On October 31, 2005, the Supreme Court granted certiorari in the case of Laboratory Corporation of America v. Metabolite Laboratories (LapCorp). The Supreme Court announced that it will hear LabCorp’s appeal the Federal Circuit’s decision on the scope of patentable subject matter under 35 U.S.C. 101 with respect to patent claims that involve laws of nature, natural phenomenon and abstract ideas. The Supreme Court will review the question of whether a patent can claim rights to a basic scientific relationship used in medical treatment if the claim is limited to “correlating” test results.
This case involves the scientific discovery that levels of homocysteine in the blood can indicate a deficiency in two B vitamins. The claim at issue, claim 13 of Metabolite’s U.S. Patent No. 4,940,658, is directed to a method of detecting a vitamin B deficiency which comprises assaying a body fluid for an elevated level of total homocysteine and then correlating an elevated level with the vitamin deficiency.
Claim 13 recites as follows:
A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
There is nothing novel about testing the blood for levels of homocysteine. The only novel and non-obvious part of the claim is the scientific discovery, the “correlating” step.
On appeal, the Federal Circuit found the claim to be valid and willfully infringed. In particular, the Federal Circuit found that the defendant had induced infringement through its publications advising doctors that elevated levels of total homocysteine correlate with vitamin B deficiency.
LabCorp argues that claim 13 is invalid for a number of reasons. LabCorp points out that although the claim requires a step of “correlating,” there is no description of how the correlation would take place. According to the petitioner, “[s]uch a vague claim cannot be valid; for if it could be, parties could claim patent monopolies over basic scientific facts rather than any novel inventions.” In addition, the claim arguably fails the written description requirement because “the specification does not describe what a practitioner must do to perform the active ‘correlating’ step.”
Prior to grating certiorari, the Supreme Court invited the U.S. Government to file a brief addressing the validity of the claim. The Government recommended against certiorari on grounds that the record was not sufficiently developed with respect to certain fact questions. The Supreme Court, nevertheless granted certiorari and will review as to whether a claim can validly cover a basic scientific relationship used in medical treatment such that the claim is necessarily infringed when a doctor merely thinks about the relationship after looking at a test result.
The Supreme Court appears to be bending on making this case a question of subject matter patentability. If the Supreme Court takes that route, it will likely answer many of the questions left open by Lundgren and Fisher.
Significance to Patent Holders
By deciding to hear LabCorp, a question of subject matter patentability, the Court may be responding to recent struggles in the PTO, Board of Patent Appeals and Interferences (BPAI), and Federal Circuit. Recently, the Federal Circuit decided that expressed sequence tags (“ESTs”) are not patentable under 35 U.S.C. § 101, basing its decision on the Supreme Court’s directive in Brenner v. Mason, requiring that inventions must have a substantial and specific utility under § 101. Since then, the BPAI has held that “there is currently no judicially recognized separate ‘technological arts’ test to determine patent eligible subject matter under § 101.” Ex parte Carl A. Lundgren, Appeal No. 2003-2088 (Bd. Pat. App. & Inter., heard April 20, 2004, decision issued October 2005) (precedential). Most recently, the PTO has provided examiners with new guidelines about patentable subject matter. By granting review, the Court may clarify the debate over the scope of patentable subject matter. However, as a general rule, the decisions from the Supreme Court raise more questions than they answer. For example, how the Supreme Court resolves the issue in Labcorp may also have substantial implications for the patentability of business methods and even of software.