University of Queensland CSL Ltd & Anor v Comptroller -General of Patents, Designs and Trade Marks

For supplementary protection certificates, Article 3(a) precludes protection for active ingredients that are not identified in the claims of the basic patent. For a product obtained by a patented process, the relevant product is the product identified in the claims; whether it is obtained directly by the process is irrelevant. Article 3(b) does not preclude a certificate for an active ingredient identified in the claims merely because the marketing authorisation covers that ingredient together with other active ingredients.

The University of Queensland and CSL Limited appealed against a Comptroller-General decision refusing eight applications for supplementary protection certificates under Regulation 469/2009. Two applications concerned combinations of active ingredients, while six concerned individual active ingredients contained in combination vaccines. The hearing officer refused the first group under Article 3(a) and the second under Article 3(b). Following rulings by the Court of Justice on references from the appeal, the central issues were whether the applications satisfied Articles 3(a) and 3(b), and whether some applications required further consideration of the first marketing authorisation requirement.

1. The appeal was partly allowed and partly dismissed.
2. The two applications in the first group failed Article 3(a). The claimed combinations included active ingredients not identified in the wording of the claims of the basic patents. The appeal was therefore dismissed in relation to those applications.
3. The six applications in the second group did not fail Article 3(b) merely because the marketing authorisations covered combinations of active ingredients rather than the individual active ingredients alone. The Court of Justice had ruled that Article 3(b) permits a certificate for an active ingredient specified in the claims where the authorised medicinal product also contains other active ingredients. The appeal was therefore allowed in relation to those applications.
4. Applications 015, 016, 017 and 021 could proceed to grant.
5. Applications 081 and 082 were remitted to the Intellectual Property Office for consideration of the remaining requirements. In particular, it had to determine whether Gardasil was the first marketing authorisation covering HPV16 VLP and HPV18 VLP, which could prevent certificates based on the Cervarix authorisation.
6. The Comptroller-General accepted that two certificates could be granted on the same basic patent where they concerned different products. The court noted the previous authority that only one certificate may be granted for a product under a basic patent, and accepted the distinction between one certificate per patent and one certificate per product per patent.

The appeal was brought against the Comptroller-General’s decision dated 24 September 2010 (O/335/10). The High Court partly allowed and partly dismissed the appeal, allowing six applications to proceed subject to further consideration of two of them.