The Australian public should take note of a landmark case that is being brought against the patent owners of an intellectual property patent that has tied up the access to, use of and future development of, significant human gene sequences. These gene sequences referred to as BRCA 1 and 2 are used to diagnose whether an individual carries gene mutations linked to breast and ovarian cancer. But this case is only the tip of the iceberg.

Initiating this court case follows on from the landmark decision in the US, which ruled against the owners of the BRCA 1 and 2 patents. This case will involve taking on the might of the global intellectual property industry and is likely to be as contentious and hard-fought as the case against tobacco.

This is not a class action case with dollars attached to it.  This is a public-interest case and Australians should recognise the courage of this advocacy group to engage in such a risky and costly task. Unfortunately, most of our politicians have failed to pay attention to this complex patent issue. The role played by the Australian Patent Office, which approved these patents, will be central to this case.

In simplistic terms, over many years there has been what could be called “patent creep”. Decisions have been taken or copied from other countries that effectively removed the need, in cases such as gene sequences, to create an “invention” before being eligible to seek a patent application.

The awarding of monopoly power is an expensive gift that should not be reduced to simply following “key IP rich countries”. Even more the case when 92% of patents awarded in Australia are to overseas owners.

What the public and the media should also be aware of is a very important Senate inquiry into the patenting of genes that is winding up after taking evidence for the past year. The disgraceful lack of coverage given to this important inquiry indicates the lack of understanding of this complex intellectual property issue but also a lack of attention by most of the mainstream media to such an important public policy issue. More than 70 submissions have been made.

The main points of contention are the differing positions on the legitimacy of the interpretation used by Australia’s patent authority of what constitutes an invention. And, importantly, if the DNA gene sequence code is captured within the scope of the patent claims. This effectively limits access to the DNA sequence  without the patent owner’s approval. More of this argumentation below.

There has been plenty to write about in this inquiry. The evidence given makes for interesting reading.

At times dialogue had descended into farce-like behaviour on the part of the bureaucracy, who have been surprised to be confronted with questioning about the nature of their governance of this issue. The approach taken by IP Australia to fulfill its mandate has been severely questioned.

The Australian public should be pleased to know that the Senators involved in this inquiry have done a sterling job. Having attended some of the public hearings and followed the Hansard trail, I would single out particularly, senators Bill Heffernan, Clair Moore, Gary Humphries and the chair, Rachel Siewert, for medals of commendation for their tenacity in struggling to come to terms with this esoteric and arcane language in which  the intellectual property industry revels.

The committee succeeded despite the unhelpful responses of the legal representatives of the patent industry in answering their questions. Their evidence required a PhD in esoteric legal mumbo jumbo. The senators have sat through excruciating detail as they tried to comprehend the issues and assess the effects on Australian’s health system, scientific research and collaboration resulting from the imposition of these gene patents.

By not following this important policy and national interest debate the media has missed some wonderful examples of Heffernan forensically calling the patent industry and IP Australia to account.

Having never been a fan of his, I  admit to being impressed by his tenacity and commitment. Without his acerbic but insightful interventions this inquiry would probably have shut down some time ago convinced of the legitimacy of the patent industry.

But this has not been the outcome. Just when you thought the inquiry was going to be hoodwinked into being convinced that there was really no barrier to ongoing research and development. Or, that the copying of the DNA gene sequence — transformed into an isolated and synthesised form was actually an invention that must be given 20-year patent monopoly status. Heffernan would question their legal rationale and add his own colourful comments to dismantle or discredit their arguments.

He also questioned the awarding of monopoly rights on such important basic scientific data when the financial control of it that could end up with publicly sourced Australian genetic material being traded on the stock exchange and blocked from future scientific research.

Heffernan has produced his own recommendations for the committee to consider and they include a comprehensive overview of the evidence given to the inquiry.

Of particular interest in his submission is a user-friendly visual representation of how patents can be awarded without locking away the basic scientific gene sequences. Echoing the call of many witnesses “to patent the cure not the basic scientific data”.

The recommendations in his submission will have to be considered seriously by the rest of the committee given the support this submission has received from significant numbers of health professionals.

The Senate Inquiry is about to hold its last public meeting to take further evidence from IP Australia on June 15. This meeting should be of interest to mainstream media and to the public and it will be interesting to see just how many key opinion makers do attend.  It will also be interesting to see how many politicians take an interest.

Whatever the outcome, politicians will have to consider that there is now a landmark court case that will have a significant effect on Australia’s intellectual property policy. Health professions and lawyers are committed to making this legal industry (that thrives on expanding the system of patent monopoly) accountable. They have made clear that they consider this issue far too important to leave to political parties alone to consider.  This fact alone should be noted.

Important in terms of assessing the quality of governance within the public service agencies will be the level of scrutiny that will be focused on Australia’s Patent Office — IP Australia — which operates under Kim Carr’s department.

Because of the esoteric nature of the work undertaken by this agency, it is able to operate largely autonomously from of the rest of the bureaucracy. The agencies that could scrutinise IP Australia’s policy decisions, DFAT and AGs, approach this task almost exclusively from a trade policy perspective. Operating from this perspective only leads to excessive focus on extending intellectual property rights to comply with our major trading partners.  There is little or no public policy analysis and some of this has been identified in the recent report on innovation.

Outside of government, the institutions that have the most contact and input into IP Australia’s work are the patent lawyers and the associated legal industry. As you would expect, their approach has been to promote the extension of patents. It should also be noted that IP Australia raises almost all its expenditure from the sale of patents.

Are there any alarm bells ringing? Can industries such as the financial or oil industry effectively operate under such  rules. Is there not a case for having a much broader range of community and public interest advocates intrinsically involved in scrutinising this important body that awards 20-year monopoly rights.

The DNA gene sequence is acknowledged by all parties as being a “scientific discovery” but this acknowledgment does not ensure that it is excluded from being included in the patent monopoly. It is here that the terms “isolated and synthesised” become the Patent Offices’ rational for turning a “discovery into an invention”.

“In lay person terms: ‘Isolated refers to the specific gene sequence being reproduced outside of, the human body; ‘Synthesised’ is the process of copying the constituent parts the DNA information contained in the gene sequence. In other words, the DNA gene sequence information is equivalent to a recipe and the isolated and synthesised process is baking the cake — this is not an invention it is producing an exact copy of the original DNA gene sequence. Importantly, and confirmed by scientific evidence given to the Senate, with current technology there is nothing novel, or inventive about this process. ”

Patent attorneys and the Australia’s Patent Office have followed the path taken by, for example, the US and interpretations based on some old case law from (1920s and 1959).  They have chosen not to test their interpretation in the court despite the fact that it falls clearly within their mandate.

Australia needs a neutral regulatory authority to oversee the awarding of monopoly patent rights. This is one of the recommendations in Senator Heffernan’s submission. Other submissions have provided significant analysis of how to improve the governance of patent offices. In particular, the work of ANU academics such as the analysis and recommendations contained in submission No.60, if implemented, would take better care of Australia’s national interest and the health and wellbeing of the Australian public.

Peter Fray

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