Patent term extension: an overreaching solution to a nonexistent problem.

Abstract

The proponents of extended life for drug patents argue that the “effective patent life” of pharmaceutical composition and use patents has been cut in half due to the additional time now required to comply with government safety and efficacy regulations prior to commercial marketing. They define “effective patent life” as the period of actual commercial exploitation of a patent monopoly and claim that it has been reduced from seventeen to 7.5 years. Since the proposed legislation (S. 255; H.R. 1937) would extend patent life only for a maximum of seven years, they contend that it would provide less than the full return of time to which pharmaceutical innovators are entitled as a matter of equity. To those who lack a basic understanding of our complex patent system, this argument seems simple and logical, and for that reason it has attracted broad support. In reality, the arguments which have been made in support of patent extension have no reasonable foundation in fact or law; and the extension legislation undermines fundamental principles on which the entire patent system is based for, at least, the following reasons: 1) Effective patent life. The term “effective patent life” is the creation of those who are promoting patent extension legislation and has no counterpart in patent law or the fundamental philosophy on which the patent system is based. The notion that the seventeen-year patent grant carries with it any guarantee that the patent owner will enjoy seventeen years of commercial exploitation of the patented invention is contrary to that philosophy, as well as to the requirements which must be met to obtain a patent, particularly in the pharmaceutical field.