Today the Supreme Court unanimously ruled that
the BRCA gene patents held by Myriad Genetics are invalid. This seems to negate a great deal of
intellectual property on gene technology going back to the Diamond
v. Chakrabarty, 447 U.S. 303 (1980) decision. The key element of the new ruling seems to lie in the phrase “A naturally occurring DNA segment
is a product of nature and not patent eligible merely because it has been
isolated, but cDNA is patent eligible because it is not naturally occurring. “ As a biologist I find this
perplexing since the cDNA still derives from a natural (RNA) sequence.
However, the major issue now is how today’s
ruling will impact the future evolution of the commercialization of genetic
technology. In simplest form the decision should prevent companies like Myriad
from monopolizing genetic tests thus lowering cost and accessibility. Clearly
this would be a very good thing.
However, the ruling is likely to have many ramifications that may not be
easily anticipated and that may have a chilling effect on some forms of
translational research. Not being a lawyer I may be naïve about the legal intricacies.
However, a few cautionary examples readily come to mind. For example, there is
a lot of interest in using short sequences of RNA (siRNAs, miRNAs) to regulate
disease genes. Since these are based on naturally occurring base sequences,
does the new ruling undermine the patentability of this approach? I would
imaging that there will be a lot of work for patent lawyers in processing the full
ramifications of today’s decision!
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