Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28 (‘Mylan v Sun Pharma’) concerns three patents relating to the drug fenofibrate. Fenofibrate is a medication used to treat abnormal blood lipid levels, in particular in diabetics. One of the patents (AU 2006313711, ‘the 711 Patent’) relates to uses of fenofibrate for treating diabetic retinopathy, and the other two patents (AU 731964, ‘the 964 Patent’ and AU 2003301807, ‘the 807 Patent’) relate to compositions and formulations of fenofibrate.

Sun Pharma (formerly Ranbaxy) proposed to market in Australia a number of fenofibrate products (‘the Ranbaxy products’), which were alleged by Mylan to infringe certain claims of the 711, 964, and 807 Patents. Sun Pharma denied infringement and challenged the validity of the asserted claims.

Two points of particular interest in this judgement concern the infringement of Swiss-style claims and inventive step with respect to the 711 Patent. A number of other issues were also considered in the decision.

Swiss-Style Claims Require ‘Objective Intention’

In Mylan v Sun Pharma Nicholas J has provided further guidance from the Federal Court regarding how infringement of a Swiss-style claim is established. The claim in question was claim 1 of the 711 Patent which was for the use of fenofibrate or a derivative thereof for the manufacture of a medicament for the prevention and/or treatment of retinopathy, in particular diabetic retinopathy.

Swiss-style claims relate to the manufacture of a medicament for a specific purpose, and thus involve a ‘mental element’ on the part of the manufacturer, in the sense that the manufacturer must have an intention that the medicament will be used for the claimed purpose. Nicholas J referred to Warner Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56 where the UK Supreme Court considered whether that intention must be a subjective or an objective intention. A subjective intention relates to the manufacturer’s actual state of mind, that is, whether the medicament is deliberately manufactured with the claimed purpose in mind. An objective intention is a legal construct where a person is taken to intend the ordinary and natural consequences of his or her acts, as would have been foreseen by a reasonable person. Although it was not necessary for him to make a decision in this regard, Nicholas J agreed with the UK Supreme Court which favoured the relevance of the objective intention.

Nicholas J considered that the intention of the manufacturer is to be ascertained objectively in light of all the relevant facts and circumstances ‘including, in particular, the approved product information (“PI”) for the product, any product labelling, and the nature, size and other pertinent characteristics of the market into which the product is to be sold’ (at 102). However, the fact that it may be ‘reasonably foreseeable or even likely that a substantial portion of the product manufactured will be used to treat that condition is certainly not determinative at least not where the product is also used extensively in the treatment of other non-designated conditions’ (at 103).

Nicholas J also pointed out that whether a medicament is effective or suitable for the claimed treatment is a poor test from a policy perspective, as ‘it would render a person liable for infringement who manufactured a medicament for the purpose of using it to treat an indication which it had been used to treat before the priority date of the Swiss-style claim merely because the medicament might also be used for the purpose of treating a second indication that provided the novelty-conferring subject matter of the claim’ (at 101).

Product Information and Labelling, Not Use, Determinative of the Manufacturer’s Intention

Although the Ranbaxy products were initially accompanied by a PI which indicated their use for reduction in the progression of diabetic retinopathy, the PI was subsequently amended to remove that indication. Despite the amended PI indicating that the Ranbaxy products were bioequivalent to the originator product which was indicated for the reduction in the progression of diabetic retinopathy, Nicholas J found that the Ranbaxy products were not manufactured with the intention that they be used for reducing the progression of diabetic retinopathy. Therefore, the infringement case was not made out.

Mixed messages

In contrast, the equivalent method of treatment claim was found to be infringed on the basis that the respondent had reason to believe that a significant portion of the Ranbaxy products will be used in a manner which will infringe the claim. Put another way, the evidence showed it could be foreseen by a reasonable person that the products will be used for the claimed purpose. It is difficult to reconcile the determination of infringement of the method of treatment claims, with the non-infringement of the Swiss-style claims. In our view, it would have been helpful if His Honour had elaborated on why the fact that it may be reasonably foreseeable that a substantial portion of the product will be used to treat the claimed condition was not determinative of the manufacturer’s objective intention.

Inventive Step

Mylan v Sun Pharma also provides some useful clarification regarding tests for inventive step. The inventiveness of the claims of the 711 Patent was considered by reference to the following modified Cripps question:

Would the notional team at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art, directly be led as a matter of course to try fenofibrate (whether alone or in combination with a statin) as a medicament for use in the prevention or treatment of diabetic retinopathy in the expectation that it might well produce a useful or better alternative to other therapies used for that purpose?

Nicholas J emphasised that in the Cripps question ‘directly led’ does not mean that only one thing may be obvious. There will be some cases in which the person skilled in the art will be directly led, as a matter of course, to try a number of different alternatives in the expectation that each may well produce a useful alternative. Multiple pathways may be obvious.

In light of a comment from one of the expert witnesses that the prospect of fenofibrate proving effective in the treatment of diabetic retinopathy was ‘no better than fifty-fifty’, Nicholas J also considered what degree of expectation of success was required to answer the Cripps question in the affirmative. His Honour concluded that the modified Cripps question may receive an affirmative answer even if the skilled person considers that the prospects of success are less than fifty-fifty. However, this will depend on the circumstances of the case.

Summary

Nicholas J’s findings regarding the infringement of the Swiss-style claims further emphasise the distinction between Swiss-style and method of treatment claims under Australian law. As we have previously reported, applicants should ensure that both Swiss-style and method of treatment claims are included in applications relating to medical uses.

Mylan have appealed this judgement, and we will continue to monitor developments in this case with great interest.