Sanofi-Aventis & Ors v Apotex Pty Ltd; Sanofi-Aventis & Ors v Spirit Pharmaceuticals Pty Ltd

Sanofi-Aventis and others (the applicants) brought proceedings against Apotex Pty Ltd and Spirit Pharmaceuticals Pty Ltd (the respondents) in the Federal Court of Australia concerning alleged infringement of Australian Patent No 577,781. The patent claimed a method of treating thrombosis by administering a specific dosage of clopidogrel bisulphate. The applicants sought interlocutory injunctions to restrain the respondents from infringing the patent by marketing generic versions of the drug.

The primary legal issue before the Full Federal Court was whether the applicants had established a sufficient likelihood of success on the merits to warrant the grant of interlocutory injunctions. This involved determining whether the respondents' proposed generic products would infringe the patent, particularly in light of the respondents' contention that their products would be formulated to deliver a different dosage regimen than that claimed in the patent. The court also had to consider the balance of convenience, including the potential for damage to the parties and the public interest in access to medicines.

The Full Federal Court, comprising Gummow and Heydon JJ, overturned the primary judge's decision to refuse interlocutory injunctions. Their Honours found that the primary judge had erred in his assessment of the likelihood of infringement. They reasoned that the respondents' proposed dosage regimen, while different in some respects, was still likely to fall within the scope of the patent claim, particularly given the broad language of the claim and the potential for the respondents' products to be used in a manner that would infringe. The court applied the principles governing the grant of interlocutory injunctions, emphasising the need for a serious question to be tried and a favourable balance of convenience. The court concluded that the applicants had demonstrated a sufficient likelihood of success and that the balance of convenience favoured the grant of injunctions.

The Full Federal Court ordered that interlocutory injunctions be granted, restraining the respondents from infringing the patent pending the final determination of the proceedings.