Pryor Bill Backs Generics On GATT Patent Term

A bill introduced in the US Senate by Democrat Senator David Pryor would allow a generic firm to market its version of a brand-name drug during the patent extension period provided by the Uruguay Round Agreements Act, the US enabling legislation of the General Agreement on Tariffs and Trade, provided it had completed the penultimate steps of the Abbreviated New Drug Approval process before June 8, 1995.

Sen Pryor's bill, the Consumer Access to Prescription Drugs Act (S 1191), would amend the 1984 Waxman/Hatch generic drug approval amendments, which state that ANDAS filed for products already under patent protection may not be approved for 30 months. His bill also defines the term "substantial investment" which would allow generics to be marketed during the transition period, stating that this refers to "the development of a product formulation and the manufacture of an experimental batch of a drug that becomes the subject of an application, or the initiation of stability of bioequivalence studies by an applicant."

Also deemed to have made a "substantial investment" in the generic product is any "person who supplied any active ingredient used by such applicant in such drug or by such manufacturer in such drug."