The Handiwork of Nature: Patentable Subject Matter and Laboratory Corporation V. Metabolite Labs
33 Pages Posted: 18 Dec 2005
Date Written: December 17, 2005
The patent statutes establish that "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof [can be patented.]" Whereas, the wording of the statute is broad, it is nonetheless well-established that mathematical algorithms, laws of nature, natural phenomena, and abstract ideas cannot be patented. The Supreme Court, in interpreting the patent statutes, has consistently held that such discoveries "are not the kind of 'discoveries' that the statute was enacted to protect". In a recent Federal Circuit case, Metabolite Labs., Inc. v. Laboratory Corp. of Am. Holdings, the court held claim 13 of Metabolite's 4,940,658 patent valid. The claim has two limitations: " 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 [vitamin B] deficiency . . . ." The Federal Circuit ruled that "[t]he correlating step is a simple conclusion that a [vitamin B] deficiency exists vel non based on the assaying step". The court also found that every time a doctor orders any total homocysteine level assay, whether it is patented by Metabolite or is part of the prior art, and merely thinks about the natural relationship between elevated homocysteine level and vitamin B deficiencies, she directly infringes claim 13. The Supreme Court has granted certiorari on this case and should overturn the decision. As it stands, the ruling would set a precedent that those who discover laws of nature can obtain patents on methods comprising  collecting data related to a law of nature and  thinking about the law of nature. Such patents, especially when taken in aggregate, have the potential to stifle the practical application of science. Such a result would be antithetical to the patent system's goal of promotion of the useful arts. In this paper, I argue that Metabolite's claim 13 is unpatentable because it is drawn to a law of nature in view of Parker v. Flook and Diamond v. Diehr. I then argue that, even if claim 13 were not a patent on the law of nature, it precludes all practical use of the law of nature and therefore is unpatentable under Gottschalk v. Benson and Diamond v. Diehr. I further argue that claim 13 is unpatentable because it merely claims what the Funk Bros. Seed Co. v. Kalo Inoculant Co. and Diamond v. Chakrabarty courts termed the "handiwork of nature".
Keywords: medical diagnosis, patentable subject matter, law
JEL Classification: I10, I18
Suggested Citation: Suggested Citation