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This article was originally published in The Tan Sheet

Executive Summary

ZANTAC PATENT TRIAL FOCUS IS LIMITED TO "INHERENCY" AND "INEQUITABLE CONDUCT" issues, Elizabeth City, N.C. federal court Judge Terrence Boyle told Glaxo and Novopharm on Aug. 12. Responding to a motion by plaintiff Glaxo for a direct ruling, Boyle stated that he would deny such an action "on the 'inherency' and 'inequitable conduct' parts of the motion, "but will rule on the 'best mode part' after consulting the law." Under Boyle's ruling, defendant Novopharm has the burden of proving in "clear and convincing evidence" its allegations that Form 2 ranitidine HCI is not novel (the inherency issue); and that Glaxo misled the U.S. Patent & Trademark Office by failing to disclose that by following example 32 in the Form 1 patent ('658), Form 2 ranitidine is produced (the inequitable conduct issue). The bench trial, which began Aug. 9, pits Novopharm, Inc., the Chicago-based subsidiary of Canadian generic drug marketer Novopharm Ltd., against Glaxo in what Glaxo attorney Stephen Judlowe (New York firm Hopgood, Calimafde, Kalil, Blaustein & Judlowe) called a "battle" of opposing scientific expert witnesses. At issue in the trial is the validity of ranitidine's Form 2 patent (#4,521,431), which expires in June 2002 and, if upheld, would give Glaxo ample time to develop an over-the-counter version of Zantac ("The Tan Sheet" Aug. 9, p. 11). Glaxo also holds a patent for Form 1 of Zantac ('658) that expires in December 1995. Novopharm filed an ANDA for ranitidine in 1991, claiming it would market the drug after the Form 1 patent expired. Glaxo then sued the company, asking the court to uphold the validity of Form 2. The thrust of Glaxo's case is that if example #32 of the Form 1 '658 patent is performed, the result is Form 1. Novopharm is arguing that its experts produced Form 2 ranitidine repeatedly by performing example #32 of the Form 1 patent. Glaxo maintains that Novopharm only achieved Form 2 because of "seeding," or contamination by Form 2, on the packaging of the ranitidine base used by Novopharm. Boyle's Aug. 12 ruling could be considered a mild victory for Novopharm in that it indicates the judge believed Novopharm presented enough evidence on the inherence and inequitable conduct issues for him to require that Glaxo present its arguments before deciding the case. At the close of the first week before Judge Boyle, Glaxo had two more expert witnesses scheduled to testify. Scheduled first for the morning of Aug. 16 is Stephen Byrn, PhD, Purdue University, an expert on polymorphic crystal structures. Glaxo was expected to rest its case by noon on Aug. 16 with the trial closing forecast for Aug. 17 or 18. A ruling is expected before year-end. Paying close attention to the court proceedings throughout the first week of the trial was Genpharm, which is also being sued by Glaxo for Zantac patent infringement. The Canadian generic drug firm was attending to any information provided by Glaxo during the Novopharm trial about the ranitidine HC1 Form 1 '658 patent. Glaxo v. Genpharm is expected to begin in May 1994 in Baltimore federal court.

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