The Advocate-General Yves Bot (AG) at the Court of Justice of the European Union (CJEU) in Case C-125/10 of June 09, 2011 holds Regulation 1768/92/EC to be interpreted in the light of Regulation 1901/2006/EC to the effect that an SPC can be granted even if the period between filing of the patent application and grant of the marketing authorization is shorter than five years. Thus, the AG accepts the grant of an SPC with a negative duration.
On June 9, 2011 the AG proposed to the CJEU to find that Supplementary Protection Certificates (SPCs) can be granted even if less than five years have passed between the filing of the basic patent and the grant of the marketing authorization. Moreover, he proposed that the extension of the patent term should start running from the expiration of the patent, whereby the negative duration of the SPC should be subtracted from the six-month extension granted after provision of the results of Paediatric studies.
When drafting the Regulation 1768/92/EC (hereinafter the Medicinal Regulation) the legislator had no reason to worry about admissibility of a negative duration. The spirit and purpose of SPCs was to extend the term of protection of the basic patent for the product. An SPC with a negative duration is not able to reach this effect. This situation has changed by enactment of the Regulation 1901/2006/EC on medicinal products for Paediatric use (hereinafter the Paediatric Regulation). According to Article 36 of the Paediatric Regulation, the duration of an SPC can be extended by six months if the results of Paediatric studies are provided together with the request for extension. If the period between filing of the patent application and grant of the marketing authorization is shorter than five years, but longer than four years and 6 months, a positive duration can finally be reached, calculated with the six months extension according to Article 36 of the Paediatric Regulation,. To maintain this possibility, applicants might be interested in getting an SPC with a negative duration.
The 15th Senate (Technical Board of Appeal) of the German Patent and Trademark Office (GPTO) had submitted to the ECJ pursuant to Article 267 TFEU the following question on Article 13(1) of the Medicinal Regulation:
“Can a supplementary protection certificate for medicinal products be granted if the period of time between the filing of the application for the basic patent and the date of first authorization for marketing in the Community is shorter than five years?”
The AG reasoned his affirmative petition as follows (recitals 60 et seq.): Firstly, the Medicinal Regulation did not make a clear statement whether negative duration was admissible or not. Furthermore, the duration of an SPC was not part of the requirements in Articles 7 and 8 of the Paediatric Regulation for granting an extension. Moreover, a positive duration was not part of the material preconditions in Article 3 of the Medicinal Regulation nor was it mentioned among the formal preconditions for granting an SPC mentioned in Articles 7 and 9 of the Medicinal Regulation. Therefore, at no point a positive duration was defined as a precondition for the grant of an SPC. An approach rejecting SPCs having a negative duration would lead to harsh results. If an applicant was granted a marketing authorization five years and one day after application of the basic patent, he would be granted an extension of six months and one day when providing the results of Paediatric studies. If the period between application of the basic patent and grant of the marketing authorization was five years, no extension of duration would be granted. Such an approach could finally lead to the result that pharmaceutical laboratories could be motivated to delay the grant of a marketing authorization to reach a positive duration. This clearly would not be in line with the aim of public health. Finally, on the other hand, an approach to round up negative duration to zero and to add a six-months extension would endanger the balance between pharmaceutical industry on the one hand and the health and welfare system on the other hand. The aim of the Medicinal Regulation was to provide a market exclusivity of maximum fifteen years and six months starting from the grant of the marketing authorization. The aim was not to extend the duration of all patents for six months.
The present preliminary question proceedings have been pending before the European Court of Justice since 09.03.2010 under Case No. C-125/10 (OJ C161, 19.06.2000 10, 17). According to information provided by telephone by the Registrar of the Court of Justice, a decision is to be expected in accordance with the present usual duration of proceedings of approximately 18 months, i.e. probably in late autumn 2011.
In the field of paediatric treatment, there is considerable need for action. In the absence of investigation results for paediatric uses, doctors are obliged when treating children to roughly adjust to their lower body weight the dosage of the medicinal product used. However, children are not small adults. Thus for instance, when treating children with beta-blockers, the dose used must be increased as compared with the dose used for adults. In fact, with adults it is reduced in accordance with the lower body weight of children. The use of many conventional anaesthetics on children is therefore possibly very problematic. In many cases, doctors are obliged to treat children on the basis of trial and error. Compared with this, systematic investigations in accordance with the requirements of the Paediatric Regulation are clearly preferable. Against this background, the entry into effect of the Paediatric Regulation is a huge step forward. The objectives and practical effects of the Regulation should therefore, if only for this reason, be taken into account in the answer to the question referred to the ECJ.
Dr. Christopher Brückner and Dr. Tilman Müller-Stoy (Bardehle Pagenberg, Munich)