Several Supreme Court justices appeared hesitant to decide a fundamental question Tuesday — what can and cannot be patented? — as the court wrangled over a disputed patent for determining vitamin deficiency.
Justices stressed that the broader question had not been asked in the case, which involves the infringement of a 1990 patent on a method of diagnosing B vitamin deficiencies, until the dispute reached the Supreme Court.
"It seems imprudent of us to discuss it here if it hasn't been discussed in the Court of Appeals," Justice Anthony M. Kennedy said.
Bush administration lawyer Thomas Hungar encouraged the court not to take up the question whether the patent covered a law of nature, a natural phenomenon or an abstract idea. None of those can be patented.
If the court does reach to that broader issue, attorneys said it could affect the claims made in literally tens of thousands of older patents on drugs, medical devices, computer software and other inventions. That makes the case a potential blockbuster.
The patent at issue in the case describes first how the level of an amino acid called homocysteine can be measured in a patient and, then, how a high level is associated with a deficiency of folic acid or B12.
The method is used by laboratory testing companies nationwide, including Laboratory Corp. of America Holdings. In 1998, LabCorp stopped paying some royalties on the patent. The patent's holders, including Metabolite Laboratories Inc. and Competitive Technologies Inc., sued. LabCorp lost, was ordered to pay about $5 million and then lost again on appeal.
LabCorp attorney Jonathan Franklin argued that the patent gave its owners a monopoly over a natural phenomenon: High levels of homocysteine suggest deficiencies in two B vitamins. The audience at Tuesday's arguments could infringe the patent by merely thinking about that relationship, Franklin suggested.
Metabolite Laboratories countered that the patent covers a practical application of the discovery when used as part of a diagnostic step.
Metabolite attorney Miguel Estrada conceded, under questioning by Justice John Paul Stevens, that a doctor could infringe the patent by ordering a homocysteine test with the intent of determining B vitamin levels and then using the test results to infer whether there was indeed a deficiency.
Justice Stephen Breyer said allowing doctors, scientists and computer experts to begin patenting every "useful idea" could establish "monopolies beyond belief." Breyer asked if it would make sense to send the case back to the lower courts.
"What was made by man here?" Justice Antonin Scalia later asked, calling the invention the discovery of a natural principle. "When there's the presence of one substance in a human being, there is a deficiency of two others."
LabCorp originally argued that the patent was overly vague, and that allowed it to use tests, called assays, developed by other companies to measure homocysteine levels. Metabolite Laboratories disagreed and sued.
Whether the court would tackle the broader question of the patent's covering a law of nature remained unclear. Estrada cautioned that answering it could "wreak havoc on the patent world."
Chief Justice John Roberts recused himself from the case because his former law firm represents LabCorp.
The case is Laboratory Corporation of America Holdings v. Metabolite Laboratories Inc., et al., No. 04-607.