What does the Supreme Court’s Bilski decision mean for the medical diagnostics industry? Roque El-Hayek, a lawyer specializing in biotech with Wolf, Greenfield & Sacks, P.C., the Boston-based IP law firm, covered what’s known and what’s still up in the air in a recent webinar.

While Bilski did not discuss medical diagnostic claims in particular, the Supreme Court has remanded to the Court of Appeals for the Federal Circuit two cases that deal with this issue: Classen Immunotherapies, Inc. v. Biogen Idec and Prometheus Laboratories, Inc. v. Mayo Collaborative Services, he said.

In earlier appeals under the machine-or-transformation (MOT) test, the Federal Circuit decided the cases differently, ruling that the Classen claims were not patent-eligible but the Prometheus claims were patent-eligible. How the Federal Circuit decides these cases on remand will provide some guidance on how it will apply the Bilski ruling, said El-Hayek, who’s also an MD.

The Classen claims are directed to correlating immunization schedules to the incidence of disorders, and the claims comprise immunizing mammals with immunogens and comparing the incidence, prevalence, frequency or severity of a disorder. Since there was neither a machine nor transformation involved, the Federal Circuit ruled the claims invalid, El-Hayek said.

In Prometheus, the claim was directed to optimizing the therapeutic efficacy of a drug and comprised administering a drug to a subject and determining level of metabolite in the subject. The level of the metabolite indicates whether there is a need to adjust dosage of the drug. The Federal Circuit ruled that administering and determining are both necessarily transformative steps, and the claims therefore satisfy the MOT test.

In re Grams was cited by the Federal Circuit in both its Bilski and Prometheus decisions to provide some insight. In Grams, the claims are directed to a method of diagnosing an abnormal condition by measuring a plurality of parameters using a plurality of clinical tests, El-Hayek said. The claims comprise performing clinical tests on an individual and determining if an abnormal condition exists using an algorithm.

The Federal Circuit ruled the claims unpatentable because the essence of the claimed method was an algorithm rather than any transformation of a tested individual. It said that performing clinical tests was just data gathering, El-Hayek noted.

In ACLU et al. v. Myriad Genetics, a decision from a U.S. District Court in New York, the claims were directed to methods of comparing or analyzing DNA sequences. The court ruled them invalid, claiming they were mental steps with no machine or transformation involved.

The Myriad decision suggests that even incorporating certain types of assay steps into claims may not be sufficient to confer patent-eligibility because they would represent nothing more than data gathering steps, El-Hayek said.

Unresolved Issues

Many key issues are unresolved. What constitutes a machine or a transformation? Physical change, chemical change, treating a patient, or determining a level should qualify, he said. Whether data transformation counts is uncertain.

And what if transformation relates to a naturally occurring phenomenon?

The machine or transformation must be more than an “insignificant extra-solution activity,” such as gathering data to input into an algorithm or a data display on paper or computer, El-Hayek added.

The machine or transformation cannot preempt all uses of a fundamental principle or turn an ineligible process claim into a patentable one, he noted.

Strategy Going Forward

“The Prometheus and Classen decisions on remand will hopefully provide more concrete guidance in the short term,” El-Hayek said.

“Meanwhile, pursue claims to different statutory groups and to cover different potential infringers,” he advised. In drafting patent applications, it’s best to indicate, describe, define and/or argue: physical, chemical or biological transformations, and data from one form to another.

Provide fallback positions to tie claims to assays, apparatus or a machine. Avoid claims directed to essentially mental, such as correlating steps, El-Hayek concluded.

Audio and slides for El-Hayek’s presentation can be heard and viewed at http://www.wolfgreenfield.com/newsstand/events_seminars-297. The seminar also covered Bilski’s impact on software patents, litigation, and universities and research organizations.