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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth