Abstract
The U.S. Supreme Court unanimously ruled that isolated DNA is a product of nature and cannot be patented. However, it emphasized that its ruling “does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”
In its heavily anticipated decision on Association for Molecular Pathology v. Myriad Genetics, the U.S. Supreme Court unanimously ruled on June 13 that isolated DNA is a product of nature and therefore cannot be patented.
The decision covered patent claims on the BRCA1 and BRCA2 genes that Myriad Genetics of Salt Lake City, UT, has used to protect its tests that assess risks of breast and ovarian cancer. After the ruling, several other diagnostic companies quickly announced plans to offer BRCA tests.
However, the court upheld Myriad's cDNA patent claims related to the two genes, reasoning that cDNA is not a product of nature. “This case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” the decision said.
Following the Myriad ruling, patent protection for genetic tests that assess heritable risk or aid in disease diagnosis and treatment will be based on narrower claims about DNA that has been altered by human intervention, comments Konstantin Linnik, PhD, a patent attorney and partner in the law firm Nutter, McClennen, and Fish in Boston, MA.
“If you don't have the ability to go after a single, big patent, then you need a collection of smaller patents that cover both the composition and method of the invention,” Linnik says. He explains that “composition of matter” claims cover how DNA has been altered by humans and “method” claims cover processes involved in achieving a specific result, such as treating a disease with a specific drug. “The claims have to be very specific,” he emphasizes.
Myriad says that it does not expect the outcome to significantly affect its business, in part because it still holds a wealth of relevant patents that are not affected. “Myriad has more than 500 valid and enforceable claims in 24 different patents, conferring strong patent protection for its BRACAnalysis test,” said Peter Meldrum, president and CEO, in a statement released after the ruling.
Legal opinions on the decision vary widely, Linnik says, and it may take 5 to 10 years for the implications for personalized medicine to be fully realized. “New cases with different fact patterns will go through the court system, and eventually we'll have a better understanding of how the Myriad decision can be applied,” he sums up.
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