The American Intellectual Property Law Association (AIPLA) has filed an amicus brief supporting the patentee in Prometheus Labs. v. Mayo Collaborative Services which is on appeal at the Federal Circuit. AIPLA is an organization of IP professionals and related entities that generally supports strong IP rights. AIPLA lobbies Congress and submits amicus briefs on behalf of its membership.
Prometheus is another case where the patent includes Metabolite-type claims. Claim 1 of U.S. Patent No. 6,680,302 reads:
1. 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 a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder, wherein a 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 a level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
In its brief, AIPLA argues that the district court judge in finding the claims to be invalid because they were not patentable subject matter, made several errors. First, the judge did not apply the machine-or-transformation test set forth in Bilski. AIPLA argues that the invention involves the physical transformation of a composition of matter, a drug, into a metabolite.
Next, the district court relied to a large extent on Justice Breyer’s dissent from the Supreme Court’s dismissal of Lab. Corp. v. Metabolite Labs. AIPLA argues that only three justices joined the dissent–the majority of the Supreme Court rejected the dissenting opinion–so it is not controlling law. AIPLA also argues that the current case is different from Lab. Corp, and that the dissent was wrong. No other judge had addressed the patentable subject matter issue in that case, so the record wasn’t sufficiently developed on the issue. The dissenting justices were acting as trial judges on this issue. Finally, the brief notes that “the statements of a Supreme Court justice appear to have had an intimidating effect” on the district court in this case.
AIPLA also argues that the district court applied the preemption test rejected in Bilski. The preemption test holds that where a patent claim attempts to preempt all uses of a natural phenomenon, the claim is not directed to patentable subject matter. The Bilski court found this test to be very difficult to apply and had generally rejected the test. By definition, a patent attempts to exclude, i.e., preempt others from practicing the claimed invention.
Finally, AIPLA implores the court to not proscribe patents for the entire field of biomedical diagnostic tools. These tools are very important in medicine and the court should not remove the incentives to innovate in this area. The Federal Circuit addressed issue here.
This case remains in the briefing stage and a decision is not expected until late spring or summer.