Application - Supplementary protection certificate - Application

University of Queensland and another v Comptroller-General of Patents, Designs and Trade Marks: ChD (Patents) (Mr Justice Arnold): 14 February 2012

The first appellant was the proprietor of three European patents: 0 595 935 (935); 1 298 211 (211); and 1 359 156 (156).

Patent 935 covered, inter alia, a method for producing papillomavirus virus-like particles (VLPs) of human papillomavirus (HPV) type 6 protein and vaccines produced from such VLPs. Patent 211 covered, inter alia, a method for producing VLPs of HPV type 16 L1 protein and vaccines produced from such VLPs. Patent 156 covered, inter alia, a method for producing VLPs of HPV type 18 L1 protein and vaccines produced from such VLPs. A company, G, had a marketing authorisation for a vaccine (the C vaccine) which contained a combination of HPV type 16 and type 18 L1 proteins in the form of VLPs.

A different company, SP, had a marketing authorisation for a vaccine (the GS vaccine) which contained a combination of HPV type six, eleven, 16 and 18 L1 proteins in the form of VLPs. The appellants made eight applications (the applications) to the respondent for supplementary protection certificates (SPCs): SPC/GB/07/014 (014); SPC/GB/07/015 (015); SPC/GB/07/016 (016); SPC/GB/07/017 (017); SPC/GB/07/021 (021); SPC/GB/07/081 (081); SPC/GB/07/082 (082); and SPC/GB/07/084 (084). The applications fell into two groups. The first group consisted of applications 014 and 084 (the first group applications) which were based on the 935 and 156 patents and the marketing authorisations for the C and GS vaccines.

The first group applications defined the product in respect of which the SPC was sought as a combination of antigens which was the subject of the relevant marketing authorisation. The second group consisted of applications 015, 016, 017, 021, 081 and 082 (the second group applications) which were based on the 935, 211 and 156 patents and the C and GS vaccines. The second group applications defined the product in respect of which the SPC was sought as a single antigen selected from those which were the subject of the relevant marketing authorisation. The respondent’s hearing officer refused the first group applications for non-compliance with article 3(a) of the European Parliament and Council Regulation (EC) 469/2009 (concerning the supplementary protection certificate for medicinal products) (the regulation) and refused the second group applications for non-compliance with article 3(b) of the regulation (the decision). The appellants appealed against the decision and certain questions were referred by the court to the Court of Justice of the European Union (the CJEU) (see[2012] All ER (D) 177 (Feb)).

The issues that fell to be determined were whether: (i) the first group applications had complied with article 3(a) of the regulation; and (ii) whether the second group applications had complied with article 3(b) of the regulation. The appeal would be allowed in part.

(1) Article 3(a) of the regulation should be interpreted as precluding the competent industrial property office of a member state from granting an SPC relating to active ingredients which were not identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate. In the case of a basic patent relating to a process by which a product was obtained, article 3(a) precluded an SPC being granted for a product other than that which had been identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it was possible to obtain the product directly as a result of that process was irrelevant in that regard (see [6] of the judgment).

On the facts of the instant case, the first group applications had not complied with article 3(a) of the regulation since the combinations of active ingredients specified in the applications included active ingredients which were not identified in the wording of the claims of the basic patents relied on in support of the applications (see [7] of the judgment). The appeal would be dismissed in relation to the first group applications (see [7] of the judgment).

(2) Article 3(b) of the regulation should be interpreted as meaning that, provided that the other requirements laid down in article 3 had also been met, that provision did not preclude the competent industrial property office of a member state from granting an SPC for an active ingredient specified in the wording of the claims of the basic patent relied upon where the medicinal product for which the marketing authorisation was submitted in support of the SPC application contained not only that active ingredient, but also other active ingredients (see [6] of the judgment).

On the facts of the instant case, the decision to refuse the second group applications could not stand. In the hearing officer’s view, the ‘product’ for the purposes of article 3(b) could only have been the combination the subject of the relevant marketing authorisation and not any of the individual active ingredients. However, it was clear that the CJEU had disagreed with that interpretation of article 3(b). It followed that the respondent had been wrong to hold that the second group applications had failed to comply with article 3(b) (see [8] of the judgment).

The appeal would be allowed in relation to the second group applications. In the case of applications 015, 016, 017 and 021, it was accepted that they would proceed to grant. As to application 081 and 082, it was common ground that they ought to be remitted to the Intellectual Property Office for further consideration so it could be determined whether they complied with other provisions of the regulation (see [8]-[10] of the judgment).

Richard Miller QC (instructed by Carpmaels & Ransford) for the ­appellants; Thomas Mitcheson (instructed by the Treasury Solicitor) for the respondent.