Israel’s Teva Pharmaceuticals has finally received approval in the world’s largest pharmaceutical market for a copycat version of Abbott Laboratories’ lipid lowering drug Tricor (fenofibrate), but the good news was tarnished by the disclosure it would seek three times its lost profits in an antitrust lawsuit against the US giant.
In the fourth quarter of 2004, Tricor reeled in some $227 million dollars for Abbott - up 40% [[19/01/05c]] – thus the company has been keen to protect its valuable offering. The final thumbs up from the US Food and Drug Administration yesterday followed a district court ruling for non-infringement of Abbott patents by the Israeli firm.
The FDA initially granted tentative approval of Teva’s regulatory dossier in March last year, but was the firm was subject to a so-called 30 month stay with regard to a Tricor patent that Teva has now been found to not infringe. The court has yet to rule on claims relating to two other US patents, and a trial on these two patents is scheduled for June 6, 2005.
Teva’s reason for seeking damages is because – it alleges – Abbott twice switched the market to a different tablet formulation, “frustrating generic competition in fenofibrate products…and the gaming of the Hatch-Waxman Act, denying consumers access to a generic alternative to Abbott's products.” Teva is seeking triple damages, including lost profits and attorneys’ fees.