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Executive Summary

ANSAID, ETHYOL PATENT EXTENSIONS OPPOSED BY GPIA on the grounds that the products receive "sufficient" market protection under existing law. In an Aug. 7 letter to Senate Judiciary/Patents Subcommittee Chairman DeConcini (D-Ariz.), the Generic Pharmaceutical Industry Association argued that the 1984 patent term restoration/ANDA law gives new chemical entities five years of exclusivity and that the vagaries of the generic review process and further to the monopoly period. GPIA President Dee Fensterer maintained that "a key provision of the 1984 [Waxman/Hatch] Act guaranteed that every new chemical entity . . . would enjoy a period of approximately seven years of market exclusivity irrespective of the existence of a patent." She noted that "no . . . ANDA may be accepted for filing by the FDA for five years after the approval of an NDA for an NCE" and that the approval process for an ANDA "normally takes at least two years, thereby providing seven years of exclusivity." "Existing laws adequately recognize and balance the interest of pharmaceutical innovators and consumers," Fensterer maintained. "Creation of exceptions to those laws on an ad hoc basis is not in the public interest but merely serves to increase the profits of individual companies, which are already extremely well off, at public expense." On the other hand, GPIA told DeConcini it does not oppose a patent extension for Procter & Gamble's fat substitute Olestra (polyester sucrose). DeConcini held a hearing Aug. 1 on three bills to extend the patents of the three products ("The Pink Sheet" Aug. 5, p. 4). "Olestra is not a drug and is not eligible for any non-patent exclusivity," Fensterer noted. "Accordingly, patent term extension may be warranted if there was unreasonable regulatory delay." However, she added, "to be consistent" any patent extension provided for Olestra "should not exceed the length of the delay or the statutory five-year NCE exclusivity" period, "whichever is shorter." The letter suggests that the Ansaid patent should not be extended because its marketer, Upjohn, deliberately delayed its development. GPIA noted that Ansaid, like Motrin, was licensed by Upjohn from Boots. "Before the Motrin patent expired in 1985, Motrin was the leading NSAID in the U.S.," the association said. "Thus, neither Boots nor Upjohn had an economic incentive to rapidly move forward" to market Ansaid, "which would only serve to reduce the sales and royalty income from Motrin." GPIA also contended that when Upjohn acquired exclusive rights to oral flurbiprofen (Ansaid) in 1986, it did so "with full knowledge of the limits of exclusivity it would acquire." Furthermore, the association argued, "it is extremely likely that some generic manufacturers have relied on the published expiration date of Feb. 19, 1993 and have already expended time and financial resources in the R&D of therapeutic equivalents to Ansaid." Because Ansaid followed the ophthalmic form of flurbiprofen to market, it received a two-year exclusivity period under the 1984 law, rather than the five-year period it would have received had it been an NCE. Regarding Ethyol, GPIA said that the drug's manufacturer, U.S. Bioscience obtained rights to the product in 1987 "with full knowledge of the remaining patent term." Additionally, the association said, U.S. Bioscience will receive seven years of exclusivity under the 1984 law, can seek new indications that may add additional years of exclusivity, and can seek orphan indications to obtain seven years of market protection. Moreover, "nothing prevents U.S. Bioscience from obtaining additional patents covering new uses of an old compound," the association said. "Clearly," Fensterer stated, "no need for a patent extension is evident in this situation."

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