Will the Supreme Court’s banning of methods of medical diagnosis from patenting in Mayo v. Prometheus be extended to patents for medical treatments? Since Mayo some have argued that some methods of medical treatment should also be banned from patenting. Up until recently these arguments have seemed futile, as the U.S. Court of Appeals for the Federal Circuit has consistently held that treating a disease or other condition is not merely a “mental process” or “natural law.” Critics of medical treatment patents are now making their case to the Supreme Court.

Will the Supreme Court Ban Medical Treatment Patents in Hikma?

The U.S. Supreme Court is now considering whether to rule on this question in the Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc. case. The Hikma case involves “personalized medicine” combining diagnosis and treatment. The invention is a method for treating schizophrenia with the drug iloperidone that is tied to determining the patient’s tolerance for iloperidone with a new genetic test. The inventors discovered certain genotypes that indicate poor metabolism of iloperidone, that in turn increase the patient’s risk of cardiac complications of iloperidone treatment at doses of at least 12 mg/day (the risk at lower doses is not increased). The claims comprise determining whether the patient has the poor metabolizer gene, administering 12 mg/day or less iloperidone if the patient has the poor metabolizer gene, but otherwise administering 12-24 mg/day iloperidone. This is a classic application of personalized medicine, in which the side effects of treatment are minimized by varying the dosage based on the patient’s genotype.

After losing at the Federal Circuit, the infringer in Hikma urged the Supreme Court to invalidate the patent. The infringer’s argument is that the patent protects only a medical diagnostic method, and that the course of treatment based on the test results are mere “window dressing” to fool the court.

Similar arguments have been made to the Federal Circuit in several recent cases without success.

The Federal Circuit’s Defense of Medical Treatment Patents

Classen Immunotherapies Inc. v. Biogen IDEC was the seminal case in this line, although arguably not the strongest. A Federal Circuit panel considered the patent eligibility of a method of immunization of a subject that involves first immunizing a number of other subjects according to two immunization schedules and determining which has the least risk of side effects, then immunizing the subject according to the schedule with the lowest risk. The panel was unanimous that the act of immunizing two groups of subjects and comparing the results to determine the best immunization schedule, without applying that schedule to a subject, was not eligible for patenting. However, with the extra step of actually immunizing a subject based on the schedule, the majority of the panel held the method was patent eligible. While the majority held that a method of medical treatment is eligible for patenting, even if it involves mental steps, a dissenting judge thought the claims were “a monopoly over the scientific method itself.”

In Natural Alternatives International, Inc. v. Creative Compounds, LLC, the patent claimed methods of increasing a human subject’s anaerobic capacity by the administration of one of three amino acids (β-alanine, an ester of β-alanine, or an amide of β-alanine). The infringer argued that the method was merely a recognition of the natural principle that the listed compounds increase human anaerobic capacity, and therefore was a patent-ineligible natural law. Although the trial court agreed and declared the patents invalid, the majority of a three-judge panel for the Federal Circuit reversed the trial court. The Federal Circuit panel decided that the method of increasing anaerobic capacity was more than a mere “natural phenomenon,” but rather a specific and useful application of a natural law: All drugs function according to natural principles, and a ban on methods of medical treatment that rely on natural principles would be tantamount to a ban on all methods of medical treatment.

In Endo Pharmaceuticals Inc. v. Mallinckrodt, LLC, the patent claimed a method of treating pain in renal patients by administering a controlled-release form of oxycodone, measuring the patient’s creatinine clearance rate, and then administering another lower dose of oxycodone until the AUC of oxycodone drops below 21 ng hr/mL. The inventors observed that a patient’s clearance rate of oxycodone was directly correlated with the creatinine clearance rate (a proxy for kidney function), and developed methods of preventing excessive levels of oxycodone by customizing the dosage regiment based on the patient’s ability to clear creatinine. This is another classic application of personalized medicine, in which the treatment is varied based on the metabolic idiosyncrasies of the individual patient. Although the trial court felt this was merely a natural law that could not be patented, the Federal Circuit panel again reversed. The Federal Circuit viewed the patent as not claiming a natural law, but as claiming a method of safely treating pain that applies a natural law.

The Federal Circuit’s Invalidation of Diagnosis Patents

There are several counter-examples in which attempts to patent methods of medical diagnosis alone have been denied by the Federal Circuit. These include Myriad (by the Federal Circuit, before it went to the Supreme Court), PerkinElmer Inc v. Intema Ltd., Univ. of Utah Research Foundation v. Ambry Genetics Corp., Cleveland Clinic Foundation v. True Health Diagnostics, LLC, Roche Molecular Systems, Inc. v Cepheid, and Ariosa Diagnostics, Inc. v. Sequenom, Inc. The facts vary in each of these cases, but in every case the end result of the method is diagnosis, not the treatment of a patient.

Will the Supreme Court Eliminate Patents for Medical Treatment Tied to Diagnosis?

This Supreme Court is hostile to patents, and if the Court agrees to review this decision, there is a real possibility that personalized medicine patents are in jeopardy. The Supreme Court has a nearly unbroken streak of deciding every patent it considers to be at least partially ineligible for patenting since the Chakrabarty case in 1980; of the four times the Court has considered that question since, it has at least partially invalidated every patent it considered except one (in J.E M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc.). Both sides have arguments that are at least plausible at first blush. Opponents to medical treatment patenting proffer that a method of diagnosis is of no use without a treatment; therefore adding a treatment step to a banned method of diagnosis actually adds nothing. Proponents of the status quo argue that if a method of treating a medical condition may be patented in the absence of a diagnostic step, it makes no sense to ban the same method of treatment in combination with a diagnostic step.

One indication that the Supreme Court might take the case is that it requested the U.S. Department of Justice to provide its opinion on the case. Typically, the Supreme Court requests an opinion from the DOJ if it considers a given case to be of significance. The DOJ has not responded yet, but it will be interesting to see what position it takes. All in all, this case and its possible consideration by the nation’s highest court are additional illustrations of the instability and constant uncertainty surrounding current U.S. patent law.