In a landmark decision regarding the patentability of genetic material, the Federal Court of Australia has held that any nucleic acid found in cells, whether it be DNA or RNA, that has been removed from the cellular environment in which it naturally exists, is patentable. The Court held that “Isolated nucleic acid is the product of human intervention…”.
This decision will be welcomed by the biotechnology community which heavily relies upon patents to underpin their business. Moreover, this decision extends beyond genetic material with a human origin to molecules from animals, plants and micro-organisms.
Despite the significant attention that this case has received, the judgement itself will not change the current landscape for patent applicants or patentees in relation to what is patentable subject matter. Perhaps of more importance to applicants will be the legislative changes that will serve to increase standards of other requirements for patentability as discussed at the end of this article.
The issue – is isolated genetic material a “manner of manufacture”?
The only issue in this case1 was whether a naturally occurring nucleic acid that has been “isolated” is “a manner of manufacture” within the statutory definition of the Act. The “manner of manufacture” requirement is in contrast to §101 of 35 U.S.C. and Art. 52 EPC, but essentially defines what is patentable subject matter in Australia.
The starting point for considering whether claimed subject matter is a “manner of manufacture” was the decision by the High Court of Australia in NRDC2. The principles in that decision can be distilled into two questions, which if both are answered in the affirmative, indicate that the subject matter is patentable:
Does the subject matter of the claim consist of an artificially created state of affairs? and
Does the subject matter of the claim provide a new and useful effect that is of economic significance?
The second question was acknowledged by both parties to be answered in the affirmative, so the sole issue was whether the claimed naturally occurring “isolated” nucleic acids consist of an artificially created state of affairs. For there to be an artificially created state of affairs in relation to a composition of matter, the judge noted that there must be some human intervention, although it is difficult to quantitate what level of human intervention is required.
In the context of biological material, the Court was of the view that an artificially created state of affairs may arise if the physical properties of the naturally occurring material have changed as a result of isolation. To this effect, the Court construed “isolated” to imply that naturally occurring nucleic acid found in the cells of the human body, whether DNA or RNA, had been removed from the cellular environment in which it naturally exists and separated from other cellular components. Even if the claimed nucleic acid had precisely the same chemical composition and structure as that found in a cell, the Court concluded that the nucleic acid is patentable subject matter on the basis that it has been extracted from cells and purged of other biological materials with which it was associated in the cell.
In reaching the conclusion that an isolated nucleic acid constitutes an artificially created state of affairs, the Court reasoned that:
the High Court in NRDC took a broad view to the concept of “manner of manufacture”;
isolation of a nucleic acid involves human intervention, i.e. extraction – rupturing the cell membrane and physical destruction of the cell – and purification – removal of other materials originally present in the cell; and
there should be reward for effort and skill for the development of the invention.
The Court also noted that decision in NRDC does not require one to ask whether a composition of matter is a “product of nature” or whether it is “markedly different” to something that exists in nature.
The Court considered the legal positions in the UK and the US in relation to the patentability of isolated DNA or RNA but did not appear to be influenced by the stance taken in those jurisdictions.
An interesting question that now arises is to what extent a nucleic acid has to be “isolated” in order to infringe a claim in this form.
A UK court3 narrowly construed “isolated” in the context of a claim to an isolated DNA sequence as meaning separated from other molecular species in the form of a purified DNA fragment. In that case, a soybean meal containing the claimed DNA sequence was not found to be an infringement as the DNA sequence in the soybean meal was not purified to the extent that it was “isolated”.
While this decision is not law in Australia, it highlights the need to carefully draft claims to nucleic acids, or at least provide carefully worded dictionary-style definitions in the description, to balance the need to meet the “manner of manufacture” requirement whilst not inviting the Court to adopt an unduly narrow construction. In this case applicants should also consider including claims to nucleic acids in a composition that represents the commercial product or an intermediate product in the production process.
Business as usual?
This decision does not change the law as it has been applied by the Australian Patent Office for over 30 years. The Australian Patent Office should continue to allow patent applicants to claim genetic material, provided the claimed material is qualified as having been “isolated”, or words to that effect.
In one sense this decision is reassuring to present and future patent applicants that the status quo in Australia hasn’t changed. However, it must be acknowledged that this decision only deals with one requirement that an invention must meet to be a patentable invention. The mere isolation of a nucleic acid, while likely to be patentable subject matter, is unlikely to meet the other requirements for a patentable invention, e.g. utility, inventive step etc. Even before this decision, it was difficult to secure a claim to an isolated nucleic acid without attributing some sort of function or additional feature to the nucleic acid in order to overcome the inventive step hurdle. Further, the rapid expansion of the prior art base of genetic sequences through second generation sequencing is likely to make obtaining claims to isolated naturally occurring DNA or RNA more difficult.
Impact of the “Raising the Bar” amendments to the Patents Act
Finally, it is worth considering the relevance of this decision in light of the new patentability standards that will soon come in to force in Australia by way of the “Raising the Bar” Act.
As a result of changes to Australian patent law, a new utility standard will be applied to certain applications after 15 April 2013 potentially making it more difficult to claim isolated naturally occurring DNA or RNA than in the past. Also, the new law will expand the prior art base and the common general knowledge relevant to testing inventive step.
The “manner of manufacture” requirement however has not been changed, and despite public pressure, the Act did not introduce any limitations as to what constitutes “patentable subject matter”. It has however introduced “an experimental use exemption” to Australian patent infringement where the predominant purpose of the relevant act is to gain new knowledge, or to test a principle or supposition regarding a patented invention. While it will be some time before we have any guidance from the Courts as to what constitutes experimental use, the provision will hopefully provide some comfort to those concerned by the outcome of this case as allegedly stifling experimental research.
Please refer to An easy guide to the changes to Australia’s patent law.
1. Cancer Voices Australia v Myriad Genetics Inc  FCA 65
2. National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252
3. Monsanto Technology v. Cargill International  EWHC 2257 (Pat)