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Europe: Recent development in SPCs

Supplementary protection certificates (SPCs) are issued under EU Regulation 469/2009 to compensate for lost patent time because of the pharmaceutical marketing authorisation procedure.

According to Article 3 of the Regulation, an extended protection may be provided for basic patents covering the product for which the first marketing authorization (MA) has been obtained. In national proceedings where the validity of SPCs is questioned, the courts may refer questions on interpretation of the Regulation to the Court of Justice of the EU (CJEU). In the recent past, however, the CJEU has not been applauded for its clear and concise rulings on this matter.

Recently, three new decisions have been issued by the CJEU on how to interpret Article 3. In C-493/12 (HGS v Eli Lilly) some light was shed on the question when a product is covered by a patent. It was explained by the CJEU that is not sufficient to argue that the product infringes the patent, but on the other hand neither is it deemed necessary that the active ingredient be identified by a specific formula in the patent. What exactly is required to satisfy the criterion according to the CJEU is still a matter of speculation.

Another question that was pending is whether a compound protected by one patent can give rise to two different SPCs (if the compound would have two different market authorisations). This was the case in C-443/12 between Actavis and Sanofi, where Sanofi had obtained an SPC for irbesartan and a combination of irbesartan with the diuretic HCTZ. The CJEU argued that in principle it could be possible to have multiple SPCs for products covered by one patent if these products are covered by the patent. However, in this case the CJEU ruled that the second SPC (on the combination) was invalid because the first SPC already protected irbesartan, no matter whether it was marketed as single product or in the combination (where it was present for the same indication).

Relating to this, but approaching from a different angle, is C-484/12 (Georgetown II) which dealt with HPV vaccines, where an MA and SPC were obtained for a combination of HPV-6, HPV-11, HPV-16 and HPV-18 (Gardasil). Also there was an MA and SPC for a combination of HPV-16 and HPV-18 (Cervirax). Now Georgetown wanted an SPC for HPV-16 alone. According to the CJEU, the basic patent covered both the combination and the individual component and the products were regarded as separate innovative products. On the basis of this, Georgetown was allowed an SPC for HPV-16 alone.

From the last two decisions it can be concluded that if one has an SPC for product A, an SPC for product A+B will not be possible. If, however, an SPC was provided for A+B, an SPC for A will still be possible (provided that all products have been "covered" by the patent). It apparently matters in which sequence MAs and thus SPCs are applied for.

Bart van Wezenbeek

V.O.Johan de Wittlaan 72517 JR The HagueThe NetherlandsTel: +31 70 416 67 11Fax: +31 70 416 67

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