In Australia, CLA is working with MPs, the Cancer Council, academics and researchers to press for a new federal law protecting human genes from being patented. In the US Supreme Court, a ‘commercial’ case now being decided will influence what happens in Australia. Here, the New York Times editorially agrees that human genes should not be patentable.
Are Human Genes Patentable?
By THE EDITORIAL BOARD of the New York Times
Published: 14 April 2013
BRCA1 and BRCA2, abbreviations for breast cancer 1 and 2, are the names of human genes linked to a significant increase in the risk of breast and ovarian cancer for women.
In 1997 and 1998, Myriad Genetics, based in Utah USA, obtained broad patents on the isolated DNA it managed to extract from these genes and on diagnostic tests to find the genes.
In granting the patents, the United States Patent and Trademark Office agreed with Myriad’s claim that, by extracting the genes from the human body, the company had invented an “isolated” DNA markedly different (and thus patentable) from the native DNA.
The Supreme Court is scheduled to hear argument about that decision in Association for Molecular Pathology v. Myriad Genetics. The petitioners in the case — doctors, scientific researchers and women’s health organizations — argue that the isolated genes are not materially different from genes before extraction, and that allowing Myriad a patent on them would allow the patenting of nature itself, at untold cost to scientific research, medical treatment and patients.
We agree with the petitioners, while recognizing that this case is one of the most important and complex disputes involving the intersection of science, law and commerce in a generation. The sharpness of the disagreement is shown in the conflicting views within the government.
The patent office sees the patents as valid and consistent with its duty to protect and promote invention; Solicitor General Donald Verrilli Jr. and the Justice Department oppose them on grounds that what nature makes cannot be patented and Myriad’s isolation of DNA did not change it enough to alter nature and be eligible for a patent.
In a case last year, Mayo Collaborative Services v. Prometheus Laboratories, the Supreme Court made it clear that the standard for invention must be high. Patent protection, it said, is a “a two-edged sword”: While “the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery,” it is possible that “that very exclusivity can impede the flow of information that might permit, indeed spur, invention.”
It was essentially for these reasons that the petitioners sued Myriad in 2009. The company’s patents, they asserted, gave it “a monopoly on clinical testing of its genes,” blocking “avenues of scientific inquiry” and creating “barriers to scientific progress and medical care.”
In 2010, Judge Robert Sweet of Federal District Court in Manhattan struck down Myriad’s patents as “improperly granted” since they involved “products of nature.” In 2011, the United States Court of Appeals for the Federal Circuit reversed, upholding the patents. It did so again last year after the Supreme Court asked the appeals court to reconsider in light of the Mayo case.
In the dissent, Judge William Bryson said that Myriad’s science lacked the kind of invention for which patents are granted and that “broad claims to genetic material” like those of Myriad are “a significant obstacle to the next generation of innovation in genetic medicine.”
In plainer language, human genes cannot be patented or “owned” by private companies. We urge the Supreme Court to embrace the same view.