Updates

Might you be entitled to a longer SPC term?

07 October 2011

Mike's article argues that a longer SPC term than is currently awarded should be available in some instances.

Background

SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation. The purpose of SPCs is to compensate patent holders for at least part of the delay in commercialising a patented "product" (an active ingredient or combination of active ingredients) caused by the need to conduct trials on safety and efficacy (and thereafter to obtain regulatory approval).

In Europe, there are two main options for obtaining regulatory approval (i.e. a marketing authorisation) for a medicinal product in all EU member states.

The first option is to file applications for approval at national offices in, using the so-called decentralised or mutual recognition procedure. The alternative is to file a single application at the European Medicines Agency, under the so-called centralised procedure. In the latter procedure, it is the European Commission that is ultimately responsible for deciding whether or not to issue a marketing authorisation that automatically becomes valid in all EU member states.

The duration of an SPC depends on the date of the first marketing authorisation in the European Economic Area (EEA) for the "product" in question. When that first authorisation 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.

New Development

In his 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 2 to 4 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 been thought to be the case. Of course, for successful medicines, even a few extra days' protection will be valuable.

Action points

Please contact us for advice if you have obtained (or applied for) SPCs that are based upon a centralised marketing authorisation. If you have, then possibly you may be entitled to longer SPC protection than you think.

When prosecuting SPC applications in the countries that currently take a contrary view, we intend to argue for the longer term. Moreover, so long as your SPC has not expired, it is not too late to take corrective action to ensure that you benefit from all of the SPC term to which you may be entitled.

If you require any further information, please contact Mike Snodin, John Miles or Michael Pears of our SPC & Regulatory group.

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