The AG, in a reference to the ECJ from Germany (Merck & Co Inc v Deutsches Patent und Markenamt (Case C-125/10)), opined on 9 June 2011 that SPCs with a negative term can be granted and their duration can be extended by a period of 6 months under the Paediatric Regulation.
- If followed by the ECJ, pharmaceutical companies may have the opportunity of obtaining a paediatric extension in circumstances where their SPC rights would otherwise have been of a negative duration – and therefore useless.
- The AG ruled-out the granting of zero term SPCs – that is rounding up the term of an SPC (which would otherwise be of a negative value) to zero. This will be a disappointment for some innovative pharmaceutical companies as, despite completing and publishing the required paediatric studies, they may be unable to claim the full 6 month period of paediatric extension if their SPC is of negative duration.
- The AG's opinion permitting paediatric extensions on the basis of a negative term SPC mirrors the earlier conclusions of the United Kingdom Intellectual Property Office ("UK-IPO") in relation to the corresponding UK SPC application (see UK-IPO decision BL O/108/08).
- The AG's opinion is usually followed by the ECJ, but is not binding.
The Paediatric Regulation (Regulation 1901/2006) was introduced by the European Commission in order to address the concern that not enough clinical studies of pharmaceuticals in the paediatric population were being conducted. As a consequence, many medicinal products were not authorised for use in children nor were the risks in paediatric use fully understood. To address this concern, the Paediatric Regulation introduced certain obligations to promote paediatric approval of drugs and sought to sweeten the package with the possibility of a 6 month paediatric extension to an SPC.
A paediatric extension to an SPC can be granted if the substantive requirements of Article 36 of the Paediatric Regulation are met and the application is made in accordance with the provisions of the SPC Regulation (originally Regulation 1768/92 but now replaced by a codified version, Regulation 469/2009). In this regard, Article 36(4) of the Paediatric Regulation provides that a paediatric extension can only be granted for products protected by an SPC or a patent which qualifies for the granting of an SPC (this is also reflected in Article 13(3) of the SPC Regulation). However, in neither the Paediatric Regulation nor the SPC Regulation is there an explicit provision that prohibits (or indeed supports) the grant of an SPC with a zero or negative term.
If the requirements of the Paediatric and SPC Regulations are met, the duration of an SPC is calculated by reference to the formula contained in Article 13 of the SPC Regulation. Articles 13(1) and 13(2) of the SPC Regulation provide that, up to a maximum of five years, the duration of the SPC is calculated as:
'a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years' (Article 13(1) of the SPC Regulation)
The reference to the ECJ seeks to resolve two key points:
- Can a 6 month paediatric extension be obtained for a product in which the underlying SPC would have no effective (positive) term?
- If such a paediatric extension is permissible, would the SPC term be rounded up to zero (such that the paediatric extension would provide an additional 6 months of protection from expiry of the basic patent) or would the SPC have a negative term (such that the effective period of protection provided by a paediatric extension will be the difference between the negative term and 6 months)?
The AG opined that SPCs with a negative term can be granted and their duration can be extended by a period of 6 months under the Paediatric Regulation.
In reaching an opinion, the AG considered the differing objectives of the SPC Regulation and Paediatric Regulation. The SPC Regulation aims to compensate patent holders for the loss of time and investment required in obtaining regulatory approval for new medicinal products. Whereas, the Paediatric Regulations introduced paediatric extensions as one of the rewards and incentives for pharmaceutical companies to undertake clinical trials and tests on the paediatric population and publish the results throughout the European Community.
The AG was swayed by the fact that there is nothing in the substantive requirements to obtain an SPC (Article 3 of the SPC Regulation) that requires an SPC to have a positive term. Likewise, Article 36(1) of the Paediatric Regulation envisages a 6 month extension of the period referred to in Article 13 of the SPC Regulation.
The AG was also concerned that an interpretation that did not allow for negative term SPCs would result in applicants trying to delay the grant of their marketing authorisations in order to ensure that the SPC would have a positive term (no matter how small) which might then be the subject matter of a 6 month paediatric extension.
The AG rejected any notion of rounding up the SPC duration to zero. In this regard, the AG noted that by looking at the purpose of both the SPC and Paediatric Regulations, a maximum period of market exclusivity of 15 ½ years was intended and that a 6 month paediatric extension was not envisaged to be granted in all cases where pharmaceutical companies had complied with the substantive requirements of the Paediatric Regulation.