Introduction

The pharmaceutical industry is an important driver of patent activity. Amongst the protections sought are second medical uses, wherein a known substance is to be used in a novel or inventive indication. However, applicants can be unfamiliar with claiming second medical uses in Australia due to significant differences in legislation compared to other jurisdictions such as Europe. We summarise below the means by which second medical uses can (and can’t) be claimed under Australian patent legislation.

Snapshot:

  • Claiming second medical uses in Australia can be significantly different to other jurisdictions.
  • Both method of treatment and Swiss-style claims are allowable, but “for use” claims are not recommended.
  • The approach to determining infringement of method of treatment and Swiss-style claims is different.

Method of Treatment Claims

Method of treatment claims are claims of the general type “a method of treating [condition Y] comprising administering [compound X]”.

Although at first Australian courts held that methods of medical treatment failed to meet the ‘manner of manufacture' requirement for patentable subject matter, this changed in 1992 when the Australian Federal Court decided that a method for treating sleep apnoea related to patentable subject matter (Rescare Ltd v Anaesthetic Supplies Pty Ltd [1994] FCA 1065). See our article discussing the history of the patentability of method medical treatment claims.

In 2013 the High Court removed any remaining uncertainty and confirmed that methods of medical treatment involving the administration of therapeutic drugs are patentable subject matter in Australia in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50). Please see our article of 12 December 2013 for a more detailed discussion of this decision.

Swiss-style Claims

Swiss-style claims are claims of the general type “the use of [compound X] for the manufacture of a medicament for the treatment of [condition Y]”. The novelty and inventiveness of the claim arises from the new therapeutic application of the medicament to “condition Y”. Although this claim type was developed to avoid claiming methods of medical treatment of humans, which have now been confirmed to be patentable in Australia (as discussed above), its use in Australia is widespread.

The validity of Swiss-style claims has yet to be explicitly considered by an Australian court, however, the relatively recent decision of Justice Yates in Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634 provides a useful discussion of the construction of Swiss-style claims. In this case, the question considered was “should an invention defined by a Swiss type claim be characterised as a product or as a method or process?” Following from decisions of European and New Zealand courts, it was concluded “an invention defined by a Swiss type claim is appropriately characterised as a method or process” (Generic Health at [120]).

“For use” claims

In Europe, second medical uses are most preferably claimed using EPC 2000 claims of the form “[Compound X] for use in the treatment of [condition Y]”. However, under Australian law, the limitation imparted by this phrase is such that the compound is considered to be suitable for the recited application rather than being restricted tothat application. Thus the above claim would be understood as being directed to “Compound X”. If an applicant were to attempt to claim a second medical use in this fashion, the Examiner would raise a novelty objection if the compound itself lacked novelty. Alternately, if the compound was novel, such a claim would not actually be directed to the medical use.

Infringement of Method of Treatment and Swiss Style Claims

The approach to determining infringement of method of treatment and Swiss-style claims is different.

Pursuant to s13 of the Australian Patents Act (1990) (“the Act”), a patentee has the exclusive right to exploit in the patent area (effectively Australia) the claimed invention, and also to authorize another person to exploit the invention. A valid claim of a patent will be directly infringed if an unauthorised party exploits the claimed invention in Australia.

Swiss-style claims are directly infringed by an unauthorised third party importing, marketing or supplying the generic products for the claimed therapeutic use. The question at hand in Generic Health was one of infringement and the correct characterisation of the relevant (Swiss-style) claims determined Justice Yates’ decision regarding their infringement.

At paragraph [174] Justice Yates held “I am satisfied that the respondent’s intention to import, market and supply the GH products, whose scope of therapeutic use, as registered, plainly includes the therapeutic use defined in claim 1, is a threatened exploitation of the invention and would have been a threatened infringement of the claim, had it been valid.”

In contrast to Swiss-style claims, method of treatment claims are not directly infringed by an unauthorised third party importing, marketing or supplying the generic products for the claimed therapeutic use.   Method of treatment claims are only directly infringed by the patient or administering physician. Therefore in order for a patentee to prevent an unauthorised third party from supplying the generic products, the patentee must rely on the contributory infringement provision of the Act, s117, which states:

“If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent.”

Recommendation

Although Swiss-style claims are of lesser significance in Australia than in other jurisdictions where method of treatment claims are not allowable, given the different approach to determining infringement of Swiss-style and method of treatment claims, we recommend the continued inclusion of both claim types in Australian patent applications. We also recommend against the inclusion of “for use” claims as they provide no tangible limitation to using the medicament for a specific medical treatment, and thus a claim to the medicament per se is more appropriate.