GATT "substantial investment" would require ANDA acceptance prior to June 8, 1995 under Hatch amendment.
Executive Summary
GATT "SUBSTANTIAL INVESTMENT" REQUIRES ANDA ACCEPTANCE PRIOR TO JUNE 8, 1995 under a replacing amendment by Sens. Hatch (R-Utah) and Specter (R-Penn.) during Judiciary Committee mark-up May 2 of legislation on marketing of generic drugs during the extended patent period under the General Agreement on Tariffs & Trade. The committee voted 10-7 to accept the Hatch/Specter amendment to replace the original bill offered by Sens. Pryor (D-Ark.), Brown (R-Colo.) and Chafee (R-R.I.).
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