Many members of the patent bar predicted that the Supreme Court would let the issue of patentable subject matter under § 101 of the patent statutes (i.e., is it the types of invention that can be patented) percolate in the lower courts for a while after it issued its Bilski decision last year. Not so.

This time, the Court will be considering the patentability of a method of optimizing a drug-dosing regimen by 1) administering the drug to the subject, 2) determining the amount of the drug available in the blood after administration, and 3) modifying the dosage based on the amount of drug present in the blood. Prometheus Laboratories, Inc. asserted this patent against Mayo Medical Laboratories and the district court concluded that this technology is not patent-eligible. The Federal Circuit disagreed, and used a “machine-or-transformation” test to allow the claims.  The Supreme Court sent the case back to the Federal Circuit for reconsideration after it rejected that test for patent-eligibility, but the court again determined that the method claims are patentable.  Perhaps the Supreme Court was not expecting that result in light of its decision in Bilski?

I expect that many amicus briefs will be filed with the Court—the pharmaceutical and diagnostics communities have a strong interest in the outcome of this case.

Read the Question Presented to the Supreme Court (and granted) here.

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