## Facts

- University researchers discovered that elevated total homocysteine in body fluid is associated with deficiencies of cobalamin (vitamin B12) or folate (vitamin B9).
- A patent issued claiming, as relevant here, a method that (1) assays body fluid for elevated total homocysteine and (2) correlates an elevated level with a cobalamin or folate deficiency.
- Through assignments and licensing, Metabolite became a licensee and LabCorp obtained a sublicense to perform the test in exchange for per-use royalties.
- LabCorp later used an alternative homocysteine test developed by Abbott Laboratories and stopped paying royalties for tests performed using that method.
- Metabolite sued LabCorp for inducement and contributory infringement of the diagnostic-method claim and for breach of the license agreement.
- A federal jury found LabCorp liable and awarded about $4.7 million in damages; the district court entered a permanent injunction.
- The Federal Circuit affirmed, rejecting LabCorp’s contention that the claim improperly covered a natural phenomenon.

## Issues

1. Whether a diagnostic method claim requiring “assaying” and then “correlating” a test result with a medical condition improperly claims a basic scientific relationship or natural phenomenon.
2. Whether such a claim can effectively make a physician an infringer based on recognition of the correlation after receiving test results.
3. Whether the Supreme Court should decide these questions on the granted petition for certiorari.

## Decision

- The Supreme Court dismissed the writ of certiorari as improvidently granted in a per curiam order.
- The Court issued no merits ruling on patent eligibility, claim validity, or infringement.
- The Federal Circuit’s judgment for Metabolite remained in effect.
- Chief Justice Roberts did not participate.
- Justice Breyer, joined by Justices Stevens and Souter, dissented from the dismissal and would have reached the merits.

## Legal Principles

- A dismissal of certiorari as improvidently granted leaves the lower-court judgment undisturbed and creates no Supreme Court precedent on the merits.
- The Court’s disposition did not resolve whether the asserted diagnostic-method claim was patent-ineligible as a law of nature or natural phenomenon.
- In dissent, Justice Breyer reasoned that a claim directed to a natural correlation, with only general “assaying” and “correlating” steps, risks impermissible preemption and is not made patent-eligible merely by framing the correlation as a “process.”

## Conclusion

The Supreme Court ended the case without addressing whether the diagnostic correlation claim was patent-eligible, dismissing certiorari as improvidently granted and leaving in place the Federal Circuit’s decision enforcing the patent against LabCorp.


Laboratory Corp. of Am. Holdings v. Metabolite Lab’ys, Inc., 548 U.S. 124 (2006)