Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.
Headline: Court declines to rule on whether a patent can cover a natural medical link, dismissing review and leaving a lower-court ruling and injunction that affect labs and doctors’ homocysteine testing.
Holding:
- Leaves the lower-court injunction limiting homocysteine-only tests in place.
- Maintains damages award against the testing lab for unpaid royalties.
- Keeps uncertainty about patenting natural medical correlations.
Summary
Background
A company that owned a patent claimed a method for detecting vitamin B deficiencies by checking for elevated homocysteine levels. A large medical testing company (LabCorp) stopped paying royalties for a different lab test and was sued. Lower courts found the patent valid, assessed damages, and enjoined LabCorp from performing homocysteine-only tests that would lead doctors to diagnose deficiencies.
Reasoning
The narrow question was whether a patent that essentially tells a doctor to “test for homocysteine and correlate the result with vitamin deficiency” improperly claims a natural medical relationship. The Supreme Court dismissed its review as improvidently granted and gave no ruling on that legal question. Justice Breyer, joined by Justices Stevens and Souter, wrote a dissent arguing the Court should have decided the issue and explaining why he believed the claim was an unpatentable natural phenomenon.
Real world impact
Because the Court declined to decide the merits, the lower-court judgment — including the damages award and the injunction limiting homocysteine-only tests — remains in effect. The dissent warned that leaving the issue unresolved could affect how doctors and labs use basic medical correlations, increase licensing and legal costs, and create uncertainty about patents on medical discoveries.
Dissents or concurrances
Justice Breyer dissented, arguing the patent improperly monopolizes a natural relationship and urging the Court to resolve the issue to protect medical practice and clarify the law. The Chief Justice did not participate.
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