US Patent Provisions, Post-GATT

Pharmaceutical companies must soon make important decisions on when to file a patent claim, as the new US patent provisions take effect June 8, following the General Agreement on Tariffs and Trade Uruguay Round, Lois Boland, attorney-advisor in the Office of Legislative and International Affairs of the US Patent and Trademark Office, has told a National Association of Pharmaceutical manufacturers meeting.

Rights of claims filed after the effective date will begin on the patent issue date and run for 20 years after the earliest effective filing date claimed by the applicant. Patents in force now and those filed but not granted by June 8 will have a patent term lasting the longer of 17 years from the patent's granting or 20 years from filing. Subsequent claims often rely on dates of earlier filings, so companies must judge the implications of each action on drugs still in R&D. They will still be able to claim patent extensions for delays in approvals, court actions and interferences. Overlapping elements of sections of the new law dealing with extensions are still being harmonized and industry comment being considered, but they must be resolved before June 8; clarification will be available at least a month before.

Companies "Must Keep Track Of Existing Patents" Remedies are unavailable for products awarded patent extensions, and only equitable remuneration as decided by the courts will be applied to invested infringers as of June 8. Infringers must have made a substantial investment to prepare to enter the market to be considered an invested infringer. The provision dealing with patents already in effect will operate automatically, and as the Patent Office will not issue new information on existing patents, companies must keep track. The USA will probably adopt a system of early publication of patent applications, she said, with applications published 18 months after filing and the applicant probably getting some rights. The Patent Office wants to ensure new technology being patented in other World Trade Organization countries is available early in the USA, and with English translations.