Intellectual Property Office
Introduction
Note: This section relates to Supplementary Protection Certificates for Medicinal and Plant Protection Products and is divided into three parts, with the paragraphs numbered using the prefixes below:
| SP | the general introduction below |
| SPM | a discussion of the details of the Medicinal Regulation by Article, including those aspects common to both the Medicinal and Plant Protection Regulations |
| SPP | a discussion of the details specific to the Plant Protection Regulation by Article |
In the margins:
| ArtM | refers to the relevant Article of Regulation (EC) No 469/2009 of the European Parliament and of the Council (for Medicinal Products) (the Medicinal Regulation), as incorporated in domestic law by the European Union (Withdrawal) Act 2018 |
| ArtP | refers to the relevant Article of Regulation (EC) No 1610/96 of the European Parliament and of the Council (for Plant Protection Products) (the Plant Protection Regulation or the EC Plant Protection Regulation), as incorporated in domestic law by the European Union (Withdrawal) Act 2018 |
| HMR | refers to the Human Medicines Regulations 2012 (SI 2012/1916; the Human Medicines Regulations); references to reg or sch alongside this refer to the relevant regulation of the Human Medicines Regulations |
| PA 1977 | refers to the Patents Act 1977, s refers to the relevant section of the Act, para and sch refer to the relevant paragraphs of the relevant Schedules to the Act. |
| reg | on its own refers to the relevant regulation of the Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007 (SI 2007/3293; the 2007 Regulations). |
| r | refers to the relevant rule of the Patents Rules 2007 (SI 2007/3291) (the 2007 Rules) and part refers to the relevant part of those Rules |
| Fr | refers to the relevant rule of the Patents (Fees) Rules 2007 (SI 2007/3292 the 2007 Fees Rules) and FSch refers to the relevant Schedule of those Rules |
Overview; historical background of UK SPC law
SP 0.01
ArtM 22 is also relevant.
Supplementary protection certificates were introduced by Council Regulation (EEC) No 1768/92 creating a supplementary protection certificate for medicinal products (the original Regulation), which entered into force on 2 January 1993. This Regulation was later replaced by the Medicinal Regulation, which codified and consolidated various amendments to the original Regulation and provided for references to it to be construed as references to the Medicinal Regulation. The Medicinal Regulation entered into force on 6 July 2009. Regulation (EC) No 1610/96 of the European Parliament and of the Council creating a Supplementary Protection Certificate for plant protection products entered into force on 8 February 1997.
SP0.01.1
As set out in the recitals to both Regulations, the certificate is intended to compensate a patentee for the loss of effective protection arising out of the time taken to obtain regulatory approval to place on the market as either a medicinal or plant protection product a product which is protected by a patent (the basic patent).
SP 0.02
The basic patent may protect the product as such, a process to obtain the product or an application of the product see SPM1.05.
SP 0.03
A certificate takes effect at the end of the lawful term of the basic patent but does not extend the term of the patent itself. It extends the protection conferred by the patent in respect of the product covered by the authorisation to place the corresponding medicinal or plant protection product on the market, and any use of the product as a medicinal or plant protection product that has been authorized before expiry of thecertificate.
SP 0.04
In the UK, the marketing authorisation for medicinal products takes the form of a Product Licence or Marketing Authorisation granted by the appropriate authority see SPM2.01. Details of granted authorisations, including the product, are listed on the Medicines and Healthcare products Regulatory Agency (MHRA) website on a monthly basis and on the Veterinary Medicines Directorate (VMD) Product Information Database (see SPM1.02). Marketing authorisation for plant protection products may be an Approval or Authorisation granted by the relevant authority (see SPP2.01) and details are published in the online Pesticides Register.
SP 0.05
reg 1 is also relevant.
Certificates granted by the Office have effect in Great Britain and Northern Ireland pursuant to the 2007 Regulations, (although see SPM5.05-5.05.4 and SPP5.01-5.03 as well as in the Isle of Man, where the provisions of the 2007 Regulations were given effect by the Patents (Isle of Man) Order 2013 (SI 2013/2602) (the previous application of the 1992 and 1996 Regulations to the territory being revoked by the Isle of Man Patents (Supplementary Protection Certificates) Regulations 2014 (Statutory Document 2014/0091)). See also paragraph 128B.03.
SP 0.06
reg 2 is also relevant.
The 2007 Regulations amended the Patents Act 1977 to introduce s.128B and Schedule 4A. These make clear how the Act applies in relation to supplementary protection certificates for medicinal products as they relate to certificates and applications for certificates that exist under the original Regulation and Medicinal Regulation and to plant protection products as they relate to certificates and applications for certificates that exist under the Plant Protection Regulation. The operation of these provisions is discussed in paragraphs 128B0.1 to 128B.12. The 2007 Rules and 2007 Fees Rules provide specific procedures for certificates and applications for certificates which differ from patents and applications for patents, including the payment and amount of fees.
SP 0.07
ArtM 19 ArtP 18 is also relevant.Where neither the Medicinal or Plant Protection Regulations nor the 2007 Rules lays down a special procedure for certificates, the provisions of the Patents Act 1977 and respective Rules apply to certificates and applications for certificates as they do to patents and applications for patents (subject to modifications applied by s.128B and Schedule 4A).
SP 0.08
The Medicinal and Plant Protection Regulations take account of authorisations granted in the European Economic Area (EEA). The territorial scope of the EEA, and how it has changed over time, is therefore relevant for certificates and applications. The original Regulation entered into force with effect from 1 July 1994 in those EFTA States which were at that date party to the European Economic Area Agreement (Austria, Finland, Iceland, Norway and Sweden). The application of the original Regulation did not have retrospective effect on applications for certificates lodged in an existing EU Member State before 1 July 1994, and this position was not affected by the accession to the EU of Austria, Finland and Sweden with effect from 1 January 1995. Liechtenstein became a party to the EEA Agreement with effect from 1 May 1995; although it has not adopted the Medicinal Regulation into its national law and does not grant certificates in its territory, authorisations granted with effect in the territory are still relevant (see SP0.09).
SP 0.08.1
The accession to the EU of ten States (the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic) on 1 May 2004 also necessitated the amendment of the original Regulation and the Plant Protection Regulation for the purposes of their application to those States (see SPM13.04.2), as did the accession of Bulgaria and Romania on 1 January 2007. The accession of Croatia on 1 July 2013 saw the amendment of the Medicinal Regulation to apply it to this State.