Statutory guidance

Invalidity and surrender of Supplementary Protection Certificates

Published 12 September 2016

1. Background

This notice outlines changes in practice of the Intellectual Property Office (IPO) in relation to:

• the invalidity of a Supplementary Protection Certificate (SPC) where the underlying patent has been revoked
• the processing of surrender applications for SPCs where there are ongoing invalidity proceedings that may affect the SPC

It also reminds SPC proprietors that, if an SPC is invalid, then the correct procedure is to file an application for a declaration of invalidity and not an application for surrender.

2. Introduction

Articles 15 of Council Regulation (EC) 469/2009 concerning the creation of a supplementary protection certificate for medicinal products and Regulation (EC) No 1610/96 of the European Parliament and the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (“the SPC Regulations”) each set out when an SPC shall be invalid. Article 15(1)(b) provides that an SPC shall be invalid if “the basic patent has lapsed before its lawful term expires”, whilst Article 15(1)(c) provides that an SPC shall be invalid if “the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation”.

Article 15(2) of the SPC Regulations sets out that any person may apply for a declaration of invalidity; this includes the proprietor. In the UK, this can be done by submitting Form SP3 and its accompanying fee (currently £50) to the IPO. It has been the IPO’s practice to wait until such a declaration is made before updating the SPC register to show that any SPC is invalid. However, it has recently come to the IPO’s attention that some SPCs were showing as valid on the SPC register when the underlying patent had lapsed or been revoked. In such circumstances, Article 15(1) means that the SPC is, as a matter of fact, invalid and the IPO considers that recording the SPC as invalid in these circumstances does not require a declaration to have been successfully applied for.

In addition, the IPO has received offers to surrender an SPC whilst invalidity proceedings that may affect the SPC are underway before the courts. Surrender should not be used to remove a possibly invalid SPC from the register. If an SPC is found to be invalid then that finding is effective ex tunc (as though the SPC had never been in force) and so the surrender would have no legal effect. However, third parties may have relied on the surrender, potentially to their detriment. There is also a detriment to the proprietor – if an SPC is declared invalid, all renewal fees that have been paid on the SPC are remitted to the proprietor; but, if an SPC is surrendered, only fees relating to the period following surrender are remitted.

3. Change in practice

3.1 Check on validity of the underlying patent

The IPO will check whether the underlying patent has been revoked or has lapsed as part of the procedures undertaken before an SPC comes into force. This check is in addition to those made when the SPC application is filed (which may have been several years previously), and is intended to reduce the possibility of an invalid SPC being retained on the register. If the check indicates that the patent has lapsed or been revoked, the IPO will write to the SPC proprietor inviting observations. The letter will set out that, unless the proprietor responds within one month, the IPO will update the SPC register to show the SPC as invalid. If observations are submitted, they will be considered before the Comptroller decides whether the SPC should be recorded as invalid.

3.2 Applications to surrender where invalidity proceedings are pending

In relation to patents, it is usual practice for a surrender application to be stayed pending the outcome of any ongoing revocation actions. The IPO will take a similar approach with applications made to surrender an SPC when there are ongoing invalidity proceedings, whether against the SPC or the underlying patent.

An offer to surrender an SPC must be made in writing and should be accompanied by either (a) a declaration that no infringement or invalidity actions that could affect the SPC are pending before the court (including any relating to the underlying patent); or (b) if such action is pending, full particulars of the action. Where an invalidity action is pending, the comptroller may stay any consideration of the offer to surrender the SPC and order the proprietor to inform the court that an offer to surrender has been made.

4. Enquiries

Any enquiries about this notice should be sent to:

Michael Warren
Patents Legal Section
Intellectual Property Office
Concept House
Cardiff Road
Newport
South Wales
NP10 8QQ
United Kingdom

Tel +44 (0) 1633 813988

Julyan Elbro
Acting Director of Patents
Intellectual Property Office