Can a natural product still be patented in Australia?

Date: 2015-10-20

Yes. While various commentaries have suggested that patentable subject matter will be restricted in Australia under the recent High Court Myriad decision to exclude naturally occurring products (whether or not isolated), my view is that is far too broad an interpretation of the decision.

There will be some limitation on the scope of patentable subject matter going forward.  But I believe it will be far less than the corresponding restriction underway in the USA at the moment under the current policy of the USPTO in implementing its view of the US Supreme Court decision in Myriad (in which far more claims were considered than in the Australian decision).

Moreover, the Australian Patent Office released a draft public consultation document yesterday which provides much more encouragement for patentees as well, consistent with my view above. While the Patent Office indicated that its proposed practice note will specify that naturally occurring nucleic acid sequences which encode polypeptides (or fragments) will not be patentable, it states that many other natural products would remain within the scope of patentable subject matter, including non-coding or regulatory DNA/RNA, bacteria, viruses, polypeptides, antibodies, cells, etc.

In this way, it can be seen that the Australian High Court (and the Australian Patent Office) are proposing a much broader scope of patentable subject matter than the US Supreme Court in its Myriad decision. One of the key outcomes from the US Supreme Court decision has become known as the ‘product of nature’ exception to patentable subject matter. This was not considered determinative in Australia.  The majority (of four judges) decision in Australia stated that the use of categories such as ‘products of nature’ versus ‘artificially created products’ may distract from the central issue for determining patentable subject matter in this case – instead, they focused on their assessment that the claims were essentially to information, and therefore not patentable. A fifth judge put the matter more clearly in saying that a contention that ‘naturally occurring things, or products or phenomena or principles of nature’ are excluded from patentable subject matter was not part of her reasoning.

However, the remaining two judges did make some suggestion that a key requirement of patentable subject matter was that a patentable invention must be different from what occurs in nature. It appears that even isolation was insufficient in the view of these remaining two judges for patentability. Their underlying rationale appears to be that a naturally occurring phenomenon by definition must lack the quality of inventiveness necessary to qualify as patentable subject matter. However, the reasoning is tied to the narrow claims before them, and they do not express the extent to which this principle would apply (or not) to other natural products. More importantly, the judges acknowledge that it was not disputed that it would be patentable to discover that the presence of a particular genetic mutation is indicative of a particular kind of malignancy in the cell. In other words, the method of diagnosis claims were not in dispute. They also noted that it was not possible, in their view, to patent the discovery of a natural correlation. But this was the view of only 2 judges out of 7.

I believe that many naturally occurring nucleic acids will remain patentable in Australia providing the claims are properly prepared so as not to encompass mere information and so that their subject matter otherwise meets the usual requirements of novelty, inventive step etc. The Australian Patent Office is currently formulating a public statement of what its practice will be on patentable subject matter, subject to any future Court decisions.  In summary, the scope or protection for most naturally derived products in Australia should not change substantially.  The Myriad decision should not therefore prompt any significant change to the Australian patenting strategy for most patent applicants.