Recent years have presented significant challenges to the biotechnology sector, both in Australia and the United States, in terms of what types of technology are to continue to be regarded as patentable subject matter. This has resulted in uncertainty in relation to the future of biotechnology patenting. It is therefore a very welcome outcome that the High Court of Australia has now affirmed that methods of treatment remain patent eligible subject matter in Australia. This decision cannot be further appealed and it is now only by legislative intervention or future reconsideration of this issue by the High Court that the question of the patentability of methods of treatment in Australia could be re-opened. Accordingly, although the future of gene patents and diagnostic methods remains somewhat uncertain, the question of the patentability of methods of treatment in Australia has been settled.
Patentability of genes
A judicial challenge to the patentability of the Myriad BRCA gene patents in the United States (Association for Molecular Pathology v Myriad Genetics) resulted in a Supreme Court ruling, earlier this year, that genes are not patentable subject matter. This decision was made on the basis that genes are naturally occurring molecules and therefore not patentable. Serious concern now exists as to what precedent this decision may have created regarding the ongoing patentability of other naturally occurring biologics in the US, such as proteins. In contrast, a decision of the Federal Court of Australia in Cancer Voices Australia v Myriad Genetics, also in respect of Myriad’s BRCA gene patents, held that genes are patentable on the basis that their isolation from the natural environment can give rise to the “artificial state of affairs” which is the threshold required to be met under Australian law for subject matter to be patent eligible. However, this decision is currently under appeal to the full Federal Court.
Patentability of diagnostic methods
The patentability of diagnostic methods has also been significantly weakened in the United States by virtue of the Supreme Court decision in Mayo Collaborative Services v Prometheus Laboratories Inc which held that patents which simply describe a natural law or relationship and provide a bare instruction to “apply it” are not patent eligible. This decision has been used to support a finding of lack of patentability for diagnostic claims which, in addition to specifying the relationship between a marker and a disease condition, merely recite the performance of conventional diagnostic steps at a high level of generality. As a result, significant uncertainty has been created in the United States in terms of which diagnostic patents fall foul of this decision and which do not. To date, the patentability of diagnostic methods has not been challenged in Australia.
Patentability of methods of treatment – Apotex Pty Ltd v Sanofi-Aventis Australia Pty Limited
Despite the fact that the patent eligibility of diagnostic methods has so far not been challenged in Australia, the patent eligibility of methods of treatment was challenged in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Limited, a case which proceeded through the Federal Court and was finally appealed to the High Court in relation to this important issue. This case was heard in the face of a backdrop of both long standing practices in Australia and the US that methods of treatment are regarded as patentable and the entirely divergent situation in Europe where methods of treatment and diagnosis are not patentable.
Apotex concerned the validity of a method directed to a new use for the off-patent drug Leflunomide, specifically a method of using leflunomide to treat psoriasis. Apotex had challenged the validity of the claims directed to this method of treatment on the ground that they did not relate to patentable subject matter.
In a decision handed down on 4 December 2013, a majority of the High Court affirmed that method of treatment claims are patentable subject matter in Australia. This decision is based on the Court’s view that the “artificially created state of affairs providing economic utility”, which is the threshold that must be met in Australia for subject matter to be patentable, is met by methods of treatment. Although a number of legal and moral issues were considered in deciding this issue, one of the primary considerations rested on whether or not a method of treatment is “an economic endeavour”. The Court considered at length the development of judicial and legislative principles in relation to the patentability of methods of treatment in Australia, UK, Europe, US and Canada and ultimately held that despite whatever views may have been held in the past, methods of medical treatment, in particular the use of a pharmaceutical drug, cannot be considered non-economic. Specifically, the method in issue was held to artificially create an improvement in human health, this having economic utility. The Court therefore concluded that to exclude methods of treatment from patentability would represent an anomaly for which no consistent foundation had previously been enunciated in Australia.
Medical practitioner liability for patent infringement
The Court discussed and acknowledged, at some length, the conflict between not interfering with the freedom of a medical practitioner to treat a patient without risking patent infringement versus encouraging and rewarding research and development in relation to drug therapy. To this end, the Court noted that a substantial consideration in relation to the issue of methods of treatment is in fact linked to ethical and moral considerations, more so than whether or not a method of treatment defines an “economic endeavour”. The Court also noted that to exclude methods of treatment of the human body would introduce a lack of harmony between Australia and its major trading partners, where none is regarded to exist at the moment. This comment is somewhat curious when one considers that methods of treatment are not patentable in Europe and New Zealand, this having been discussed in detail by the Court. Ultimately, the Court also held that issues of public policy and ethics should be left for the legislature to decide and not the Courts.
Interestingly, there was an opinion expressed by the Court that a distinction exists between a method of medical treatment directed to a new use for a pharmaceutical drug versus the activities of doctors when physically treating patients. Despite acknowledging this distinction, the Court noted that it was unnecessary to decide whether or not the latter class of method of treatment should remain patent eligible. In fact, it is this very distinction which underpins the European exclusion of the patentability of methods of treatment generally, in favour of an alternative form of protection directed to the “use” of a drug. With two members of the Court having acknowledged the issue of the existence of a distinction between these two classes of methods of treatment, and the fact that it has not been necessary to decide this question in this case, one is led to question whether the door has been left open to a future consideration of the issue of liability of medical practitioners who infringe, usually unknowingly, method of treatment claims.
This decision therefore affirms the current Australian practice that methods of treatment are patent eligible. In the face of the changing biotech landscape in the United States in relation to patents for genes and diagnostics, together with the current Australian Myriad appeal, the decision of the High Court is a welcome outcome. It provides the certainty and robustness which the healthcare industry requires in order to continue to support the translation of research from the laboratory to the clinic.