A five-judge panel of Full Court of the Federal Court of Australia in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116 has rejected importation of a mental element step when considering infringement of a Swiss-style claim.

Mylan Health (“Mylan”) is the patentee of three (3) patents broadly relating to use and formulations of fenofibrate, having the trade name of Lipidil that has been on the Australian market since 2006. Fenofibrate is a fibric acid derivative (or fibrate) that is used to regulate lipoproteins and triglycerides in the blood. It is also used to treat diabetic retinopathy, a condition characterised by damaged blood vessels inside the retina at the back of the eye that may lead to poor vision or in severe cases, blindness. Mylan unsuccessfully sued Sun Pharma for infringement of these patents and appealed the primary judge’s decision to the Full Court. For the purpose of the present infringement discussion, this article will only relate to Patent No. 2006313711(the ‘Patent’) relating to the use of fenofibrate or a derivative thereof for preventing diabetic retinopathy.

Mylan contended that Sun Pharma infringed claim 5 of the Patent relating to use of fenofibrate for the manufacture of a medicament for the prevention and/or treatment of retinopathy (in particular diabetic retinopathy) in specific dosages. The alleged infringement by Sun Pharma constituted listing on the Australian Register of Therapeutic Goods of fenofibrate film-coated tablets, which Sun Pharma proposed to market and supply in Australia.

Notwithstanding that the primary judge held the relevant claims invalid for lack of novelty and/or inventive step, the primary judge found that Mylan had not established that there was a threatened infringement of the Swiss-style claims. In a nutshell, the primary judge considered that Swiss-style claims imported a purposive element which, in order to establish infringement, requires proof of the manufacturer’s intention when making the medicament – that is, a mental element step component. In relation to the Patent, the intention to be proved was use of the alleged infringing products for the prevention or treatment of diabetic retinopathy. It was the primary judge’s view that Mylan had not proved that intention.

Mylan appealed this decision on the grounds that the manufacturer’s intention in making the medicament was irrelevant. According to Mylan, a Swiss-style claim can be infringed if the manufacturer has prepared the relevant medicament knowing that it is suitable for use in the treatment of the condition specified in the claim.

In rejecting Mylan’s contention, the Full Court reiterated that while Swiss-type claims are method or process claims, these claims are not method of treatment claims. The monopoly afforded by a Swiss-style claim is in respect of the method or process of making a medicament, being a process that is complete upon manufacture. Moreover, Swiss-style claims are purpose-limited claims 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. That is, the medicament must be for the specified use. Saliently, the Court considered that the purpose limitation in a Swiss-style claim is an essential feature of the invention as claimed and “like any other essential feature, it must be proved in order for infringement of the claimed method or process to be established.”

The Full Court flatly rejected the primary judge’s construction that a Swiss-type claim adds a further essential feature to the invention, namely the manufacturer’s intention in making the medicament. At paragraph 222:

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.

The Full Court concurred with the primary judge’s finding that mere suitability of a medicament for a claimed purpose cannot be determinative of the question of infringement of a Swiss type claim.

The product information document supplied by Sun Pharma with the alleged infringing products made no mention of diabetic retinopathy. The Full Court considered that the statement in the product information document that the Sun Pharma products are bioequivalent to Lipidil merely relate to the bioequivalence that has been found in the majority of clinical trials that have been conducted. And that the product information for Lipidil including the suitability of that product for treatment of diabetic retinopathy is not to be read in conjunction with the bioequivalence to conclude that the Sun Pharma products are medicaments for the specified therapeutic purpose, namely diabetic retinopathy. Moreover, the lack of a disclaimer by Sun Pharma to diabetic retinopathy is not required to avoid infringement since “the absence of a disclaimer is hardly proof that, as manufactured, a medicament is one for a therapeutic use that has not been disclaimed, when the medicament’s therapeutic use has been clearly stated.”

Ultimately, the Full Court reached the same conclusion as the primary judge, albeit by different reasoning: claim 5 of the Patent is not infringed by Sun Pharma.

The Full Court also upheld the primary judge’s determination that Sun Pharma would have have been liable for contributory infringement under s 117(1) of the Patents Act in respect of the corresponding method of treatment claims, if these claims were valid.

It could be argued that the Full Court has provided a mud map for generic companies to avoid infringement of Swiss-style claims in Australia.

But it is worth remembering that it has been known since the decision in Prosidion Limited v Novo Nordisk [2006] APO 6 that under Australian law, method of treatment claims and Swiss-style claims are construed as having different infringing acts, and thus provide different forms of protection. The present decision by the Full Court affirms this position and highlights the importance of including both method of treatment claims and Swiss-style claims prior to acceptance of an Australian patent.

Please contact Dr Hedie Meka here if you have any questions regarding this case or Australian practice in general.