ECJ Clarifies Requirements for Award of Supplementary Protection Certificate for Medicinal Product

On 24 November 2011, the Court of Justice of the European Union (“ECJ”) delivered its judgments in case C-322/10 Medeva BV (“Medeva”) v. Comptroller General of Patents, Designs and Trade Marks and case C-422/10 Georgetown University, University of Rochester, Loyola University of Chicago v. Comptroller General of Patents, Designs and Trade Marks. The ECJ judgments address the requirements for granting a Supplementary Protection Certificate (“SPC”) to medicinal products. In particular, the judgments clarify the requirement for the relevant active ingredient or combination of active ingredients to be found in the wording of the claims of the basic patent relied on. The judgments of the ECJ are likely to affect how SPCs will be granted in the future and may even open the door for invalidation procedures against existing SPCs.

Under Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the “SPC Regulation”), SPCs are granted for medicinal products for which the period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to recover the investment that went into the research of the product. Article 13 of the SPC Regulation allows for a single extension of the period of exclusivity afforded by the patent for a maximum period of five years. However, the subject matter of the SPC is different to the subject matter of the patent. Whereas a patent can be granted for any invention, an SPC is granted specifically for a medicine for which a marketing authorisation was obtained.

The cases at hand relate to the application for SPCs for vaccines. Patents underlying these vaccines are often granted for a single vaccine, with a specific combination of active ingredients. However, vaccines put on the market by the applicants for the SPC are often based on a market authorisation for a multi-disease vaccine, including a number of active ingredients that are not mentioned in the basic patent.

In the first case, case C-322/10, Medeva filed five applications for SPCs which were refused by the UK Patent Office. Four of the five applications were rejected because the SPC application mentioned more active ingredients than the basic patent, and the fifth application was refused because the marketing authorisation to which it referred contained more active ingredients than those mentioned in the basic patent and the SPC application. Medeva appealed against the decision of the Patent Office and the Court of Appeal of England and Wales sought guidance from the ECJ.

The second case, case C-422/10, arose in connection with various applications for SPCs by Georgetown University, Loyola University of Chicago and the University of Rochester relating to vaccines marketed as Gardasil® and Cervarix®. In particular, the UK Patent Office had refused a number of applications. As in the case of Medeva, the Patent Office was of the opinion that the SPC applications had to be refused because the medicinal product for which the marketing authorisation had been granted contained more active ingredients than those for which the SPC protection had been sought. The applicants in the main proceedings subsequently brought actions for annulment of the Patent Office’s decisions before the High Court of Justice of England and Wales which referred a number of questions to the ECJ for a preliminary ruling.

Due to the similarity of the questions, the ECJ joined the cases for purposes of the oral procedure. However, the cases were later disjoined in view of the factual differences between the situations at issue. Nevertheless, the second case, Case C-422/10, essentially copies the reasoning from the Medeva judgment.

The ECJ stated that Article 3(a) of the SPC Regulation precludes an industrial property office of a Member State from granting an SPC for active ingredients not specified in the wording of the claims of the basic patent relied upon in support of the application. The ECJ thus limited the SPC to what is covered by the patent.

On the other hand, the ECJ maintained that Article 3 of the SPC Regulation does not preclude an industrial property office of a Member State from granting an SPC for a combination of active ingredients, corresponding to the wording of the claims of the basic patent relied on, where the relevant market authorisation contains not only that combination of the two active ingredients, but also other active ingredients.

Consequently, though the ECJ restricted the SPC to what is covered by the patents, multi-disease vaccines can still receive extended protection under an SPC. Multi-disease vaccines will have to do so, though, under the basic patent granted for the original single vaccine.

Finally, the ECJ judgments may have another important effect beyond the specific questions raised. The ECJ referred to its judgment in Biogen of 23 January 1997. The ECJ held that Biogen had established that only one SPC can be granted per basic patent. As this rule may not always have been followed, this may prompt litigation seeking to annul SPCs that were granted in breach of this rule.