Cells

The essential element of Myriad’s claimed invention may not be as concerning to the biotechnology industry as it may seem.

As we recently reported the Australian High Court, in D’Arcy v Myriad Genetics Inc [2015] HCA 35 has, in a unanimous judgment, held that naturally-occurring DNA sequences, even when extracted from the native cell nucleus and isolated by human involvement, cannot be validly made the subject of patent protection in Australia.

The case was deliberately pursued as a test case to determine the boundaries of patentability in Australia in relation to patent claims directed to isolated genetic material. At the time of the High Court judgment the patent claims in suit had expired.

In itself, the decision to find patent claims directed to isolated DNA comprising certain BRCA mutations invalid is unlikely to have earth shattering consequences given that, with the rapid development of technology since the completion of the human genome project, claims of this kind are unlikely to be either novel or inventive in any event.

Of greater interest and relevance, is the rationale upon which the High Court reached its conclusion on patentability. Although the High Court decision was unanimous, with all seven High Court justices reaching the same conclusion, they reached that outcome by different routes.

The impact of the decision for Australia

The emphasis given by the High Court to the essential element of Myriad’s claimed invention being information derived from the naturally occurring DNA may not be as concerning to the biotechnology industry as it may seem. The biotechnology industry is a fast paced environment and the types of claims in issue in this case are no longer common. There is a reasonable prospect that the decision will be given a rather narrow interpretation. However, it remains to be seen how the decision will be applied in practical terms.

The Australian Commissioner of Patents has already given consideration to the High Court decision and has issued, for comment, a draft practice note. The note suggests that the Patent Office will not accept claims for:

  • naturally occurring gene sequences (human) or fragments thereof – either isolated or synthesised;
  • naturally occurring gene sequences (non-human) or fragments thereof – either isolated or synthesised;
  • cDNA;
  • naturally occurring human and non-human RNA and fragments thereof – either isolated or synthesised;
  • Single Nucleotide Polymorphisms;

However, the Commissioner proposes to accept patent eligible inventions that do not merely represent information coding for a polypeptide.

Importantly, the following would remain patent eligible:

  • not naturally occurring isolated bacteria;
  • naturally occurring isolated virus;
  • synthesised/modified polypeptides;
  • isolated polyclonal antibodies;
  • isolated stem cells;
  • probes; and
  • monoclonal antibodies.

It is interesting that the High Court decision goes even further than that of the US Supreme Court which held cDNA to be patent eligible.

In truth the judgments say very little about cDNA and the reason for that is disclosed in the decision of Gordon J in which her Honour stated “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)”.

A further effect of the decision may play out in the context of the implementation in Australia of the Trans Pacific Partnership (TPP) agreement which was reached just prior to the decision being handed down by the High Court. During the final part of those negotiations the Australian negotiators stood firm on resisting US pressure to impose a twelve year data exclusivity period in relation to biologics. One of the bases upon which they did so was by making the point that the Australian patent law was stronger and of broader scope in the context of biotechnology inventions than in the US and that therefore data exclusivity protection was less critical in this country.

That ground seems to have been firmly cut away from the Australian position which may have some interesting ramifications for the implementation of the TPP.

The test for patentability

The central question being considered in this case was whether the subject matter of the claims in suit were to an invention that was a manner of manufacture within the meaning of s6 of the Statute of Monopolies as described in section 18(1)(a) of the Patents Act 1990.

As was emphasised in National Research Development Corporation v Commissioner of Patents (NRDC) (1959) 102 CLR 252 the conception of a manner of manufacture is not limited to physical production but takes meaning from the whole category under which all grants of patents which may be made in accordance with the developed principles of patent law are to be subsumed.

In NRDC it was held that it was enough for a process (which was in issue in that case) to constitute a manner of manufacture that it resulted in an artificially created state of affairs of economic significance. That broad categorisation of a manner of manufacture was the touchstone of the debate before the High Court. It is the various judges’ approach to the concept of “artificiality” dictated by that question which is of most interest and which has the capacity to have significant ramifications for patent law in Australia.

The majority judgment

The four judges in the majority began their judgment by referring to the three claims in issue. Claim 1 is representative and is in the following form:

"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."

The majority judges referred to the fact that the claims are formally expressed as product claims but that, despite that formulation, the substance of the claims was to information embodied in arrangements of nucleotides. The information is not “made” by human action, rather it is discerned. The majority judges reiterated that a patentable invention must be something brought about by human action. Their Honours considered that the limitation in the claims in suit that the sequence in the isolate bear specified mutations or polymorphisms had nothing to do with the person who isolates the nucleic acid bearing the mutant sequence, and the necessary intervention of human action was therefore, in their view, absent.

The majority identified six factors which they said were relevant to determining whether a claimed invention was a manner of manufacture and therefore a patentable invention pursuant to the Patents Act 1990. The six factors are:

1. Whether the invention, as claimed, is for a product made, or a process producing, an outcome as a result of human action.

2. Whether the invention as claimed has economic utility.

3. Whether patentability would be consistent with the purposes of the Patents Act, specifically:

- Whether the claimed invention could give rise to a large new field of monopoly protection with potentially negative effects in innovation;

- Whether the claimed invention could, because of the content of the claims, have a chilling effect on activities beyond those formally the subject of exclusive rights granted to the patentee;

- Whether to accord patentability to the invention as claimed would involve the court assessing important and conflicting public and private interests and purposes.

4. Whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability.

5. Considerations of international law and the comity of Australian patent law with that of other countries.

6. Whether to accord patentability to the class of invention as claimed would involve law-making of a kind which ought to be done by the legislature rather than by a court.

The majority went on to state that the third, fourth and sixth factors were to be of primary importance in the consideration of the patentability of a claimed invention.

Myriad’s argument was that the claims in suit were for a chemical compound and that to assess patentability they must be construed in the same way as another other claim for an invention that is a product. The claimed chemical compound, in Myriad’s submission, had no counterpart in nature. Although they may have been derived from naturally occurring DNA they were brought into existence by human artifice and, in that sense, relevantly “made”.

The majority was not persuaded by that argument which, they stated, elevated form over substance to the detriment of the proper application of the concept of “manner of manufacture” applicable pursuant to s18(1)(a) of the Patents Act 1990 and as explained in NRDC.

The majority viewed the claims in suit as referring to a sequence of nucleotides which, in a cellular environment, can ultimately be translated into the BRCA1 polypeptide and that sequence can properly be described as information. The judges considered the information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide is the same information as that contained in the DNA of the person from which the nucleic acid was isolated. They held that the essential element of the invention was the existence of the information and that the product was merely the medium in which the information resides.

As the majority held that an essential integer of the claims in suit was genetic information that took the claims outside the category of that which can be “made” and therefore outside the concept of patentability.

In passing, the majority noted that the categorisation of the essential element of the invention as claimed as one involving information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide, also attaches to cDNA which is synthesised but replicates a naturally occurring sequence of exons.

The majority considered that their conclusion was supported by the scope of the claims in suit. It was admitted by Myriad that the claims cover a very wide number of chemical compounds – indeed no upper limit on the number of isolated nucleic acids in the classes covered by the claims was identified. The majority held that the unquantified size of the relevant class of isolated nucleic acids, all of which bear the requisite information, raised the risk of “a chilling effect on legitimate innovative activity outside the formal boundaries of the monopoly and risks creating a de facto monopoly impeding the activities of legitimate inventors”.

The decision of Gageler and Nettle JJ

In a separate, but concurring judgment, Justices Gageler and Nettle emphasised that, to qualify as a manner of manufacture, an invention must be something more than a “mere discovery”. The essence of invention was said to inhere in its artificiality or distance from nature – in the case of a product it depends on the extent to which the product individualises nature.

Their Honours were of the view that the artificiality of a product may be perceived in a number of different ways, including the labour required to create it and the physical differences between it and the raw material from which it is derived. Importantly however, their Honours stressed that it wasn’t enough that there was merely a difference between the product and nature – the inventive concept, made the subject of the claim, must be seen as making a contribution to that essential difference. That is what distinguishes a patentable invention from a mere discovery or observation of a law of nature. Their Honours viewed the essence of the claims in suit as being the correlation between the incidence of cancer and the presence of the specified mutations and polymorphisms in the mutated BRCA1 gene – the ingenuity lay in the idea of examining a patent’s isolated DNA constituted of the BRCA1 gene for the presence or absence of the specified mutations and polymorphisms. However, the subject matter of the claims did not give rise to the inclusion or absence of the specified mutations and polymorphisms from the isolated fragment, rather their presence or absence in or from the fragment was a result of the isolated BRCA1 gene being part of the naturally occurring DNA from which the sequence was isolated.

Their Honours stated:

"…it is one thing to say that [Myriad] has invented a process which consists in isolating and examining the fragment comprising the BRCA1 gene for the presence of the specified mutations and polymorphisms as an indicium of malignancy. It is quite another and different thing to say that [Myriad] as inventor of that process is entitled to a monopoly over the mutated BRCA1 gene which is used merely as an ingredient in that process."

Their Honours went on to state:

“…nothing that is done in the course of isolating the BRCA1 gene has any effect on whether the specified mutations and polymorphisms will be present. Their presence or absence in or from the isolated nucleic acid is entirely dependent on whether they were present in or absent from the DNA of the patient whom the isolated nucleic acid was extracted, and in effect that is the antithesis of a man-made artificial state of affairs.”

Decision of Gordon J

A further concurring opinion was delivered by Gordon J.

Her Honour categorised the claims in suit (by representative claim 1) as a claim to a product comprised of isolated nucleic acid having a particular characteristic.

Her Honour considered that it was the combination of an isolated nucleic acid and the existence of one or more of the mutations or polymorphisms that provides the subject matter claimed. Because Myriad was unable to delineate the bounds of the class of compounds claimed by reference to the chemical composition of that class it sought to delineate the boundaries of the claims by reference to what it described as the “characteristics identified within the claim” – the specific mutations and polymorphisms.

Her Honour placed emphasis on the wording within the claims that the isolated nucleic acid was coding for the mutation or polymorphism. Myriad did not create, make or alter any of the nucleic acid sequence in the BRCA1 gene, not did it create, make or alter of the mutations, polymorphisms listed in the tables specified in the claim. Each mutation and polymorphism identified in the tables had the same sequence in its native state in the cell. That the specific mutations and polymorphisms were indicative of a predisposition to breast cancer and ovarian cancer was, according to her Honour, a “fact” and one which existed before Myriad worked it out. The presence or absence of the mutations and polymorphisms had nothing to do with Myriad.

Her Honour tested the proposition by taking an alternative approach, that is to identify what was Myriad’s idea, concept or principle and what did it do with that idea, concept or principle that could be categorised as a manner of new manufacture?

Her Honour categorised Myriad’s idea, concept or principle, as that of specific mutations or polymorphisms in the BRCA1 gene sequence that suggested a predisposition to breast cancer and ovarian cancer and she then asked the question of how that idea is carried out in claim 1. Her Honour concluded that it is not carried out as claim 1 suggests by creating a product comprising isolated nucleic acid from a patient which contains the identified characteristic in any one of its many forms.

Her Honour did consider that Myriad arrived at a patentable invention, an example of which was claim 4 of the patent. Claim 4 was for a probe – that claim carried into effect the idea that specifically identified mutations or polymorphisms in a sequence of the BRCA1 gene suggest a predisposition to breast cancer and ovarian cancer by testing for the presence of one or more of the specifically identified mutations or polymorphisms.

It remains to be seen whether the implications of the High Court decision are considered to be so detrimental to innovation in the biotechnology sector as to justify legislative intervention.

On any view, the debate in this highly emotionally charged area is likely to be ongoing.

Our Expert Project Lead

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