'Metabolite Labs': the big one that got away
Lab. Corp. of America Holdings v. Metabolite Labs. Inc.
U.S. Supreme Court declined an opportunity to decide a case with
potentially far-reaching consequences for the medical
By Todd Patterson
and Keith M. Tackett/Special to the national law journal|August 28, 2006 at 12:00 AM|Originally published on National Law Journal
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In Lab. Corp.of America Holdings v. Metabolite Labs. Inc. , 126 S. Ct. 2921 (2006), the U.S. Supreme Court declined an opportunity to decide a case with potentially far-reaching consequences for the medical profession. The Supreme Court initially granted certiorari and then dismissed the case per curiam after the briefs were filed. While the court did not provide a reason for dismissing the case, a dissenting opinion addressed several points that suggested that the principal issue of interest to the court was whether anyone can patent the making of a medical diagnosis by correlating lab tests to specific diseases. Although dismissal of the case does not reflect how the court will ultimately resolve this issue, the dissenting opinion indicates that at least three justices will likely vote that patenting a medical diagnosis requires more than discovering a correlation between measurable components in the human body and specific diseases. Section 101 of the Patent Act, 35 U.S.C. 101, authorizes private ownership of inventions and discoveries that are not “natural phenomena.” Numerous patents have been granted in recent years for medical discoveries including improved diagnosis and treatment of diseases. In 1996, Congress enacted � 287(c), making patent infringement damages unavailable against doctors who infringe patents solely by performing “medical activities.” Although doctors may still be held to infringe a patent, the doctors are not liable for damages caused by their medical activities. Congress did not protect medical and pharmaceutical suppliers from liability for patent damages based on contribution to infringement by the doctors or inducement of the infringement by the doctors. Also, Congress did not protect doctors from damages for patents that were effectively filed before Sept. 30, 1996. 35 U.S.C. 287(c)(4). Metabolite involves an action against a medical equipment supplier that induced doctors to correlate specific test results to find vitamin B12 or folic acid deficiency. Although the patent was filed before Sept. 30, 1996, doctors were not named as defendants, likely because the medical suppliers received sufficient profits from test equipment used by the doctors to cover any likely damage award. The patent at issue, U.S. Patent 4,940,658 (the ’658 patent), is owned by Competitive Technologies Inc. and licensed to Metabolite Laboratories Inc. The action filed by Metabolite against Laboratory Corp. Holdings of America (Lab. Corp.) focuses on claim 13, which recites “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.” Metabolite had originally sublicensed homocysteine analysis to Lab. Corp., a testing company, but Lab. Corp. switched to a new homocysteine test offered by Abbott Laboratories, in the belief that this test did not infringe claim 13 and other claims, and stopped paying royalties to Metabolite on the patented test. Metabolite initiated the patent infringement suit in the U.S. District Court for the District of Colorado. The jury found for Metabolite, and the court assessed damages of nearly $6 million and issued a permanent injunction. Lab. Corp. appealed to the U.S. Court of Appeals for the Federal Circuit on the ground that claim 13 was indefinite. That court decided that claim 13 was definite, thus valid and infringed. 370 F.3d 1354 (Fed. Cir. 2004). Upon request by Lab. Corp., the Supreme Court granted certiorari. Ruling: not ready for review The question presented was whether a method patent 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.” After receiving seven party briefs, 21 amicus briefs and numerous other sundry documents, and after oral arguments in which the solicitor general of the United States participated, the Supreme Court dismissed the writ of certiorari as improvidently granted.
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