By Pam Bertani
On October 31, 2005 the United States Supreme Court granted a petition for writ of certiorari to hear argument in the case of Metabolite Laboratories, Inc., et al. v. Laboratory Corp. of America, a patent infringement case that will once again test the boundaries of what constitutes patentable subject matter, and one that has already stirred some controversy in the world of jurisprudence. (Metabolite Laboratories, Inc. et al. v. Laboratory Corp. of America Holdings (Fed. Cir. 2004) 370 F.3d 1354; Petition for Writ of Certiorari granted (October 31, 2005) WL 2838583.) In an interesting twist to what already promises to be a closely watched decision, not more than two days after granting certiorari, the High Court vacated its October 31, 2005 Order, having been advised by freshly appointed Chief Justice John Roberts that, after initially participating in the vote on whether to hear the case, the Chief Justice realized he should have recused himself from participation. On November 2, 2005, the Court issued a subsequent Order, again granting the petition, but expressly without the Chief Justice’s participation in the vote to withdraw the October 31, 2005 Order, and without the Chief’s participation in reconsidering the petition. Chief Justice Roberts did not provide a detailed explanation as to why recusal was appropriate, but reportedly acknowledged that he made a mistake in participating in the early stages of the Federal Circuit appeal. Chief Justice Roberts’ former law firm filed the appeal on behalf of defendant Laboratory Corporation of America Holdings (LabCorp), the company that stands accused of infringing Metabolite Laboratories, Inc.’s (Metabolite’s) broadly patented method for detecting vitamin deficiencies in humans.
In yet another interesting twist, in February 2005 the Supreme Court reportedly sought the Bush Administration’s opinion regarding whether the case should be heard, and the Bush Administration weighed-in against hearing the case, recommending that the Court reject the Appeal. All the more intriguing then was the Court’s subsequent decision to hear the case, both before and after the Chief Justice’s recusal. The Supreme Court invited the Solicitor General to file a brief expressing the views of the United States limited to the following question:
Respondent’s patent claims a method for detecting a form of vitamin B deficiency, which focuses upon a correlation in the human body between elevated levels of certain amino acids and deficient levels of vitamin B. The method consists of the following: first, measure the level of the relevant amino acids using any device, whether the device is, or is not, patented; second, notice whether the amino acid level is elevated and, if so, conclude that a vitamin B deficiency exists. Is the patent invalid because one cannot patent ‘laws of nature, natural phenomena, and abstract ideas’? (Laboratory Corporation of America Holdings, et al. v. Metabolite Laboratories, Inc. (2005) 125 S.Ct. 1431) (citing Diamond v. Diehr (1981) 450 U.S. 175).)
Over a year and a half later, in its November 2, 2005 Order, the Court limited LabCorp’s petition for certiorari to Question 3 as presented in the petition – namely “[w]hether 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.” (Laboratory Corporation of America Holdings v. Metabolite Laboratories, Inc. et al., Petition for Writ of Certiorari, 2004 WL 2505526) (emphasis added.)
United States Patent No. 4,940,658 (the ‘658 patent) is at issue in this case. The ‘658 patent broadly claims a method for detecting Vitamin B12 and folic acid deficiencies, which, if left unchecked, can cause serious human infirmity, including vascular disease, cognitive dysfunction, birth defects, and cancer. However, if these deficiencies are detected early enough, fairly simple vitamin supplements can successfully treat the deficiencies and prevent catastrophic illness. The ‘658 patent claims a method for detecting Vitamin B12 and folic acid deficiencies by testing body fluids for a key amino acid – homocysteine – which is metabolized by Vitamin B12 and folic acid. Basically, high homocysteine levels correlate to low Vitamin B12 and/or folic acid levels – deficiencies that may warrant treatment. Claim 13 of the ‘658 patent – one of the key claims in dispute – claims “[A] method for detecting a deficiency of cobalamin [Vitamin B12] or folate [folic acid] 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 Laboratories, Inc. v. Laboratory Corporation of America Holdings (Fed. Cir. 2004) 370 F.3d 1354, 1358-1359.)
Metabolite licensed the ‘658 patented technology from patent owner Competitive Technologies, Inc., and subsequently sublicensed the technology to LabCorp, which as a lab testing company originally performed the total homocysteine assay under the sublicense. In 1998, LabCorp switched to a total homocysteine assay developed by Abbot Laboratories, and discontinued royalty payments to Metabolite. Metabolite subsequently sued LabCorp for patent infringement. (Id. at 1359.)
At the District Court level, a jury found that LabCorp indirectly infringed the ‘685 patent, and that LabCorp partially breached its contract with Metabolite. The district court correspondingly assessed damages of approximately $3.6 million for contract breach, and $1 million for indirect infringement. (Metabolite Labs. Inc. v. Lab. Corp., No 99-Z-870 (D. Colo. Dec. 3, 2001).) After denying LabCorp’s motion for judgment as a matter of law, and in light of willfulness findings, the district court doubled the infringement award for willful infringement and issued a permanent injunction.
The Federal Circuit affirmed the ‘685 patent’s validity, and held that the awarded enhanced damages did not constitute an abuse of discretion. (Metabolite Laboratories, Inc. v. Laboratory Corporation of America Holdings, supra, 370 F.3d 1354, 1372.) The Federal Circuit evaluated and affirmed the District Court’s claim construction of the key claims in this case, and not only found that the claims were properly construed, but that they were aptly enabled and described by the specification. The Court further concluded that the ‘658 patented invention was not anticipated by LabCorp’s prior art references, which the patent examiner considered during the prosecution stage of the ‘658 application, and nonetheless allowed the disputed claims.
LabCorp will have a formidable hurdle to overcome at the Supreme Court. Based on LabCorp’s Question 3 presented in its petition – and to which the High Court’s consideration will be limited – the Federal Circuit has already analyzed, in considerable detail, the very issues that will form the foundation of LabCorp’s main arguments. The language of Question 3 indicates that LabCorp intends to challenge, once again, the ‘658 patent’s validity by arguing that the invention is not adequately described in, or enabled by, the specification, and that the patent inappropriately claims a basic scientific relationship, based on human metabolic function, which in and of itself is unpatentable subject matter. Commentators, practitioners, and industry participants alike await a ruling in this scientifically and legally fascinating case.