ANDA filing does not constitute "substantial investment" under GATT, Bristol asserts in comments to FDA.
ANDA FILING DOES NOT CONSTITUTE "SUBSTANTIAL INVESTMENT," BMS ARGUES, under implementing legislation for the General Agreement on Tariffs & Trade. Bristol-Myers Squibb contends in March 13 comments to FDA that: "There is nothing in the [Uruguay Rounds Agreement Act] that indicates a determination by Congress that every ANDA was, as a matter of law, `a substantial investment' sufficient to comply with the statute." URAA provides that firms that have made a "substantial investment" in a product based on a current patent expiration date may proceed with marketing before expiration of the GATT-extended patent.
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