New Delhi: US-based Wyeth Pharmaceuticals has sued Mumbai-based Sun Pharmaceutical Industries Ltd. and its US subsidiary Caraco Pharmaceutical Laboratories Ltd. for claiming that their heartburn drug was a generic version of its Protonix drug.
The complaint, filed on 5 May in the US district court for the Eastern District of Michigan, claims false advertising by Sun and Caraco under the Lanham Act, according to two law journals—Law 360 and Justia.
“Wyeth is seeking its damages caused by Sun and Caraco’s false advertising,” said Gwen Fisher, a Wyeth spokesperson.
“We are not making any statement on this,” said a Sun spokesperson.
The Lanham Act prohibits a number of activities, including trademark infringement, trademark dilution and false advertising.
According to Justia, the amount demanded by the plaintiff (Wyeth) from the defendant (Sun) is $75,000.
Sun had commercially launched its generic pantoprazole sodium tablets on 30 January 2008, saying in its statement that the product is AB rated to Wyeth’s Protonix (DR). According to the FDA, drug products that are rated as AB are considered to be therapeutically equivalent to the listed drug.
Sun’s product is being sold in the US by its marketing partner Caraco. The company shares a 180-day marketing exclusivity with Teva Pharmaceuticals Industries Ltd for this product. It is also currently involved in a patent litigation with Wyeth and Nycomed concerning this product.
In January 2008, Wyeth had launched its own generic version of Protonix in the market. Sun’s launch of the copycat version was a so-called “at risk” launch.
Hence, if Wyeth wins the patent litigation, Sun will have to withdraw the product from the market and pay damages to the patent holder.
Mint couldn’t independently ascertain the details of the case or its financial impact on Sun or its subsidiary Caraco.