CAMBRIDGE, Mass. — Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.
Momenta said Teva infringed two patents covering analysis processes for the drug enoxaparin sodium. Momenta co-developed and marketed enoxaparin under a partnership with Sandoz, the generic drug division of Novartis. The drug is a generic version of Sanofi-Aventis’ Lovenox.
Teva, whose application for its own generic version of Lovenox is under review by the Food and Drug Administration, denied that it infringed the two patents and said the lawsuit was “without merit.”
The marketing of generic Lovenox by Momenta and Sandoz became a hot topic because of its potential implications for the implementation of the regulatory approval pathway for biosimilars provided by the healthcare-reform law. Though the FDA classifies Lovenox as a pharmaceutical drug, its chemical complexity and manufacturing process mean it has more in common with biologics than with traditional pharmaceuticals, and experts said the FDA’s approval of the generic version could influence its approach to biosimilars in the future.