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Supplementary Protection Certificates for Medicinal and Plant Protection Products

Intellectual Property Office

January 2
12:55 2020

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 or the EC Medicinal Regulation)
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)
ArtPd refers to the relevant Article of Regulation (EC) No 1901/2006 of the European Parliament and of the Council (on medicinal products for paediatric use) (the Paediatric Regulation or the EC Paediatric Regulation)
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 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)
FSch refers to the relevant Schedule of those Rules

SP 0.01

ArtM 22 is also relevant.

Council Regulation (EEC) No 1768/92 creating a Supplementary Protection Certificate for medicinal products was published in the Official Journal of the European Communities on 2 July 1992, with consequential entry into force on 2 January 1993. This Regulation has subsequently been codified under Regulation (EC) No 469/2009 of the European Parliament and of the Council, which was published in the Official Journal of the European Union L152 on 16 June 2009 and entered into force on 6 July 2009.

Various amendments that had been made to Regulation (EEC) No 1768/92 were consolidated but no substantive changes were made. Regulation (EC) No 469/2009 repealed Regulation (EEC) No 1768/92 and provides for references to it to be construed as references to Regulation (EC) No 469/2009. Regulation (EC) No 1610/96 of the European Parliament and of the Council creating a Supplementary Protection Certificate for plant protection products was published in the Official Journal of the European Communities on 8 August 1996 and entered into force on 8 February 1997.

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 Licences, including the product, are no longer published in the London, Edinburgh and Belfast Gazettes but are now advertised on the Medicines and Healthcare products Regulatory Agency (MHRA) website 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 Pesticides Register (monthly).

SP 0.05

reg 1 is also relevant.

A certificate only has effect in the EU State in which it is granted. Certificates granted by the Office have effect in Great Britain and Northern Ireland pursuant to the 2007 Regulations, 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 old Regulation Council Regulation (EEC) No 1768/92; the new Regulation (EC) 469/2009 and to plant protection products as they relate to certificates and applications for certificates that exist under Regulation (EC) No 1610/96. 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.

SP 0.08

Regulation (EEC) No 1768/92 entered into force with effect from 1 July 1994 in those EFTA States which were at that date party to the European Economic Area Areement (Austria, Finland, Iceland, Norway and Sweden). This necessitated amendment of the Regulation for the purposes of the application of the Regulation to those States, but the amendments do not have retrospective effect on applications for certificates lodged in an existing EU Member State before 1 July 1994. 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 European Economic Area Agreement with effect from 1 May 1995, but did not adopt the Regulation (EEC) No 1768/92 and has not adopted the EC Medicinal Regulation (see SP0.10).

SP 0.08.1

The accession to the EU of the 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 Regulation (EEC) No 1768/92 and the Plant Protection Regulation for the purposes of their application to those States (see SPM13.04.2). The accession of Bulgaria and Romania on 1 January 2007 further amended Regulation (EEC) No 1768/92 and the Plant Protection Regulation for the purposes of applying it to these States. The accession of Croatia on 1 July 2013 has amended Regulation (EC) No 469/2009 for the purpose of applying it to this State.

SP 0.09

Paragraph 8 of Protocol 1 on Horizontal Adaptations to the European Economic Area Agreement reads:

Whenever the acts referred to contain references to the territory of the Community or of the common market the references shall for the purposes of the Agreement be understood to be references to the territories of the Contracting Parties as defined in Article 126 of the Agreement.

This has the effect that for medicinal product applications l

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