Supreme Court Sidesteps Ruling on Patent for Medical Test

The U.S. Supreme Court has decided not to consider a controversial patent case concerning a test for diagnosing B vitamin deficiencies, sidestepping for now the question of whether a basic scientific relationship between chemicals in the body can be patented.

The high court voted 5-3 not to hear the case, saying in a one-sentence opinion that it had "improvidently" granted review last October.

Three justices dissented, arguing that the majority was putting off an important question of patent law.

"[T]hose who engage in medical research, who practice medicine and who as patients depend upon proper health care might well benefit from this court's authoritative answer," Justice Stephen Breyer wrote for the dissent.

The case involved a patent that claims a process for helping to diagnose deficiencies of two vitamins, folate and cobalamin.

According to the dissenting opinion, the process involves using any test to measure the level of an amino acid called homocysteine in a body fluid. If the level is above the norm, a vitamin deficiency is likely.

Metabolite Laboratories sublicensed the patent to Laboratory Corporation of America Holdings. But when LabCorp began using a different method for measuring homocysteine and stopped paying Metabolite royalties for the process, Metabolite sued the company for patent infringement in the U.S. District Court for the District of Colorado.

Both the District Court and the U.S. Court of Appeals for the Federal Circuit agreed with Metabolite that its patent was infringed every time a doctor made the association between an elevated homocysteine level and vitamin deficiency.

LabCorp filed for a writ of certiorari in November 2004, seeking to overturn the infringement ruling. The company maintained that the patent claim is invalid on the grounds that it seeks to claim a monopoly over a basic scientific relationship.

But after receiving nearly 30 briefs in the case, the high court backed away from ruling on the matter.

Failure to take on the case "threatens to leave the medical profession subject to the restrictions imposed by this individual patent and others of its kind," Justice Breyer wrote for the dissent.

"Those restrictions may inhibit doctors from using their best medical judgment, they may force doctors to spend unnecessary time and energy to enter into license agreements, they may divert resources from the medical task of health care to the legal task of searching patent files for similar simple correlations, [and] they may raise the cost of health care while inhibiting its effective delivery," he said.

Justices John Paul Stevens and David H. Souter joined in the dissent.

A spokeswoman for LabCorp told the International Herald Tribune that the company was "very disappointed that the court decided not to hear the case."

Metabolite's co-plaintiff in the case, Competitive Technologies Inc., said the court's action represents a "significant victory" for the companies.

"We are pleased with the court's decision," Competitive CEO D.J. Freed said in a statement. "As a public company specializing in bringing new technologies to market, we are charged with protecting our clients' intellectual property rights. This is a perfect example of that."

Chief Justice John Roberts, whose former law firm represented LabCorp, recused himself from the case.