1. SPCs and the unitary patent package
Dr Beatriz San Martín
28 September 2015

2. Introduction UPC jurisdiction over
existing national SPCs
SPCs granted during the transitional period
SPCs granted after the transitional period
Opt-out and withdrawal of opt-out during transitional period
National SPCs on the basis of a unitary patent
Unitary SPCs

3. UPCA – UPC jurisdiction over SPCs
Article 2
(h) "Supplementary protection certificate" means a supplementary protection certificate granted under Regulation (EC) No 469/2009 or under Regulation (EC) No 1610/96 …
(g) "Patent" means a European patent and/or a European patent with unitary effect.
Article 3
This Agreement shall apply to any:
(b) supplementary protection certificate issued for a product protected by a patent;
Article 30
A supplementary protection certificate shall confer the same rights as conferred by the patent and shall be subject to the same limitations and the same obligations.

4. UPC jurisdiction for SPCs – the UPCA
Article 32
1. The Court shall have exclusive competence in respect of:
(a) actions for actual or threatened infringements of patents and supplementary protection certificates and related defences, including counterclaims concerning licences;
(b) actions for declarations of non-infringement of patents and supplementary protection certificates; …
(d) actions for revocation of patents and for declaration invalidity of supplementary protection certificates;
(e) counterclaims for revocation of patents and for declaration of invalidity of supplementary protection certificates;
2. The national courts of the Contracting Member States shall remain competent for actions relating to patents and supplementary protection certificates which do not come within the exclusive competence of the Court.

5. Which SPCs will be subject to the exclusive competence of the UPC?
SPCs granted prior to the UPCA
Where reference basic patent is
a European patent
a national patent
SPCs granted during the transitional period
an unitary patent
SPCs granted after the transitional period

6. UPCA - the transitional period
Article 83
1. During a transitional period of seven years after the date of entry into force of this Agreement, an action for infringement or for revocation of a European patent or an action for infringement or for declaration of invalidity of a supplementary protection certificate issued for a product protected by a European patent may still be brought before national courts or other competent national authorities.
2. An action pending before a national court at the end of the transitional period shall not be affected by the expiry of this period.
Even if do not opt-out, infringement and invalidity proceedings may be brought nationally during the transitional period?

7. UPCA – the opt-out Article 83
3. Unless an action has already been brought before the Court, a proprietor of or an applicant for a European patent granted or applied for prior to the end of the transitional period under paragraph 1 and, where applicable, paragraph 5, as well as a holder of a supplementary protection certificate issued for a product protected by a European patent, shall have the possibility to opt out from the exclusive competence of the Court. To this end they shall notify their opt-out to the Registry by the latest one month before expiry of the transitional period. The opt-out shall take effect upon its entry into the register.
4. Unless an action has already been brought before a national court, proprietors of or applicants for European patents or holders of supplementary protection certificates issued for a product protected by a European patent who made use of the opt-out in accordance with paragraph 3 shall be entitled to withdraw their opt-out at any moment. In this event they shall notify the Registry accordingly. The withdrawal of the opt-out shall take effect upon its entry into the register.

8. More on the opt-out – Rules of procedure
a) An Application to opt out a European patent or application pursuant to Rule 5.1 or an Application to withdraw an opt-out pursuant to Rule 5.8 shall extend to any supplementary protection certificate(s) based on the European patent.
b) Where any such supplementary protection certificate has been granted at the date of lodging the Application, the holder(s) of the supplementary protection certificate(s) shall if different from the proprietor(s) of the patent lodge the Application together with the proprietor(s).
c) Where any such supplementary protection certificate is granted subsequent to lodging the Application, the opt-out shall take effect automatically on grant of said supplementary protection certificate(s). …
e) For the avoidance of doubt, it is not possible to opt out supplementary protection certificates (whether granted by the authorities of a Contracting Member State or otherwise) based on a European patent with unitary effect.

9. The opt-out for SPCs - summary
Need for both patent proprietor and SPC holder(s) to apply for opt-out
What if proprietorship in EPO register not up to date?
What if European patent has expired?
What if multiple SPC holders?
If SPC not granted at time of opt-out application, SPC will automatically be opted out on grant
Can only opt-out if no UPC proceedings afoot
Can only withdraw opt-out if no national proceedings commenced

10. SPCs for unitary patents – national SPCs?
Article 3 SPC Regulation
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
Article 1 SPC Regulation
(c) ‘basic patent” means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate
Unitary patent included within definition of basic patent?
Does the MA need to be granted through the centralised procedure?

11. SPCs for unitary patents – national SPCs?
Article 9(1) SPC Regulation
The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorisation referred to in Article 3(b) to place the product on the market was obtained, unless the Member State designates another authority for the purpose.
EPO not currently a competent industrial property office – so where should application be made?
Could the grant of unitary patents by the EPO be deemed to be on behalf of all IP offices of those member states that have ratified the UPCA?
Could member states individually designate another competent authority to deal with applications?

12. Need to amend reference to “national law” in SPC Regulation?
Article 15(2) - Invalidity
Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent
Article 16(2) - Revocation
Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent
Article 18 - Appeals
The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 16(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents

13. Unitary SPCs?
UPCA and Rules of Procedure contemplate the possibility of unitary SPCs
Would need EU legislation to create new unitary SPC right
What would be the relevant MA for the purposes of a unitary SPC?
What would be the basic patent for unitary SPCs?

14. Unitary SPCs? European Commission position:
The 'patent package' that lays the ground for the creation of unitary patent protection in the EU does not explicitly provide for a 'unitary SPC'. To ensure that companies which choose unitary patent protection can benefit from the SPC extension, the European Commission is working on the articulation of unitary patent protection and SPC legislation.
3 July ECPA, EFPIA and IFAH-Europe Joint Position Paper:
Proposal for a unitary SPC

15. THANK YOU Dr Beatriz San Martín Partner – London FieldfisherE:
T: +44 (0)