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EDITOR'S PAGE

A previous editorial (May 2006) discussed the patent infringement case of Laboratory Corp. of America v. Metabolite Laboratories, recently heard by the U.S. Supreme Court, and how its outcome could affect the IVD industry. Last month, the Court dismissed the case entirely.

In the original case, Metabolite had sued LabCorp for infringing its patent on a test for homocysteine level, which is used to ascertain a subject’s vitamin B level. LabCorp counterargued that since the relationship between the levels of homocysteine and vitamin B is a naturally occurring phenomenon, it cannot be patented.

In accepting the case, the Court initially agreed to consider whether the granting of a patent can establish a monopoly over a basic scientific relationship used in medical diagnosis if the claim is limited to correlating test results.

The Court gave no explanation for dismissing the case, but legal analysts believe that the Court dismissed the case for procedural reasons. The Court thus declined to rule on LabCorp’s argument that Metabolite’s patent constituted unpatentable subject matter—something that should have been but was not raised in the lower courts. In effect, the court decided that this was not the right case in which to issue a ruling on this matter.

With the Supreme Court’s decision, or lack thereof, it’s business as usual in the IVD industry—at least for now. IVD manufacturers won’t be scrambling to determine whether they must revise or refile their existing patents. And for now, IVD manufacturers have been given a sign that patents covering a broad scope of potential claims may be acceptable, so long as the patent documents have been drafted carefully.

If the Court’s dissenting justices have their way, however, it’s almost certain that this will not be the Court’s last opportunity to address the patent issues raised in the LabCorp case. Justices Breyer, Stevens, and Souter dissented from the Court’s decision to dismiss the case, and may have been inclined to rule in favor of LabCorp. In his dissenting opinion, Justice Breyer wrote, “It still would be valuable to decide this case. Our doing so would help diminish legal uncertainty in the area, affecting a substantial number of patent claims.”

In the next case that raises similar patent issues, attorneys will make certain to plead the issue of unpatentable subject matter at the trial court level. Before long, some court, somewhere, will have to rule on whether a company can patent a natural phenomenon.