As discussed in our previous article,[1] ‘Swiss-type’ format is one of several claim types that can be used in Australia for obtaining protection related to therapeutics. The general structure of a Swiss-type claim is as follows (or similar):
Use of compound X in the manufacture of a formulation for the treatment of condition Y
Swiss-type claim format was originally devised by the Swiss Patent Office to allow for protection of a new therapeutic use of a known compound, in view of the inadmissibility of claims to therapeutic treatment.[2] Subsequently, this claim format was accepted at the European Patent Office (EPO), and affirmed in the Enlarged Board of Appeal G05/83.
More recently, according to the provisions of the European Patent Convention 2000 (EPC 2000), the claim format “Compound X for use in treating condition Y” is permissible and considered use-limited. According to the EPC 2000, this format (EPC 2000 use format) was to be given an interpretation as close as possible to that of Swiss-type format, and, as such, Swiss-type claims are no longer permissible in Europe. It is notable, however, that under a recent decision of EPO Appeal Board,[3] the scope of EPC 2000 use and Swiss-type claims are not considered to be identical.
In Australia, given the permissibility of method of medical treatment claims (as well as claiming of therapeutics in ‘when used’ format, which has essentially the same scope[4]), Swiss-type claims are not required to achieve protection for new uses of a known therapeutic. Nevertheless, this Swiss-type claim format has been established as permissible in Australia.[5] Relevantly, it has been assumed that Swiss-type claims would be directly infringed by pharmaceutical manufacturers, and that these claims therefore offer a different scope of protection than method of medical treatment claims which would typically be infringed by a medical practitioner or patient (in the case of self-administration). As such, although there are provisions relating to indirect infringement of method claims under Australian law,[6] Swiss-type claims have been considered desirable to complement these claims, as establishing indirect infringement can be complicated,[7] and the manufacturer, rather than a patient or physician, would typically be the primary target of infringement proceedings.
Recently, the Australian Federal Court decision in Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94 (Apotex), has further established potential benefits of the inclusion of Swiss-type claims in Australia. This decision dealt with the particular scenario of the offer within the term of a patent by a competitor to supply a pharmaceutical (pregabalin) the subject of a current patent, after the expiry of the patent. The patent at issue (AU 714980) includes both method of medical treatment and Swiss-type claims directed to pregabalin used in the treatment of pain. In Australia, it is an infringement of a claim of a granted patent to ‘exploit’ the claimed invention; under the Patents Act 1990 (Cth), “exploit” is defined as:
(a) where the invention is a product – make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or
(b) where the invention is a method or process – use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use[8]
Importantly, in Apotex, when considering the method of medical treatment claims, it was held that contributory infringement provisions could not apply to an offer to supply a product to be used for a method after the expiry of the patent. This was on the basis that there could be no exploitation of the method using the product within the term of the patent, which would be required for the contributory infringement provisions to be engaged.[9] However, in regard to the Swiss-type claims, it was held that an offer to supply the pharmaceutical constituted an offer to use the process to manufacture the pharmaceutical as defined in these claims, and would therefore infringe these claims, in view of the definition of ‘exploit’ set out above.[10]
The decision in Apotex provides further clarification that there is a difference in scope of Swiss-type and method of medical treatment claims in Australia, and demonstrates that, in some instances, Swiss-type claims may offer broader protection. This emphasizes the benefits of including Swiss-type claims in Australian applications to complement method of medical treatment claims.
Notably, after acceptance, it is impermissible in Australia to amend the claims such that a “claim of the specification would not in substance fall within the scope of the claims of the specification before amendment”.[11] Although there is currently no clear precedent in Australia as to whether the addition of a Swiss-type claim to a claim set including corresponding method of medical treatment claims would be considered contrary to this provision, to avoid doubt any Swiss-type claims should be included prior to acceptance. As an aside, it is notable that, in a recent decision of the Singapore High Court,[12] an amendment to convert a method of medical treatment claim to a Swiss-type claim was refused on the basis that this would change the scope of the claims post-acceptance.
As a final point, as discussed in our previous article, Swiss-type claims are typically directed to the use of active compounds in the manufacture of formulations or compositions for treating particular conditions. There is presently no clear guidance as to whether a similar claim structure could be validly used for protection of medical devices, e.g.:
Use of component X in the manufacture of a device for the treatment of condition Y
More broadly, Swiss-type format could theoretically be adopted in Australia for any suitable application, rather than being restricted to therapeutic subject matter. That is, the use of a particular component for the manufacture of any formulation or device for any purpose could potentially be claimed. Where permissible, such a strategy may be desirable for protection of new uses of known components, and/or to protect important components in the absence of reliance on contributory infringement provisions, across all technology areas. In this regard, it is notable that, although Swiss-type claims originally developed to address the specific issue of impermissibility of method of medical treatment claims in Switzerland, and were adopted by the EPO for the same reason, this was not a relevant consideration in Australia where method of medical treatment claims are allowed, as explained above. As such, there does not appear to be any clear rationale for restricting the use of this claim format to therapeutic subject matter in Australia, notwithstanding that the format has predominantly been used in this manner to date.
[1] Fitzgerald and Egerton (2016). A comparative study of strategies for patenting human therapeutics in the Asia Pacific Region: IP In Depth. Lexology. <https://www.lexology.com/library/detail.aspx?g=4871ff52-add2-4401-8685-db503f34a282>.
[2] Official Journal of the European Patent Office (1984) 11: 581-584.
[3] T1780/12.
[4] Wellcome Foundation Ltd v Commissioner of Patents (1980) 145 CLR 520.
[5] See, Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634.
[6] As per Section 117 of the Patents Act 1990 (Cth).
[7] See our discussion of this issue in 1, above.
[8] Schedule I.
[9] Apotex [19]-[20].
[10] Ibid [21]-[25].
[11] As per Section 102(2)(a) of the Patents Act 1990 (Cth).
[12] Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd [2016] SGHC106.