On Wednesday, the U.S. Supreme Court heard oral arguments in an important patent case involving the right of physicians to think about how a patient has reacted to a drug, Mayo Collaborative Services v. Prometheus Laboratories.
Prometheus’ patents claim routine steps taken by doctors in order to see how a patient responds to drugs commonly used to treat automimmune disorders, such as Crohn’s disease. You can check out the precise language of the patent claims at issue here, but in short, Prometheus’ patents consist of the following steps: (1) administer a drug to a patient; (2) determine the effect of the drug by measuring the resulting metabolite levels in a patient’s blood through a standard test; and (3) think about whether to increase or decrease the drug dosage in light of how the patient responded.
When Mayo Medical Laboratories, drawing on research conducted by the Mayo Clinic, developed a test that it found was more effective in adjusting drug dosages than Prometheus’ method, Prometheus sued for patent infringement. Prometheus’ lawsuit was not based on having patented a specific drug or unique test. It attacked Mayo because it asserted rights over thinking about the medical correlation between the patient’s metabolite level and the optimal drug dosage. That correlation is nothing more than the biological reaction of the patient to the drug. It must be used anytime a doctor wants to tailor the drug dosage for a patient.
The patents prohibit doctors from mentally considering that correlation and advising patients based on how their bodies reacted. Our amicus brief, the first filed by the ACLU in a patent case before the U.S. Supreme Court, argues that the patents should be found invalid because natural phenomena, such as medical correlations, and abstract thought, such as doctors’ consideration of those correlations, are not patentable under the patent law and the First Amendment. At its core, the First Amendment protects freedom of thought. From the brief:
All patents of course begin with a thought, but thought itself is not patentable . . . A patent that explicitly targets and restricts thought cannot be reconciled with the First Amendment.
By barring physicians from considering the effect of a drug in their patients, these patents stop them from using information about how a patient has responded to a drug, and from thinking about what next steps, if any, should be taken for treatment. They impede freedom of thought and scientific inquiry, restrict doctors’ ability to provide care to their patients, and violate the constitutional requirement that patents “promote the progress of science.”