A recent unanimous decision (Mayo Collaborative Sevices. v. Prometheus Labs. Inc.) by the United States Supreme Court has invalidated two patents held by Prometheus Labs Inc. on the basis that the claims contained patent ineligible subject matter.
Prometheus' claims covered a method of optimizing treatment of gastrointestinal disorders by administering a drug providing 6-thioguanine to a subject and then determining the level of 6-thioguanine in the subject. A 6-thioguanine level below a specified amount indicated a need to increase drug dosage and a level of 6-thioguanine greater than a specified amount indicated a need to decrease drug dosage.
The Supreme Court reversed the decision of the Federal Circuit Court of Appeals and held that in claims incorporating elements based on "laws of nature", the other elements must be separated out to determine whether they meet patentability requirements of novelty, non-obviousness, enablement and patentable subject matter. The decision also held that a determination of patent eligibility (that is patentable subject matter) must be made, even when a decision on patent validity could be made on the other grounds of novelty, non-obviousness or enablement (written description requirements).
Applicability of the "machine-or-transformation" test in determining patentability also came under fire again. In 2010's Bilski v. Kappos decision, the Supreme Court determined that the test cannot be the exclusive test for patentability. In Mayo, the Court states that the test may also not be sufficient for determining patentability of claims applying the laws of nature.
The decision will have significant repercussions not only for diagnostic and life science-based patentees, but in other technology areas as well. Particularly, in the case of business method and software patents reciting a natural law such an algorithm, it may now need to be determined if the remaining elements of the claim add sufficient patentable subject matter for the claim to be considered patent eligible.
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