There's a new fight over generic Lovenox, and it doesn't involve the company that actually makes the branded version. Momenta Pharmaceuticals ($MNTA) and its partner Sandoz, which recently won FDA approval for their version of the Sanofi-Aventis ($SNY) blood thinner, sued Teva Pharmaceutical Industries ($TEVA) for infringing production-method patents.
The patents cover "the company's innovative methods of producing enoxaparin sodium," Momenta said in a statement, including a method of analyzing the drug for a particular "structural signature." Momenta CEO Craig Wheeler said that his company "has made a substantial investment in the development of novel methods that make it possible to assure the quality of complex products" and that it intends to "vigorously enforce our patent rights to protect our investment."
Teva, for its part, said that its manufacturing methods don't infringe on Momenta's patents and said the lawsuit is "without merit." The company has complained about FDA's decision to approve the Momenta/Sandoz version of Lovenox, given that it and fellow generics maker Amphastar both applied for the FDA nod on their versions two years prior. Teva is still awaiting the FDA's decision.
- see the Momenta release
- read the Reuters article
- get more from the Wall Street Journal