Legislation proposed by US Senator David Pryor which seeks to get generic drugs onto the market more quickly would weaken the US position in negotiating and enforcing strong international patent protection, says a new report.
The Consumer Access to Prescription Drugs Act (S 1191: Marketletter September 4) would amend the 1984 Waxman-Hatch Act and permit generic makers to sidestep its requirements that they wait for the patented drug's full expiry before entering the market. The bill was voted down in committee, but Sen Pryor says he will bring it directly to the Senate floor. the report, Balancing and Rebalancing the National Interest in the Patent System, says S 1191 would encourage other countries to seek similar special exemptions to the Trade Related Intellectual Property Act negotiated as part of the General Agreement on Tariffs and Trade.
Authors Claude Barfield and Cynthia Beltz of the American Enterprise Institute say that to undo Waxman-Hatch and weaken the patent system during this critical period of implementing TRIPs "could well give developing countries a pretext for backing away from their GATT commitments to strengthen the protection of intellectual property." Given the implications for international patent protection and future trade negotiations, Congress should not enact a bill that denies US pharmaceutical manufacturers their full patent protection. S 1191 targets what the Generic Equity Coalition has identified as patents for about a dozen medicines currently on the market that were extended under other GATT provisions for periods ranging from a few weeks to just over two years (Marketletter July 24).
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