Last year, a rainbow coalition of civil liberties campaigners, cancer patients and eminent geneticists – heck, even Jim Watson! – argued before the US Supreme Court that gene sequences are a product of nature and therefore ineligible for patent protection.
And the Supreme Court replied, in all its refined wisdom:
A nine-to-nothing unanimous decision.
A difference of opinion
But the US has long known that truths held to be 'self-evident' are not always in for a smooth ride, and so we perhaps should not be too surprised – if still perplexed and saddened – to learn that the Australian Federal Court, when faced with the same question, responded: 'um, maybe not'.
I do not pretend to understand what brand of logic could arrive at such a decision (legal geeks will tell you something about a precedent set in a 1950s suit of tangential relevance), although perhaps we should question how well placed legal scholars are to rule on matters of science.
The US Supreme Court's decision saw one of its own justices – Antonin Scalia, known for his abrasive candor – admit that he didn't understand (or even believe in) the scientific foundations on which the case rested.
But, irregardless. The law is the law, and Australians are now faced with a closed door when it comes to ownership of their own gene sequences.
Gene patents have a real impact. Rival companies announced price-slash tests within hours of the US Supreme Court nullifying Myriad Genetics' patent on testing BRCA genes in breast cancer patients.
It's not only cost that is at issue: genetic testing is too primitive a science in most instances to be a black-and-white diagnostic, and so a patent holder's monopoly in offering a medical opinion is a cause for concern.
One sharp critic of Myriad's BRCA patents has been Perth-based patent lawyer and academic Luigi Palombi, who likens IP on genes to 'patenting oxygen'. Not reassured by Myriad's claim to have 'gifted' these patents to the Australian people, which is to some extent borne out by lax enforcement, he points out that in the US 'Myriad hasn’t been terribly useful in giving permission'.
Open science as an opportunity not a burden
Arguments over gene patents are part of a wider issue as to how to deal with ownership of, access to and openness for medical data. Policy and law have struggled to keep up with a rapidly shifting landscape driven by advances in biotech and data infrastructure.
However, such a challenge is not without precedent – as Allison Dobson and Jim Evans explained in a Genome Biology Opinion article, 'History is full of examples in which existing law could not keep up with what was happening on the ground.'
Legislative change may therefore offer the best protection to the public against gene patents. This is not only true of Australia: even in the US, some forms of gene patent remain, at least until they are challenged on new grounds.
Cancer patients involved in the Federal Court case have already called on politicians to patch up patent laws. Any such maneuvers will inevitably face opposition from those who believe that gene patents offer a boost to Australian business. But when it comes to biotech and healthcare, building walls around science is not the only route to profit: industry can increasingly make money from openness.
One savvy company in this regard has been Oxford Nanopore Technologies (ONT), which has encouraged widespread distribution of genome sequence data generated by its protype 'MinION' nanopore sequencing devices, so that the research community can crowdsource solutions to data interpretation and analysis at their own expense. This both saves ONT money on R&D and makes for a more attractive product to sell to their users.
Come senators, congressmen/Please heed Angelina's call
Without changes to the law, gene patents threaten to put the brakes on a rise in both the uptake and power of genetic testing.
While technology has improved our ability to carry out and understand gene tests, actress Angelina Jolie's brave human brand of openness about her own BRCA testing has seen the numbers of high risk women seeking genetic advice surge.
23andme's own research has shown that DTC BRCA tests not only inform healthcare decisions, but also help to change behavior and spread awareness to family members.
Are we to wait in vain for our lawmakers to infect themselves with a spoonful of Angelina's gutsiness and a dash of 23andme's vision, and stand up for the rights of people to own their own genes? – Or, at the very least, to borrow them rent-free from nature.