Fitch, Even, Tabin & Flannery: Mayo Case Could Clarify Patentability Standards for “Personalized Medicine”

Fitch, Even, Tabin & Flannery: Mayo Case Could Clarify Patentability Standards for “Personalized Medicine”

On Wednesday, December 7, 2011, the U.S. Supreme Court heard oral arguments in a major patent case, Mayo Collaborative Services, v. Prometheus Laboratories. The decision in this case should clarify the metes and bounds of what qualifies as patentable subject matter under the patent laws. The Mayo case, which deals with technology in the medicinal field, follows another seminal Supreme Court case, Bilski v. Kappos, which dealt with a similar question in the computer sciences field.

Prometheus Laboratories holds two patents in the field of thiopurine drugs, which are used for treating autoimmune diseases. The claims at issue in each patent are directed toward "optimizing therapeutic efficacy" for administration of a drug dose. These claims specify administering a thiopurine drug and determining the level of a metabolite in the patient, where the amount so determined signals the need to adjust the dosage of the drug if the amount is outside a range specified by Prometheus. Mayo Collaborative Services, an entity associated with the Mayo Clinic, challenged the patents as being invalid.

The Supreme Court will decide whether these claims are drawn to a fundamental principle, which does not qualify as patentable subject matter, or to an application of a fundamental principle, which does so qualify. Although the specific holding of the case will be limited to the patents at issue, the Court's decision will have a sweeping impact on pharmaceutical patents. The ruling will have broad implications particularly in the developing area of personalized medicine.

At oral argument, Mayo focused on the broad range of metabolite levels recited in the claims as evidence of a wide-ranging preemptive effect. Mayo also appeared to argue that the claims lacked a final method step of reducing dosage and were defective for this reason. Prometheus argued that the claims did not recite merely a broad idea of correlating metabolite levels and treatment, but instead that the claims are limited to a specific class of drugs, to specific metabolite levels, and to defined diseases.

One justice's questions were of particular note. Justice Elena Kagan suggested that had the claim recited specific treatment based on test results (e.g., "when you reach 400 units, a real number, a specific number, you adjust the dosage by XX percent"), there would be no issue. "Why didn't you file a patent like that?" she asked. "Because that clearly would have been patentable" (emphasis added).

The Supreme Court's ruling is expected next year. Those who are invested in the patenting of medical procedures should watch closely for developments in the area. If you have any questions regarding this case, please contact Fitch Even partner Steven G. Parmelee.

--Written by Eggerton A. Campbell, Ph.D.

 

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