Every day counts -- but how do we count them?

“Every day counts: why pharmaceutical companies in the EU need to make sure they get the right SPC term” is the title of an article by Mike Snodin (Potter Clarkson) which has just been published in the October 2011 edition of Scrip Regulatory Affairs. Mike's article addresses the calculation of SPC term (and the deadline for applying for an SPC) in circumstances where the relevant marketing authorisation has been issued by the European Commission (under the centralised procedure).

Mike notes that, when the first marketing authorisation in the EEA for a medicinal product is obtained via the centralised procedure, the standard practice of many patent offices in Europe (including the offices of Germany, France, the UK, Italy, Ireland, Sweden, the Czech Republic and the Netherlands) has been to set the SPC term based on the date that the European Commission decided to issue the centralised authorisation.

In his new article, Mike argues that the standard practice of many patent offices is incorrect, and that the term of SPCs should (where relevant) instead be calculated using the date of notification to the applicant of the European Commission decision to authorise the medicinal product.

The date of notification is typically two to four days later than the date of the Commission's decision. For this reason, Mike argues that a correspondingly longer SPC term should be available where:

(i) a medicinal product is first authorised in the EEA by way of the centralised procedure;(ii) that authorisation represents the first authorisation in the EEA for a "product" that represents the (combination of) active ingredient(s) present in the medicinal product; and(iii) less than 10 years has elapsed between the date of filing of a patent that protects the "product" and the date that the European Commission decided to issue the centralised authorisation.

If Mike's theory is correct, then in these circumstances the duration of the SPC may be a few days (e.g. 2 to 4 days) longer than has previously been thought to be the case. Of course, for successful medicines, even a few extra days' protection will be valuable.

Moreover, Mike points out that Article 17(2) and Recital 17 of Regulation 1610/96 together make it possible for an SPC holder to file an appeal aimed at correcting the term of a granted SPC.  This means that, provided the SPC in question has not expired, it may not be too late for a proprietor to take action to correct the official registers of those patent offices that have incorrectly calculated the term of the SPC.

You can read Mike's article in full here.