Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd)  FCA 28 (22 January 2019)
A recent Federal Court of Australia decision held that in order for a party to infringe a Swiss-style claim the alleged infringer must manufacture the medicament with the objective intention to treat the same condition designated in the Swiss-style claim.
The Federal Court of Australia cited the reasoning of the recent United Kingdom Supreme Court in Warner Lambert Company LLC v Generics (UK) Ltd  UKSC 56regarding the mental element requirement of objective intention or subjective intention for infringement of Swiss-style claims.
Whilst the Federal Court of Australia was not required to decide whether Swiss-style claims required subjective or objective intention of the manufacturer, the Australian Court did find persuasive, the United Kingdom Supreme Court requirement of objective intention of the alleged infringer is determinative as to whether they are infringing the Swiss-style claim.
The crucial question is whether the manufacturer has made (or will make) the relevant medicament with the intention that it be used in the treatment of the designated condition. The question is to be ascertained objectively in the approved product information, any product labelling and the nature, size and other pertinent characteristics of the market into which the product is to be sold.
The patentee’s product (Mylan Health Pty Ltd) was indicated for treatment of retinopathy and more particularly diabetic retinopathy covered by the Swiss-style claims of the Australian patent. The alleged infringer’s (Sun Pharma ANZ Pty Ltd) product was originally approved for the same indication (retinopathy and more particularly diabetic retinopathy) but was subsequently removed and amended to another indication being hypercholesteremia. Although the alleged infringer (Sun Pharma ANZ Pty Ltd) was manufacturing the product having the same bioequivalence (fenofibrate), it appeared to avoid infringement on the basis that the product information did not disclose treatment of retinopathy and more particularly diabetic retinopathy.
Adrian M Trioli
Patent and Trade Mark Attorney
4th June 2019
 Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd)  FCA 28 at paragraphs -
 Ibid 1 at paragraph 
 Ibid 1 at paragraphs  to 
 Ibid 3