High Court of Australia finds that isolated genetic material not patentable

In a landmark decision handed down 7 October 2015, the High Court of Australia has reversed the decisions of the lower courts and found that isolated genetic material is not patentable subject matter.

In D'Arcy v Myriad Genetics Inc [2015] HCA 35 the High Court of Australia unanimously held that claims 1 to 3 of Australian Patent No. 686004 did not relate to patentable subject matter and so were invalid. Claims 1-3 read:

“1. An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

2. An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a mutant BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations set forth in Tables 12, 12A and 14.

3. An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a polymorphic BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more polymorphisms set forth in Tables 18 and 19.”

What was the basis of the decision?

The central question in Australian law is whether the claimed invention relates to a “manner of manufacture” within the meaning given by the statute of monopolies. A description of how the lower courts considered this issue can be found here and here. The three concurring judgments of the High Court of Australia approached the question in different ways:

The decision of the majority (French CJ, Kiefel J, Bell J, and Keane J) found that the essential element to the invention as claimed in these claims was the genetic information they provided, and thus they should not be considered as a class of chemical compounds. Once this emphasis was understood it followed, they felt, it was clear that the claims were “at the boundaries of the concept of 'manner of manufacture'”. Including the claims within the concept of patentability would therefore be an extension of the law, which should not be the province of the judiciary.

Justice Gordon followed a similar form of reasoning, holding that the characterisation of the claims (by the lower court) as "an isolated nucleic acid, a chemical molecule characterised in a certain way, which is chemically, structurally and functionally different to what occurs in nature" did not take into account the focus on the code in the words of the claim. Thus, in arriving at his decision, Justice Gordon placed a similar emphasis on the information aspect of the claim.

In contrast to the above judgments, the judgment of Justices Gageler and Nettle considered that, within the test for manner of manufacture there was a “threshold” test for inventiveness, which distinguishes the subject matter from a mere discovery. This inquiry was said to be distinct from the considerations of novelty and inventive step (which were not at issue). According to Justices Gageler and Nettle, as the step of isolating the genetic material was known, the claims did not meet the threshold test and so could not be considered patentable subject matter.

What does it mean?

It seems clear that isolated naturally occurring nucleic acid sequences will not be considered patentable subject matter in Australia. We do not yet know how IP Australia will go about implementing this change, but it seems likely that new guidelines will issue shortly.

What about cDNA?

On the basis of the decision of the majority, it seems that cDNA will also be unpatentable. In fact Justice Gordon specifically eludes to this fact at paragraphs 283 and 284 of the decision:

“A claim must be valid across its whole scope. It was common ground that if claims 1-3 did not contain patentable subject matter, then those claims would not be saved where they extend to forms of nucleic acid that have been synthesised in the laboratory (cDNA).

Myriad submitted that such a result would put Australia out of step with some of its trading partners including the European Union and the United States of America. That issue, if it is to be addressed, is a matter for the legislature. It is no basis to extend s 18(1) of the Act to claims 1-3.”

In contrast, if it can be argued that the approach taken by Justices Gageler and Nettle is correct, then cDNA may do enough to meet the “threshold” test for inventiveness.

What about diagnostic claims?

Only product claims 1-3 were challenged in the present case. AU 686004 still includes diagnostic claims, for example claim 17:

“A method for diagnosing a predisposition for breast and ovarian cancer in a human subject which comprises determining whether there is a germline alteration in the sequence of the BRCA 1 gene in a tissue sample of said subject compared to the nucleotide sequence set forth in SEQ.ID No: or a wild-type allelic variant thereof, said alteration indicating a predisposition to said cancer being selected from the mutations as set forth in Tables 12, 12A and 14.”

The High Court of Australia did not consider these claims in detail, however they did suggest that the remaining claims of AU 686004 represented a better reflection of the invention. Accordingly, at least until there is a case specifically addressing them, such diagnostic claims remain patentable.

What about other natural products?

The judgement of the majority and of Justice Gordon are very clear that it is the informational content of isolated nucleic acids when claimed in this manner which made the claims unpatentable. On this approach other compounds isolated from nature, such as proteins (such as antibodies), small drug molecules, natural pesticides etc., should remain patentable subject matter.

However, the decision of Justices Gageler and Nettle suggests that using known means to isolate a product which exists in nature would not meet the “threshold” test. Accordingly, naturally occurring products isolated by known methods may also be unpatentable. The extent to which this is the case should become clearer over time.

What about New Zealand?

New Zealand applies the same standard for a patentable invention of “manner of manufacture”, and traditionally has referred to Australian case law as a guide. Many New Zealand cases have applied the test for patentable subject matter set down in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252, which was discussed at length by the High Court of Australia in the present case. There is thus a possibility that New Zealand will follow the lead of Australia. However, there are some differences in New Zealand patent legislation which could lead to New Zealand diverging from Australia in this area. Again we will be watching the Intellectual Property Office of New Zealand closely for guidance in this area.

David Nowak - 7 October 2015

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