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Test based on natural processes cannot be patented,
rules US court
Clare Dyer
BMJ
The US Supreme Court has ruled as invalid two patents on a
test that helps doctors determine drug dosage for autoimmune
disorders such as Crohn’s disease, in a landmark decision that
will affect the growing field of personalised medicine.
The justices ruled unanimously that patents on a test developed
by Prometheus Laboratories were invalid because they were
based on the laws of nature.
The test was designed to find out the level of thiopurine that
should be administered to an individual patient: too much might
be toxic, and too little would be ineffective. The patent covered
administering thiopurine to the patient, then the measurement
of metabolites in red blood cells, using the finding to adjust the
dosage.
Mayo Clinic originally bought the test from Prometheus, but
then developed its own similar though not identical test.
Prometheus sued and initially lost, but the US Court of Appeals
for the Federal Circuit ruled that the patents were valid. Now
that decision has been overturned by the Supreme Court.
Applying a law of nature to a known structure or process may
be patentable, but the laws of nature themselves are not
patentable. “We conclude that the patent claims at issue here
effectively claim the underlying laws of nature themselves,”
said Justice Stephen Breyer. “Those claims are consequently
invalid.”
He said the patents comprised three steps: telling the doctor to
administer the drug, then instructions to measure the metabolite
levels, then setting out the concentrations above which there
was a risk of harmful adverse effects and below which the drug
was likely to be ineffective.
Justice Breyer said the claims in the Prometheus patents
informed a relevant audience about certain laws of nature, but
that, “any additional steps consist of well understood, routine,
conventional activity already engaged in by the scientific
community; and those steps, when viewed as a whole, add
nothing significant beyond the sum of their parts taken
separately.”
Medical organisations, including the American Medical
Association and the Association for Molecular Pathology, had
told the court that if “claims to exclusive rights over the body’s
natural responsesto illness and medical treatment are permitted
to stand, the result will be a vast thicket of exclusive rights over
the use of critical scientific data that must remain widely
available if physicians are to provide sound medical care.”
Legal commentatorssuggest that the Supreme Court’sjudgment
could be a pointer to the final decision in the pending Myriad
Genetics case, which challenges the patenting of human genes.
The Myriad Genetics case also raises the issue of patenting a
naturally occurring phenomenon, isolated DNA.
Cite this as: BMJ 2012;344:e2290
© BMJ Publishing Group Ltd 2012
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