US Supreme Court Rules Unmodified Human Genes Cannot be Patented. (June 14, 2013)

The US Supreme Court (9-0) has ruled that companies cannot patent human genes. The ruling overturns Myriad Genetics patent on genes with links to breast and ovarian cancer. The court has however upheld the ruling that synthetically created exons-only strands of nucleotides known as composite DNA (cDNA) are patentable. The ruling found 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” (see pages 16-17 of the rulling)*.

The nine justices of the US Supreme Court

Eliot Marshall and Michael Price writing in ScienceInsider note:  "The impact of the decision on other companies may depend on exactly how gene patent claims are worded. While the court ruled out "natural" DNA patents, it also permitted cDNA patents. Although 'cDNA retains the naturally occurring exons of DNA … it is distinct from the DNA from which it was derived,' the court wrote. 'As a result, cDNA is not a 'product of nature' and is patent eligible.'"

Francis Collins, director of the National Institutes of Health, said today: "Our position all along has been that patenting DNA in its natural state does not provide any benefit to the public. There have been concerns that you might have a $1000 genome sequence, but a $500,000 royalty fee to use it. We can breathe a big sigh of relief that this will no longer threaten to inhibit the progress of DNA research."

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On the local Australian scene Dr Luigi Palombi, a patent lawyer and author of ‘Gene Cartels: Biotech Patents in the Age of Free Trade’ as well as an academic at the Centre for the Governance of Knowledge and Development at The Australian National University viewed: This decision is to be welcomed. It removes 30 years of uncertainty over the patenting of biological materials existing in nature and deals a blow to the semantics over the word 'isolated'. According to the Court merely isolating genetic material from the human body does not render the genetic material patentable subject matter. The Court also make it clear that while cDNA is patentable subject matter, if the genetic sequence housed in the cDNA is "indistinguishable" from the information in the natural DNA, that cDNA is also not patentable subject matter. In other words, before genetic material is patentable the genetic sequence housed in that material must be distinguishable from what exists in nature.

While Professor Ian Olver, CEO of the Cancer Council said: This is a welcome decision that addresses the issue of commercial monopolies over genetic mutations that are vital to cancer prevention, diagnosis and treatment. If there had been greater clarity on the issue back in 2008, the Australian licensee for the BRCA1 and BRCA2 patents would not have been able to demand public laboratories cease conducting the tests. Eventually the patent enforcement claim was withdrawn, but there was, and still is, nothing in Australian law to prevent commercial interests trying to monopolise the use of genetic materials.
      The US Supreme Court’s ruling paves the way for Australia’s federal parliament to change the Patents Act and clarify that human genetic materials are not inventions and are not patentable. We welcome innovation in medical research, which should rewarded by a robust patents system. However, discovery and isolating genetic material is not innovation. The US Supreme Court’s decision is a landmark ruling that provides a clear precedent for Australia.

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*The full ruling of the court is available here.