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This article was originally published in The Tan Sheet

Executive Summary

Canadian generics firm countersues Glaxo, claiming the company is using "sham litigation to protect its monopoly on Zantac (ranitidine HCl)." Novopharm filed an ANDA for Form I ranitidine in June. Glaxo subsequently sued the company, claiming that Novopharm's application infringed Glaxo's '658 patent, which expires in December 1995. Novopharm asserts that Glaxo's action is "for the sole purpose of delaying" the ANDA approval past the patent expiration date. A related case involving a Novopharm challenge of Glaxo's Form 2 ranitidine patent ('431) is before the U.S. Court of Appeals in Washington, D.C. and a decision is expected soon. Novopharm appealed a ruling in North Carolina federal court that favored Glaxo and the validity of the patent. Novopharm challenged the patent's validity in August 1993. Glaxo's '431 patent expires in 2002

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