Laboratory Corporation of America Holdings (Lab. Corp.)
v. Metabolite Laboratories, Inc (Metabolite)

The patent at issue in the case relates to methods for detecting Cobalamine (Vitamin B12) and Folate (Folic Acid) deficiency by determining the levels of homocysteine in the body. The claim in question pertains to a method of detecting deficiency of cobalamine or folate in warm-blooded animals comprising the following steps: assaying a body fluid for an elevated level of total homocysteine and correlating the values to an elevated level of total homocysteine in said body fluid with a deficiency of cobalamine or folate.

The successor of University Patents Inc. (the patent holder), Competitive Technologies Inc., licensed the patent to Metabolite which in turn sublicensed the patent to Roche Biomedical Laboratories (now Lab Corp). Lab Corp. exercised the licensed patent and paid royalties under the License to Metabolite. For some time, LabCorp performed total homocysteine assays under the sublicense. However, after a while, it switched to another total homocysteine assay developed by Abbott Laboratories and discontinued royalty payments to Metabolite for total homocysteine assays.

In response, Metabolite sued LabCorp for infringement in the District Court of Colorado. The district court held that LabCorp was liable for contributory infringement and granted damages to a tune of seven million dollars. The court said that the doctors by co-relating levels of homocysteine to Vitamin B deficiency infringed claim 13 of the patent. As Lab Corp. supplied the data to make such an analysis, it said that Lab Corp. was liable for contributory infringement. During the proceedings, Lab Corp. argued that claim 13 was not valid because it claims a scientific principle, i.e. the relationship of homocysteine to cobalamine and folic acid deficiency and not a specific method based on it. The court rejected this argument and stated that the claim is not a scientific principle. The Federal Circuit upheld the decision of District Court on validity of the patent claim and infringement by Lab Corp.

The US Supreme Court accepted the writ of certiorari filed by Lab Corp., challenging the decision of the Federal Circuit on validity of claim 13 of the patent. The question to be decided by the court was "Whether a vaguely worded patent claim "directing a party simply to correlate test 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."

About eighteen Amici briefs were filed by different parties in addition to briefs of petitioner and respondents. The briefs pointed out different issues involved in the case. The arguments primarily revolved around whether the co-relation between homocysteine and cobalamine/folic acid was a scientific principle or natural law. The petitioner argued that it is a natural law or principle and the respondent argued that it is not. Most Amici in support of both parties submitted that granting or not granting a patent over the co-relation would have an impact on scientific progress, medical treatment and diagnosis. Amici that filed neutral arguments submitted that the jurisprudence relating to business methods or software that evolved based on Diehr should not be disturbed by the Laboratory Corp. case.

After hearing all the arguments, the US Supreme Court dismissed the writ of certiorari as improvidently granted. By dismissing the writ, the Supreme Court effectively upheld the decision of the Federal Circuit, which means that Claim 13 of the patent is valid and that Laboratory Corp. is liable for patent infringement. As the court did not decide the case, it did not change the existing principles relating to patentability. Three judges of the Supreme Court dissented the dismissal of the case by stating that the case is too important to be dismissed. They observed that the procedural objection raised by the Respondent was tenuous and that it was necessary in furtherance of public interest to clarify the line between a patentable invention and a non-patentable natural principle. The judges also pointed out that the record was comprehensive enough to merit a decision.