Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634

In Europe it is not possible to obtain patents for new methods for treating the human body. However, it is still possible to obtain patent protection in Europe for new, second or subsequent medical uses of a previously known product or composition. Until recently the preferred method for securing such protection in Europe was through the use of the Swiss type claim.  While  the Australian Patent Office has for many years now granted patents containing such claims, there has been little judicial guidance on the either their scope or validity … until recently.

Are Swiss type claims a valid claim format in Australia?

Swiss type claims are typically presented in the general format: 

“Use of compound X in the manufacture of a medicament for the treatment of disease Y.”

In Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634, the patent at issue,Australian Patent No. 2005201772, concerned the use of aripiprazole for the treatment of cognitive impairments caused by schizophrenia.  The patent contained claims in both the Swiss type and method of treatment formats.  

While Justice Yates expressly did not address  the “fundamental question” of whether Swiss type claims are a valid form of claiming (because Generic Health itself did not develop the question other than in a fact specific manner and in the context of grounds of invalidity under section 18(1)), His Honour nevertheless did proceed to make findings on the validity and infringement of the Swiss type claim at issue.  The inference then is that Swiss type claims are a valid form of claiming in Australia.

Swiss type claims are different from method of treatment claims 

His Honour held that the Swiss type claim is appropriately characterized as a method or process claim, being directed to a method or process of manufacturing a medicament using the compound recited in the claims: and not to a product or to the use of the medicament for treating the disease recited in the claims. This confirms that Swiss type claims are not the same as method of treatment claims and that the two claim formats provide monopolies of differing scope.  This is consistent with the approach taken by the Australian Patent Office.1 

Novelty and inventiveness of Swiss type claims lies in the therapeutic use

In reviewing the history and development of Swiss type claims, His Honour noted that a Swiss type claim is accepted as satisfying the requirement for novelty because the specified therapeutic use of the medicament is new.  Therefore, although Swiss type claims are directed to a method of manufacture, any assessment of the novelty and inventiveness of the claims is based on the recited therapeutic use of the manufactured medicament.  

Infringement of Swiss type claims 

Following on from the  characterization of Swiss type claims as method or process claims, His Honour found that Swiss type claims are, by virtue of the definition of “exploit” in the Patents Act 1990, directly infringed by a manufacturer of the medicament that has the therapeutic use defined in the claims.  Thus, the contributory infringement provisions of section 117 have no relevant application. 

His Honour noted that it is “(T)he therapeutic use defined in the claim that qualifies and confines the scope of the monopoly claimed”, and that the therapeutic use of the medicament can be manifest from the marketing approval and registration granted for the medicament. Determining infringement therefore revolves around the question of "whether, objectively obtained, the medicament that results from the claimed method or process is one that has the therapeutic use defined in the claim." .  His Honour therefore considered it unnecessary for a manufacturer to advertise or promote the medicament specifically for the therapeutic use recited in the claims for infringement to occur.  

Support and enablement for Swiss type claims

Under the new “Raising the Bar” provisions, a claim must be supported by the description, that is to say, the description must provide an enabling disclosure and the claims cannot be broader than what is justified by the description and contribution to the art.  

These considerations did not apply to the patent at issue, which was subject to pre-Raising the Bar law, and so there was no consideration of what might be required to satisfy these requirements in respect of Swiss type claims.  However, given that Swiss type claims are to be construed as method or process claims, it is possible that a disclosure that might otherwise be sufficient to support a corresponding method of treatment claim, typically enabled and supported by describing administration/treatment steps and evidence of efficacy, might not be sufficient to support a Swiss type claim.  For such a method or process claim, some enabling disclosure of the method or process of manufacturing the medicament is likely to be required.  It is therefore important to keep this in mind when drafting a specification directed to a second medical use invention, and not just focus on providing enablement and support for the therapeutic use.   

Summary

While not formally stating that Swiss type claims are a valid form of claiming, the decision in Otsuka v Generic Health nevertheless implies that they are, and provides some much-needed guidance on the validity and scope of this type of claim format in Australia.  The decision indicates that Swiss type claims:

  • are likely a valid form of claiming
  • are directed to a method of manufacturing a medicament
  • are assessed for novelty and inventive step on the basis of the recited therapeutic use of the medicament
  • are distinct from method of treatment claims
  • can be infringed by a manufacturer that makes the medicament 
  • can be infringed even when the alleged infringer does not advertise or promote the medicament for the recited therapeutic use

This decision confirms the value in including both method of treatment claims and Swiss type claims in patent applications, where appropriate, as the two types of claims provide differing scope of protection and can capture different types of potential infringers.