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GATT patent terms may be challenged under "modified" procedure, FDA says.

Executive Summary

FDA ESTABLISHES "MODIFIED" PATENT CHALLENGE PROCEDURE FOR GATT extended patents that will require sponsors to notify FDA within 30 days of the challenge that the new expiration date conforms to the Patent & Trademark Office method for calculating patent terms under the General Agreement on Tariffs & Trade, according to a July 21 Federal Register notice. Companies with patents extended by GATT submitted new patent information to FDA between June 8 and July 8. FDA will publish the new dates unless the sponsor explicitly stated that the information does not comply with PTO policy.
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PS026551

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