US Court Favors Novopharm In Ranitidine Battle

The US Court of Appeals for the Federal Circuit has ruled thatNovopharm USA can produce a Form 1 generic version of Glaxo Wellcome's antiulcer drug Zantac (ranitidine), following the Form 1 patent expiry in July 1997.

GW holds two patents covering Zantac, Form 1 and Form 2. The two forms of ranitidine have a different crystalline structure and different general characterisitcs, says the company. However, Form 2 ranitidine is the only version that GW has ever marketed, it says, and is protected by a patent until the year 2002.

GW failed to "establish that the existence of Form 2 in Novopharm's product is even a reasonable possibility," concluded the Appeal's Court, thus allowing Novopharm to proceed with its marketing plans for Form 1 ranitidine.