Australia: Allowability Of "Mirror-Image" Swiss-Style And Method Of Treatment Claims

A recent decision of the Australian Patent Office has clearly stated that Swiss-style claims cover the manufacture of a medicament wherein the medicament is intended for a specific medical treatment, but do not extend to the method of medical treatment itself.

The accepted claims of the subject patent were in Swiss-style format, being directed to the "use of activity-lowering effectors of dipeptidyl peptidase (DPIV), or of DPIV-like enzyme activity, for the preparation of a medicament for lowering elevated blood glucose levels". The patentee had sought to add "mirror-image" claims to a "method of lowering elevated blood glucose levels by the administration of a therapeutically effective amount of activity lowering effectors of DPIV, or of DPIV-like enzyme activity".

However, more than three months had elapsed from the date of advertisement of acceptance. Australian practice requires that, under such circumstances, the amended claims must fall within the scope of the accepted claims.

Recent Patent Office practice was to accept an amendment to introduce method of treatment claims that mirrored accepted Swiss-style claims under these circumstances, notwithstanding the fact that such claims are clearly directed to different potential infringers. However, inclusion of the additional claims was opposed in the present case on the grounds that such claims would not fall within the scope of the accepted Swiss-style claims and that the claims would not be succinct (the latter being a requirement under Section 40 of the Patents Act 1990).

The Patent Office considered relevant European, British and New Zealand decisions related to the construction of Swiss-style claims. It was concluded that there appears to be a general agreement as to the proper construction of Swiss-style claims, i.e. that they are directed to the manufacture of a "good" and do not extend to a method of treatment. Any reference to "therapeutic use" in a Swiss-style claim, it was said, is not determinative of the scope of the claim. For instance, the construction adopted by the New Zealand Court of Appeal in Pharmaceutical Management Agency Ltd. v Commissioner of Patents (Pharmac) (2000) NZCA 330, was that "the Swiss-form of a claim has been devised to avoid claiming the method of treatment..."

The abiding principle adopted in the present case was that, in Australia, such claims should be construed for consistency with accepted international practice. The practical effect of such a construction is that a Swiss-style claim is regarded as being directed to the manufacture of the medicament with the intention of a specific 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, and not to that treatment, per se.

When assessing the allowability of an amendment lodged more than three months after acceptance of the patent application, the present case confirms that the relevant test is the so-called "Distiller’s Test" (The Distillers Co Ltd’s Application (1953) 70 RPC 221), which asks whether a proposed new claim would extend the monopoly such that something that was previously not an infringement in respect of the original claims now becomes an infringement. Since the original Swiss-style claims were directed only to the manufacture of a medicament, the medicament being intended for a specified medical treatment, they were deemed not to extend to the method of medical treatment itself. As a consequence, the method of treatment claims were not allowed.

At Shelston IP, it is our standard practice to include Swiss-style claims to mirror method of treatment claims and vice versa prior to acceptance of patent applications - and, in particular, to ensure that we do so for patent applications drafted in foreign jurisdictions. The benefits of doing so are clearly illustrated by the outcome in this case.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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