Eric E. Bensen on the Supreme Court's Decision in Mayo Collaborative Servs. v. Prometheus Labs. on the Patent Eligibility of a Medical Diagnostic Claim

Eric E. Bensen on the Supreme Court's Decision in Mayo Collaborative Servs. v. Prometheus Labs. on the Patent Eligibility of a Medical Diagnostic Claim

[originally posted 3/27/2012]

In Mayo Collaborative Servs.v. Prometheus Labs., Inc., 2012 U.S. LEXIS 2316 (U.S. 2012) [enhanced version available to lexis.com subscribers], the Court addressed the question of whether a claim that includes a law of nature (or a natural phenomenon or a mathematical algorithm) has "enough" in the way of other limitations to distinguish the claim from one drawn to the law of nature itself. However, Prometheus Labs. arguably resolves a number of questions that have been part of the patent eligibility debate since the Court's last decision in Bilski v. Kappos, 130 S. Ct. 3218 (2010) [enhanced version available to lexis.com subscribers]. In this Analysis, Eric E. Bensen discusses the Court's recent decision. He writes:

The Supreme Court's Decision

     The Court began its discussion by repeating now familiar rules:

1. Laws of nature, natural phenomena, and abstract ideas are not patent eligible.

2. A process is not ineligible simply because it contains a law of nature or mathematical algorithm.

3. An application of a law of nature or mathematical formula to a known structure or process may be patent eligible.

     Getting to the heart of the matter, the court further observed that to transform a patent ineligible law of nature into a patent eligible application of the law, "one must do more than simply state the law of nature while adding the words 'apply it.'" As a court explained, the question of patent eligibility should not "depend simply on the draftsman's art," rather, the question of patent eligibility should be determined with reference to the principles underlying the prohibition against patents on laws of nature, i.e., the policy against patent claims that preempt any use of a natural law. Thus, where a natural law is part of the patent claim, eligibility will turn on whether the other elements, i.e., the "inventive concept," are sufficient to ensure that the patent claims something more than the natural law itself.

     With respect to Prometheus' patent, the question in the court's view was whether the claims added "enough" to the natural law they recite, i.e., the correlation between the metabolites in the patient's body and the proper dosage of the administered drug, to constitute a patent eligible application of the natural law. Put differently, the question was whether the claims included additional features that would provide practical assurance that the claimed process was more than a drafting effort designed to monopolize the law of nature they recited.

     The court concluded that the claim limitations not drawn to the natural law, i.e., the "administering" step, the "determining" step and the comparison of metabolite levels (the last of which the court referred to as the "wherein" clauses) were insufficient to distinguish the claim from a claim drawn to the natural law itself. As a court explained, the "administering" step simply referred to the preexisting audience of doctors who used thiopurine drugs and, in any event, was a mere field of use limitation that was not sufficient to render an otherwise mere law of nature patent eligible. The "wherein" clauses, in the Court's view, merely suggested to doctors that they should take the natural law into account when treating a patient. The "determining" step merely told doctors to engage in a "well understood, routine, conventional activity previously engaged in by scientists to work in the field" and, thus, was a mere "conventional or obvious ... [pre-]solution activity" that did not transform a law of nature into a patent eligible application of the law. The three steps viewed in combination similarly failed to distinguish the claim from one drawn to a law of nature itself because the three steps simply told doctors to gather data from which they could draw an inference in light of the correlations.

     ....

Comments

     Prior to Bilski, courts had only on occasion addressed questions of patent eligibility and, one could argue, appeared content to resolve those issues on a case-by-case basis. Since Bilski, however, whether due to the nature of contemporary innovation or simply a new focus on a potential defense to infringement, eligibility challenges have become commonplace. As a result, courts have been under increased pressure to better define the contours of eligibility.

     Time will tell whether the Court made much headway in that respect with its Prometheus Labs. decision. By adhering closely to its precedent, the Court arguably did not change the law respecting eligibility. At the same time, its holding that for a claim that incorporates a law of nature to be patent eligible, the other elements of the claim must be "enough" to ensure that the claim as a whole is not drawn to the law of nature itself, if not viewed by courts as a new rule, is likely to be viewed as at least a significant tool for resolving the eligibility question. What constitutes "enough," however, is certain to be the source of much dispute.

(citations omitted)

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