LabCorp v. Metabolite, Inc., 548 U.S. 124 (2006), is the first case since Diamond v. Chakrabarty[1] in which the U.S. Supreme Court indicated a renewed interest in examining the limits of patentable subject matter for advances in life sciences.
The single claim at issue, claim 13, is reproduced in full below: "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."
Claim 13 is a diagnostic method for detecting deficiencies of vitamins B6 and B12 that relies on the correlation of that condition with elevated levels of homocysteine.
Breyer's dissenting opinion cited numerous cases in which scientific and mathematical principles had been held to be patent ineligible, including O'Reilly v. Morse[4] and Gottschalk v.
[7] That did not lead, however, to invalidation of all drug patents on the grounds that the inventors "merely discovered that certain chemicals interact with the human body in ways directed by chemistry."