Plugging the holes: Swiss claims in Australia

This claim was formulated to overcome the problem of validly claiming methods of treatment of humans and animals. The format of this claim type is generically:

“Use of substance X in the manufacture of a medicament for the treatment of disease Y”

Subsequent to the Swiss adoption of this claim type, importantly the European Patent Office accepted the validity of this claim language.[1] Other patent offices, such as Australia and New Zealand, also accepted the validity of this claim type.

Whilst the holes in Emmental are essential, they are certainly not desirable for a patentee’s Swiss claims. By “hole” we mean subject matter that could be validly claimed having regard to the usual criteria of novelty, inventive step, support and sufficiency but was not claimed.

How are Swiss claims construed in Australia?

To understand how a hole could exist in a Swiss claim, it is important to understand the approach to their construction.

The unusual format of a Swiss claim arises from the circumstances surrounding their introduction. In Europe, where a new substance is found to have a therapeutic application, a claim to that new substance per se is allowable. However, claims to methods of treatment of the human or animal body by therapy are prohibited. Despite that prohibition, it was recognised that there is value in research identifying whether substances already known for use in treating one disease may also be useful in treating others, and so the Swiss claim was introduced as a means of encouraging such research, whilst working within the boundaries of what constituted patentable subject-matter in Europe.

In Australia, it is settled case law that Swiss claims are interpreted as being method or process claims, rather than product claims.[2] Similar to the position that normal process claims are infringed by importation into Australia of a product of a patented process made overseas, Swiss claims are infringed by the importation of a medicament manufactured overseas, if imported with the intention that it be used in the treatment of the specified disease.[3]

Holes in Swiss claims exist

Licensing or litigation usually provides the spotlight that identifies any holes in a Swiss claim.

A limitation in the coverage provided by Swiss claims was highlighted in Mylan v Sun Pharma.[4] That case concerned proposed importation and marketing in Australia of a generic medicinal product containing fenofibrate for treatment of diabetic retinopathy. The crucial question for infringement of Swiss claims was whether the manufacturer made the medicament with the intention that it be used in treating the claimed condition, with the answer being dependent on an objective assessment of all the relevant circumstances, including what is specified in the product information (the PI).[5]

In the Mylan case, the PI for the alleged infringing product had been amended to remove any reference to diabetic retinopathy (skinny labelling) and referred only to other indications. As a result, the evidence relied on for infringement was that:

• the generic PI asserted that the generic product was bioequivalent to the originator product,
• the originator product (Lipidyl®) PI stated that it was indicated for diabetic retinopathy, and
• the generic PI did not contain a disclaimer that it was not indicated for diabetic retinopathy.

In the circumstances, the Court held that such evidence was insufficient to find the required intention, and the Swiss claims were not infringed.

Divergence between Europe and Australia

Whilst Australia has followed Europe’s lead in introducing Swiss claims, there are differences between the European and Australian approaches to patent protection for inventions in the field of therapy.

Firstly, unlike Europe, Australia also allows for US-style method of treatment (MOT) claims[6], and Swiss claims are only one of several claim types that can be obtained.

Europe has introduced the EPC 2000 “substance for use” claims which are purpose-limited product claims directed to new therapeutic uses of known substances. Whilst not prohibited in Australia, such claims are interpreted as being directed to the substance itself rather than to the new use, and so will lack novelty over a prior disclosure of the same substance. Further, the EPO has now gone full circle and no longer allows Swiss claims, on the basis that there is no need for such claims now that EPC 2000 “substance for use” claims are available.[7]

Europe also permits first and second medical use claims, respectively directed to the general use of a substance in therapy (where no previous therapeutic application of the substance is known), and to further new therapeutic applications of known medicinal substances. In Australia, Swiss claims provide protection for second medical uses only, and it is only possible to pursue patent protection for general therapy via MOT claims. However, whilst in the past Australian Examiners were willing to grant broad claims, the introduction of higher support and sufficiency requirements a few years ago[8] has resulted in IP Australia raising objections against general MOT claims and broad Swiss claims, on the basis that such claims are not supported across their entire breadth.

Plugging the holes in Swiss claims

As mentioned above, method of treatment claims are permissible in Australia. In the Mylan case, the question of infringement was also considered for the corresponding MOT claims, leading to a different outcome on infringement. Since the MOT claims could only be directly infringed by a medical practitioner, the infringement case was brought under the indirect infringement provisions of s.117(2)(b),[9] and the key question was whether the generic company had reason to believe that a significant portion of its products would be used in a manner which would infringe.[10]

The evidence was essentially the same as discussed above for the Swiss claims, but with the Court also accepting the following:

• Medical practitioners do not typically read the PI for a generic product and assume the indications are the same as for the originator,
• Independent third party materials directed to practitioners refer to the use of fenofibrate generally (rather than the originator product) for treatment of diabetic retinopathy, and
• The generic company was likely to be aware of the above when supplying generic fenofibrate.

Based on the above, it was found that the generic company had reason to believe that its products would be used in an infringing manner, and consequently there was indirect infringement of the MOT claims.

Approaches to Australian claim drafting for new therapeutic applications

It is important to understand Australian law and patent practice governing new therapeutic applications of known substances, in order to maximise the protection available.

It is essential to include both Swiss claims and method of treatment claims, due to the different scope of protection provided.

Although broad medical use claims are not allowable, if there is evidence in the specification that the substance has beneficial effects for some conditions, it is usually permissible to extend MOT claims or Swiss claims to encompass other conditions that it is plausible that the substance will also treat. One such example is in the case where the mechanism of action of the substance is such that it would be expected to have effects in multiple diseases. Example claims would be:

“Use of substance x in the manufacture of a medicament for the treatment of a disease related to the inhibition or modulation of Y pathway.”

"Use of substance x in the manufacture of a medicament for the treatment of a disease selected from the group consisting of [all diseases disclosed in the application that inhibit or modulate the Y pathway]”

In addition to Swiss claims and MOT claims, further claim types available in Australia for new therapeutic applications are:

“Use of substance X for the treatment of disease Y”

“Substance X when used for the treatment of disease Y”

Whilst there is little case law governing what constitutes infringement of these claims, including at least one independent claim of each claim type alongside Swiss claims and MOT claims ensures that the claim coverage is maximised.

We conclude that with a good understanding of an invention and its scope, together with an appreciation of the patent protection available, a “hole free” set of claims may be achieved.