US Industry groups Clash Over GATT

The Pharmaceutical Research & Manufacturers Association has urged the US Food and Drug Administration not to exempt Abbreviated New Drug Applications from patent certification filings under the new patent expiration dates set by the Uruguay Round Agreements Act, which implements the General Agreement on Tariffs and Trade's increase in patent term to 20 years from filing from 17 years from date of issue.

Transition measures will permit patents in force at June 8 to be extended to 20 years from filing. The Act says this should not remove from the market firms which have made a "substantial investment" based on the previous date, provided they pay the innovator "equitable remuneration." The PhRMA says ANDAs cannot be exempted from certifying to the new patent expiry dates, because neither the Act nor the 1984 Waxman/Hatch amendments allow the FDA to disregard a revised patent expiration date mandated by law.

Request From GPIA The PhRMA's statement was in response to a call from the Generic Pharmaceutical Industry Association, urging the FDA to let pending ANDAs seeking approval following the expiry of listed patents remain eligible for approval on expiry of the patent term currently published in the FDA Orange Book. The GPIA also said that applicants submitting ANDAs for a patent term extended by the Act should be able to file certification seeking approval on expiry of the original patent term that excludes any GATT extension. This would state that the applicant had made the required substantial investment in the development before June 8, while for pending applications, the application itself would be ample proof of such investment.