In an unanimous decision yesterday, the U.S. Supreme Court ruled that the gene testing company Myriad Genetics' patents on versions of the BRCA1 and BRCA2 genes are invalid. Those variants greatly increase a woman's risk of breast cancer. The Court specifically held:
A naturally occurring DNA segment is a product of nature andnot patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring….
We also address the patent eligibility of synthetically created DNA known as complementary DNA (cDNA), which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins. For the reasons that follow, we hold that a naturally occurring DNA segment is a product of nature and not patent eligiblemerely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring. We, therefore, affirm in part and reverse in part the decision of the United States Court of Appeals for the Federal Circuit.
Based on this split decision, both sides in the case claimed some vindication. As GenomeWeb News reported:
"Today, the court struck down a major barrier to patient care and medical innovation," Sandra Park, senior staff attorney with the ACLU Women's Rights Project, said in a statement this morning. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."
Though the decision invalidates patents covering the BRCA1 and BRCA2 genes, which underlie Myriad Genetics' BRACAnalysis test, the firm noted in a statement after the decision that "many of Myriad's unchallenged claims are method claims applying knowledge about the BRCA1 and BRCA2 genes."
"We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Myriad President and CEO Peter Meldrum.
The ruling that cDNA is patentable also is being viewed as favorable to Myriad by some industry observers.
William Quirk, an analyst with investment firm Piper Jaffray, called the ruling "a clear victory for Myriad." He said the court's decision to leave cDNA patents intact "means it will be very unlikely for competitors to introduce competing tests short of using whole-genome sequencing, in our opinion. There are schools of thought suggesting genomic DNA as a probe, but we have not seen scientific evidence to back up that claim."
…The stock market reacted favorably to the news, sending Myriad's shares up 10 percent to $37.31 in early afternoon trade on the Nasdaq.
Myriad's stock price might have bounced up, but other analysts think that won't last.
It will be interesting to see how this new ruling affects investment in the development of genetic testing and medical biotechnology going forward. One additional thing can be concluded from this decision: I am no patent lawyer.