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Nature 440, 587 (30 March 2006) | doi:10.1038/440587a
US to rule on research patent
Jacqueline Ruttimann, Washington DC
Supreme Court considers the law on natural phenomena.
It is a case that questions the very nature of what can be patented.
Before the US Supreme Court adjourns at the end of June, it may decide
whether a patent based on a biological relationship between two
substances can be issued. A verdict could have implications for many
other US and worldwide patents.
"The United States is often an incubator for these issues," says Francis
Gurry, deputy director-general of the World Intellectual Property
Organization in Geneva, Switzerland. "The world is watching with a great
deal of interest."
A natural phenomenon or a law of nature generally cannot be patented,
but a process that takes advantage of that phenomenon or law can be.
Lawyers have been battling over this rule in biotechnology cases since
at least 1980, when the Supreme Court ruled that a newly discovered
microbe capable of digesting petrol could be patented. That case opened
the door for the biotechnology industry and ushered in patents for
antibodies, microorganisms and cells.
Some feel that it is now too easy to patent natural phenomena. "There
might be some individuals who would like to close that door," says Nick
Godici, a former US Patent and Trademark Office commissioner.
The latest case — Laboratory Corporation of America Holdings (LabCorp)
against Metabolite Laboratories — deals with the field of biomedical
diagnostics. It stems from a patent-infringement case over a method for
diagnosing vitamin B deficiencies. In 1990, Metabolite patented a
diagnostic test, based on an assay that measures blood levels of
homocysteine, an amino acid. High levels of homocysteine are correlated
with low levels of vitamin B12. Physicians often order such tests
because high homocysteine levels are also correlated with increased
health risks such as heart attacks, stroke and birth defects.
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Metabolite licensed the test to LabCorp, a clinical testing company.
LabCorp stopped using it in 1998 and replaced it with a similar test
developed by another company. When LabCorp stopped paying royalties,
Metabolite sued for patent infringement. LabCorp lost, was ordered to
pay $7.8 million, and lost again on appeal.
In the case heard by the Supreme Court on 21 March, LabCorp argued that
Metabolite had patented a law of nature by asserting ownership of the
relationship between homocysteine levels and vitamin B12. Under these
circumstances, LabCorp said, physicians infringe the patent simply by
thinking about the relationship when studying test results.
Miguel Estrada, an attorney for Metabolite, told the court that the
natural relationship is integral to the diagnostic step. Addressing the
broader issue, he argued, could "wreak havoc on the patent world".
A corresponding European patent does not claim to cover the relationship
between levels of homocysteine and vitamin B12, and is not currently
being challenged, says Siobhan Yeats, a biotechnology director at the
European Patent Office in Munich, Germany.
The Supreme Court could now come to a verdict, pass the case back to the
lower courts, or dismiss it altogether. One complication is that the
biological-relationship argument was not addressed in the lower courts.
And although no one can predict which way the vote will go, at least one
justice indicated his thoughts during the hearing. Justice Stephen
Breyer hinted that patenting a scientific phenomenon might limit
researchers' motivations to search for new cures. "If you don't provide
them with an incentive," he said, "they may think of less."
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