- The Washington Times - Monday, March 20, 2006

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 been so widely used. It is done tens of millions of times a year, at a cost of a dollar or two, by laboratory testing companies nationwide.

Now, to the surprise of patent lawyers, 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 today.

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 — all verboten under patent law.

At stake, lawyers on both sides of the case say, are 25 years of patent law and 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.

But regardless of the outcome, that the Supreme Court even asked that question guarantees the case’s lasting effect on patents and patent law, lawyers said.

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 on 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 lost again on appeal. It wants the Supreme Court to reverse the judgments.

LabCorp 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.

Metabolite Laboratories counters that the patent covers a practical application of the discovery made when used as part of a diagnostic step.

LabCorp originally argued the patent was overly vague, and that allowed it to use tests 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 attract much attention.

But the Supreme Court asked the federal government to weigh in on the case, specifically asking whether Metabolite succeeded in patenting a law of nature, natural phenomenon or abstract idea.

The solicitor general’s office told the Supreme Court that the question wasn’t asked in the lower courts and thus LabCorp’s isn’t the case to decide it. The office recommended that the previous judgments be affirmed or the case be dismissed or sent back to the lower courts.

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