...about drug product equivalency in no way lessens our support for the approval mechanism established by the Drug Price Competition and Patent Term Restoration Act of 1984 but, in fact, underscores our firm belief that each generic alternative must be comprehensively evaluated...

...injunction and criminal proceedings in the US District Courts. This Act was amended on September 24, 1984, by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, $S 301-307, 98 Stat. 1585, 1603, to require that a textile fiber product processed or manufactured...

...agency proposed regulations to implement the patent term restoration provisions (Title II) of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L 98-417). Patent term restoration, extending patent life, is available for certain patents related to human drug...

...APPROVALS IN FISCAL YEAR 1986 — 616 PRODUCTS, AS COMPARED WITH 389 IN 1985 -- LARGELY MADE POSSIBLE BY THE DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984. THAT LAW MADE IT POSSIBLE FOR FDA TO APPROVE GENERIC PRODUCTS ON THE BASIS OF DEMONSTRATING B IOEQUI...

...in fiscal year 1986 —— 616 products, as compared with 389 in 1985 —— largely made possible by the Drug Price Competition and Patent Term Restoration Act of 1984. That law made it possible for FDA to approve generic products on the basis of demonstrating bioequivalency...

...mechanism for transferring Government inventions to the private sector. The NIH/AD AM HA Pueni PoUcy Board March 27, 1989 importance of patents to commercialization...patent system is that the owner of a patent have a tunelimited "right to exclude others from making, using, or selling the [patented] invention." The...

...surge in competition from generic products as soon as the patent on the pioneer drug expires, spurred by the Drug Price Competition and Patent Term Restoration Act of 1984. That Act, together with generic drug substitution laws in the states, results in a virtual collapse...

...action in certain cases for condemnation of such products. This Act vas amended on September 24, 1964, by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. Mo. 98-417, ff 301-307, 98 Stat. 1585, 1603, to require that wool product labels indicate the country...

...competition from generic products as soon as the patent on a pioneer drug expires. This action was spurred by the Drug Price Competition and Patent Term Restoration Act of 1984, which was a watershed act for the industry. That act together with generic drug substitution laws in...

...competition from generic products as soon as the patent on a pioneer drug expires. This action was spurred by the Drug Price Competition and Patent Term Restoration Act of 1984, which was a watershed act for the industry. That act together with generic drug substitution laws in...