This site uses cookies to help make it more useful and reliable. Our cookies page explains what they are, which ones we use, and how you can manage or remove them.
Reviewed 20 November 2013

Calculation of the duration of a Supplementary Protection Certificate

Issue

1. This Practice Notice outlines a change in practice of the Intellectual Property Office (IPO) as regards the calculation of the duration of a Supplementary Protection Certificate (SPC) where the first authorisation in the Community is one granted by a decision of the European Commission.

Introduction

2. Article 13 of Council Regulation (EC) 469/2009 concerning the creation of a supplementary protection certificate for medicinal products ("the SPC Regulation") sets out how the duration of an SPC may be calculated. Article 13(1) provides that the duration is calculated having regard to the "date of the first authorisation to place the product on the market in the Community", and Article 13(2) provides that the duration of an SPC may not exceed 5 years.

3. In the situation where the earliest authorisation is one granted by a decision of the European Commission following a favourable opinion from the European Medicines Authority, it has been the IPO's practice that the date of the first authorisation in the Community, for the purposes of Article 13(1) of the SPC Regulation, is the date of grant by the European Commission of this European authorisation.

The Practice Change

4. In decision BL O/418/13 (Genzyme Corporation) the hearing officer determined that the duration of the SPC should be rectified (Under Article 17(2) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (which recital 17 applies to the SPC regulation) because the date of the first authorisation in the Community, for the purposes of Article 13(1) of the SPC Regulation, should be the date of notification.

5. The date of notification is the date that the applicant for the marketing authorisation is notified of the decision by the European Commission to grant the marketing authorisation and this is the date from which the granted authorisation takes effect. This date is recorded in the Official Journal of the European Union (OJEU). The date of notification is often a few days later than the date of grant of the marketing authorisation. As a consequence, when Article 13(1) is applied the duration of the SPC based on the authorisation date may be correspondingly longer (unless it exceeds the limit of 5 years provided for in Article 13(2)).

6. We will now calculate SPC duration in accordance with this decision. This may also affect the dates, but not the duration, of related paediatric extensions (Under Article 13(3) of the SPC Regulation and Article 36 of Regulation (EC) No 1901/2006).

The Procedure

7. This change will affect applications for SPCs, granted SPCs and paediatric extensions to SPCs.

SPC Applications

8. To amend a SPC application you should:

a. write to the comptroller, for the attention of the examiner, either when a response to an official action comes due, or in a separate letter; and

b. provide the number of the SPC and a copy of the relevant entry in the OJEU which shows the date of notification of the European marketing authorisation entered at item 8 of Form SP1.

9. The IPO will acknowledge receipt and notify you of the amended maximum expiry accordingly.

Granted SPCs

10. To rectify the term of a granted SPC you should:

a. write to the comptroller, for the attention of the examiner; and

b. provide the number of the SPC and a copy of the relevant entry in the OJEU which shows the date of notification of the European marketing authorisation entered at item 8 of Form SP1.

11. The IPO will issue a corrected version of the SPC certificate and extension certificate as necessary; publish the correction in the Patents Journal; and amend the Register entry for the basic patent to reflect the change.

Paediatric Extensions

12. To amend the dates of an extension you should mention the extension when you write to the IPO about the granted SPC or application.

13. The IPO will then ensure the necessary steps are taken to amend the dates in line with our practice set out above.

Further Information

Decision BL O/418/13 PDF document(277Kb) is available on the IPO website.

Enquiries

Any enquiries about this notice should be sent to:

Jason Bellia
Senior Patent Examiner

Tel +44 (0) 1633 813544
Fax +44 (0) 1633 817777

or

Mary Taylor
Patents Legal Section

Tel +44 (0) 1633 813822
Fax +44 (0) 1633 814491

Intellectual Property Office
Concept House
Cardiff Road
Newport
South Wales
NP10 8QQ
United Kingdom

Sean Dennehey
Deputy Chief Executive
Intellectual Property Office

20 November 2013