Document Type
Article
Publication Date
2025
Abstract
Alfred Engelberg’s article of a quarter-century ago, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, raised a provocative question that retains currency today. The special provisions that Hatch-Waxman established, and Engelberg addressed, have come to be known as patent linkage. Following the principle of linkage, the Food and Drug Administration (FDA) cannot approve generic drugs for marketing if they would infringe a patent.
Hatch-Waxman’s complex patent provisions aspire towards multiple salutary purposes, including encouraging the prompt availability of generic drugs, improving public notice of pharmaceutical patents, and accelerating dispute resolution proceedings. Congress also attempted to ameliorate perceived patent term distortions introduced by the interaction of drugmakers with the administrative state, and to ensure that the FDA and U.S. Patent and Trademark Office speak consistently as to whether generic drugs may be sold or not.
Yet, as Engelberg suggested, patent linkage is largely unnecessary. Those provisions that supplement garden variety patent provisions could achieve their policy objectives through alternate measures at lower cost. Merely providing public notice that a generic manufacturer seeks FDA approval to market during the term of the originator’s patent would do essentially all the work linkage sets out to accomplish.
This analysis suggests that the success of Hatch-Waxman’s patent provisions is not because they were innovative—as they were not—but rather because they are mandatory. And although largely confirmatory of established patent rights, Hatch-Waxman’s linkage provisions are not simply harmless. They have instead raised persistent concerns in view of their compliance burdens, complexity, and likely unintended consequences. This analysis also suggests that linkage concepts, when adopted abroad, should call for the public notice of applications for generic marketing approval rather than more elaborate mechanisms.
Publication Citation
Texas Intellectual Property Law Journal, Vol. 33, Issue 3, Pp. 291-324.
Scholarly Commons Citation
Thomas, John R., "Revisiting Patent Linkage" (2025). Georgetown Law Faculty Publications and Other Works. 2678.
https://scholarship.law.georgetown.edu/facpub/2678