B vitamin deficiencies can cause a range of serious health effects, including spinal defects in children born to women with below-normal levels of folic acid and anemia in people not getting enough B12.
That's why a two-step method of diagnosing those deficiencies that three medical school doctors patented in 1990 has become so widely used. It's performed tens of millions of times a year, at a cost of just a dollar or two, by laboratory testing companies nationwide.
Now, to the surprise of patent attorneys, a case involving one of those companies, sued after it stopped paying some royalties, has landed in the Supreme Court, where arguments will be heard Tuesday.
Even more surprising is that the Supreme Court may dredge up a bombshell question not asked when the lower courts considered the case: Have inventors been busy patenting laws of nature, natural phenomena and abstract ideas?
At stake, attorneys on both sides of the case say, are 25 years of patent law and literally tens of thousands of patents on drugs, medical devices, computer software and other inventions. If the court reins in what can be patented, they say, it could be among the most important patent law decisions ever made.
The two-step method covered by patent No. 4,940,658 is straightforward: The level of an amino acid called homocysteine is measured in a patient's blood or urine and, if elevated, it can be correlated with a deficiency of folic acid, or B12.
The question before the Supreme Court is whether a doctor could infringe the patent "merely by thinking about the relationship" between homocysteine levels and B vitamin deficiencies after looking at a test result.
In 1998, testing company Laboratory Corp. of America Holdings 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. It now wants the Supreme Court to reverse the previous judgments.
LabCorp, its attorneys and supporters argue in court filings that the patent gives its owners an effective monopoly over a basic scientific principle or natural phenomenon: high levels of homocysteine suggest deficiencies in two B vitamins.
"If someone observes a correlation between X and Y and then announces he is going to use that correlation in a lab test, is that a patentable process? I think the court is troubled that that sort of correlation would be possible," said Jack Bierig, a Chicago attorney who filed a friend-of-the-court brief supporting LabCorp on behalf of the American Medical Association and five other medical groups.
Metabolite Laboratories counters that the patent covers a practical application of the discovery made by the inventors when used as part of a diagnostic step.
"The test itself is obvious when you have the correlation. It is the discovery of the correlation that is the real novelty here," said Mark Lemley, a Stanford University law professor who is helping represent Metabolite Laboratories.
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. That sort of narrow dispute is the crux of many patent suits and normally wouldn't grab much attention.
But the Supreme Court asked the federal government to weigh in on the case, specifically asking whether Metabolite Laboratories succeeded in patenting a law of nature, natural phenomenon or abstract idea — all no-no's under patent law.
"They did pretty much shock everybody," said Chicago-Kent College of Law professor Lori Andrews, who submitted a friend-of-the-court brief supporting LabCorp.
The Solicitor General's office replied to the Supreme Court that the question wasn't asked in the lower courts and thus LabCorp's isn't the case to decide it. It recommended the previous judgment be affirmed or the case be dismissed or sent back to the lower courts.
Regardless of the outcome, that the Supreme Court even asked that question guarantees the case's lasting effect on patents and patent law, attorneys said.
Glenn Beaton, an attorney for Metabolite Laboratories, suggested:
"I think it's fair to say there will be a sudden surge in claiming unpatentable subject matter because defendants' lawyers out there are going to see someone on the Supreme Court has a question in their mind whether patents are getting granted on the type of thing when they shouldn't be."
Since the original LabCorp ruling, there has been a rush to file patents on "scientific facts" or "mental processes," Andrews said.
The case is Laboratory Corporation of America Holdings v. Metabolite Laboratories Inc. et al., No. 04-607.