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Advocate General issues opinion on Supplementary Protection Certificates for Combination Products

Advocate General issues opinion on Supplementary Protection Certificates for Combination Products

01/01/2011 12:41:40

Advocate General issues opinion on Supplementary Protection Certificates for Combination Products

Yesterday Advocate General Trstenjak delivered her opinion in the joined references before the CJEU C-322/10 Medeva and C 422/10 Georgetown University. Both cases have been closely watched by the pharmaceutical industry as they concern the application of the SPC (Supplementary Protection Certificate) Regulation (EC) No 469/2009 to combination products.

The references concerned SPC applications for vaccines. For public health reasons, it is desirable to have vaccines against multiple diseases combined in a single shot. However, this poses an issue for a patentee that has a patent against a component or sub-set of components of a multi- disease vaccine. If the "product" that is authorised in Europe is the multi-disease vaccine containing components A+B+C+D can an SPC be granted for a patent that only claims components A+B? The approach of the UKIPO and the UK courts has been to deny SPC protection in such cases, on the basis that there is a mis-match between the totality of the active ingredients of the authorised combination product and the subject matter of the patent.

The Advocate General recognised that applying a literal interpretation of the SPC Regulation would lead to a conclusion that such SPC's should be refused. However, she was concerned that taking such a literal approach would not be in accordance with the aims of the Regulation as it would lead to the denial of SPC protection for extremely valuable combination products. In some therapeutic areas manufacturers find themselves obliged to include multiple components for legal or practical reasons. The Advocate General therefore adopted a "teleological" interpretation of the Regulation, concluding that it was possible to select a sub-set of components of a multi-component medicinal product as forming the subject matter of the certificate. A certificate could issue on this sub-set and would extend to all medicinal products containing that sub-set of active ingredients authorised before the certificate expires. However the abuse of "evergreening" (which had been of concern to the UK courts) would be avoided because a patentee could not apply for further SPC's of longer duration under the same patent even if later product approvals issue to the sub-set which is the subject of the SPC in combination with different active ingredients.

On balance, this Opinion seems favourable to the research based pharmaceutical industry in that the Regulation has been interpreted to avoid an unduly harsh refusal of SPC protection. It remains to be seen whether the CJEU will follow the decision of the Advocate General, although the Court does so in the majority of cases.

If you have any questions about this briefing, please contact Tim Powell of Powell Gilbert. A link to the full opinion is below.