Counting the days: making sure it all adds up
20 October 2015
On 6 October 2015, the Court of Justice of the European Union (CJEU) delivered a judgment on the question of how the term of an SPC should be calculated if the grant of the relevant marketing authorisation (MA) is notified to the MA holder some time after it is granted.
Action may be desirable in relation to already-granted SPCs, and strategic decisions based on SPC expiry dates may need to be revisited. As is often the case, the decision leaves open whether there is any effect on the deadline for filing SPC applications.
Background: term and deadline for applying for SPCs
Supplementary Protection Certificates (SPCs) provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation before they can be placed on the market.
Both the term of an SPC and the deadline by which an application must be filed are calculated by reference to the date of the marketing authorisation. For example, Article 13 of the SPC Regulation defines the term of an SPC as being the time that has elapsed between the patent filing date and the date of the first marketing authorisation (in the European Economic Area (EEA)) minus five years, but capped to a maximum of five years (or five and a half years if a paediatric extension is obtained).
An increasing number of medicinal products are being authorised via the so-called "centralised" procedure in which the marketing authorisation is issued by the European Commission. Two dates are associated with the grant of these marketing authorisations:
- • the date of the European Commission's decision to issue an authorisation (the “decision date”); and
• the date on which the applicant is notified of the Commission's decision (the “notification date”).
The decision date is cited on the front page of the marketing authorisation, whereas the notification date is referred to in Article 4 of the marketing authorisation and is noted in the Official Journal of the EU.
The issue then arises as to which of these dates should be used to determine the term of the SPC (as well as the deadline for filing SPC applications).
The CJEU’s decision
The notification date is typically 1-5 days later than the decision date, and so would have the effect of extending the term as cited in Article 13. At least the UK and Belgian Patent Offices appear to rely on the notification date. However, the standard practice of many other national patent offices, including the offices of France, Germany, Italy, Ireland, Sweden, the Netherlands, Greece and the Czech Republic, is or has been to use the decision date.
The CJEU decided in favour of the SPC holder (Seattle Genetics) and agreed that the expiry date should be determined on the basis of the date of notification of the marketing authorisation, rather than on the basis of the decision date. Thus, the expiry date of this SPC will be extended by 5 days.
Action from national patent offices
A consequence of the CJEU’s decision is that, at least for the purposes of determining the term of SPCs based on centralised authorisations, national patent offices should rely on the date of notification of the marketing authorisation, rather than the date of the Commission’s decision to grant that authorisation.
If the centralised authorisation is the first authorisation of the relevant medicinal product in the EEA and the decision date is less than 10 years after the date of patent filing, the use of the notification date will lead to longer SPC terms. Although the time lag between the date of decision and date of notification is typically only 1-5 days, the extra SPC term could be of tremendous significance to both SPC holders and those seeking to launch generic products upon SPC expiry.
For pending and future SPC applications based on centralised authorisations (having a decision date of less than 10 years from patent filing), it is now possible for applicants to request that SPC terms are calculated based on the date of notification. This ruling should lead to a change in practice for a significant number of patent offices throughout Europe.
For granted SPCs, it may be a question of national law as to whether it is possible to appeal the grant decisions and have the SPC term rectified if the date of the first marketing authorisation for the calculation of the SPC term is incorrect. In the UK at least, a similar decision was made in 2013 (see here
) with the result that the UKIPO issued a Practice Notice advising SPC holders of the option to seek rectification of the term of granted SPCs by contacting the patent office directly. It remains to be seen whether other national patent offices will put similar provisions in place.
Consequences of requirement for “uniform interpretation throughout the European Union”
Part of the decision concerned whether the relevant date should be determined under national or European law. In the absence of any reference to the laws of Member States in Article 13 of the SPC legislation, the CJEU concluded that (in line with earlier decisions) the provision must be interpreted in a uniform manner throughout the EU.
In C-577/13 (Actavis v Boehringer Ingelheim), a number of questions were asked (but never answered) concerning whether Member State law or EU law should prevail on the issue of post grant amendments and whether an SPC application may be temporarily suspended whilst the claims of the basic patent are amended. If the CJEU were asked again to decide on these matters, the present decision would suggest that the court would seek territorially uniform solutions to the questions.
Effect on SPC filing deadline?
The decision did not address the question of whether the period for filing an SPC application is also extended if it is triggered by the date of a centralised marketing authorisation. The wording in Articles 7 and 13 of the SPC legislation may be considered to be sufficiently different that the CJEU’s answer when considering Article 13 would not apply to Article 7. Article 7(1) explicitly refers to “the date on which the authorisation … was granted
” (emphasis added), whereas Article 13 does not. Indeed, the wording in a Practice Notice
issued by the UKIPO following its 2013 decision, which appears to equate the date of decision (not the date of notification) with when the MA is granted, would support this.
However, the CJEU’s rationale would suggest the contrary. Acknowledging that the intention of the SPC system is to compensate the SPC holder for the marketing delays caused by an increasing regulatory burden, the CJEU decided that it is only proper to calculate the term based on the first date on which the SPC holder is actually able to enjoy the benefit of the MA (i.e. the date on which the MA holder is notified of the Commission’s decision to grant the MA). Following the same logic, there is a good argument that the period during which the patentee has to file an application for an SPC should also run from the first date on which he is aware that the MA has been granted (i.e. the date on which the MA holder is notified of the decision to grant).
However, until the practice of the UKIPO and other national patent offices on this point becomes clearer, it would be prudent to rely on the earlier deadline set by the decision date for a marketing authorisation when filing new SPC applications.
Please contact us for advice if you are interested in filing SPCs, or already have pending or granted SPCs, particularly where the SPCs are based on centralised marketing authorisations with a date of decision of less than 10 years after the date of patent filing. This decision may entitle you to a longer SPC term than previously expected.
If you require any further information, please contact David Carling of our SPC and Regulatory group.