In February, Australia's Federal Court handed down a decision relating to whether isolated but otherwise unmodified human genetic material is patentable in Australia. The decision confirmed US Myriad Genetics’ patent over the BRCA1 gene mutation linked to breast and ovarian cancer. The ruling was met with surprise by scientific and health experts, who expressed concern that this category of privately owned patents would limit access to genetic testing and have negative consequences for research and innovation.
Need for transparency
The patenting of gene sequences is not a new problem. The contentious issue has rippled through selective policy circles for years, unresolved partly because policy cohesion is generally weak and disjointed. This disconnect can distort health, innovation and intellectual policy (IP) policy objectives - nationally and within international negotiations, including at the WTO and WHO.
Engagement in the minutiae of esoteric patent arguments is unlikely to address the fundamental problem that access to the original DNA is blocked by this specific type of patent practice. We need to go back to first principles to understand economic and other interests, including national interests, which influence IP governance.
In the US and Australia, for example, IP governance can be adapted by Patent Offices' interpretative guidelines - often in response to patent attorney’s claims of 'invention'. Patent subject matter has gradually expanded to include naturally occurring genetic materials (such as the BRCA gene mutation).
When a gene sequence is merely copied through a scientific process - labelled and claimed as 'isolated DNA', and, legally described as 'an artificially created state of affairs' - access to the original gene sequence is also blocked. This is because the chemical composition of the 'isolated' DNA is identical to the original genomic DNA.
This outcome is seldom explained or discussed by those actively involved in the patent industry. In Australia the Senate Inquiry has helped to open this debate up. However, the legal challenge to Myriad’s BRCA 1 patent by Cancer Voices' has failed to prevent this patent practice.
IP governance: Watch this space
The US Supreme Court will shortly rule on a similar case. Myriad Genetics is defending its patent which provides the exclusive right in the US to perform clinical tests on the BRCA gene sequences. The case will have far-reaching and global consequences – whatever the outcome. Patent policy is defined at the national level but the US is important for setting global standards for patent practice.
The American Civil Liberties Union (ACLU) and other health advocacy groups initiated the case. Of interest are two politically important Amicus Curiae Briefs.
The first astonished the IP and biotech industry. The US government brief included an unambiguous statement that isolated, but otherwise unmodified, genomic DNA is not patent-eligible subject matter and acknowledged this decision was contrary to longstanding practice of the USPTO, National Institutes of Health and other government agencies that have obtained patents for isolated genomic DNA.
A Brief submitted by Eric Lander, a leader in the human genome project and a scientific adviser to President Obama, is also likely to shock. Lander agrees 'isolated but otherwise unmodified genomic DNA is not patent-eligible and suggests a narrowly crafted decision would not undermine the biotechnology industry but would foster innovation.'
Lander articulates why it is important to maintain open access to unique genetic resources and he provides a powerful rationale that may chasten the patent industry. Lander hypothesizes the outcome if the HIV virus or its genome had been patented. 'The patent holder could block anyone from observing, characterizing or analyzing the virus by any means whatsoever. Scientists would not have been able to rapidly learn the secrets of this insidious virus; drug developers would not have been able to develop life-saving drugs; technologists would not have been able to develop effective diagnostics; and patients would not have been able to know their HIV status'.
This argument will be politically difficult to ignore. It is an argument that sweeps away esoteric patent logic and empowers the public to understand the actual consequences of allowing patents over the human genome.
Consequences for global health security
We are at the early stages of the genomic health revolution. The capacity to develop personalized medicines, essential diagnostic tools, pharmaceuticals and potential cures will be significantly curtailed if the current interpretation of what is patentable stands.
Patents over unique, naturally occurring, gene sequences can be owned and traded by individuals; hedge funds; institutions; insurance; and, sovereign wealth funds. Negotiating access to purchase licensing rights (to avoid infringing) in such a highly diffused trading environment, across differing legal jurisdictions is highly problematic. These costs register against health outcomes, national health budgets and can lead to the stifling of innovation.
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