In brief 5 min read
In Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116, an enlarged bench of the Full Federal Court considered the principles applying to infringement of Swiss-style claims.
The decision potentially limits the application of Swiss-style claims in the context of so-called second medical use patents, where the allegedly infringing products are ʽskinny-labelled’.
Key takeaways
- The manufacturer’s intention in making the medicament is not a feature of Swiss-style claims. When considering infringement of Swiss-style claims, the relevant question is: as the product of the claimed method or process, is the medicament for the claimed therapeutic purpose?
- Where the allegedly infringing products are skinny-labelled, such that their packaging, labelling and Product Information means the products are presented to the market for a non-patented therapeutic purpose, patentees may find it difficult to establish infringement of Swiss-style claims for a different therapeutic purpose, particularly where there is a substantial market for the non-patented purpose.
- Notwithstanding the outcome in the Mylan case, we recommend that patent applicants continue to include both Swiss-style claims and method of treatment claims in their Australian applications, to provide the broadest base from which to capture all potential infringers.
The decision
Background – second use and Swiss-style claims
Fenofibrate is a medication used to treat abnormal blood lipid levels. Mylan Health (Mylan) owned three patents relating to fenofibrate products. One of those patents was a so-called second medical use patent – being a new medical use for a known compound. That patent claimed methods of treating diabetic retinopathy using fenofibrate, as well as Swiss-style claims relating to such therapeutic use.
Swiss-styles claims are method or process claims. They generally appear in the format: ʽThe use of (substance X) for the manufacture of a medicament for the therapeutic and/or prophylactic treatment of (medical condition Y)’. They protect a new therapeutic use (ie second or other medical use) of a known substance, rather than the substance itself. They therefore avoid the prohibition on methods of medical treatment that many jurisdictions impose.
Sun Pharma ANZ, formerly known as Ranbaxy Australia, proposed to market a number of fenofibrate products in Australia (Ranbaxy Products) which are indicated for the treatment of hypercholesterolaemia. The Ranbaxy Products are not indicated for diabetic retinopathy – that is, they adopt what is commonly referred to as a ʽskinny label’, which does not reference the patented indication. The Product Information (PI) for the Ranbaxy Products states they are ʽbioequivalent to Lipidil’ (Mylan’s fenofibrate products, indicated for diabetic retinopathy), but does not expressly disclaim the use of the products for the treatment of diabetic retinopathy.
Mylan alleged threatened infringement of the method of treatment and Swiss-style claims. The trial judge, Justice Nicholas, found those claims invalid for lack of novelty and inventive step, but also held there was no threatened infringement of the Swiss-style claims in any event.
Swiss-style claims do not import any mental element
Justice Nicholas held that a Swiss-style claim imports a mental element with respect to the manufacturer’s intention, the crucial question being whether the manufacturer had made or will make the medicament with the intention that it be used in the treatment of the claimed condition.
An enlarged panel of five judges of the Full Federal Court disagreed, emphatically rejecting the finding that the manufacturer’s intention is crucial. Rather, infringement of a Swiss-style claim is concerned with what the allegedly infringing manufacturer has done, not what it intended to do. Despite this, the Full Court reached the same conclusion that there was no infringement of the Swiss-style claims.
The crucial question
The Full Court reframed the ʽcrucialʼ question for infringement of Swiss-style claims as follows: 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, having regard to all the circumstances.
A most important consideration, according to the Full Court, is the physical characteristics of the medicament as it emerges from manufacturing, including its formulation and dosage, packaging and labelling, and the PI. Direct evidence of the manufacturer’s intention in making the medicament (where available), and of the reasonably foreseeable use(s) to which the medicament would be put after manufacture, will be relevant, but not determinative.
The Full Court held there was no infringement for the following reasons:
- The PI for the Ranbaxy Products states the indications for which they are registered and, inferentially, the therapeutic purpose they serve as medicaments (which was not the therapeutic purpose claimed in the patent).
- There was ʽa substantial therapeutic use’ for the products in treating the conditions for which they are indicated, and the PI presented the products to the market for such a purpose. Although the PI referred to the products as bioequivalent to Mylan’s products, this did not necessarily mean the products are medicaments for the therapeutic purpose claimed in the patent.
- That the PI did not disclaim the use of the Ranbaxy Products for the treatment of diabetic retinopathy was not persuasive. If anything, a disclaimer would bolster the alleged infringer’s case.
We will have to wait to see the impact of the Full Court’s decision on the ability of patentees to establish infringement of Swiss-type claims. At trial, Mylan adduced only anecdotal evidence of the extent to which fenofibrate is prescribed by medical practitioners to treat diabetic retinopathy, and it appears there was only limited evidence regarding the process by which drugs are prescribed and dispensed in Australia.
It is possible that a different outcome may be reached in future cases, particularly where there is evidence of:
- the extent to which the medicament is prescribed for the patented therapeutic purpose, and the market for use of the medicament for the patented therapeutic purpose versus the non-patented therapeutic purpose;
- the alleged infringer’s marketing plans; and
- the manufacturer’s subjective intention in making the medicament,
suggesting the alleged infringing medicament is intended to be dispensed for the patented therapeutic purpose.
Don’t forget method of treatment claims
The Full Court’s decision suggests that, in the case of patents directed to a second or subsequent medical use, it may be difficult for a patentee to establish infringement of Swiss-style claims, where a skinny label is adopted by the alleged infringer and there is a substantial market for the non-patented therapeutic use.
However, patentees should not forget that method of treatment claims are permitted in Australia. In determining infringement of such claims, the relevant question is whether the supplier of the alleged infringing products has reason to believe the recipient will put the products to an infringing use, ie use in the claimed method of treatment. If the patentee can adduce evidence that there is a substantial market for the use of the products for the claimed condition, then they may establish infringement, even where the products are skinny-labelled. This was the result in the Mylan case, the Full Court agreeing with Justice Nicholas that there was threatened infringement of the method of treatment claims.
Actions you can take now
A well-drafted Australian patent application includes both Swiss-style claims and method of treatment claims, which increases the chance of capturing all possible infringers. Despite the limited scope the Full Court gave Swiss-style claims in this case, we recommend that patent applicants continue that practice, and check that any applications on foot include both forms of claims.
In our view, Swiss-style claims will still have application where the patentee can adduce evidence that supports a finding that the infringing medicament is, in fact, ʽfor’ the patented therapeutic purpose.