Reflections on the Gene Patent War: The Myriad Battle, Sputnik and Beyond

“You, or someone you love, may die because of a gene patent that should never have been granted in the first place. Sound far-fetched? Unfortunately, it's only too real” (1). This quote from an editorial by the best-selling author Michael Crichton written shortly before his death is typical of the rhetoric surrounding human gene patents. Those who are against gene patents often cast them as morally reprehensible and illogical emblems of ownership wielded by a biotech industry more concerned about profit than improving health. And those who favor patents often claim they are essential tools of innovation. Without patents, the proponents claim, innovation would diminish, and knowledge translation would grind to a halt. No genetic tests, no money for research, and no new therapies—or so the arguments go.But as is so often the case when policy debates become polarized, the outermost positions have become disconnected from what the available evidence actually says. There are grains of truth to many of the extreme assertions, to be sure, but as we will see, the evidence about the impact of gene patents—both good and bad—is pretty thin. Although there are a range of arguments that have relevance to the policy debates associated with patents, including interesting legal and conceptual questions about the patentability of genetic information (2), it is the extreme claims of harm and benefit that get the most publicity and policy attention, as the Crichton quote exemplifies.The polarized nature of this debate cannot be good. In fact, it seems axiomatic that, whenever possible, it is better to base social policy not on hyperbolic assertions but on sound evidence.Although the debate about the appropriateness of gene patents has raged for decades, last year's stunning decision by the US District Court for the Southern District of New York [ Association …