IP News

On Oct. 31, 2005, the U.S. Supreme Court agreed to review a question arising from the decision in Metabolite Labs., Inc. v. Lab. Corp. of America Holdings, 370 F.3d 1354 (Fed. Cir. 2004). (After voting to grant certiorari, Chief Justice John Roberts recused himself from participation in the case. After reconsideration, the Court again granted the petition.) The question presented by this case is:

Whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to 'correlat[e]' test results can validly claim a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result.

This case involves claim 13 of U.S. Patent 4,940,658 (“the '658 patent”), which recites: “[a] method for detecting a deficiency of cobalamin or folate [B vitamins] 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.” Deficiencies in cobalamin and folate can cause illnesses such as vascular disease, cognitive dysfunction, birth defects, and cancer. Once detected, however, a deficiency can be treated with vitamin supplements.