Guidance

Supplementary Protection Certificates

A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.

Pharmaceutical or plant protection products need regulatory approval to be sold in the UK and must obtain:

  • a marketing authorisation
  • or product licence

If your patent protects the active ingredients used in these products, this requirement can delay you using the patent.

A Supplementary Protection Certificate (SPC) compensates for the delay.

An SPC will not extend the term of your patent, but gives similar protection. It protects the specific pharmaceutical or plant protection product authorised, and any use of the active ingredient in an authorised pharmaceutical or plant protection product whilst the SPC is in force and which is protected by the patent.

It enters into force when your patent expires and can last for up to 5 years. An SPC for a medicinal active ingredient may also be extended for a further six months if it has undergone the appropriate paediatric testing.

Requirements

You must have a valid UK patent that protects the active ingredient and a marketing authorisation to place the active ingredient on the UK market as a pharmaceutical or plant protection product must have been granted.

The SPC is granted to the holder of the patent protecting the active ingredient, not to a licensee or a manufacturer of a pharmaceutical or plant protection product.

The patent can protect:

  • the active ingredient
  • a process to obtain the active ingredient
  • an application of the active ingredient

If you have several patents, protecting the same active ingredient you can use any of them.

Marketing authorisation

The marketing authorisation is either

  • a national product licence issued by the Medicines and Healthcare Products Regulatory Authority, the Veterinary medicines Directorate or a valid UK plant protection product authorisation
  • an authorisation issued through the European Agency for the Evaluation of Medicinal Products

It must be the first one granted to place the active ingredient on the UK market.

You should tell us if an earlier authorisation for the active ingredient exists in another country of the European Economic Area. The date of the first valid authorisation in the European Community, determines the length of the certificate.

Restrictions

An SPC is only granted to the holder of the patent that protects the active ingredients and it only protects the active ingredients present in a medicinal or plant protection product. It does not extend the patent.

An SPC does not give protection abroad. It is only effective in the UK.

You can only have 1 SPC for an active ingredient, but others may also have an SPC for the same product if they have a patent that protects the active ingredient. If another patent holder has an SPC for the same active ingredient this may prevent you getting one.

SPCs are granted in the UK under European legislation, i.e. Regulation (EC) No 469/2009 of the European Parliament and of the Council for pharmaceutical products and Regulation (EC) No 1610/96 of the European Parliament and of the Council for plant protection products, and related UK legislation, i.e. section 128B and Schedule 4A of the UK Patents Act 1977 (as amended). Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use amended the pharmaceutical products Regulation to provide for a six month extension of a SPC.

You can search our records by SPC number or the patent document and information service (Ipsum) to identify granted SPCs or patents for which SPCs have been granted.

Further guidance on SPC is available in the manual of patent practice.

Published 16 May 2014