The Gloves Are Off In Glaxo/Novopharm Dispute

Britain's Glaxo announced on July 22 that it has instituted patent infringement proceedings regarding its leading antiulcerant Zantac (ranitidine) against the Canadian generic drugmaker Novopharm (in the US District Court for the Eastern District of North Carolina, Raleigh Division). And on July 23, Novopharm initiated action to sue Glaxo for $300 million in potential lost sales and punitive damages for delaying it from launching a generic form of Zantac.

Glaxo that says Novopharm notified it in June that it had filed a Form 1 version of ranitidine hydrochloride. In accordance with the provisions of the Waxman-Hatch Act (which provides an accelerated procedure for the approval of generic drugs upon patent expiry), Novopharm has certified to Glaxo that it will not market a generic product prior to the expiration in December 1995 of Glaxo's basic US patent on ranitidine HCl.

It has further certified that such a product would not infringe Glaxo's US product patent on Form 2 ranitidine HCl, which expires in the year 2002.