Where Does Bilski Leave Biotech?
While much awaited, the Supreme Court Bilski decision leaves the patent world in much the same situation as it was before. Indeed, the U.S. Patent and Trademark Office (PTO) instructed examiners to continue to apply the machine or transformation test, but also consider whether there is a “clear indication” that the claimed method is or is not directed to an abstract idea. On the other hand, the Court vacated and remanded Prometheus, a diagnostic method case that the Federal Circuit had upheld under the machine or transformation test. This remand indicates that the patentability of such methods may not be settled after all.
The PTO has granted patents related to diagnostic and personalized medicine methods without much controversy until somewhat recently. In 2006, diagnostic method claims made their way to the Supreme Court in Laboratory Corp. of America Holdings v. Metabolite Labs., Inc.
Metabolite sued LabCorp for inducing infringement by marketing blood tests that measured homocysteine levels, which doctors used to diagnose vitamin deficiencies. Both the district court and the Federal Circuit upheld the validity of the patent and assessed damages against LabCorp.
The Supreme Court originally agreed to hear LabCorp’s appeal, but then dismissed the case. Justice Breyer wrote a dissenting opinion to the dismissal, explaining why he believed the claims were invalid under § 101. In an opinion joined by Justices Stevens and Souter, Justice Breyer reasoned that Metabolite’s methods “embody only the correlation between homocysteine and vitamin deficiency,” and so are unpatentable as claiming a “natural phenomenon.” Because Justice Breyer’s opinion was not precedential, however, it did not negate the patentability of diagnostic and personalized medicine methods.
The Prometheus case raises this issue again. Prometheus’ patents describe methods of optimizing dosage by measuring metabolite levels. A representative claim reads:
“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8 X 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8 X 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”
The Federal Circuit determined that the methods satisfy § 101 because they recite the transformative steps of administering a drug to a patient or determining the level of a metabolite in a patient sample. The court stated that “methods of treatment [claims] . . . are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.”
With regard to the “determining steps,” the court noted that “determining the levels of the metabolites in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection.” That is, “the determining step, by working a chemical and physical transformation on physical substances, . . . sufficiently confines the patent monopoly.”
Now that the Supreme Court has vacated and remanded Prometheus, the Federal Circuit will have to reconsider its decision to uphold these method claims. Indeed, the Supreme Court may be signaling that it wants the Federal Circuit to specifically consider the patent eligibility of diagnostic and personalized medicine methods regardless of whether they pass the machine or transformation test.
If the Federal Circuit is going to uphold Prometheus’ claims again, Prometheus will have to show that its methods do not fall under the recognized exceptions to § 101: “laws of nature, physical phenomena, and abstract ideas.”