In Part 1 and Part 2 of this series of articles, we looked at how patent laws in Australia and leading overseas territories treat inventions relating to medical methods around devices. In Part 3 we analyse these contrasting approaches and look at related ethical and practical issues in foreshadowing how Australian courts may deal with similar questions in future cases.
Medical compositions vs. medical devices
On a conceptual level, when it comes to protecting ideas with patents, we need to ask ourselves what is the fundamental difference between subject matter that is a medicament (a compound or substance) and subject matter that is an assembly of components (a device or apparatus). After all, in essence they are both compositions of material. The ‘building blocks’ may be at a different scale level, but should that give rise to a distinction at a legal level?
The answer should be that any distinction should not concern any structural distinction in how the ‘composition’ is arranged. If there is a difference, it must be a functional division regarding how such inventions are used, and the ethical considerations concerning who may be potentially impacted by any restriction in acting in a certain way in a healthcare environment.
The ethical issues and other considerations
It is clear from the comments made earlier in this series of articles that there a number of different ways of dealing with the particularly thorny issues around methods of medical treatment. Proponents of medical method patents turn to economic justifications, arguing that the patent incentives are necessary to the development of new medical and surgical procedures, including using products and instruments in those new procedures.
On the other hand, opponents look to ethical considerations to justify their position, as well as practical reasons for the medical procedure exclusion. They also argue that, unlike drug development, most advancement in medical procedures advance gradually, through on-the-job improvements to known techniques, and at relatively low cost. Arguments have also been raised in the US that litigation over - or licensing of - medical process patents increases the cost of health care, which costs will invariably be passed back onto patients, thus violating the ethical obligation of physicians not to place additional financial burdens on their patients. Countering that, supporters point to the cost savings that can be made in adopting the benefits (in terms of reduced operational time or lower risk) that new patented procedures can bring, far outweighing any additional costs due to the subsistence of patent rights.
There are, of course, other solutions to the problem. Compulsory licensing for medical process patents could be used to ensure patient access to new technologies without withdrawing the economic incentives of the patent system from inventors in the field. Alternatively, regulations around licensing agreements on medical procedure patents could be implemented in contract law so to effectively control health care costs.
Discussion and conclusion
So, returning to the question of the Apotex restriction, it is clear the general area of patent protection to medical procedures has been held under the microscope for some time by stakeholders in other parts of the world. While the laws in those jurisdictions differ markedly from that in Australia, there is a common thread – the need to strike the right balance between providing economic incentives for the development of new medical and surgical procedures, and the need to avoid tying the hands of medical professionals in meeting their Hippocratic obligations.
This commentator suggests that, if the medical method involves a device that is specifically marketed for a particular new surgical use, such protection should not be seen to potentially undesirably limit the activities of a physician, any more than is the case with a drug that can be administered to a patient. After all, the commercial value of such a patent attaches to actions of the supplier or manufacturer, and promotion or supply of that product would need to be accompanied with clear instructions, guidance and safety notes on exactly how to employ it for that use.
To explore that further, let’s look to what the health professionals themselves say. In the US, both the AMA and the AAOS (the American Academy of Orthopaedic Surgeons) advocate against the patenting of inventions of ‘pure medical and surgical procedures’. For the purposes of their stance, the AAOS defines such a procedure as ‘a medical diagnostic procedure or treatment, or a method or process, where the ‘invention’ is independent of the use of a medical device and drug.
So the medical community appears only to oppose granting patents for a medical or surgical method per se, used by physicians to treat their patients. This opposition does not extend to patents on medical procedures where those procedures are tied to (ie. not independent of) the use of a medical device.
Reviewing the different approaches in this way, logic might suggest that a patent for the use of a known device for new medical procedures should indeed be free of objection, provided the device is not a standard, staple medical product (a scalpel, clamp, ligature or suture, for example) employed in precisely the manner in which it is conventionally used. Patent rights would continue to be available for a method of using a medical product (device, instrument, tool, apparatus or piece of equipment) in a new manner, where that manner of use would generally be indicated in the commercial provision of that product.
This approach seems to make a great deal of sense, and neatly avoids the somewhat artificial strictures of the situation in Europe. If that is indeed correct, inventions for which the novelty of a medical method can be seen to reside in a newly-identified functional attribute of a device would remain eminently patentable in Australia. The reservation expressed by the High Court in Apotex would simply not apply.
This article expresses the author's view. It should not be regarded as legal advice.
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If you have any queries about this subject, please contact the author Chris Bird, Principal, FPA Patent Attorneys, at email@example.com