Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?

Posted: 6 Dec 1999

Abstract

The Drug Price Competition and Patent Term Restoration Act of 1984 was an unprecedented attempt to achieve two seemingly contradictory objectives, namely, 1) to make lower-costing generic copies of approved drugs more widely available and 2) to assure that there were adequate incentives to invest in the development of new drugs. Recent data strongly suggests that it has accomplished both purposes. The '84 Act modified conventional patent law for drugs to include provisions (1) allowing for the extension of the normal term of a patent for up to five years to compensate for time lost in the FDA approval process; (2) a statutory exemption from claims of patent infringement which allows generic drug development and tenative approval to occur before a patent expires so that competition may begin immediately upon expiration; (3) special procedures for challenging the validity or infringement of drug patents which include a mandatory 30-month preliminary injunction against the patent challenger; and (4) a "bounty" for challenging patent validity, infringement or enforceability in the form of 180 days of market exclusivity to the first generic applicant to file a patent challenge. It is tempting to conclude that these provisions are responsible for the success of the '84 Act. However, a careful analysis of how these provisions became law and what they were actually intended to accomplish reveals that they are not truly relevant to the current economic environment in the pharmaceutical industry; are being abused by both the brand name and generic industries and produce no public benefit which would not otherwise occur.

Suggested Citation

Engelberg, Alfred, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?. Available at SSRN: https://ssrn.com/abstract=185171

Alfred Engelberg (Contact Author)

Attorney at Law ( email )

1050 North Lake Way
33480

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