US Senate Votes Against Ending GATT Loopholes

In a barely-publicized vote which came on a rider to the Defense Department Appropriations measure, the US Senate has rejected a proposal to end legislative loopholes in the General Agreement on Tariffs and Trade. By a 53-45 vote, it adopted Senator Orrin Hatch's substitute amendment on generic introductions for drugs with patents extended by GATT. This would also grant a two-year patent extension for Wyeth-Ayerst's Lodine (etodolac); the extension was passed by the House in June.

The Hatch amendment defines the term "substantial investment," which GATT says would allow the marketing of a generic version of a patent-extended drug before the end of the patent. It requires manufacturers to prove in court that the substantial investment was made before June 8, 1995, and says the investment must consist of more than the "expenditures related to the development and submission of the information contained in" an Abbreviated New Drug Application.

Pryor: "I Am Defeated" Senator David Pryor said this ended his attempts to enact a bill to allow generics to be marketed before the end of some GATT-extended patents. "I think I know when I am defeated," he said: "the Senate has spoken." But, he said, if he found another way to frame the issue in the future, he would try again. The Pryor-Brown Amendment would have corrected the GATT Uruguay Round Agreements Act oversight (Marketletter April 8), by allowing the Food and Drug Administration to approve new generics in accordance with URAA transitional provisions allowing a competitor making a substantial investment before the URAA effective date to market its drug after expiry of the original pre-URAA 17-year patent term. Generic substitution would mean consumers paying 40%-50% less for Glaxo Wellcome's Zantac (ranitidine), he said.