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Executive Summary

NAPM, NPA JOIN IN ASKING USTR TO SEEK "BOLAR" EXEMPTION to European Community patent law. In an Oct. 6 statement, the National Association of Pharmaceutical Manufacturers and the National Pharmaceutical Alliance jointly announced their agreement to work together to persuade the U.S. Trade Representative to lobby the European Community for patent law amendments that would allow generic manufacturers to use patented drug products in tests to meet pre-approval regulatory requirements. Now 20-year patent laws enacted by EC countries have not included provisions parallel to the U.S. patent law experimental/regulatory use exemption (under what has been called the "Bolor provision" of the 1984 Waxman/Hatch Act). The experimental/regulatory use exemption permits U.S. generic companies to test their prospective products against brand name drugs before expiration of the reference product's U.S. patent. However, without a similar exemption in EC patent laws, they say they will be unable to obtain bulk from their European suppliers. If the industry is forced to wait for European patent expiry before obtaining raw material for testing, generic competition could be delayed three to six years after brand name products are off patent in the U.S., the associations explain. NAPM has discussed the issue with USTR officials since early spring, and NPA more than doubles the number of companies (to nearly 200) pushing for an amendment. NAPM expects that "the addition of NPA with its 125 member companies will add more impetus to this urgent matter." Last March, Sen. Pryor (D-Ark.) wrote to USTR Ambassador Mickey Kantor urging that he "strongly advise our trading partners of the need for a special exemption in foreign patent laws" ("The Pink Sheet" March 29, T&G-5).

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