Holes in Australian Swiss claims: Plugged in 2020

In deciding on an appeal concerning validity and infringement of a patent protecting second medical uses of the known active compound fenofibrate, the judgment of the full Federal Court (FFC) in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116 again highlighted the importance of including both MOT and Swiss claims in an Australian patent. The FFC agreed with the lower Court in finding the MOT claims indirectly infringed and the corresponding Swiss claims not infringed, albeit applying different reasoning. Therefore, this case provides useful guidance on how infringement of Swiss claims in Australia is to be assessed.

Swiss claims and method of treatment claims

A Swiss claim is typically of the form: Use of compound X in the preparation of a medicament for the treatment of condition Y.

A MOT is typically of the form: A method of treating condition Y comprising administering compound X to an individual in need thereof.

Swiss claims in 2019

In our November 2019 article we explored the relationship between Swiss and MOT claims. We recommended that whenever possible both claim types should be included. This recommendation was reinforced by the decision in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2019] FCA 28 where it was found that the Swiss claims were not infringed whilst the MOT claims were found to be indirectly infringed. As such, Sun Pharma was found to be a contributory infringer.

The first Court found the Swiss claims not to be infringed because there was no evidence of intention on the part of the manufacturer to manufacture a product for the therapeutic purpose recited in the Swiss claims. In making this finding, the Court relied on the UK case Generics (UK) v Warner-Lambert Company LLC [2018] UKSC 56; [2018] RPC 21.

By contrast, the Court found indirect infringement of the MOT claims as it was reasonably foreseeable that the alleged infringing product would be used for the treatment recited in the MOT claims. This was despite the fact that the prescribing information (PI) of the alleged infringing product did not recite suitability for use the treatment recited in the MOT claims. Here the evidence showed that medical practitioners typically did not read the PI for generic products. Rather they assumed that the PI was the same as the originator product.

The Full Federal Court appeal

Although the MOT claims were found to be infringed, no infringed claims were found to be valid. On appeal, the FFC was asked to review a number of matters including claim validity and infringement of the Swiss and MOT claims.

Swiss claims not infringed

In their analysis, the FFC reiterated the position that Swiss type claims are to methods or processes of making a medicament, emphasising that the method or process is complete upon manufacture, and went on to highlight at [196] that:

Swiss claims are purpose-limited in the sense that the medicament resulting from the method or process is characterised by the therapeutic purpose for which it is manufactured, as specified in the claim.

Following a comprehensive review of Generics (UK) v Warner-Lambert Company LLC, the FFC concluded that the Swiss claims were not infringed but not for the reason given in the original decision. In essence, the FFC found that “intention” on the part of the manufacturer was not determinative but rather a factor to be considered in assessing each instance of purported infringement of a Swiss claim.

Importantly, the FFC noted that whereas the UK Supreme Court was bound by the Protocol on the Interpretation of Article 69 of the European Patent Convention, at [221] it explained:

Australian patent law does not provide a fiat by reference to which patent claims are to be construed. Patent claims are construed by reference to common law principles applicable to patent specifications as documents created in a particular setting and serving particular ends. There is no requirement to construe patent claims by reference to stated policy objectives such as those contained in the Protocol.

At [222], the FFC clearly stated that “As a matter of claim construction, we do not read Swiss type claims, such as those in this proceeding, as adding a further essential feature to the invention, namely the manufacturer’s intention in making the medicament.”.

Rather in assessing infringement of Swiss claims, the FFC stated:

“Infringement arises from the taking of the essential features of the invention as claimed. Therefore, infringement of a Swiss type claim is concerned with what the allegedly infringing manufacturer has done, not what it intended to do. Bearing in mind the limited scope of such claims, a single factual question is presented when considering infringement: as the product of the claimed method or process, is the medicament for the specified therapeutic purpose? This question is directed to the characteristics of the manufactured product. It is answered having regard to all the circumstances of the case” (emphasis added).

So what might the circumstances to be considered in each case be? Well, the FFC indicated that the:

“…physical characteristics of the medicament as it emerges as a product of the manufacturing process, including its formulation and dosage, packaging and labelling, and its patient information…is a most important consideration.”.

It also indicated that, when available, evidence of the manufacturer’s actual intent would be relevant. Further, the FFC indicated that considering reasonably foreseeable use or uses of the product is a relevant circumstance. However, the fact that it might be reasonably foreseeable that a product is likely to be used for the purpose set out in the Swiss claims was not necessarily determinative of infringement. One needed to have regard to the extent of other uses which may be multiple and substantial. According to the FFC, just because a product may be suitable for the Swiss claim purpose does not mean that necessarily it was manufactured for that purpose.

In the present case, the evidence showed that there was substantial use for both the purpose of the Swiss claims and other therapeutic treatments. However, taking all of the circumstances into consideration, the FFC found non-infringement of the Swiss claims.

The MOT claims are infringed

Although on appeal it was argued that the original decision in finding infringement of the MOT claims and non-infringement of the Swiss claims was inconsistent, the FFC agreed with the original findings for both types of claims. Of relevance here was that it was reasonably foreseeable that the alleged infringing product would be prescribed for the treatment of retinopathy, the subject of the MOT claims. This arose out of the fact that typically medical practitioners did not read the PI of generic products. Accordingly there was a reasonable likelihood that the generic product would be prescribed for infringing use.

The future

Unusually, this was a decision made by five judges of the Federal Court rather than the usual three judge panel. Whilst potentially an appeal lies to the High Court of Australia, special leave of that Court must be secured which would seem unlikely to be granted in these circumstances. Further, it is very unlikely that any subsequent UK cases will have any bearing on the position of Swiss claims in Australia.

Accordingly, the prospect that this decision must be regarded as settled law is quite high.

Therefore, for applicants it remains critical to ensure that properly formulated Swiss claims and MOT claims are included during the prosecution of a patent application. It being noted that once an application is allowed an amendment to add a new category of either a Swiss claim or an MOT claim will be not be possible as it will be regarded as impermissible claim broadening.