Mayo Collaborative Services V Prometheus Labs IncEdit
Mayo Collaborative Services v. Prometheus Labs, Inc. (566 U.S. 66, 2012) is a landmark ruling from the Supreme Court of the United States that reshaped the boundaries of patent-eligible subject matter in the biotechnology and medical diagnostics arenas. The case centered on whether a diagnostic method that links a natural biological relationship to treatment decisions could be protected as a patent, or whether such protection would improperly monopolize a natural phenomenon. The Court held that the claimed diagnostic steps—when framed as a law of nature combined with routine, conventional clinical steps—were not patent-eligible under 35 U.S.C. § 101.
In practical terms, Mayo Collaborative Services v. Prometheus Labs, Inc. established and reinforced a two-part test that courts would rely on to distinguish truly inventive diagnostics from claims that merely recite a natural correlation. The ruling underscored that patent protection should not be extended to fundamental natural relationships that could preempt a broad swath of future medical research and patient care. The decision is frequently cited as a touchstone in debates about how to incentivize biomedical innovation while avoiding overreach that would hamper clinical practice or steer research into narrow, patent-protected channels.
Background
Mayo Collaborative Services, a division associated with the Mayo Clinic, partnered with Prometheus Labs, Inc. to develop and commercialize a diagnostic test that measured a patient’s metabolite levels and used that information to guide dose adjustments for a drug therapy. The parties sought patents on the method that connected measured metabolite levels to therapeutic decisions, arguing that the patent would cover a clinically useful, non-obvious process. See also Mayo Clinic for organizational context and Prometheus Laboratories for the company involved.
The claimed methods were premised on a natural correlation: certain biochemical markers in a patient’s blood or plasma vary in a way that reflects how the patient metabolizes or responds to a medication. The question was whether patent law could extend to cover the practical application of this natural law in a clinical setting.
The Case
Procedural posture: Prometheus Labs sued for patent infringement, and the matter moved through the federal courts, culminating in a decision by the Supreme Court on whether the asserted claims were patent-eligible subject matter under 101.
Court’s reasoning: The Court laid out a framework in which a claim is first analyzed to determine whether it is directed to a patent-ineligible concept (such as a natural law, a natural phenomenon, or an abstract idea). If it is, the claim must add something “significantly more” than the natural law to qualify for patent protection. In Mayo’s view, the steps that followed the discovery of the natural correlation (for example, administering a drug and measuring its metabolites) were routine and conventional clinical steps that did not transform the correlation into a patent-eligible invention.
Outcome: The claims were deemed not patent-eligible because they effectively covered the natural phenomenon itself and added only conventional steps. The decision did not preclude patent protection for other kinds of diagnostic innovations, but it set clear limits on attempts to monopolize natural relationships through routine clinical procedures.
Legal framework implications: The decision contributed to the broader 101 jurisprudence surrounding diagnostic methods, laying groundwork that later cases would rely on and refine, including the ongoing dialogue illustrated by Alice Corp. v. CLS Bank International and later discussions around personalized medicine and diagnostic patents.
Legal framework and subsequent impact
The Mayo framework: The decision helped crystallize what is now described as a two-part analysis for patent-eligibility under 101: first, identify whether a claim is directed to a natural law or other ineligible concept, and second, determine whether the claim contains an “inventive concept” that amounts to something more than the natural phenomenon itself.
Influence on later cases: Mayo is frequently cited in conjunction with later decisions shaping diagnostic and software-related patent eligibility, including Alice Corp. v. CLS Bank International and, in related biomedical contexts, Myriad Genetics’s discussions on genetic patents. The evolving body of case law continues to balance incentives for innovation with safeguards against preempting fundamental natural phenomena.
Industry implications: For a period, the ruling encouraged biopharma and diagnostics companies to rethink claim strategies—shifting away from attempts to patent broad correlations and toward patenting specific, non-obvious technical improvements, data-processing innovations, or novel applications that go beyond the natural relationship at issue. See also Biotechnology industry and Intellectual property in medicine for broader context.
Controversies and debates
Pro-innovation perspective: Supporters argue that Mayo protects the core idea that natural laws and biological correlations should remain in the public domain, while preserving room for genuine invention that meaningfully improves diagnostic methods through non-obvious technical contributions. They contend that this approach supports patient access and competitive markets by avoiding a patent landscape where natural phenomena are locked up and clinicians must navigate expensive, monopolized diagnostic regimes.
Critics' concerns and the right-of-center view: Critics often worry that overly strict 101 limitations chill investment in high-risk, high-cost biotech ventures. They argue that until a clear, enforceable boundary is established, researchers and startups may fear that their discoveries will be unfairly blocked from patent protection, undermining long-run incentives to invest in expensive diagnostics development and clinical validation. From this vantage, Mayo is part of a broader debate about how best to incentivize bold research while ensuring that medical advances remain accessible and affordable.
Controversy and “woke” criticisms: Some observers link patent policy to broader social concerns about access to healthcare, pricing, and equity. From a conservative, innovation-centered perspective, the counterargument is that robust IP rights are essential to attract capital for risky biomedical ventures, which ultimately expands the pipeline of new tests and treatments. Critics who frame patent policy as primarily a tool for social justice may overlook the empirical link between strong property rights and the capacity to fund early-stage research. Supporters of the Mayo approach often argue that fixing problems in healthcare access and cost is better achieved through targeted regulatory and competition policies rather than weakening patent protections that support R&D funding.
Practical takeaway: The central controversy remains whether the legal framework should emphasize preventing preemption of natural laws at the cost of slowing diagnostic innovation or whether it should safeguard investment incentives by requiring a more substantial, non-obvious technical contribution beyond the natural correlation.