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The Supreme Court Rewrites Patentable Subject Matter... Again

March 23, 2012

Hamilton Brook Smith Reynolds Alert

The Supreme Court has finally issued its anxiously-awaited opinion in Mayo v. Prometheus concerning the fundamental question of whether certain methods relating to medical treatments are patentable under U.S. law. The immediate impact of the Court's decision will be to call into question the patentability of medical treatment claims that use known procedures in combination with laws of nature to treat patients. However, the decision will also impact claims in other areas of technology that use known methods to apply "laws of nature."

In the unanimous decision, the Court reversed the Federal Circuit, and held that the asserted claims of two of Prometheus's patents were not directed to patent eligible subject matter and therefore were invalid under U.S. patent law. While the claims at issue were in the field of personalized medicine - specifically, methods of optimizing treatment of an immune-mediated gastrointestinal disorder by administering a drug and determining the levels of a metabolite of the drug in the blood of the subject with a "wherein" clause that describes when dosages of the drug should be changed to optimize the therapeutic effect of the drugs - the Court's decision has broad implications that may reach other fields and will have to be resolved by the courts, the USPTO, patent stakeholders, and possibly Congress, in the months and years to come.

The patent laws, specifically 35 U.S.C. § 101, define patent eligible subject matter broadly as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof...." Prior decisions have construed an implicit exclusion of "laws of nature, natural phenomena, and abstract ideas" from patentable subject matter. Tuesday's decision reiterated this long-standing precedent and framed the issue of this case as determining "whether the claimed processes have transformed these unpatentable natural laws [the relation between blood levels of a drug metabolite and the efficacy of the treatment of a disease with the drug] into patent eligible applications of those laws."

The answer was direct: No. The Court reasoned that "the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field" and noted that "the patent claims at issue here effectively claim the underlying laws of nature themselves [and are]... consequently invalid." The Court further ruled that "a process reciting a law of nature [is not patent eligible], unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself."

The Court gave little practical guidance for stakeholders to deal with the new issues raised about what is patent eligible subject matter, and appears to have heightened the requirements for patent eligible subject matter under §101. Consider the following position, which could be construed as a new requirement, under § 101, that each step of a claimed process be patentable in a § 103 "non-obvious" way:

To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.

This decision creates uncertainty for patent owners, licensees, and applicants trying to protect important innovations in all fields, not just the still-nascent field of personalized medicine. The Court specifically said they were not opining as to whether "less conventional" steps would avoid the same decision reached here, leaving open the possibility that, for example, new analytical steps could rescue otherwise ineligible methods. One further hint might come from the Court's indication that it was troubled that the claims "tie up the doctor's subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations." That is, the claims did not require a doctor to change treatment based on the test results. Because the Court was troubled by that fact that the invalidated claims still capture situations where the doctor's treatment does not change, this leaves open the possibility that methods that expressly require a change in care based on the test results might be patent-eligible. Another approach may be to use a claim preamble that is more "active"-i.e., methods of treatment or diagnosis as opposed to arguably more abstract ideas such as "methods of optimizing therapeutic efficacy." This could allow stakeholders to reiterate that claim steps such as "administering" carry more weight than "simply help[ing] to pick out the group of individuals who are likely interested in applying the law of nature."

Click here for a full copy of the decision. We encourage you to carefully consider this decision's impact on your individual cases and to direct any questions you might have to your contacts at the firm.

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