That is the question that we hoped Australia’s final appeal Court to have answered in the Myriad decision that it handed down last week. Some observers have been quite forthright on the point: ‘Yes, the High Court of Australia has answered that question, and Yes, the answer given by the Court is that isolated nucleic acid molecules are not patent eligible’.
Clearly the High Court has given an answer to a question, but was that question the one we anticipated? That in itself is an open question!
On one reading, it can be argued that the question that has been answered by the Court is ‘Does the information in a nucleotide sequence constitute patent eligible subject matter under Australian law?’
This becomes apparent from the majority: “Identification of the subject matter of the claims as a class of chemical compounds ….is a premise which …elevates form over substance”. It also becomes apparent from the majority in the statement relevant to patent eligibility of sequence information in cDNA molecules: “That characteristic also attaches to cDNA, covered by the claims, which is synthesised, but replicates a naturally occurring sequence of exons.”
Further, according to the majority: “It seems to have been assumed by all parties that a nucleotide sequence [derived from a nucleic acid originating in a human cell] may itself appropriately be designated as a “nucleic acid”. That assumption can be treated as taxonomical, and accepted for the purposes of this appeal”.
Assuming that the question answered was regarding patent eligibility of nucleotide sequences (but not nucleic acid molecules), it is perhaps not surprising given established Australian patent law, that the view of the majority is that a nucleotide sequence is not patent eligible subject matter. As said, such a sequence is mere information, and to the extent that it is information, it is not “brought about by human action”. This should apply equally whether the relevant sequence is one that is found in nature, or one that arises from genetic engineering.
If it is true that the High Court’s decision concerned whether nucleotide sequences are patentable subject matter, the practical question for Australian patent owners is what, if anything should be done now? In answer, an appropriate step would be to ensure that patent claims are structured so as to clearly define that the subject matter to be protected is the relevant nucleic acid per se; and not the descriptor of it, i.e. not the nucleotide sequence information that describes it.
An obvious claim drafting style to avoid would probably be that of the Myriad claims at issue, for example:
“An isolated nucleic acid coding for polypeptide X, the nucleic acid containing in comparison to polypeptide X encoding sequence…….”.
It is clear that the majority was concerned by the language “coding for” and “encoding” and the fact that the claim appears to call for a comparison of sequences, perhaps leading the majority to conclude that the claim is for sequence information.
What is perhaps most important to note is that nowhere did the Court opine that, because of an observed biological function, any and all nucleic acid molecules are inherently patent ineligible. In the words of the majority: “this decision is not about gene patenting.” Instead, it was the opinion of the Court that the subject matter of Myriad’s disputed claims was patent ineligible.
The logical extension of this appears to be that, even if the Court did answer the question of whether a nucleic acid constitutes patent eligible subject matter under Australian law, the answer it has given is limited to the facts of the Myriad claims that it considered. As noted by the Court, the subject matter of those claims fell foul of the policy considerations that the Court considered applicable to the patentable subject matter question.
So where are we now regarding the patent eligibility of isolated nucleic acids that have a sequence that exists in nature? Are these compounds, because of their sequence, excluded from patent protection? Is the position so clear that the correct advice is not to file these patent claims in Australia? The answer seems to be ‘no’.
It appears from the decision that questions on the breadth and clarity of the relevant claims, public policy considerations and coherence of law relating to inherent patentability are to be asked on a case-by case basis. According to the majority: “In Australia, the Parliament has left it to the courts to carry out a case-by case development of a broad statutory concept according to the common law method in a representative democracy”.
Having said this, one should reasonably expect that it will be more challenging to obtain an allowance of these patent claims, although, that in itself should not mean that it will not be possible to obtain an allowance. Nor does it mean that once issued, any and all claims to an isolated nucleic acid having a sequence existing in nature are not enforceable.
In the circumstances, it appears that the prudent and conservative approach for Australia will be to continue to file for and seek issuance of these claims. This is particularly the case where there is no indication from the decision, that the Australian legal threshold for patent eligibility of claims to nucleic acids is the same as, or higher than currently understood US law. On this basis, a claim that would be allowable under US law should also be patent eligible under Australian law.