Mental Steps in Method Claims
Laboratory Corp. of America v. Metabolite Laboratories
On October 31, 2005, The United States Supreme Court granted a writ of certiorari in the case of Laboratory Corp. of America v. Metabolite Laboratories in order to review the question:
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.
On June 22, 2006, the Supreme Court (with three dissenters) decided that its writ of certiorari had been improvidently granted1 and that it would therefore dismiss the writ and not decide the question.
The claim in question was:
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.
The Court of Appeals for the Federal Circuit had upheld a jury verdict of induced infringement where the literature issued by the supplier of a homocysteine assay advocated using it for identifying a need for cobalamine/folate supplements. In testimony before the district court, the patentees had agreed that the correlation step of the claim could take place in a physician's brain. In the lower courts, the defendants had never clearly argued the issue of whether this claim complied with the requirements of 35 USC § 101. The arguments had rather focused on the written description requirement of 35 USC § 112, which the Federal Circuit had found to be met. In their brief to the Supreme Court, the defendants argued that since, on the court's construction of the claim, the only activity required to reach this conclusion was the mental activity of a physician on receiving results of the assay, to read the claim this broadly meant that what was in fact being claimed was any use of the underlying discovery of a correlation between homocysteine values and a cobalamine or folate deficiency, homocysteine assays being used already for other purposes. They argued that this was tantamount to patenting a rule of nature which was contrary to established case law, while avoiding relying on 35 USC § 101 directly.
Many had felt in view of the fact that the issue of 35 USC § 101 had not been squarely before the lower courts that it was rash of the Supreme Court to grant certiorari. It seems that a majority of the court ultimately came to the same view. Justice Breyer, with whom Justices Stevens and Souter agreed,2 took the view that although 35 USC § 101 was not formally in the case, the arguments put forward clearly raised all of the relevant issues so there was no reason why the Supreme Court should not have gone ahead with its consideration of the case and find the claim invalid as being an impermissible claiming of a natural phenomenon.
1 By custom, in order for the Supreme Court to agree to review a lower court decision by way of certiorari, it is necessary that at least four of the nine justices on the court vote in favor of doing so. On occasion the Supreme Court will request the opinion of the Solicitor General of the United States on whether certiorari should be granted - as it did in this case - but it need not follow the Solicitor General's recommendation and did not in this case. Even when certiorari has been granted, this does not mean that the Supreme Court will actually decide the case since there always remains a possibility, albeit a small one, that the Court will change its mind on the grant of certiorari and conclude that this was "improvidently granted".
2 All three of whom had joined with Kennedy J in his concurring opinion in e-Bay v. Mercantile Exchange in which they had gone beyond the reasoning of the majority (which had essentially said that when considering the grant of a permanent injunction in a patent case the statute requires the court to look to the requirements of equity) to argue that in the present environment there were cases where it might be difficult to justify the grant of an injunction, for example certain situations where the patent owner was not itself using the invention.
