Mayo Collaborative Services v. Prometheus Laboratories, Inc.
566 U.S. (2012)
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Rule of Law:
A process claim is not patent-eligible under 35 U.S.C. § 101 if it is directed to a law of nature and the additional steps consist of well-understood, routine, conventional activities, as such a claim fails to add a sufficient 'inventive concept' to transform the unpatentable natural law into a patent-eligible application.
Facts:
- Prometheus Laboratories, Inc. was the exclusive licensee of two patents related to optimizing the dosage of thiopurine drugs used to treat autoimmune diseases.
- The patents were based on the discovery of correlations between the concentration of certain metabolites in a patient's blood and the likelihood that a given dosage would be toxic or ineffective.
- The patents claimed a process involving (a) administering a thiopurine drug and (b) determining the resulting metabolite levels in a patient's blood.
- The claim then stated that if metabolite levels were outside a certain range, it 'indicates a need' to adjust the dosage.
- Scientists already knew that metabolite levels were correlated with drug efficacy, and the methods for determining these levels were well-known in the medical field.
- Mayo Collaborative Services, which had previously purchased Prometheus's tests, began using and selling its own similar diagnostic test that was based on the same natural correlations but used slightly different thresholds.
Procedural Posture:
- Prometheus Laboratories, Inc. sued Mayo Collaborative Services in U.S. District Court for patent infringement.
- The District Court granted summary judgment in favor of Mayo, holding the patents invalid under § 101 for claiming unpatentable laws of nature.
- Prometheus appealed to the U.S. Court of Appeals for the Federal Circuit, which reversed the District Court's decision, finding the claims patent-eligible.
- Mayo (the petitioner) filed a petition for a writ of certiorari, which the U.S. Supreme Court granted. The Court then vacated the Federal Circuit's judgment and remanded the case for reconsideration in light of its decision in Bilski v. Kappos.
- On remand, the Federal Circuit reaffirmed its earlier conclusion that the claims were patent-eligible.
- The U.S. Supreme Court granted Mayo's second petition for a writ of certiorari to hear the case.
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Issue:
Does a patent claim for a medical diagnostic process satisfy the subject matter eligibility requirements of 35 U.S.C. § 101 when it sets forth a natural law correlation and adds only the conventional steps of administering a drug to a patient and determining the resulting metabolite levels?
Opinions:
Majority - Justice Breyer
No. A patent claim for a medical diagnostic process does not satisfy the requirements of 35 U.S.C. § 101 when it merely recites a natural law and adds conventional steps to apply it. The claims do not transform the unpatentable natural correlations into a patent-eligible application because the additional steps are well-understood, routine, conventional activities previously engaged in by researchers. The 'administering' step simply identifies the relevant audience of doctors, the 'determining' step orders a routine blood test, and the 'wherein' clauses simply state the unpatentable law of nature. Viewing the steps as an ordered combination adds nothing inventive, as they amount to a simple instruction to 'apply the law.' Unlike the patentable process in Diamond v. Diehr, which integrated a formula into a specific, inventive industrial process, these claims are more like the unpatentable claims in Parker v. Flook, which added only conventional post-solution activity. Upholding these patents would improperly preempt the use of the underlying natural correlations, tying up the basic tools of scientific work and inhibiting future innovation.
Analysis:
This unanimous decision significantly narrowed the scope of patent-eligible subject matter for diagnostic methods and personalized medicine. It established a framework requiring an 'inventive concept' beyond the discovery of a natural law itself, effectively invalidating many patents that merely correlated a biological marker with a health condition. The case raised the bar for patentability under § 101, shifting the focus from whether a process was transformative to whether it added something genuinely new and non-routine to an underlying natural principle. This ruling, later solidified in Alice Corp. v. CLS Bank Int'l, has had a profound impact on the biotech and pharmaceutical industries, making it more difficult to protect investments in diagnostic research.
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