Apotex Pty Ltd (formerly GenRx Pty Limited) v Les Laboratoires Servier (No 2)

The matter before the court involved Apotex Pty Ltd, formerly known as GenRx Pty Limited, and Les Laboratoires Servier. The dispute centred around the substitution of a generic drug, specifically perindopril erbumine, for the brand drug Coversyl. The court was tasked with determining the impact of the substitution on patient confusion and whether the promotional activities of Les Laboratoires Servier were misleading and deceptive.

The court had to consider the legal issues surrounding the potential for patient confusion when substituting generic drugs for branded drugs, particularly in the context of perindopril. It also needed to evaluate whether the promotional activities by Les Laboratoires Servier were misleading and deceptive under Australian consumer law. The court examined the evidence provided by experts, including Professor McLachlan, who highlighted the importance of considering patient understanding and the risk of medication misadventure when substituting drugs. The court also considered the views of pharmacists and the role of doctors and pharmacists in managing potential patient confusion.

In its reasoning, the court found that while substitution of generic drugs could potentially cause patient confusion, this was not inevitable and could be managed through appropriate counselling by healthcare professionals. The court acknowledged that some patient confusion could be minimised or eliminated with proper explanation by doctors or pharmacists. However, the court concluded that the promotional activities by Les Laboratoires Servier were misleading and deceptive as they failed to adequately address the potential for patient confusion and the serious medical consequences of double dosing in the case of perindopril. The court determined that the advertisements were directed to medical practitioners, who hold the primary responsibility for deciding whether to permit substitution.

The court ordered that the parties submit orders within 14 days to give effect to the reasons for the decision.