Mayo Collaborative Services and Mayo Clinic Rochester (Defendant) argued that processes claimed by patents exclusively licensed by Prometheus Laboratories, Inc. (Plaintiff) basically claimed natural laws or natural phenomena, that is, the correlations between thiopurine metabolite levels and the toxicity and efficiency of thiopurine drugs, and, therefore, were unpatentable.
Under Â§ 101 of the Patent Act, a patent is invalid as a natural law where steps in the claimed processes involve, in addition to natural laws themselves, well-understood, routine, conventional activity previously participated in by researchers in the field and where upholding the patent would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.
Prometheus Laboratories, Inc. (Plaintiff) was the one and only licensee of two patents that concerned the use of thiopurine drugs to treat autoimmune diseases.Â The body metabolizes the ingested drugs, producing metabolites in the bloodstream.Â Because patients metabolize these drugs differently, doctors have found it hard to determine whether a particular patient’s dose is too high, risking harmful side effects, or two low, making it ineffective.Â The patent claims for the patents set forth processes embodying researchers’ findings that identified correlations between metabolite levels and likely harm or ineffectiveness with precision.Â Each claim recited (1) an â€œadministeringâ€ stepâ€”instructing a doctor to administer the drug to his or her patient; (2) a â€œdeterminingâ€ stepâ€”telling the doctor to measure the resulting metabolite levels in the patient’s blood; and (3) a â€œwhereinâ€ stepâ€”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 â€œindicate a needâ€ to decrease or increase (respectively) the drug dosage.Â Plaintiff sold diagnostic tests incorporating these processes.Â For awhile, Mayo Collaborative Services and Mayo Clinic Rochester (collectively â€œMayoâ€) (Defendant) bought and used Plaintiff tests, but then decided to market and sell its own similar tests using metabolite levels somewhat higher to determine toxicity.Â Plaintiff brought suit against Defendant for patent infringement.Â The district court, although concluding that Defendant infringed the patents at issue, still held that the patents were invalid as laws of nature under Â§ 101 of the Patent Act.Â The Federal Circuit reversed, holding that the processes were patent eligible under the â€œmachine or transformation testâ€ as they included steps that involve the transformation of the human body or blood taken from it.Â That holding was appealed to the United States Supreme Court, and, on remand from the Supreme Court for reconsideration in light of Bilski v. Kappos, 130 S. Ct. 3218 (2010), which clarified that the â€œmachine or transformation testâ€ is not a definitive test of patent eligibility, the Federal Circuit reaffirmed its earlier conclusion.Â The United States Supreme Court granted certiorari.
Is a patent invalid under Â§ 101 of the Patent Act, as a natural law where steps in the claimed processes involve, in addition to natural laws themselves, well-understood, routine, conventional activity previously participated in by researchers in the field and where upholding the patent would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries?
(Breyer, J.)Â Yes.Â Under Â§ 101 of the Patent Act, a patent is invalid as a natural law where steps in the claimed processes involve, in addition to natural laws themselves, well-understood, routine, conventional activity previously participated in by researchers in the field and where upholding the patent would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.Â Because the laws of nature recited by Prometheus’ patent claimsâ€”the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harmâ€”are not themselves patentable, the claimed processes are not patentable unless they have added features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations.Â The three additional steps in the claimed processes here are not themselves natural laws but are also not enough to transform the nature of the claims.Â The â€œadministeringâ€ step simply identifies the audience that will be interested in the correlations, namely, doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders.Â Doctors had been using these drugs for this purpose long before these patents existed.Â In addition, a prohibition against patenting abstract ideas cannot be circumvented by trying to limit the use of the formula to a particular technological environment.Â The â€œwhereinâ€ clauses simply tell a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions.Â The â€œdeterminingâ€ step tells a doctor to measure patients’ metabolite levels, through whatever process the doctor prefers to use.Â Since methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field.Â Such activity is usually not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.Â Finally, considering the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately.Â A more detailed consideration of the controlling precedents reinforces this conclusion.Â Precedents addressing processes using mathematical formulas held that, like laws of nature, such formulas are not themselves patentable.Â However, where additional steps of the process transformed the process into an inventive application of the formula, the overall process was eligible for patent.Â But where the additional steps of the process did not limit the claim to a particular application, and the processes at issue were all â€œwell known,â€ to the point where, putting the formula to the side, there was no â€œinventive conceptâ€ in the claimed application of the formula the process was held not patent eligible.Â In this case, the claim presents a case for patentability that is weaker than under precedent finding a patent-eligible claim and no stronger than precedent where the process was held to be unpatentable.Â The three steps add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.Â Still another concern that the Court has emphasized is that patent law not inhibit future discovery by improperly typing up the use of laws of nature and the like.Â Rewarding those who discover laws of nature with patents might encourage their discovery, but because those laws and principles form the basic tools of scientific and technological work, there is a danger that granting patents that tie up their use will inhibit future innovation.Â This danger becomes acute when a patented process is no more than a general instruction to â€œapply the natural law,â€ or otherwise excludes more future invention than the underlying discovery could reasonably justify.Â The patent claims at issue implicate this concern, notwithstanding that the laws of nature involved are narrow ones with limited applicability.Â In telling a doctor to measure metabolite levels and to consider the resulting measurements in light of the correlations they describe, they tie up her subsequent treatment decision regardless of whether she changes the dosage in light of the inference she draws using the correlations.Â They also threaten to inhibit the development of more refined treatment recommendationsâ€”such as those presented by Mayo (Defendant)â€”that combine Plaintiff’s correlations with later discoveries.Â This reinforces the conclusion that the processes at issue are not eligible for patent, while removing any temptation to depart from case law precedent.Â Additional argument supporting Prometheus’ position must be rejected.Â The argument that the process is patent eligible because it passes the â€œmachine or transformation testâ€ fails for insufficient transformation of the body or its blood.Â Similarly, the argument that the process is patent eligible because the particular laws of nature that the claims embody are narrow and specific also fails because the underlying functional concern is a relative one that measures how future innovation is foreclosed relative to the contribution of the inventor.Â Also unpersuasive is the argument that the Court should not invalidate these patents under Â§ 101 because the Patent Act’s other validity requirements will screen out patents that are overly broad; such an approach would make the â€œlaw of natureâ€ exception to Â§ 101 patentability useless.Â Finally, the argument that a principle of law denying patent coverage here will discourage investment in discoveries of new diagnostic laws of nature is also not convincing, because while protecting some discoveries, such a principle will also inhibit further scientific research and discovery by tying up critical scientific data.Â Reversed.
This decision makes clear that once a law of nature is identified in a claim, the remaining elements, in order to satisfy Â§ 101, cannot be as generic as â€œapply it,â€ and they cannot be â€œwell-understood, routine, conventional activity already engaged in by the scientific communityâ€ or â€œwhen viewed as a whole, add nothing significant beyond the sum of their parts taken separately.â€Â However, the decision fails to explain how the steps of a process might serve to limit the application of a law of nature in a way to render a claim patent-eligible.Â This shortcoming can be seen in guidelines issued by the Patent & Trademark Office shortly after the Supreme Court’s decision in Mayo was handed down.Â Those guidelines basically direct examiners that if a claimed invention is a process that focuses on a law of nature, in order to be patent-eligible, it must include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself.Â However, other than providing some examples of sufficiency, it does not provide guiding principles for what constitutes sufficient additional steps or combination of elements.Â In the absence of broad guidance from the Supreme Court,Â examiners and the courts will have to make that determination on a case-by-case judgment-call basis.