The swinging pendulum of patentable subject matter in Australia.

By: HEDIE MEKA PhD

The law relating to what constitutes patentable subject matter is a moving target in Australia. However, the authorities have set down some guidelines for interpreting s 18(1)(a) of the Patents Act 1990 relating to patentable subject matter. According to the Australian Patent Office Manual of Practice and Procedure, decisions relating to s 18(1)(a) “suggest” that examiners can approach examination of patentable subject matter in a way similar to that formulated in Aerotel Ltd v Telco Holdings Ltd & Ors Rev 1 [2007] RPC (“Aerotel“) as follows:

  • construe the claim;
  • identify the substance of the claim to determine the alleged or actual contribution to the state of the art;
  • ask whether the substance of the invention lies within established principles of what does not constitute a patentable invention (for example, is it merely a scheme, plan, rules of gameplay, intellectual or genetic information?);
  • if not, consider whether the substance otherwise lies outside of existing concepts of manner of manufacture and is to be treated as a “new class” of subject matter.

It is important to understand that the underlying principle of patent practice, that is, that the authorities reward applicants for technical contributions, does need to be conveyed to prospective applicants. The above test has made it easier for examiners to determine whether the state should be granting such rewards to applicants.

This article is limited to a consideration of biotechnology-related inventions. Such inventions are generally of significant commercial value due at least in part to the highly regulated market and the cost of R&D compared to their software-related counterparts. Thus, decisions made by the authorities in this field can have substantial ramifications in the industry.

Since the High Court’s watershed decision in D’Arcy v Myriad Genetics Inc [2015] HCA 35  (“Myriad”) regarding the patent eligibility in Australia of DNA isolated from humans, the body of case law regarding biotechnology-based inventions has been steadily evolving. This evolution is necessary since the High Court made plain that the decision in Myriad was not a blanket ban on the patentability of inventions derived from nature and other biotechnology-related inventions. Rather than draw an immovable line between what is, and what is not, patentable subject matter, or generate a precise formulation, the High Court provided a general framework within which to assess whether such inventions satisfy s 18(1)(a). The Court upheld a case-by-case approach having regard to the substance of the invention, and not simply the form of the claim under consideration.

The following decisions from the Australian Patent Office Opposition Division have been chosen to showcase how, in light of Myriad, the Office approaches evaluation of what is patentable subject matter with respect to different biotechnology-based inventions.

Academisch Ziekenhuis Leiden and BioMarin Technologies B.V. [2018] APO 49 

This decision from Delegate Lim arose from a request by the Applicant to be heard in relation to objections raised during examination of Australian Application No. 2015252074, including the Examiner’s objection that claims 1-14 were not directed to patentable subject matter.

The invention under consideration broadly relates to a therapeutic invention for the treatment of Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD). DMD and BMD are genetic disorders in which the gene that codes for the dystrophin protein is mutated. In non-diseased individuals, dystrophin maintains fibre stability during muscle contraction. The genetic mutation in DMD results in the absence of a functional dystrophin whereas the BMD dystrophin gene mutation permits synthesis of a partially functional dystrophin. This divergence accounts for the difference in severity between the diseases, with DMD being the more severe form of the disease.

The claims under consideration encompass short forms of nucleic acids (oligonucleotides) that convert the mutated dystrophin gene in DMD to a form that can produce the partially functional dystrophin protein found in BMD patients, which will prolong the viability of muscle tissue. The oligonucleotides are designed to induce skipping of a region in genomic DNA of DMD sufferers referred to as exon 44, a region which causes disruption to dystrophin production. Skipping of exon 44 leads to production of a partially functional dystrophin. The oligonucleotides claimed are of a specific length, have a nucleotide sequence complementary to a sequence present in exon 44, and include a modification in the form of a nucleotide analogue that is a locked nucleic acid (LNA). The nucleotide sequence includes a mismatch to the respective exon 44 sequence such that the oligonucleotide is capable of hybridising to complementary sequence in exon 44 of dystrophin pre-mRNA and inducing skipping of exon 44 to produce a partially function dystrophin that is present in BMD patients. The LNA modification increases the stability of the oligonucleotide, and thereby increase the functional efficiency of the oligonucleotide.

The Examiner considered that the substance of the claim to be the genetic information that the claimed oligonucleotide encodes since “…the genetic information of the claimed oligonucleotide alone is responsible for the hybridisation [to a native sequence in the pre-mRNA], and it is the hybridised complex that causes the spliceosome to skip, not the oligonucleotide alone…” .

The crux of the Examiner’s objection was that the substance of the invention was genetic information that the claimed oligonucleotide encodes, and the “…invention is considered to have a natural counterpart, as the oligonucleotide is the complement of the natural dystrophin gene, and as discussed above, the claim is considered to be genetic information and not a product.”  The Examiner seemed to place no weight on the inclusion of the non-natural modification of the oligonucleotide in the form of LNA.

In response, the Applicant argued that the claimed oligonucleotide is a non-naturally occurring product for use in therapy (due at least to the presence of the LNA) and more particularly, the claimed oligonucleotide is not synthesised in any known natural process, even in the absence of the LNA.

The Applicant went further to state that “… the substance of the claim does not reside in the information embodied in the sequence of nucleotides of the molecule, but rather in bringing into existence the oligonucleotide as claimed, the exon 44-skipping function of the oligonucleotide as claimed, and further improvement in exon 44-skipping function by incorporating a LNA into the oligonucleotide as claimed.”

Delegate Lim reviewed prevailing authority from the High Court and application of this authority in subsequent decisions to apply the following approach for determining the patent eligibility of the subject matter of the claims:

“…to determine what is the substance of the claimed invention, and whether or not that substance has been “made”. I note that the substance of the claimed invention is not necessarily the subject matter of the claim as defined by the words of the claim.”

In determining the substance of the invention, Delegate Lim set out that he was to consider:

  • how the invention works;
    • the nature and contribution of the nucleotide sequence to the working of the invention;
    • the nature and contribution of the other claimed features to the working of the invention;
  • the nature of the contribution to the art; and
  • whether the nature and contribution of the features of the invention claimed as a whole, on balance, weigh towards being characterised as genetic information, or a chemical compound.

Moreover, when establishing the substance of the invention, the nature and contribution of the features of the invention as a whole must be considered and “…no single consideration is conclusive in determining the substance of the claimed invention. Some considerations may be more significant than others.”

Using the above approach, Delegate Lim ruled in favour of the Applicant and thus over-turned the Examiner’s objection that the claimed invention is not a manner of manufacture.

Saliently, Delegate Lim rejected the premise that where a claim encompasses an artificially made chemical compound incorporating a nucleic acid, the substance of the claimed invention is not genetic information and consequently is patentable subject matter. Conversely, it also does not follow as a matter of course that where the subject matter of a claim is a pharmaceutical composition, the substance of the claimed invention is not genetic information and consequently is patentable subject matter. Following High Court authority, Delegate Lim held that “…consideration must be given to the true nature of the claim, and not simply the form of the claim.”

While acknowledging that the claimed oligonucleotide uses the information embodied in a specific nucleotide sequence and, in some forms, embodies information that corresponds to that contained in genomic DNA, Delegate Lim distinguished the information encompassed by claim 1 from “genetic information” as follows:

  • The information embodied in the specific nucleotide sequences is not a genetic code that is ultimately translated into an expressed polypeptide, but rather the nucleotide sequences are used to effect the production of an altered, but partially functional, protein to a level not normally present in DMD or BMD patients.
  • The information in the altered, but partially functional, dystrophin protein is not the same as the information embodied in the specific nucleotide sequences of the claimed oligonucleotide.
  • The information embodied in the specific nucleotide sequences of the claimed oligonucleotide is not used to ascertain information about a nucleic acid sequence.

Upon review of the specification as a whole and applying the above approach, the delegate determined that “…because the contribution of the specific nucleotide sequence towards the working of the present invention lies in how the nucleotide sequence is used and the result of that use…” , it was considered that the “…contribution of the nucleotide sequence, on balance, weighs towards the substance of the claimed invention being a chemical compound” , and thus a product that is patentable.

Furthermore, the structural features of length and presence of LNA are significant to the working of the invention, and weigh towards the substance of the claimed invention being a chemical compound.

Delegate Lim concluded that the substance of the claimed invention is an artificially made compound and thus is a manner of manufacture in accordance with s 18(1)(a).

Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited [2018] APO 11

Australian Application Number 2008322739 to Reckitt Benckiser Healthcare (UK) Limited was opposed on a number of grounds, including lack of manner of manufacture. The invention relates to the use of the anti-bacterial compound 2,4-dichlorobenzyl alcohol (DCBA) in combination with other anti-bacterial compounds in the form of amylmetacresol (AMC), cetyl pyridinium chloride (CPC) and hexetidine (HT) to achieve an anaesthetic effect, and preferably in the form of a lozenge. All of these compounds were known before the priority date, but none were known to have an anaesthetic use.

Claims 1 and 2 are Swiss-type method claims. Swiss-type claims are construed under Australian law as being directed to a method, wherein the method involves the preparation of the medicament with the intention of using it for the specific purpose recited in the claim. Accordingly, claims 1 and 2 were construed as defining a method, wherein the method is the manufacture of a medicament (claims 1 and 2 having different compositions) with an intention to use the medicament to provide an anaesthetic effect. The remainder of the claims are directed to methods of obtaining a local anaesthetic effect (claims 7 and 8), methods of locally anaesthetising a patient (claims 12 and 13), and methods of locally anaesthetising the throat of a patient (claims 17 and 18), by administering a composition comprising DCBA and any one of AMC, CPC, HT and HR, or a composition comprising DCBA and AMC.

Unsurprisingly, Delegate Barker cited Myriad to define the approach “that the assessment of whether a claimed invention is a manner of manufacture is one of substance rather than form” . The invention under consideration was predicated on the finding that certain known anti-bacterial compounds can be used to provide a previously unknown anaesthetic effect, and as such extended the manner of manufacture consideration to include whether the invention is a mere discovery without producing a new or useful result or having practical application (and thus not a manner of manufacture). As noted by Delegate Barker, the Courts have not delineated a general definition of what constitutes a discovery as opposed to an invention. As such, the assessment of manner of manufacture taken by the delegate was as set out in Myriad: determine the substance of the claims, and whether or not the substance is patentable subject matter, taking note that the substance of the claim is not necessarily the subject matter as defined by the words of the claim.

Using this approach, Delegate Barker concurred with the Applicant’s submission that the substance of the claims is the use of known compositions to provide an anaesthetic effect, and methods of obtaining an anaesthetic effect or anesthetising a patient. Moreover, the substance of the claims is a second medical use and not merely a scheme, plan, intellectual or genetic information and thus is patentable subject matter. The delegate considered that the substance of the claims went beyond a mere discovery since “the claims define a practical application of the discovery that DCBA, AMC, CPC, HT and HR have anaesthetic properties.”

The Opponent also sought to argue that the claims do not define a manner of manufacture since the claimed invention is no more than the use of a well-known composition in the form of Strepsils® lozenges (which include DCBA and AMC) for a purpose which was also well known (treating sore throats), thus applying the approach to manner of manufacture laid out in Commissioner of Patents v Microcell Ltd . The High Court in Microcell stipulated that:

“We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter of a patent.”

This argument was rejected, at least in part due to failure of any evidence (either in the specification or common general knowledge) to suggest that any of DCBA, AMC, CPC, HT or HR provide an anaesthetic effect, and more particularly “the invention is not merely the use of the composition to treat sore throats, but the use of the composition to achieve an anaesthetic effect.”

The claims were found to define patentable subject matter, and the opposition was unsuccessful on this ground.

Novavax, Inc. v GlaxoSmithKline Biologicals SA [2018] APO 84 

Australian Application No. 2012211278 to GlaxoSmithKline Biologicals SA relates to improved immunisation regimens for protecting against respiratory syncytial virus (RSV). RSV is the most common cause of bronchiolitis and pneumonia among children in their first year of life.

The claims are directed to a two-step vaccination regimen to provide protective immunity against RSV in an infant, comprising (a) administering a first anti-RSV immune response inducing composition to a female during pregnancy; and (b) administering a second anti-RSV immune response inducing composition to the infant that is born from that pregnancy at about 4 months old or younger.

As part of the opposition, Novavax, Inc alleged that the claims do not define a manner of manufacture. In laying out the authorities for an assessment of manner of manufacture, Delegate Triffett not only cited Myriad for determining the substance of the invention, but also cited Hickton’s Patent Syndicate v Patents and Machine Improvements Co. Ltd  in relation to the assertion that a mere idea is not patentable subject matter. However, Hickton’s made plain that at an idea may be considered patentable subject matter if the Applicant suggests a way of carrying out the idea.

The Opponent asserted that the substance of the invention was merely a known idea of administering a “largely unspecified vaccine having a particular effect” , first to a pregnant mother followed by administration to a baby born to that immunised mother and is without technical application. According to the Opponent, any technical application would arise from creation of a vaccine and possibly, an administration regime for the vaccine. However, the claims under consideration fail Hickton’s since the specification does not disclose the creation of any suitable vaccine.

Delegate Triffett favoured the Applicant’s argument that the substance of the invention is a therapeutic method involving a two-step vaccination regimen comprising administration of an RSV antigenic protein and in particular:

“The substance of the claims is not an idea without technical application, as the technical application is the particular two-step regimen of administering RSV F glycoprotein in order to provide protective immunity against RSV in an infant. The fact that the invention does not lie in the creation of an RSV vaccine per se is immaterial, as the invention lies in the particular administration regimen which is carried out using an RSV F glycoprotein antigen.”

Accordingly, the claims were found to define patentable subject matter.

Conclusion

Regardless of the nature of the subject matter or technology considered in the decisions above, analysis of manner of manufacture by the delegates had the following common features taken from Myriad:

  • Determine what is the substance of the claim, and whether the substance is patentable subject matter.
  • The substance of the claim is not necessarily the subject matter of the claim as defined by the words of the claim. The true nature of the claim must be considered, which may require looking beyond the form or wording of the claim.
  • The nature and contribution of the features of the invention as a whole must be considered.

Evident from these decisions is that the formulation for assessing manner of manufacture set down by the Court in Myriad has achieved the Court’s aim to provide a flexible and workable framework for determining what is patentable subject matter, at least for biotechnology-related inventions.

(This article was first published in LexisNexis’ Australian Intellectual Property Law Bulletin Vol 31)