Mayo Collaborative Services v. Prometheus Laboratories, Inc.
132 S. Ct. 1289
| SCOTUS | 2012Background
- Mayo Collaborative Services sued Prometheus Laboratories for patent infringement regarding diagnostic tests tied to Prometheus’s thiopurine metabolite correlations.
- Prometheus owned two patents, the ’623 and ’302 patents, claiming methods to optimize thiopurine drug dosing by measuring metabolite levels.
- Claims recited three steps: administer a thiopurine, determine metabolite levels, and employ “wherein” limits to suggest dosage changes.
- The claimed correlations related to levels of 6-thioguanine and 6-MMP metabolites predicting toxicity or efficacy.
- Lower courts held the patents invalid under §101 as claiming natural laws, with remand after Bilski confirming that machine-or-transformation is not a definitive test.
- The Supreme Court reversed, holding the claimed processes are not patent-eligible because they effectively claim natural laws without an inventive concept.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the claims patent natural laws themselves | Prometheus argues the claims apply natural correlations through additional steps | Mayo argues conventional transformations render claims patentable | Not patent-eligible; laws of nature excluded, no sufficient inventiveness to qualify |
| Do the three steps add enough to transform the laws into patentable applications | The steps transform the laws into a practical application | Steps are well-understood, routine activities that do not amount to an inventive concept | No; steps add nothing significant beyond the natural correlations |
| Is the machine-or-transformation test controlling for eligibility | Test supports patent eligibility | Test is only a clue, not a definitive standard | Not controlling; cannot override the law-of-nature exclusion |
| Should narrowing the scientific law affect patent eligibility | Narrow laws should be patentable | Narrowness does not cure preemption or prevent blocking innovation | No; patent-eligibility depends on preemption risk, not the law’s breadth |
Key Cases Cited
- Diamond v. Diehr, 450 U.S. 175 (Supreme Court (1981)) (patentable when additional steps integrate a formula into the process)
- Gottschalk v. Benson, 409 U.S. 63 (Supreme Court (1972)) (abstract ideas not patentable; transformation not enough)
- Parker v. Flook, 437 U.S. 584 (Supreme Court (1978)) (post-solution activity must contribute something; mere formula not enough)
- Morse v. Morse, 15 How. 62 (U.S. Supreme Court (1854)) (early concern about monopolizing fundamental tools of science)
- Diamond v. Chakrabarty, 447 U.S. 303 (Supreme Court (1980)) (not all discoveries of nature are excluded; but patenting requires invention beyond mere discovery)
- Bilski v. Kappos, 130 S. Ct. 3218 (Supreme Court (2010)) (machine-or-transformation not definitive; abstract ideas not patentable)