Bayh-Dole Reform and the Progress of Biomedicine

摘要: I INTRODUCTION Advances in fundamental biomedical research play an important and growing role the development of new therapeutic diagnostic products. Although pharmaceutical end products has long been a proprietary enterprise, (1) comes from very different tradition open science. Within this tradition, longstanding norms call for relatively unfettered access to knowledge developed by prior researchers. (2) The science eroded considerably over past quarter century as claims have reached farther upstream cover discoveries that provide base future product development. One reason change narrowing conceptual gap between commercial application. Once largely matter serendipity or trial-and-error, drug discovery is now critically dependent on basic genes, proteins, associated biochemical pathways. foreseeable practical payoffs make it easier obtain patents that, earlier era, would seemed too far removed useful applications patent protection. As these early-stage advances human understanding become patentable, firms emerged, raising capital develop market lies somewhere traditional academic end-product This shift patenting activity met little resistance courts. In 1980, Supreme Court held genetically engineered microorganisms were eligible protection, construing language statute permitting "anything under sun made man." (3) Shortly thereafter, Congress created specialized court hear appeals matters, Appeals Federal Circuit ("Federal Circuit"). (4) further extended Court's expansive approach eligibility (5) while relaxing stringency standards such utility (6) non-obviousness, (7) might otherwise prevented incremental research. Circuit's generally supportive attitude towards encouraged imaginative claiming strategies unprecedented levels activity. These changes economic structure case law factors promoting intellectual property discoveries. Perhaps even more significant factor, however, explicit U.S. policy allowing grantees seek rights government-sponsored results. policy, which was codified beginning 1980 with passage Bayh-Dole Act, (8) Stevenson-Wydler (9) turned universities into major players biopharmaceutical arena. goal legislative initiatives promote widespread utilization federally-sponsored inventions. sponsors legislation believed grantee ownership rights, permit convey exclusive licenses their inventions private firms, necessary motivate investors pick up where government left off transform (10) But draws no distinction downstream lead directly broadly enable scientific investigation. Universities taken opportunity file discoveries, DNA sequences, protein structures, disease pathways, are primarily valuable inputs research, thereby accelerating encroachment system what formerly domain …