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"DUE DILIGENCE" REVIEWS WOULD BE DONE ONLY UPON REQUEST OF THIRD PARTY

Executive Summary

Patent extension applications would be subject to "due diligence" reviews by FDA only when the agency is petitioned by a third party to make the evaluation, according to the revised patent extension proposal contained in the April 25 draft of Rep. Waxman's bill. The revised patent extension section deletes from the original proposal a triggering mechanism for due diligence determinations. Under the original proposal, FDA would automatically determine if the patent holder pursued an NDA diligently if the IND phase of the regulatory review period exceeded four years, or if the NDA phase exceeded 18 months. If FDA's review concluded that a pioneer sponsor was responsible for prolonging the review period, that delay would be subtracted from the amount of patent extension granted to the applicant. The new draft adds a requirement that patent holders seeking patent extension must include in their applications "a brief description of the activities undertaken by the applicant during the applicable regulatory review period." The information could serve as a basis for third parties petitioning for due diligence reviews. The change in the due diligence provision is the one major revision in the patent extension section of Rep. Waxman's original draft. One other addition to the original draft would allow the Commissioner of Patents and Trademarks to grant a one year temporary patent extension to a product. The provision states that "if the term of a patent for which an application has been submitted expires before a determination is made concerning patent extension, the Commissioner may, in his discretion, extend the term of the patent for one year if he determines that the patent is eligible for extension."

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