Three university doctors found a correlation between high levels of homocysteine in the blood and deficiencies of two essential vitamins, folate and cobalamin.
They also developed more accurate methods for testing body fluids for homocysteine. They obtained a patent.
LabCorp licensed the tests from Metabolite in return for 27.5% of related revenues. Their agreement permitted LabCorp to terminate the arrangement if a more cost effective commercial alternative is available that does not infringe a valid and enforceable claim of the patent.
Years later, LabCorp decided to use a different test which it deemed far superior.
Metabolite sued LabCorp for using the other test claiming that they had a patent for checking the body fluid for an elevated level of homocysteine and correlating this level with a deficiency.
Procedural History:
Lower court found for Metabolite.
Circuit Court affirmed, found for Metabolite.
SCOTUS dismissed its writ of certiorari. Dissent given.
Issues:
Is a method patent valid if it merely directs a party to correlate test results to a certain human condition?
Holding/Rule:
(not really the holding since dissent) A method patent is not valid if it merely directs a party to correlate test results to a certain human condition.
Reasoning:
Laws of nature, natural phenomena, and abstract ideas are excluded from patent protection.
One cannot patent the law of gravity, the theory of relativity, or some mathematical formula.
They are excluded because too much patent protection can impede rather than promote scientific progress.
These phenomena are the basic tools of scientific and technological work; if they were patentable, then there would be enormous transaction costs placed on users.
The category of non-patentable phenomena of nature is not easy to define. However, this case is not on the boundary.
The correlation between homocysteine and vitamin deficiency is a natural phenomenon.
Metabolite argues that an application of a law of nature to a known process may be patentable.
This won't fly here though because their claim does not describe a process for transforming blood or any other matter.
The process instructs the user to "(1) obtain test results and (2) think about them."
Metabolite also argues that it should be patentable since it produces a useful, concrete, and tangible result.
SCOTUS has never said that; in fact, Court has rejected many such claims (telegraphy, binary -> decimal converter, etc.).
Even if it were patentable it still falls short because it amounts to a simple natural correlation, i.e., a natural phenomenon.
Their process is no more than an instruction to read some numbers in light of medical knowledge.
Their process might be reduced to a series of steps, but any process can be reduced to steps.
