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Executive Summary

PATENT CERTIFICATIONS WILL BE INCREASED BY LISTING OF FORMULATION PATENTS and composition patents, FDA predicted in a May 1 letter to approximately 400 drug mfrs. FDA publication of formulation and composition patents under the Hatch/Waxman law "is important because any firm wishing to submit an ANDA or paper NDA for a listed drug must make a certification with respect to each patent published by the agency," the letter states. "The agency anticipates a substantial increase in the number of such certifications as a result of formulation and composition patents." Under the law, when an ANDA applicant "certifies" that its product will not infringe upon an active patent, the patent holder has 45 days to file for an injunction in federal count. Even when such cases remain pending, the law prevents the ANDA applicant from going to market for at least 30 months. When FDA first published its policy on agency handling of patent information, it said only product (active ingredient) and use patents would be included in FDA files ("The Pink Sheet" Nov. 19, p. 5). However, responding to comments from PMA, the agency told the assn. in a March letter that FDA would also list formulation and composition patents ("The Pink Sheet" April 8, T&G-1). The agency's May 1 letter disseminated that information to holders of approved and pending applications.

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