Swiss-style claims in Australia: strictly limited to therapeutic uses?

Recent Australian Court decisions have provided clarity to the patentability of Swiss-style claims in Australia.  However, as a result of these decisions, the Australian Patent Office is now applying a restrictive approach when assessing the allowability of the Swiss-style claiming format, excluding from patentability some claims directed to diagnostic methods.

The key benefit of Swiss-style claims

While briefly discussed in the Australian High Court’s decision in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, the decision by Justice Yates of the Australian Federal Court in Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634 (‘Otsuka’) provides a comprehensive summary of the origin and interpretation of Swiss-style claims.  The Courts view on such claims was upheld in separate appeals to the Full Federal Court.[1]  The key points relevant to the present discussion are as follows:

  • Swiss-style claims originate from the European patent system as a ‘workaround’ to protect a new medical use for a known compound (i.e. a ‘second medical use’) without claiming ‘a method of treatment’ which is prohibited under European law[2] (and also New Zealand law, whereas no prohibition exists in Australia).  Swiss-style claims can also be used in the context of a ‘first medical use’.
  • The generalised form of a Swiss-style claim is ‘the use of compound X in the manufacture of a medicament for a specified (and new) therapeutic use’.[3]  Revisions to the European Patent Code introduced in 2000 abolished the requirement for this ‘generalised form’ in favour of a simplified form (‘substance X for use in a method for treating medical condition Y’).  The generalised form (but not the ‘simplified form’) is the form recognised by the Australian and New Zealand Patent Offices.
  • With respect to the ‘generalised form’, the use of a compound in the manufacture of a medicament for use in particular treatment is not itself use of the medicament for that treatment.[4]  Rather, Swiss-style claims are construed in Australia (and New Zealand) as claims directed to a ‘method’ or ‘process’ of manufacturing the medicament.[5] The therapeutic use in a Swiss-style claim reflects an intended use[6] that qualifies, and thus confines, the scope of the monopoly that is claimed.[7]

Thus, the key benefit of a Swiss-style claim is the class of infringer it captures.  Specifically, an infringer of a Swiss-style claim is a person who might illegitimately manufacture the medicament with the intention that it be used to treat the named disease.  By contrast, an infringer of a method of treatment claim would be a clinician or person who administers the medicament.  Given that pharmaceutical companies are likely reluctant to sue the people to whom sale of the medicament is ultimately intended, it would be necessary to rely on contributory infringement provisions[8] to sue an illegitimate manufacturer of the medicament based on indirect infringement of a method of treatment claim.

Notably, Justice Yates in Otsuka emphasised that, for the purposes of determining infringement of a Swiss-style claim:

  • the question is whether the medicament that results from the infringing method or process is one that has,[9] or would inevitably provide,[10] the therapeutic use defined in a Swiss-style claim,
  • the infringer’s actions in advertising or promoting the medicament so as to avoid infringement (i.e. skinny labelling) do not change characterisation of the medicament as one that is ‘effective in the treatment’ defined by the Swiss-style claim[11] (the infringers liability will be determined based on the facts of the case and reasonableness of any expectation that the medicament would not be used for the claimed purpose), and
  • the contributory infringement provisions of the Australian Patents Act 1990 are not relevant to the determination of infringement of a Swiss-style claim, regardless of the need to determine the infringers intentions with regard to the use of the medicament for the claimed indication.[12]

As exemplified in Otsuka, proving direct infringement of a Swiss-style claim may be less onerous than proving indirect infringement of a method of treatment claim, depending on the facts.

So what about diagnostics? IP Australia’s surprising change in practice

As stated above, Swiss-style claims originate in Europe where patent claims directed to methods of medical treatment are excluded from patentability.  Notably, European patent law also excludes claims directed to diagnostic methods practiced on a human or animal body.  Accordingly, it has been the present author’s experience that Swiss-style claim format can be employed to protect ‘first’ or ‘new’ (‘second’) uses of compounds/substances in methods of diagnosis (e.g. in a claim form such as ‘the use of compound X in the manufacture of a diagnostic agent for diagnosis of disease y’).[13]

However, in a surprising turn, the Australian patent office has begun objecting to the use of Swiss-style claim format when used in relation to diagnostics where the compound/substance used in the manufacture of the diagnostic agent is known.  Citing the Ostuka decision, IP Australia has formed the view that Swiss-style claims are applicable only to therapeutic methods and not to diagnostic methods.  Thus, the use of the word ‘for’ in a claim such as ‘the use of compound X in the manufacture of a diagnostic agent for diagnosis of disease y’, where compound X is known and diagnosis of disease y amounts to a new use, is not considered limiting.[14]

Alternative language for claiming second medical indication

As stated above, Australian and New Zealand Patent Offices do not permit the ‘simplified form’ of Swiss-style claims – ‘substance X for use in a method for treating medical condition Y’ – as the word ‘for’ in this context is not considered limiting.  Hence, a claim in this form would be redundant on compound per se claim, or not novel over prior art disclosures of the compound.

One option to achieve patent protection for a second medical indication, at least in Australia, would be to limit the ‘substance’ to a specific use (e.g. ‘substance X when used in the treatment/diagnosis of disease Y).  In fact, such an approach is applicable following the Australian High Court’s ‘Myriad’ decision which has excluded isolated nucleic acid sequences from patent eligibility.[15]  That is, where a nucleic acid sequence per se is known, but use of said sequence in therapy or diagnosis is considered novel, a claim of the form ‘an isolated nucleic acid molecule of SEQ ID NO: X when used in treatment/diagnosis of disease y’ can overcome a patent eligibility rejection.  In New Zealand, diagnostic and treatment methods practiced on the human body are excluded from patent eligibility (like Europe).  Thus, further limiting the claim to an in vitro test may be required in New Zealand.

Regarding the Australian Patent Office’s objection to the use of the Swiss-style claim form for diagnostics (such as ‘the use of compound X in the manufacture of a diagnostic agent for diagnosis of disease y’), assuming that the new diagnostic use is in fact novel, one could similarly amend ‘for’ to read ‘when used’ to overcome the objection (e.g. ‘use of compound X in the manufacture of a diagnostic agent when used in the diagnosis of disease y’).

Notably, the ‘when used’ language makes it less clear whether a third party that illegitimately manufactures a product or diagnostic would directly infringe the above product or Swiss-style claims as the ‘when used’ limitation imports a further treatment/diagnosis step.

Conclusion

Given the instability created by the Australian High Court’s ‘Myriad’ decision as to the patent eligibility of isolated nucleic acids, and the Australian Governments promise to ‘improve’ the patent term extension system, the above change in the Australian Patent Office’s practice provides a further challenge for the life sciences sector that may ultimately impact local and foreign biotech and pharma companies seeking to patent inventions in Australia.

The Australian Patent Office’s change in practice also places it out of step with other jurisdictions, and particularly our closest neighbor New Zealand, with respect to the use of Swiss-style claims covering diagnostics.  Further clarification on the applicability of the Swiss-style claiming format in Australia is necessary.

[1] Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 2) [2016] FCAFC 111 and Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129
[2] Otsuka at [102]-[110]
[3] Otsuka at [101]
[4] Otsuka at [112]
[5] Otsuka at [117-120]
[6] Otsuka at [168]
[7] Otsuka at [169]
[8] Section 141 of the New Zealand Patents Act 2013 or section 117 of the Australian Patents Act 1990.
[9] Otsuka at [172]
[10] Otsuka at [327]
[11] Otsuka at [173]
[12] Otsuka at [168]
[13] There is European case law that provides legitimacy to this format e.g. European Board of Appeals decision T 0233/96 (Adrenaline/MEDCO RESEARCH) of 4.5.2000
[14] Consider, for example, a claim that recites ‘use of DNA sequence A, B and C in the manufacture of a DNA chip for diagnosis of disease y’ where the DNA sequences per se are known.
[15] Notably, sequences that are modified from those that appear in nature, such as by codon optimisation, are considered patent eligible.

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