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The results of a patent infringement case that was recently argued before the U.S. Supreme Court could have a significant impact on the IVD industry and the development of diagnostic technologies.

In the case, Laboratory Corp. of America (LabCorp) v. Metabolite Laboratories, Metabolite sued LabCorp for infringing its patent on a method for testing homocysteine levels, which in turn are used to correlate vitamin B levels. In rebuttal, LabCorp argued that the relationship between homocysteine levels and vitamin B deficiency is a natural phenomenon and cannot be patented. The question presented to the court was whether a patent can claim a monopoly over a basic scientific relationship used in medical diagnosis if the claim is limited to correlating test results.

It is difficult to predict how the Court will rule in this case, but many legal experts believe that the justices may return the case to the lower courts to determine whether Metabolite’s patent complies with patent law. According to these experts, the justices may opt not to address the issue because the patent law was not properly applied and addressed by the lower courts.

Assuming that the Court decides to issue a ruling, however, there are differing opinions about how the outcome of the case might affect the IVD industry. Some industry analysts believe that if the Court ends up ruling in favor of LabCorp, it could have a negative effect on the industry. If the Court were to rule that Metabolite’s patent centers on an unpatentable natural phenomenon, it would affect all other patents with claims that are equally broad. Consequently, when IVD companies attempt to enforce such patents, alleged infringers will have access to a ready defense: the patent is invalid because the company has attempted to patent a naturally occurring phenomenon, so no infringement has taken place.

Other industry analysts believe that it would be in the IVD industry’s best interests for patent claims to be upheld only if their scope is clearly defined and directed to patentable inventions.

Given that the IVD patent field is a crowded one, the risk of such litigation is very high. Allowing questionable patents into the mix only complicates matters further. In the future, IVD companies may need to rethink the claims that they write into their patents and ensure that the focus of each patent is clearly defined.

The Supreme Court is expected to reach a decision on this case sometime in June. Stay tuned.