Alphapharm Pty Ltd v H Lundbeck A/S

Alphapharm Pty Ltd sought leave to appeal against the decision of Bennett J in the Federal Court of Australia, who dismissed their application for a review of a decision of the Commissioner of Patents. The Commissioner had granted H Lundbeck A/S an extension of the term of a patent, which Alphapharm opposed. The central issue was whether the patent claim to a (+)-enantiomer of citalopram included an implicit requirement for isolation or purity, thereby excluding it from the definition of a pharmaceutical substance as per section 70 of the Patents Act 1990. Alphapharm argued that such a limitation would render the claim ineligible for the patent term extension under the Act.

The court assessed the claim's construction and whether it included additional limitations beyond the pharmaceutical substance itself. Alphapharm contended that the claim should be interpreted as requiring the enantiomer to be isolated or pure, which they argued made it ineligible for the term extension. The court found that the claim, as construed in the prior decisions, did not inherently include such a limitation. The reasoning of the previous judges, including Bennett and Middleton JJ, was that the claim was to the substance per se without any additional requirement for isolation or purity.

The court dismissed Alphapharm's argument, holding that the claim was to the substance as required by section 70 of the Act and did not include a limitation of isolation or purity. The court noted that the prior decisions correctly interpreted the claim and that the evidence showed that the skilled person would not have recognised the enantiomers without experimentation. Therefore, the extension of the patent term was appropriately granted.

The court granted the application for leave to appeal but dismissed the appeal, ordering that Alphapharm pay the respondent’s costs of and incidental to the application for leave to appeal and the appeal.