According to two landmark ECJ rulings on the calculation of an SPC period of validity, the right to an appeal for a longer period of validity of the SPC is available not only to those whose application has not yet been completed, but also to those whose SPC period has not yet expired.
In a reference for a preliminary ruling from the Hungarian Court of Justice in the Incyte Corporation v Szellemi Tulajdon Nemzeti Hivatala case (EU:C:2017:995) the ECJ had to decide on the interpretation of whether the date of the first marketing authorisation for a supplementary protection certificate (SPC) requires a new interpretation since the ECJ ruling in the Seattle Genetics case.
The preliminary ruling in the Incyte versus Szellemi case is based on the earlier Seattle Genetics judgment (C:2015:659) of the ECJ. In Seattle Genetics, the ECJ interpreted Art 13.1 of the SPC Regulation, in particular the term “date of first marketing authorisation in the European Union”.
- The ECJ clarified that the “date for placing the product on the market” may not be determined from state to state on the basis of national laws, but is determined by Union law.
- The ECJ ruled that the date of the first marketing authorisation is the date on which the marketing authorisation decision is notified to its addressee, not the date of issue specified in the decision.
The Seattle Genetics judgment improved unity between Member States by clarifying the relevant data for calculating the period of validity of an SPC. At the same time, it was precisely this ruling that created new legal uncertainty. Many SPCs were granted before in case Seattle Genetics the verdict was pronounced, which resulted in shorter terms than if Seattle Genetics had taken the verdict into account. In addition, for many of these SPCs, the national appeal conditions ended. As a result, Member States took inconsistent decisions on a possible recalculation.
Incyte’s SPC was approved prior to the Seattle Genetics judgment. Therefore, Incyte requested the Hungarian Intellectual Property Office (HIPO) to correct the validity period of the SPC with respect to the new interpretation of the Seattle Genetics judgment. However, Incyte’s application was rejected under Hungarian law.
Questions referred for a preliminary ruling
The Hungarian Court stayed the proceedings and referred three questions to the ECJ for a preliminary ruling:
- Is “the date of the first marketing authorisation in the European Union” incorrect in an application for an SPC if that date was fixed without taking into account the legal interpretation in the Seattle Genetics judgment?
- Is it appropriate to correct the expiration date of the SPC even if the decision to grant that certificate was taken before that judgment and the period for appeal against that decision has expired?
- Is the authority of a Member State empowered to issue a supplementary protection certificate required to correct of its own motion the expiry date of the certificate so that it is consistent with the legal interpretation in Seattle Genetics?
The calculation of the duration of medical SPCs is laid down in the SPC Regulation EC/469/2009. In Article 13 of that Regulation, the duration is determined by two cut-off dates, one being the date of filing of the basic patent application and the other being the date of the first marketing authorisation of the medicinal product concerned in the Community. The difference between the two shall be used to calculate the duration of the SPC. Article 14 defines that the SPC shall expire at the end of the period calculated on the basis of Article 13.
The PPP Regulation EC/1610/96 on SPCs of plant protection products also contains identical provisions on duration. Appeals against the SPC decisions of the national patent offices are available in the same way as under national law against similar decisions on national patents, but there is an additional statement of grounds in the context of plant protection products.
Seattle Genetics judgment must be taken into account
The first two questions were clearly answered in the affirmative by the ECJ. For an SPC for which the time limit has not yet expired, the Seattle Genetics judgment must be taken into account when calculating the period of validity and such an SPC must also be corrected accordingly. The Court justified this with its interpretation of the date in Seattle Genetics. Since the date indicated in the application should always have been the date of notification, any other date must be considered incorrect. And decisions granting a certificate may be appealed against the same remedies provided under national law against similar decisions concerning national patents (Art. 18 of Regulation No. 469/2009). This right also applies to those whose SPC deadline has not yet expired. The ECJ also pointed out that the right to such a request is not limited by the purpose of the SPC decision.
With regard to the third question referred for a preliminary ruling, the ECJ stated that, according to settled case-law, Union law does not require that an administrative authority is in principle obliged to revoke an administrative decision which has become final. This would contribute to legal certainty. However, under the principle of cooperation, an administrative authority is obliged, upon request, to review a decision in order to take account of the interpretation of the relevant provision now given by the Court of Justice – if the decision in question has become final following a judgment of a national court of last instance and if the person concerned, having become aware of the Court of Justice’s decision in question, has addressed himself to the administrative authority.
Furthermore, the authority granting the SPC has no discretion as to the duration of the SPC, since it is entirely determined by the criteria of the SPC Regulation itself.
Advice on Union law independent of questions referred for a preliminary ruling
The reasoning for the judgment also contains an interesting aspect on questions referred for a preliminary ruling in European case law, which goes beyond patent law and the granting of SPCs. Although the Hungarian court had expressly requested the interpretation of Article 17(2) of the PPP Regulation, the ECJ responded with regard to the interpretation of Article 18 of the SPC Regulation. The fact that a national court formulated its reference for a preliminary ruling by reference to certain provisions of Union law does not prevent the Court from providing that court with any guidance on the interpretation of Union law which might be useful to it in deciding the case pending before it, irrespective of what it referred to in its questions.
Patent protection and SPC for pharmaceuticals – an issue for you too?
Please take your chance and contact us. Our lawyers are experienced in trademark and patent law, national and international law.