Biomedical Patent Found Invalid in Mayo Collaborative Services v. Prometheus Laboratories
Mayo Collaborative Services v. Prometheus Laboratories, which has had a confusing track from the Federal Circuit to the Supreme Court, finally received a ruling earlier this week. The short answer is that the claims were found in a unanimous decision to be non-patentable subject matter.
The court summarizes the claims as:
“Each claim recites (1) an “administering” step—instructing a doctor to administer the drug to his patient—(2) a “determining” step—telling the doctor to measure the resulting metabolite levels in the patient’s blood—and (3) a “wherein” step—describing the metabolite concentrations above which there is a likelihood of harmful side-effects and below which it is likely that the drug dosage is ineffective, and informing the doctor that metabolite concentrations above or below these thresholds “indicate a need” to decrease or increase (respectively) the drug dosage.”
The Court found that patent claims must do more than just apply a law of nature in order to be patent eligible subject matter. According to the Court, the additional steps claimed were insufficient to transform the nature of the patent claims into something more than a recitation of a law of nature. The justices found that the step of adjusting the dosage based on the level of the drug in the blood is well known in the art, and was insufficient to transform the claims to patentable subject matter.
The court did not reinstate the machine or transformation test it overruled as the sole determining factor for patentability under 35 U.S.C. § 101 in Bilski v. Kappos. Instead the court relied on its prior precedent of Diehr and Flook, analogizing the claim to Flook’s non-patentable well-known chemical process. The Court reaffirmed its stance that laws of nature are non-patentable subject matter, with the reasoning that although allowing the patenting of laws of nature might encourage their discovery, it could otherwise foreclose more future invention than the underlying discovery would reasonably justify.