In this article, which first appeared in the Life Sciences Intellectual Property Review 2011, DCC partner Tania Obranovich explains why an Australian legislative bill could have grave consequences for the country’s life sciences industry and, potentially, for patients as well.
The BRCA patents, which claim breast cancer diagnostic methods and BRCA DNA molecules, have courted significant controversy in Australia. Specifically, the Australian licensee’s attempt to centralise BRCA diagnostic testing in-house caused great public concern and triggered the establishment of a Senate enquiry into the impact of granting gene patents. This enquiry was followed by the introduction of legislation proposing to ban the patenting of all biological materials that are identical or substantially identical to such materials as they exist in nature, and itself led to the establishment of a second Senate enquiry to report on whether the Bill should be pursued. The validity of the Australian BRCA DNA claims is also currently the subject of judicial revocation proceedings.
The community concerns underpinning this controversy are essentially that:
- Patents risk public health, drive up health costs and stifle research
- Genes are a discovery and not an invention; and
- Patenting biological materials is tantamount to patenting the human body.
Community concerns should always be addressed. However, this Bill is a blunt instrument that does not provide a sensible solution. It proposes to simply exclude from patentability all biological materials resembling those that exist in nature. Since this proposed ban encompasses an enormous range of molecules and extends to all organisms, it would have a significant impact on the functioning of not only healthcare, but also sectors as diverse as agriculture, the livestock industry and food technology. Ironically, however, what would nevertheless remain patentable is the technology that ignited this issue—diagnostic methods. Still further, healthcare delivery necessitates access to a much broader range of technologies than just biological materials, yet the Bill does nothing to safeguard access to these other technologies.
Of most concern, however, is that in addition to doing little to alleviate community concerns, the Bill may also create a range of new problems. Specifically:
- The Bill would introduce uncertainty as its language would require interpretation to clarify its actual scope. The issue of interpretation can only be settled by the courts and a significant risk is that judicial interpretation may result in the inadvertent exclusion of molecules that were never intended to be excluded.
- Any suggestion that the Bill would only exclude isolated biological materials but not corresponding medicinal forms is misplaced. Where medicines essentially comprise the biological material itself, they would also be arguably excluded.
- All other developed countries would continue to grant patents to biological materials and Australia therefore runs the risk of an adverse impact on accessing new patented medicines. Ultimately, the decision by patentees to pursue regulatory approval in Australia and to release a product in competition with other companies will be made case by case. However, Australia is a small market when considered globally and enacting legislation that would effectively make it less desirable as a potential market would seem unwise.
- Australia would likely be placed in breach of its international obligations under TRIPS and its US Free Trade Agreement. These treaties require Australia to make patents available in all fields of technology. In particular, Europe has expressly legislated in favour of the patentability of biological materials and enacting this Bill would immediately place Australia at odds with Europe.
In terms of the question of discovery versus invention, the fact is that across the developed world isolated biologicals are regarded as patentable subject matter on the basis that they represent an artificially created state of affairs. However, what is generally not appreciated by the public is the fact that this does not mean that they can be patented. In order to be patented, they must also be new, not obvious and useful. This is the reason why human gene patents are now, in fact, rarely granted.
Accordingly, on any logical risk/benefit analysis, enacting this Bill exposes Australia to significant adverse risks for the sake of very little apparent actual benefit. The community’s concerns would be better addressed by providing technology neutral solutions to regulate the exercise of patent rights, rather than the existence of the right itself. To this end, the Patents Act already provides compulsory licence and Crown use provisions, and a legislated research use exemption will be imminently enacted. It would be better to focus on the smooth operation of these safeguards in respect of all technologies, including future technologies, rather than banning patents for certain technologies.
In terms of the ethical issues, these represent difficult considerations since they reflect personal views that generally change over time. For example, would the community as a whole hold the same ethical objection to the patenting of a cone toxin protein, which can provide pain relief to morphine-resistant patients, as it may hold to the patenting of human genetic material?
A better way forward would be to consider the recommendations made by the Australian Government’s Advisory Council on Intellectual Property (ACIP) in its recent 2010 report. The ACIP proposes a general patentability exclusion for an invention “the commercial exploitation of which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public”. This recommendation is clearly an attempt to provide a mechanism for dealing with ethical issues in a manner that provides the flexibility to consider inventions on a case-by-case basis and to accommodate changing community values. For example, would the reasonable and fully informed person object to the granting of a patent to a biological material that is being developed as a cancer drug if patent grant would make the difference between the availability or not of that drug in Australia. Is it more ethically abhorrent to risk denying access in Australia than enabling patent grant in the context of a patent system that has been designed with robust safeguards regulating the exercise of such patent rights? Although this particular recommendation may not represent the best answer to the complex issue of ethical patenting it should, at least, form part of the current discussion in relation to the merits of the Bill.
There have been five Australian enquiries held in the last seven years in relation to the issue of patentable subject matter. All of these enquiries have consistently recommended that amending the patentable subject matter provisions of the Patents Act to exclude specific subject matter is not the correct way forward and that we should instead focus on ensuring both the existence of effective safeguards and that patentability thresholds are appropriately set and properly implemented. Consideration of this Bill should be discontinued in favour of discussing these recommendations. Ultimately, this approach would be of significantly more benefit in terms of achieving the outcomes that are actually sought by the wider community, while avoiding the raft of unintentional but nevertheless detrimental consequences that would inevitably flow from the current Bill.