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NOVOPHARM WILL APPEAL FEDERAL COURT RULING UPHOLDING GLAXO's ZANTAC PATENT

This article was originally published in The Tan Sheet

Executive Summary

NOVOPHARM WILL APPEAL FEDERAL COURT RULING UPHOLDING GLAXO's ZANTAC PATENT, the Canadian drug manufacturer announced Sept. 20. Referring to a Sept. 17 ruling by Elizabeth City, N.C. federal court Judge Terrence Boyle reaffirming Glaxo's Zantac patent for Form 2 ranitidine, Novopharm President Robert Gunter stated that "while Judge Boyle's ruling agrees with many points we made in court, we differ on some significant issues, and, if any one of these issues is overturned on appeal, the Glaxo patent would become invalid." Gunter added that "the real losers here are the American people -- we will appeal this decision and continue our plight to make a more affordable generic version of the drug available." Novopharm hopes to market a generic ranitidine product "at 30-50% less than the present cost [of Zantacl]." 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 HCI once Glaxo's Form I patent expires in December 1995. In addition to inherency and inequitable conduct charges, Novopharm also had alleged that Glaxo did not disclose the "best mode" in its patent. The judge's decision came one month after the conclusion of a nine-day trial held Aug. 9-18 ("The Tan Sheet" Aug. 16, p. 18). The Sept. 17 ruling states that "based on the evidence, Novopharm has failed to carry its burden on the defense of invalidity. The court upholds that U.S. Patent No. 4,521,431 is not invalid, and that Novopharm infringed the patent by filing - its ANDA on Aug. 9, 1991." Judge Boyle ordered that "Novopharm not be granted approval to sell Form 2 ranitidine HCl prior to the expiration of the "431 patent [and] to refrain from the commercial manufacture or sale within the United States of Form 2 ranitidine HCl prior to the expiration of the "431 patent." Novopharm also contended that the "431 patent is invalid because Glaxo was guilty of inequitable conduct in that it intentionally made material misrepresentations to the patent office during the prosecution process. Novopharm claimed that the misrepresentations are contained in two declarations submitted in response to the patent examiner's Aug. 28, 1983 rejection of the Form 2 patent application. One of the declarations, the Hunt Declaration, contained the results of analytical tests of samples of Form I and Form 2 that reported to show that in the solid state the products have different crystal structure. The other declaration, the Collin Declaration, claimed that "Form 2 had certain qualities which made it less difficult and expensive to manufacture than the prior art," the court decision says. Boyle determined that "Novopharm has failed to carry its burden of proving that Glaxo's submission of the Hunt Declaration constituted inequitable conduct in the prosecution of the "431 patent. "Boyle also found that the Collin Declaration "cannot be the basis for a finding of inequitable conduct." The judge also concluded that "as a matter of law, Novopharm failed to show that "431 should be invalidated based on a best mode violation." The Canadian firm argued that Glaxo failed to disclose the best mode of manufacturing Form 2 ranitidine HCl for pharmaceutical use, the azeotroping process. Patent law requires that applicants disclose the best mode for making and using inventions. The ruling says that some "officials within Glaxo made a deliberate choice not to reveal what they believed to the best mode of making the patented invention, but instead to protect the knowledge as a trade secret." However, the statute stipulates that in a best mode violation, the inventor must know about the best mode or be the one concealing it. The court believes the inventor did not know about the best mode and was not consulted about not revealing the information. Glaxo reported Sept. 17 that Judge Boyle ruled that defendant Novopharm did not prove "in clear and convincing evidence" its charges that Form 2 ranitidine (patent'431) was inherent in the Form 1 patent ('658) nor that Glaxo was guilty of "inequitable conduct." Glaxo said the decision reaffirms that it can market Zantac on an exclusive basis until the Form 2 patent expires in June 2002. In its Sept. 20 response, Novopharm pointed out that another Canadian drug company, Genphann, is challenging the ranitidine patent. through a jury trial that is scheduled to begin in May 1994 in Baltimore, Md.
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