Framework for Swiss-form claim construction in Australia: Is it really about objective intent?

Date: 2017-09-15
Author: Carol Burnton

This article looks at the current status of construction of Swiss-style claims in Australia, provides a framework by which construction of Swiss-style claims can be assessed, and concludes that although the position is not yet clear, there are observable trends.

Swiss-form claims

Attorneys commonly use the term “Swiss-form claim” to refer to claims of the following structure “use of compound [X] in the manufacture of a medicament for [a new therapeutic use]”. Swiss-form claims were developed in countries that do not permit claims for methods of medical treatments out of concern that the possibility of a doctor being sued for patent infringement could result in a denial of treatment to patients. The Swiss-form claim was designed to be directly infringed by the manufacturer of the medicine and not a doctor but was often deemed to have a construction similar to a method of medical treatment claim.

In Australia, methods of medical treatment are patentable so there is no specific need for Swiss-form claims. Nevertheless, Swiss-form claims are permitted. The juxtaposition in Australia is between two claim types that are meant to serve the same purpose but which need to be interpreted differently to avoid redundancy. This has always meant that Swiss-style claims had the potential for unusual construction.

Methods of making medicaments

In our article here, we considered a 2015 Federal Court decision that held that Swiss-form claims were appropriately categorised as directed to methods of making medicaments.1

In our article, we questioned the function of the claim language specifying the medicament is for treating a specific condition.  Given Australian literal claim construction, a tension has always existed around whether the part of the particular indication is inherent to the product or can be regarded as qualifying the product for the purposes of assessing novelty and inventive step.

We posit that there are currently four options for the construction of “for” in the second half of a Swiss-form claim ie “medicament for treating [a condition]”.

“for” means “suitable for”
The indication is inherent in the product. If this construction is applied, many Swiss-form claims for second medical uses of various medicaments will lack novelty. Fortunately, this deficit is likely to be capable of correction by post-grant amendment.
“for” means “objectively intended for”
Under this construction, reference could be made to, for example, the product’s label to determine the intended use of the medicament. However, determining the objectively intended use of a product could be difficult where the product is not yet registered with the Therapeutic Goods Administration (TGA), the Swiss-form claim is for an off-label use or the Swiss-form claim is not for a medicine.
“for” means “reasonably expected to be used for”
Under this construction, a broader consideration of the use the market is likely to put the medicament to could be relevant. This could involve looking beyond the label for a medicament to consider off-label and non-medical uses.
“for” means “actually used for”
Under this construction there is a genuine double method in the sense that the first method of making the medicament is actually followed by a method of treating a patient with the medicament to treat the specified condition. Proof of infringement of this claim is likely to be difficult as the party that manufactured the medicament is unlikely to be the party treating the patient. It is also unclear how (or if) contributory infringement under section 117 of the Patents Act 1990 would apply to claims of this type.

Judicial comments

The 2015 decision mentioned that:

  • the therapeutic use qualifies the monopoly;
  • the therapeutic use of the medicament will usually be manifest from the marketing approval and registration that has been granted for it;
  • a failure to advertise or promote the medicament for the claimed use may not avoid infringement; and
  • the question is whether, objectively ascertained, the medicament that results from the claimed method is one that has the therapeutic use defined in the claim.

It was also not entirely clear from that judgment:

  • whether showing the therapeutic use is an inherent feature of the medicament claimed in the Swiss-form claim will be enough to show the medicament “has the therapeutic use”; or
  • if something more is required for a medicament to have a therapeutic use, such as, evidence the medicament will be put to the therapeutic use or evidence the supplier of the medicament has a reasonable expectation that the medicament will be put to the therapeutic use.

Recently the Full Federal Court commented, in Commissioner of Patents v AbbVie Biotechnology, that Swiss-form claims are method claims which exhibit a dual character.2 First, they are directed to a method in which a substance is used to produce a medicament and second, they have an additional method element constituted by a specific purpose to which the medication is to be used.

The reference to a first and second method suggests a new potential double-method construction where a Swiss-form claim is a method of making a medicament followed by a method of treating a condition using that medicament. However, the reference to the “specific purpose to which the medication is to be used” could refer to the objectively intended use of the medication or the reasonably likely use of the medication rather than its actual use in a method of medical treatment. Consequently, the function of the claim language specifying the medicament is for treating a specific condition remains unclear.

In addition, as the recent Full Federal Court decision issued following an unopposed appeal by the Deputy Commissioner of patents and the construction of Swiss-form claims was not considered in detail in the judgment, the weight of these comments on construction is limited.

Predicted outcome

While recognising that the construction of Swiss-form claims remains open, we do see a trend in the judicial consideration. Our current opinion is that options 1 and 4 are less likely and options 2 and 3 more likely to be ultimately applied. The judicial comments to date indicate that the use of the medicament is considered limiting rather than inherent. There is also nothing suggesting the need for evidence that the medicament has in fact been used to treat the relevant condition as would be required to show infringement of a double method claim.

Therefore, the key tension may be between “objective intention” and “reasonable expectation of use”. We consider that the comments to date are suggestive of an “objective intention” type construction. However, as the issue has not yet been fully considered or fully articulated in a judgment and the difference between these two options is subtle, we consider it too soon to make a call regarding the option most likely to “win” this construction “race”.

1 Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634.
2 Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 at [55].