After being bombarded with 20 amicus briefs, the U.S. Supreme Court has opted out of ruling on the LabCorp v. Metabolite Laboratories case (U.S., No. 04-607) saying that it had “improvidently” agreed to hear the case in the first place and it dismissed the appeal. Basically, thousands of patents on medical tests and genes dodged a serious bullet since the Court could have deemed such tests “natural phenomena.”

Review was granted only with respect to whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to “correlat[e]” 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.

A District Court trial jury found that LabCorp indirectly infringed Metabolite’s U.S. Patent No. 4,940,658. The ’658 patent claims methods for detecting cobalamin or folate deficiency. Cobalamin and folate are both B vitamins, commonly known as B12 and folic acid, respectively. A deficiency in these vitamins can cause serious illnesses in humans, including vascular disease, cognitive dysfunction, birth defects and cancer. Claim 13 claims a method for detecting a deficiency of cobalamin or folate in warmblooded 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.

On appeal to the CAFC, LabCorp argued that claim 13 is invalid on grounds of indefiniteness, lack of written description and enablement, anticipation, and obviousness. Likewise, LabCorp contends that claim 18, directed to the panel test, is also invalid on grounds of indefiniteness, and lack of written description and enablement. The CAFC upheld the district court’s decision.

Three justices dissented, saying the court should have decided the case after expressing concerns that patents in areas like biotechnology and financial services were being granted too liberally and over concerns that physicians could become unwitting patent infringers if they make the same test conclusion linking the presence of cobalamin or folate in a patient’s blood and vitamin B deficiency.

The dissent stated that:

Claim 13’s process instructs the user to (1) obtain test results and (2) think about them. Why should it matter if the test results themselves were obtained through an unpatented procedure that involved the transformation of blood? Claim 13 is indifferent to that fact, for it tells the user to use any test at all. Indeed, to use virtually any natural phenomenon for virtually any useful purpose could well involve the use of empirical information obtained through an unpatented means that might have involved transforming matter.

At most, respondents have simply described the natural law at issue in the abstract patent language of a “process.” But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge. … In my view, that correlation is an unpatentable “natural phenomenon,” and I can find nothing in claim 13 that adds anything more of significance.

Further consideration on natural phenomena will have to wait for another day.

See the dissent here. See also Patently-O, Phosita, and the WSJ Blog.

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