In a unanimous decision yesterday, the United States Supreme Court held that “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.”
So what does this mean?
In his written opinion, Justice Clarence Thomas focused on the fact that Myriad did not create anything by isolating DNA sequences. They merely discovered, and seek to patent, naturally occurring genetic information.
“Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”
Slip Opinion p. 14-15
It is a fundamental principal of patent law that “laws of nature, natural phenomena, and abstract ideas are basic tools of scientific and technological work that lie beyond the domain of patent protection.” Because Myriad merely discovered the DNA sequence as it occurs in nature, that discovery is not accorded patent protection.
However, the news was not all bad for Myriad.
The Court made a distinction between unpatentable isolated DNA and patentable complementary DNA, or cDNA, synthetic versions of DNA that omit non-coding portions.
cDNA can be patented according to Justice Thomas’ Opinion because:
“the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.”
Slip Opinion p. 16-17 (Emphasis added.)
It is important to note the exception spelled out at the end. It appears that the Supreme Court is requiring a certain amount of human manipulation that results in significant changes to the DNA to put cDNA in a position for patent eligibility.
I for one am happy to see the US Supreme Court supports the idea that the human component of invention , the creating of something new, as opposed to discovering something as it exists in its natural state (like DNA, laws of physics, naturally occurring elements) is still an important part of patent eligibility.
Could you imagine the slippery slope that would be created if companies were allowed to own naturally occurring genes? Imagine a world where one company owns the autism gene and another owns the gene for Parkinson’s disease. This is an absurd notion. How can someone own a gene that so many people share? Do those that have the gene infringe the patent?
Discovery is important and expensive and I sympathize with Myriad, but they did not invent the BRCA1 and BRCA2 genes. (If they did, that would be a completely different legal discussion.) They found them. And I’m glad there’s still a difference.