The US Supreme Court heard oral arguments yesterday in the case of Laboratory Corporation of America Holdings v. Metabolite Laboratories Inc., et al. This case has been described one of whether basic truths of nature can be patented, most colorfully by Michael Crichton in a New York Times Op-Ed piece last Sunday. As is usually true of high profile legal stories, there are more subtle aspects that have not appeared in the popular press.
The story begins with three medical school professors, Sally Stabler and Robert Allen of the University of Colorado and John Lindenbaum of Columbia University, who discovered that high levels of the amino acid homocysteine are indicative of deficiencies in cobalamin (vitamin B12) and folate (folic acid), both of which are essential. As is often the case with scientific discoveries, the established authorities were initial skeptical but years later came to accept their work as the standard. Meanwhile, the professors developed a clinical test for measuring serum homocysteine which doctors could use to test for B12 deficiency, received U.S. Patent No. 4,940,658. The patent was assigned to Competitive Technologies, Inc. (CTI) who in turn graanted a license to the newly formed Metabolite Laboratories, Inc. which in turn provided a license and know-how to Laboratory Corporation of America (LabCorp) who performed tests for doctors. This arrangement went on for six years until Abbott Laboratories came up with their own test for homocysteine, whereupon LabCorp stopped paying royalties to Metabolite and started using an automated test provided by Abbott. As it turns out, while the bulk of '658 patent covers the somewhat complex process of doing the test, one claim covers the relationship between homocysteine and cobalamin or folate:
Claim 13: A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
Metabolite has used this claim to argue that LabCorp still owes it royalties no matter which test it uses. In fact, in Tuesday's arguments, Metabolite's attorney conceded, under questioning by Justice John Paul Stevens, that a doctor could infringe the patent by ordering a homocysteine test with the intent of determining B vitamin levels and then using the test results to infer whether there was indeed a deficiency.
In attempting to invalidate the patent, LabCorp has argues that this claim would "allow an effective monopoly over a scientific principle" and thus violates the Courts longstanding rule on patenting laws of nature.
Of course it gets even more complicated, because Metabolite argues that LabCorp didn't raise this issue earlier in the appeals process. Nonetheless, the question the Supreme Court has agreed to consider is:
Whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to “correlate[e]” test results can validly claim a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result.
Invalidating the '658 patent could, in turn invalidate a lot of other biotech patents, including those based on discoveries of the human genome. Whether you find that scary depends on whether you own those patents. Ultimately I think one needs to return to the original intent of the patent system as set forth in the U.S. Constitution [Article I, Section 8, clause 8]: "To promote the progress of Science and useful arts." So, the question is whether discoveries such as those of Stabler, Allen, and Lindenbaum would have been made and, more importantly exploited, without the promise of a monopoly on any such exploitation. Also, would subsequent improvements be more or less likely if they had to negotiate around such monopolies. And on a more abstract level, would scientific progress be furthered if laws of nature could be patented?