31 October 2013

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.

Both the term of an SPC and the deadline by which the application must be filed are calculated by reference to the date of the marketing authorisation:

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).

Article 7 of the SPC Regulation states that an SPC application must be filed within the later of six months from the date on which the marketing authorisation is granted in the territory concerned or within six months of the date of grant of the basic patent in the territory concerned.

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:

    (i) the date of the European Commission's decision to issue an authorisation; and
    (ii) the date that the applicant is notified of the Commission's decision.

    Date (i) is cited on the front page of the marketing authorisation, and Date (ii) 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 SPC term and the deadline for filing SPC applications.

Date (ii) is typically 1-4 days later than Date (i), and so would have the effect of extending both the term and deadline as cited in respective Articles 13 and 7. At least the Belgian Patent Office appears to rely on this date. However, the standard practice of many other national patent offices, including the offices of the UK, France, Germany, Italy, Ireland, Sweden, the Netherlands and the Czech Republic, is or has been to use Date (i).

Genzyme's SPC for Cholestagel®

Genzyme was granted a UK SPC for colesevelam hydrochloride based on European patent EP 764 174 and their (centralised) marketing authorisation for Cholestagel®. By making use of Date (i) above, the UKIPO had identified the expiry date of the SPC as being 9 March 2019.

Represented by Potter Clarkson, Genzyme subsequently filed a request at the UKIPO to correct the term of its SPC. Genzyme believed that Date (ii) should be used, such that the term would expire on 11 March 2019 instead of 9 March 2019. The matter was heard by a Hearing Officer at the UKIPO.

Genzyme's principal argument was that the date of notification marks the date when centralised marketing authorisations first take legal effect. Article 4 of centralised marketing authorisations clearly states "The period of validity of the authorisation shall be 5 years from the date of notification of this decision". Also, Article 254(3) of the Treaty Establishing the European Community states that "Other directives, and decisions, shall be notified to those to whom they are addressed and shall take effect upon such notification". To put it another way, the applicant is unable to lawfully sell the product that is subject of the authorisation until the notification date. The logical deduction here is that an authorisation cannot said to have been "granted" until the point in time that it takes effect.

UKIPO decision

The Hearing Officer of the UKIPO decided in Genzyme's favour and agreed that the expiry date should be 11 March 2019, as based on the date of notification of the marketing authorisation.

Although the deadline for filing an SPC application was not at issue, the same rationale would suggest that this also should be calculated based on the date of notification.

Practical significance

The upshot of the UKIPO's decision is that, at least for the purposes of determining the term of UK SPCs based on centralised authorisations, the UKIPO should rely on the date of notification of the marketing authorisation.

This means that where 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 1-4 days, the extra SPC term could be of tremendous significance to both SPC holders and those seeking to launch generic products upon SPC expiry.

Hence, for pending and future SPC applications based on centralised authorisations (having a decision date of less than 10 years from patent filing), it is possible for applicants to request that SPC term is calculated on the date of notification. Outside of the UK, it remains uncertain whether such requests would be accepted.

For granted SPCs, 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. Again, whether such requests are successful outside of the UK is not clear.

The decision would also imply that the period for filing an SPC application may be extended in those circumstances where it is triggered by the date of the marketing authorisation. However, until it becomes clearer whether the UKIPO and other national patent offices adopt this as standard practice, it would be prudent to rely on the earlier deadline set by the date of decision. Of course, if that deadline was inadvertently missed by a sufficiently small margin, it may be possible to make use of the later deadline set by the date of notification.

Action point

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. At least in the UK, this decision entitles you to a longer SPC term than expected previously.

If you require any further information about SPCs, please contact Michael Pears of our SPC & Regulatory Group.


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