Supreme Court Prometheus Diagnostic

On Tuesday the Supreme Court issued an important decision in a patent case relating to the question of whether Prometheus’ diagnostic methods/processes, which 1) analyze the amount of a drug in a patient’s blood, and 2) relate that concentration to the likelihood that the drug will prove ineffective or cause harm to that patient, are patentable. Justice Breyer—writing for a unanimous Court—stated that laws of nature, natural phenomenon, and abstract ideas are not patentable and concluded that Prometheus’ patent claims essentially cover laws of nature (and little more).

This decision will likely significantly impact diagnostic, biotechnology, and pharmaceutical patent portfolios. Companies routinely pursue patents that include claims based on biological responses to certain drug products or disease states. The question they will be asking now is whether they have enough application language related to the “natural phenomenon” to pass muster under the standard described in Prometheus. It may also impact other technology areas that routinely cover algorithms or mathematical equations in the claimed invention.

In its opinion, the Court noted that it’s attempting to walk a tightrope that neither eviscerates patent protection through broad application of this rule nor allows patent claims that merely recite natural phenomenon. Noting that all inventions, at some level, embody or rely on laws of nature or abstract ideas, the Court focused on whether that law is applied to the diagnostic process in a manner that makes it deserving of patent protection.

Diagnosing Efficacious Doses of Drugs

Prometheus’ patent claims cover processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases (like Crohn’s disease and ulcerative colitis). Because the way in which people metabolize thiopurine compounds varies, the same dose of the drug affects different people differently, making it hard for doctors to determine whether a given dose is too high (risking harmful side effects) or too low (and likely ineffective) for a particular patient. Prometheus sells diagnostic tests that embody the patented processes for determining that blood level and evaluating the risk of under or overdosing. It sued Mayo for patent infringement after they stopped purchasing the Prometheus tests and announced that they would begin selling and using their own alternative tests.

Patentable, Or Not Patentable: That Is the Question

During the summary judgment stage, the district court determined that Prometheus’ claims are not patentable because they are natural laws or phenomenon, but the Federal Circuit disagreed. (The Federal Circuit actually determined that the claims were patentable twice because the Supreme Court sent the case back for it to consider the patent eligibility issue again after the Supreme Court’s Bilski decision.) The Federal Circuit concluded that those working in the field did not know the precise correlations between thiopurine metabolite levels and likely harm or ineffectiveness, so the patent claims involved something beyond natural phenomena.

The Supreme Court soundly disagreed with the Federal Circuit’s conclusion on patent eligibility. While it takes human action (taking the drug) to trigger the drug-effect relationship in a human, the Supreme Court concluded that the relationship between drug levels in the blood and the likely effects of those levels on the patient exists entirely apart from any special human invention or activity covered in the claims. Purely “conventional or obvious” “[pre]-solution activity” involving administration of the drug is not sufficient to transform unpatentable natural laws into a patent-eligible application of that law.

Exploring the Gatekeeping Question

The Court also considered and rejected the U.S. government’s view (offered through the Solicitor General’s office) that any claim steps that cover aspects beyond a natural law may make those claims potentially patentable under 35 U.S.C. § 101, but they may still fail to meet the other patentability requirements found in § 102, § 103, and § 112 of the statute. The Court said this approach would make the law of nature exception to § 101 patentability a “dead letter” and inconsistent with prior cases that have explained the contours of patent eligibility. So the Supreme Court sees § 101 as a gatekeeper section of the statute, and as relevant as the other sections that act as patentability hurdles.

Find for Me, Or the Sky Will Fall

Finally the Court considered the policy arguments in favor and against concluding that Prometheus’ claims, and those like them, would be eligible for patent protection. Prometheus argued that denial of patent coverage for claims like these would significantly interfere with the ability of medical researchers to invest in and make valuable discoveries relating to diagnostic technologies. In contrast, the American Medical Association and a number of other leading medical groups asserted that patent protection for claims over the body’s natural responses to illness and medical treatment will leave us with a “vast thicket of exclusive rights” over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.

While it acknowledged these divergent views, the Court announced that it hesitates to depart from its established § 101 jurisprudence or make policy-driven decisions to tweak the scope of patent protection. It explicitly left that tailoring effort to Congress—perhaps this was a formal nod to Congress’ recent overhaul of several major provisions of the patent laws.

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