Valid MAs, Centralised MAs and the date of notification: extra days up for grabs?

The SPC Blog has received a cheerful note from Mike Snodin (who now heads Pharma & Nutrition at Avidity IP). What brings such good cheer? Mike has been working hard to talk the UK Intellectual Property Office round to his point of view, with some success.  Writes Mike:

By way of a decision issued on 22 October 2013 (BL O/418/13), the hearing officer, Dr Lawrence Cullen, essentially agreed with Mike’s arguments that:

(i)         Article 3(b) of Regulation 469/2009 requires there to be a valid Marketing Authorisation (MA) in force;

(ii)         following the CJEU’s decision in Case C-127/00 (Hässle AB), Article 13(1) must be interpreted as referring to the same type of MA as Article 3(b) (i.e. a valid MA); and

(iii)        for a “centralised” MA (from the European Commission / EMA) the earliest date that the MA becomes valid is the date of notification of the European Commission’s decision to the applicant.

This development follows similar arguments first proposed by Mike in his October 2011 article in SCRIP Regulatory Affairs (as reported here in this blog).

Longer SPC Term

As a result of the decision, longer term should now be available in the UK for those SPCs where:

(a)        the earliest marketing authorisation (MA) in the European Economic Area is a “centralised” MA issued by the European Commission (EC); and

(b)        less than 10 years have elapsed between the filing of the basic patent and the date of the EC’s decision to grant a MA.

The number of SPCs potentially affected is significant.  For example, longer exclusivity could now be available for over 140 human or veterinary medicinal products.  Further, the percentage of SPCs that could benefit from longer term appears to have significantly increased in recent years.  For example, for SPCs filed to date in the UK in 2013, over 40% could gain additional days of term.

For affected SPCs, the additional term that will now be obtainable in the UK is typically in the region of 2 to 4 days.  However, research conducted by Mike has identified numerous examples of SPCs in the UK for which the additional term would be longer than this, even in excess of 1 week (or, in one instance, in excess of 2 weeks).

At least for granted SPCs, positive action by proprietors will be necessary in order for them to benefit from the additional term now available.

Implications for filing deadline

Where the MA for the UK is a “centralised” MA, the deadline mentioned in Article 7(1) should now be interpreted as meaning 6 months from the date of notification of the “centralised” MA.  This (later) deadline ought not to be relied upon outside of the UK unless and until practice of the national patent offices becomes completely harmonised on this point.

Euratom

As an aside, Mike advises that he personally has not given up on trying to persuade patent offices such as the UK IPO to accept further arguments based upon provisions of the Euratom treaty - though such arguments were not accepted on this occasion.  If they had been, they could have provided an additional day of SPC term for almost all UK SPCs where (a) and (b) above are true.