An unresolved question in Australia is whether Swiss form claims add to the scope of protection afforded by corresponding method of medical treatment claims. It is settled that both may co-exist in a granted patent, but is yet to be settled if there are different requirements for proving infringement depending on the claim structure used to claim a second medical use. A recent trial decision1 of the Federal Court of Australia suggests that the answer is “yes”. In that case, a Swiss-form claim was found to be directly infringed while a method of medical treatment claim was indirectly infringed (although both claims were also held invalid).
The possible infringement consequences of claim structure are analysed below, in light of this rare opportunity to directly compare proof of infringement of mirroring Swiss-form and method of medical treatment claims.
By way of background, a so-called “Swiss-form claim” (ie “Use of compound [X] in the manufacture of a medicament for [a new therapeutic use]”developed as an alternative to method of medical treatment claims for second medical uses. For further information on the use and construction of Swiss-form claims in Australia, see “Swiss-form claims: not the same as methods of medical treatment?”. Such claims have co-existed in Australia with method of treatment claims for many years.
Direct infringement of the Swiss-form claim required proof that the relevant compound was used in the preparation of a medicament. Ordinarily this will be evident from the ingredients in the medicament.
Where the medicament is not manufactured in Australia it will also be necessary to show that the medicament has been or will be imported into Australia, which again will usually be evident.
Finally, the court assessed whether the medicament had the therapeutic use defined in the claim. It was not clear from the decision if this necessarily required:
The court did specifically state (as would be expected) that the “therapeutic use defined in the claim qualifies, and thus confines, the scope of the monopoly”. It therefore concluded, based on the label, that this element was proven, although with less detailed analysis than the other aspects of infringement.
The Australian Patents Act sets out the circumstances in which a supplier of a product will be liable for contributory (indirect) infringement because the product sold was used in a patented method (s 117). Justice Yates found that contributory infringement did not apply to the relevant Swiss-form claim because:
Therefore, there was no use of the product sold in an infringing method. This aspect of the decision was not so important in this case given that direct infringement had already been found.
The supplier of a medicament does not directly infringe a method of medical treatment claim because the supplier (usually a pharmaceutical company) never carries out the claimed method of medical treatment (usually a physician or patient does). However, the supplier can be liable for contributory infringement of a method claim in Australia by sale of a product where:
In this case, the second of these was in issue. Proof of contributory infringement of the method of medical treatment claim in the decision was held to require, in addition to proof that each integer of the claim would be taken, proof that the product was not a staple commercial product and proof there was reason to believe the product would be put to an infringing use (this last one was quite contentious based on the facts but ultimately found). Therefore, the finding of contributory infringement of the method of medical treatment claim required significant additional analysis by the court, including additional judicial determinations not set out in the finding of direct infringement of the Swiss-form claim.
In this case, the patentee was successful in proving direct infringement of the Swiss-form claim and indirect infringement of the method of treatment claim. What was left unclear is whether it will inevitably be easier to prove infringement of a Swiss-form claim.
One possibly unintended result of the construction of Swiss-form claims in the decision is that Swiss-form claims may be used by patentees as a more direct and potentially less expensive path to proof of infringement. In addition, the decision supports the view that inclusion of Swiss-form claims to mirror method of medical treatment claims may provide a patentee with additional protection, for example, by avoiding some of the difficulties with the contributory infringement law by relying on direct infringement of a corresponding Swiss-form claim.
1 Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4)  FCA 634.