The Crikey article, Turnbull, rent seeking and patenting genes, penned by Glen Gordon elicited some well-thought-out comments, all rebuffing his arguments. There are, however, other aspects of Gordon’s article that need to be addressed and also relate to the role of the patent attorney profession (represented by IPTA) who promote similar views on the patenting of basic scientific discoveries such as gene sequences.
This debate reflects a major public policy battle currently being played out in parliament, the bureaucracy and in a Senate Inquiry into the patenting of gene sequences. This dialogue and associated lobbying activities will have consequences for the future implementation of Australia’s patent law.
Gordon does not appear to understand the importance of the erudite statements from parliamentarians who supported the motion put by Melissa Parkes, Mal Washer and Malcolm Turnbull and five other parliamentarians. This debate represented an important and welcome shift in parliamentary behaviour — the support came from Labor, Liberal and National Party members speaking to issues of public interest. Gordon unfortunately reduces this important debate to being driven by either a “misunderstanding of the patent system” or motivated by “the desire by some pathologists and medical researchers to opt out of the patent system”.
So why does he think that elected politicians comments should be suppressed when they deal with issues of important public policy, health and the national interest? Does he not understand that the public want their elected representatives to develop public policy positions that serve the public and Australia’s national interest?
But there are other developments that Gordon failed to mention and that the patent industry will be mulling over with great anxiety. An extremely important development with implications for patent policy came out of the US on Friday October 29. As a patent attorney, Gordon would or should have been aware of the release of the brief submitted by the US Government’s Justice Department to the US Court of Appeals. This brief strongly argues against the patenting of gene sequences such as the breast and ovarian cancer gene patents.
The extraordinary news out of the US will have resonated thought the patent lobby and the pharma and biotech industries and signalled to them that the legitimacy to patent gene sequences is now not only being questioned but in fact stated by the US Government not to be an invention therefore should not be allowed to be patented.
The US government’s amicus curiae brief addressed national interest issues and stated: “The extent to which basic discoveries in genetics may be patented is a question of great importance to the national economy, to medical science, and to the public health.” And the conclusion was that “The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolate’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.”
This outcome questions and should overturn the policy positions taken by the US Patent Office and that have been copied without question or legally tested by Australia’s Patent Office, IP Australia. This quote from the US Government’s Brief clearly registers the level of policy rethink:
“We acknowledge that this conclusion is contrary to the long-standing practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA. The district court’s judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature. For the reasons below, the United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.”
With the report from the Australian Senate Inquiry into the patenting of gene sequences due to be released at the end of November, let’s hope that the effort and commitment of health professionals, experts and individuals, including myself, who have argued against patenting of gene sequences and the need for much better regulatory governance of Australia’s patent system, will prevail.
Gordon labelled these developments, which have been under way for almost two years, as a campaign by pathologists and single-interest groups pushing to “opt out of the patent system”. If he had read the evidence and submissions given to Senate Inquiry he would have seen that the same cases cited by the US Government in its brief had been provided as evidence to the Senate Inquiry by Dr Luigi Palombi; that the pathologists and their industry representatives had argued in support of patents but not on the basic scientific discoveries such as gene sequences; that sufferers of cancer had argued to patent the cure not the basic scientific tools (gene sequences) needed for ongoing research.
In contrast, the evidence given by the patent attorney professional body defended the existing system, they claimed just to be implementing what was legally admissible. Their comments on the aggressive “desist or you will be sued” legal letters sent to the Peter MacCallum Centre and other hospital laboratories (which had significant consequences across all the health laboratories in Australia) were simply “shots across the bow” to encourage compliance. That the patenting of gene sequences, such as the breast and ovarian gene sequences, were simply teething problems that would be sorted out over time. This claim was made in the face of evidence of the thousands of gene patents awaiting assessment in patent offices around the world.
Finally, Gordon’s comments that stopping the patenting of gene sequences will damage the medical industry in Australia by complicating the legal procedures involved will cause real difficulties, has no legitimacy. The patent system is justified on the basis that awarding a 20-year monopoly in a market-based economy and must cross the first threshold test — be an invention. Drawing on the analysis in the US brief “Crossing the [invention] threshold … requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.”
Let’s watch this space to see how this all plays out in the next few weeks.