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Executive Summary

GENERIC MARKETING FOLLOWING SUCCESSFUL PATENT CHALLENGES should be permitted after a favorable district court decision and should not have to wait for an appeals court to hear the case, Bass & Ullman attorney Milton Bass suggested at the National Association of Pharmaceutical Manufacturers' annual meeting in Palm Beach, Fla. Jan. 24. Bass questioned the requirement in FDA's proposed ANDA regs that a patent challenger must wait to market its product until an appeals court decision. Bass's point was underscored at the meeting by James Rubin, who as a new partner at Bass & Ullman, will be helping NAPM draft its formal comments on the proposed regs. In tying the effective date for marketing to the appellate decision, Rubin maintained, "FDA got mixed up between the 180-day exclusivity and the effective date of the application." Rubin asserted that FDA's proposed requirement should be changed to allow the ANDA sponsor the option to market his product at the time of the district court decision. In waiting for the appellate decision, Rubin maintained: "we are potentially talking about a nine or 12 month time period during which the patent may expire." Rubin also questioned whether FDA should require that a generic company be sued by the patent holder following a patent challenge in order to receive an award of exclusivity. Rubin maintained that the 180-day exclusivity award should be based on a generic manufacturer's willingness to challenge the patent and should not require a countering lawsuit. He argued that generic firms have already made a sizable commitment by the time they challenge. Commenting on the importance of the ANDA regs to the industry, Bass declared: "This paper is your bible. It sets forth the rules of conduct that we are going to have to play by in the next four or five years." He added that the document should be a "vitally important tool in planning where you will use your money." American Home Products Senior Counsel for Regulation Michael Peskoe agreed with Bass and Rubin that the patent certification provisions of the proposed regs are "ripe for disagreement." He suggested that the unresolved patent problems raised by the regs may have to be resolved by the courts. Highlighting recent PMA comments on the proposed regs, Peskoe noted that the association has strongly objected to FDA's proposed use of a referee to settle patent disputes. PMA maintained that the ANDA holder must give sufficient information on the formulation process and product directly to the firm whose patent is being challenged in order for that firm to make a valid determination if infringement has occurred. Peskoe was formerly with FDA and Bass & Ullman before joining American Home Products last year. Also discussed at the NAPM meeting was the issue of bioequivalency testing of active metabolites. The proposed regs call for in vivo bioequivalency testing to be conducted on both "the active moiety and its active metabolites." Halsey Drug official Fred Shainfeld, who moderated the NAPM session on the proposed regs, emphasized the importance of the issue, joining other speakers at the meeting in pointing out that the reg statement, if taken literally, could in some cases, present a substantial obstacle to bringing new generic products to market. "We are going to have to address this question through the association and as individual companies," Shainfeld declared.

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