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Australia adopts international construction of Swiss-style claims

Date: 29 July 2009
Author: Paul Whenman
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Key Points:
  • Swiss-style claims are to be construed in a manner such that the claims are directed to the manufacture of a medicament in which the medicament is intended for a specified medical treatment. Such claims do not, however, extend to the intended medical treatment per se.
  • Both Swiss-style claims and claims to “methods of therapy” should be included in an application as they are of different scope.
The decision in Prosidion Limited v Novo Nordisk [2006] APO 6 (28 February 2006) is important as it aligns the construction of Swiss-style claims with the interpretation of such claims under European, British and New Zealand practice. From a global perspective, harmonisation of claim construction is desirable as it provides patentees with a higher degree of certainty in any evaluation of patent scope.

However, in marked contrast to European, British and New Zealand law, Australian practice allows claims directed to methods of medical treatment of both humans and other animals.

The issue for determination in this case related to whether certain amendments were allowable after the acceptance of application no 721477 entitled “Dipeptidyl Peptidase IV Effectors for Lowering the Blood Glucose Level in Mammals”

More particularly, claim 1 in the accepted application was in the following form:

“1. The use of activity lowering effectors of Dipeptidyl Peptidase (DP IV), or of DP IV-like enzyme activity, for the preparation of a medicament for lowering elevated blood glucose levels, such as those found in mammals demonstrating clinically inappropriate basal and post-prandial hyperglycaemia.”

The applicant proposed to include, for example, a claim in the following form:

“8. A method of lowering elevated blood glucose levels in mammals, such as those found in mammals demonstrating clinically inappropriate basal and post-prandial hyperglycaemia comprising administering to a mammal in need of such treatment a therapeutically effective amount of an activity lowering effector of Dipeptidyl Peptidase (DP IV), or of DP IV-like enzyme activity.”
 
Whilst claim 1 was clearly in Swiss-style form, proposed claim 8 is clearly in “method of therapy” format.

Under Australian law, the Patents Act 1990 requires, inter alia, that such an amended claim must in substance fall within the scope of the claims of the specification before amendment. The test usually followed is the “Distiller’s Test” (The Distillers Co Ltd’s Application (1953) 70 RPC221). This test asks whether a proposed new claim would extend the patent monopoly in a manner such that something which was not an infringement prior to amendment now infringed the proposed new claim.

Adopting the Distiller’s Test in this case required a determination of whether conducting a method of therapy, as exemplified by claim 8, would have fallen within the ambit of claim 1 and hence infringed that claim.

In investigating the construction of Swiss-style claims, the Delegate noted that there had been no judicial consideration in Australia. However, the Delegate referred to an earlier Patent Office Decision (Smithkline Beecham plc and Smithkline Beecham Corporation v Lek Pharmaceutical and Chemical Company d.d. 2004 [APO 10]. In that decision, the Delegate considered that Swiss-style claims should be interpreted in a manner consistent with other jurisdictions. However, no conclusion on interpretation was reached. Based on the Smithkline decision, the Delegate reviewed the appropriate British, European and New Zealand authorities and concluded that the correct interpretation of a Swiss-style claim under Australian law is that the claim is:

“...directed to the manufacture of the medicament with the intention of a specified medical use without the claim extending to that use. It is therefore limited to the preparation and sale of a product for the purpose of carrying out a specific medical treatment”.

On that basis, claim 8 was found to fail the Distiller’s Test and therefore not to be an allowable amendment.

The situation would have been somewhat different had the amendment been filed during prosecution. This arises out of the fact that, prior to acceptance, an amended claim need only be fairly based on the specification. In this case, claim 8 would have been allowable during prosecution as there was clearly basis for the claim in the specification.

Accordingly, in order to gain maximum coverage of all the aspects of a relevant pharmaceutical invention, both Swiss-style and method of therapy claims ought to be included prior to the acceptance of an application.

This is particularly applicable to specifications that are drafted and filed initially in Europe where method of therapy claims may not have been included in the claim set as they are not allowable.
 
It is also applicable to specifications that are drafted and filed in the US where method of therapy claims are allowable but Swiss-style claims may not have been included.

There are a number of opportunities to introduce relevant claim sets during filing and/or prosecution of an Australian patent application. These are:
  • at filing or national phase entry,
  • on filing a request for examination, and
  • during examination.
Filing an amendment to introduce a new claim set after filing a request for examination is highly undesirable since an application may be accepted without an examiner’s report issuing. As discussed above, this would preclude an amendment to add a claim set. It should, however, be noted that filing a request for postponement of acceptance with the request for examination provides an opportunity to safely file an amendment.

It will also be appreciated that a hearing before the Patent Office is not a judicial hearing. Until such time as Swiss-style claims are subject to full judicial consideration by an Australian Court, it cannot be stated with certainty how they will be interpreted. An Australian Court may well place an alternate construction on such claims. This has been demonstrated previously in the Australian Federal Court’s alternate construction of the term “comprise”, a term with a well established international meaning. Some support for an alternate construction may be found when it is appreciated that the construction adopted in this decision is an exception limited to pharmaceuticals. Swiss-style claims are only required in Europe, Britain and New Zealand because claims to methods of therapy are precluded. Indeed in the British Court of Appeal in Bristol-Myers Squibb Co v Baker Norton Pharmaceutical Inc [2001] RPC 1, whilst it was argued that the claims were in Swiss-style format, these claims were found to be disguised claims to methods of therapy and hence not patentable subject matter.

Nevertheless, since the introduction of Swiss-style claims ought not to prejudice the validity of any other claim set, we recommend their continued inclusion.
 
For more information about patent protection in Australia and overseas contact Paul Whenman.
 
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