GLAXO ZANTAC PATENT FOR FORM 2 RANITIDINE UPHELD

Executive Summary

GLAXO ZANTAC PATENT FOR FORM 2 RANITIDINE UPHELD in a Sept. 17 ruling by Elizabeth City, N.C. federal & court Judge Terrence Boyle. Glaxo said Judge Boyle ruled that defendant Novopharin did not prove "in clear and convincing evidence" its charges that Form 2 ranitidine (patent '431) was inherent in the Form I patent ('658) nor that Glaxo was guilty of "inequitable conduct." Glaxo sued Novopharm in November 1991 for patent infringement when the Toronto-based generic drug firm filed an ANDA with FDA to market a generic version of Form 2 ranitidine HCl at the expiration of Glaxo's Form I patent in December 1995. In addition to the inherency and inequitable conduct charges, Novopharm also had alleged that Glaxo did not disclose the "best mode" in its patent. Glaxo said the decision reaffirms that it can continue to market Zantac on an exclusive basis until the Form 2 patent expires in June 2002. The judge's decision comes one month after the conclusion of a nine-day bench trial held Aug. 9-18 ("The Pink Sheet" Aug. 16, p. II). It is probable that Novopharm will appeal the decision.