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Executive Summary

UPJOHN's ANSAID PATENT EXTENSION ARGUMENTS ARE "PROBABLY STRONGEST" for the two-year period May 1984 -- May 1986, the Government Accounting Office (GAO) finds in an April 7 report to Capitol Hill. "Upjohn's primary arguments (extraordinary circumstances, additional requests from FDA for various formats and displays of Ansaid test data, and few contacts with Upjohn) to support its claim that the patent term for Ansaid should be extended are most relevant to this 2-year period," GAO declares. The Congressional research group notes that FDA "acknowledges" that its NDA review activities "took longer" during that two-year period. The GAO report was prepared for Chairman DeConcini's (D-Ariz.) Senate Patents Subcommittee and Chairman Hughes (D-N.J.) House Intellectual Property Subcommittee. GAO compiled the report from interviews with FDA and Upjohn representatives and reviews of FDA documentation. It took four months for GAO to compile the information. Upjohn is seeking 53 months of patent restoration. The narrow, two-year focus of GAO's review is presumably disappointing from the company's perspective. However, it can be used by the company's Capitol Hill supporters to indicate the determination of some evidence of inequities during the Ansaid review. Upjohn has the public support of Rep. Dingell (D-Mich.) for its patent extension request. Dingell has suggested that Upjohn should get extra exclusivity for Ansaid from an amendment to the FD&C Act if the patent extension approach continues to be a slow process ("The Pink Sheet" Feb. 24, p. 3). DeConcini may schedule a markup on the bill before the summer. GAO noted that the slow reviews during the period 1984-1986 were due in part to the problems experienced by already-approved NSAIDs. "As a result of its need to resolve problems with approved NSAIDs," GAO said, "we found that FDA was concentrating on safety questions related to this class of drugs between May 1984 and May 1986." The agency added "more requirements for data, making NDAs for these drugs complex and time-consuming." Upjohn was asked by FDA reviewers to resubmit NDA data in different formats during the period of increased caution about NSAIDs, GAO found. Those request, however, were reasonable in GAO's opinion. "We found no evidence to suggest that the reviewers were being anything but judicious in their review," GAO said. The GAO report does not indicate that there were any unusual delays during the first two years of the NDA-pending period for Ansaid. Upjohn submitted the application in March 1982, received a non-approvable letter from FDA nine months later, and resubmitted the NDA in May 1983. At the time of the resubmission, the company and FDA discussed whether priority should be placed on the Ansaid application or the ibuprofen OTC applications (Nuprin). "According to the FDA Chief Medical Reviewer," GAO said, FDA "discussed with the company which NDA had priority, and reached agreement with Upjohn to work on the Nuprin application first." FDA told GAO that such agreements on priority of application review are "not unusual." Upjohn described the discussions as one-sided with no options offered to the company. GAO notes that "according to the company chairman [Theodore Cooper], they had no alternative but to accept FDA's proposal." From Upjohn's point-of-view, the OTC switch has less commercial potential. Upjohn received a $10 mil. payment from Bristol-Myers for marketing rights to Nuprin and a 6% royalty payment per year on sales (for the first four years of marketing).

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