Alphapharm Pty Ltd v H Lundbeck A/S and Ors

Alphapharm Pty Ltd (Alphapharm) sought to import and sell a generic version of the antidepressant drug citalopram, the active ingredient of which was Lundbeck's patented drug Cipramil. Lundbeck, the patent holder, and its Australian subsidiary, H. Lundbeck A/S, sought to prevent Alphapharm from importing and selling its generic product. The dispute ultimately came before the High Court of Australia.

The central legal issue before the High Court was whether Alphapharm's proposed importation and sale of its generic citalopram product would infringe Lundbeck's Australian patent. This involved a determination of the scope of Lundbeck's patent claims and whether Alphapharm's product fell within that scope. A further issue concerned the interpretation of certain provisions of the Patents Act 1990 (Cth) relating to the infringement of pharmaceutical patents.

The High Court considered the construction of Lundbeck's patent claims, particularly in light of the doctrine of equivalents. Their Honours applied established principles of patent law, including the approach to claim construction and the assessment of infringement. The Court analysed the evidence regarding the chemical composition and therapeutic effect of both Lundbeck's and Alphapharm's products to determine if Alphapharm's product was equivalent to the patented invention. The Court found that Alphapharm's product did not infringe Lundbeck's patent.

The High Court ordered that Alphapharm's appeal be allowed and that the orders of the Full Federal Court be set aside. The Court declared that Alphapharm's proposed importation and sale of its citalopram product did not infringe Lundbeck's patent.