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Executive Summary

The formation of a fact-finding advisory board might be "helpful" in providing a standard procedure for reviewing requests for patent extensions, Patent & Trademark Office Commissioner Harry Manbeck suggested at an Aug. 1 hearing of the Senate Judiciary/Patents Subcommittee. "It does seem to me that it would be very helpful if there were a fact-finding board formed of people experienced in the patent area, to examine these situations and make recommendations," Manbeck told the subcommittee. The hearing was scheduled by Subcommittee Chairman DeConcini (D-Ariz.) to consider three bills to extend the patent terms of three products approved or under review by FDA: Upjohn's Ansaid, U.S. Bioscience's Ethyol and Procter & Gamble's Olestra. DeConcini, who has not cosponsored any of the bills, expressed a need for a uniform, standard method for reviewing patent extension requests. "In the past, Congress has dealt with private patent relief bills on an ad hoc basis," the senator noted. "We hope to establish some systematic standards that this subcommittee can apply to private patent relief requests." Without standard guidelines, the senator said, "we will continue to encounter the situation that we face today -- where each proponent will claim their situation is 'unique.'" DeConcini added that he does not want his subcommittee to "become an indiscriminate processing mill for private extension bills." Manbeck emphasized that the decision to grant the patent holders' requests to extend the patents belongs to Congress. However, he seemed to indicate that PTO does not find the companies' arguments compelling. The PTO has "not been made aware of any evidence of misconduct by a federal agency which might have contributed to a shortened effective patent term of any of the patents in question," the commissioner said. "Consequently, we are unable to determine whether the circumstances are extraordinary enough for us to recommend enactment." On the other hand, Manbeck added that "the facts appear to be such that relief should not be rejected out of hand." Manbeck commented that Upjohn has already received a two-year extension of the patent for its anti-inflammatory Ansaid (flurbiprofen) under the 1984 patent term restoration act. He pointed out that granting Upjohn's request "contravenes" current law, "which mandates that no patent shall be extended more than once." FDA Pilot Drug Evaluation Staff Director John Harter, MD, who reviewed the Ansaid NDA, testified that FDA's average premarket review periods for NSAIDs increased from two years before 1982 to four years following 1982. Harter said that the increased review time is due to the lower priority now given to NSAIDs compared to the 1970s and early 1980s when there were few NSAIDs available. But after the first few NSAIDs were approved, NDAs for additional products did not reveal any advantages over previously approved NSAIDs. In addition,the FDAer testified, "Ansaid also had some product-specific problems that took us longer to work through." Upjohn submitted the Ansaid NDA in 1982. After FDA's initial review, the agency asked Upjohn to reanalyze the data, Harter said. Upjohn resubmitted the NDA in 1985 and FDA had to re-review the data according to Harter. Upjohn Chairman Theodore Cooper, MD/PhD, had a somewhat different recollection of the Ansaid review. Cooper said the factors in the agency's delay in approving Ansaid included "a substantial reduction of FDA resources." In addition, "the agency was extremely cautious due to the unprecedented safety failure of three" NSAIDs (Oraflex, Zomax and Suprol) and agency resources were consumed in addressing congressional oversight. These factors were unrelated to the safety and efficacy of Ansaid, Cooper maintained. U.S. Bioscience's anti-radiation agent Ethyol (ethiofos) will receive five years of market exclusivity under the 1984 act and it has obtained orphan designation for Ethyol as a cancer treatment, which could earn an additional seven-year exclusivity period, Manbeck said.

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