The U.S. Court of Appeals for the Federal Circuit expressed its belief in the continued validity of its “machine-or-transformation” test in wake of the Supreme Court’s Bilski decision, but left the fight for the patent eligibility of medical treatment claims for another day. King Pharmaceuticals, Inc. v. Eon Labs, Inc. Case Nos. 09-1437, 1438 (Fed. Cir., Aug. 2, 2010) (Gajarsa, J.).
King owned two patents based on the discovery that the bioavailability of metaxalone (a muscle relaxant) was increased when the drug was ingested with food. One claim was directed to a method of increasing the bioavailability of the drug by administering a therapeutically effective amount of metaxalone with food. A second claim was directed to a similar method but recited an additional step of “informing” the patient about the benefit of taking metaxalone with food. This step presumably had the benefits of increasing the likelihood that the patient would ingest the drug with food and any potential placebo effect.
Certain prior art references had suggested taking metaxalone with food to decrease nausea but had not suggested that this would increase bioavailability. The Federal Circuit affirmed the district court’s holding that the increased bioavailability was an inherent result of the prior art methods. Although the prior art may not have recognized this particular benefit of administration with food, it necessarily occurred when metaxalone was so administered. Thus, the Court found the first claim anticipated under the doctrine of inherency.
With respect to the second claim, the district court found the claim invalid under §101 because the informing step did not meet the machine-or-transformation test. On appeal, the Federal Circuit held that this was error because any patentable subject matter analysis must focus on the claim as a whole and not on one specific limitation. Citing to its Prometheus decision, which held that that methods of treatment are “always transformative” when a defined group of drugs is administered to the body—a decision now (along with the Classen case) on remand from the Supreme Court in the wake of Bilski—the Federal Circuit expressed its belief in the continued validity of the “machine-or-transformation” test, noting that the Supreme Court’s Bilski decision “rejected the exclusive nature of our test, but not the wisdom behind it.”
Nonetheless, the Federal Circuit concluded that this case was not the proper vehicle to determine the patent eligibility of medical treatment claims. Instead, the Court found that even if the second claim satisfied §101, it did not meet the novelty requirement under §102. Because there was no “functional relationship” between the “informing” limitation and the increased bioavailability, the Court concluded that informing the patient of the benefits of the treatment regimen did not transform the process itself. That is, whether or not the patient was informed, the method remained the same. Drawing analogy to precedents that held a known product is not patentable by simply including “printed matter” describing the product, the Court concluded that the “informing” limitation did not impart patentability to an otherwise unpatentable claim.
Practice Note: Drafters of diagnostic or personalized medicine claims should be mindful of both §101 and §102 requirements. A prior art method cannot be rendered patentable (under §102) by simply adding an “informing” step that informs a patient of an inherent (but previously unknown) benefit or disease risk.