap Pharmaceutical's proton pump inhibitor Prevacid (lansoprazole) delayed-release capsules, 15mg and 30mg. US customers will begin receiving product on November 11, 2009.

Annual sales of Prevacid delayed-release capsules were approximately $2.97 billion in the USA for the 12 months that ended June 30, 2009 based on IMS sales data.

Court rules non-infringement

The move follows the announcement yesterday that the US District Court for the district of Delaware had issued a decision with regards to the litigation of Teva ANDA to market its generic version of Takeda Pharmaceuticals Prevacid SoluTab concluding that Teva's generic lansoprazole orally disintegrating tablets do not infringe US Patent No 5,464,632.