Supplementary Protection Certificates
Source: gov.uk (2025-01-23)

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.

Legal basis for SPCs

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.

Supplementary protection certificate search

You can search for granted SPCs or patents with granted SPCs on the search for a patent service (https://www.gov.uk/search-for-patent).

Further guidance on SPC is available (https://www.gov.uk/guidance/manual-of-patent-practice-mopp/supplementary-protection-certificates-for-medicinal-and-plant-protection-products) in the manual of patent practice.

Supplementary Protection Certificate (SPC) manufacturing waiver

Legislation amending SPC Regulation 469/2009 comes into force on 1 July 2019. This legislation is sometimes called the “SPC manufacturing waiver”. The amendment provides an exception to the protection provided by an SPC. It allows third party manufacturers (“makers”) to make SPC-protected medicines for export outside the EU. It also allows making and storage of medicines during the last six months of an SPC ready for sale in the EU after the SPC expires.

The exception will initially only apply to SPCs that are applied for on or after 1 July 2019. From 2 July 2022, it will also apply to SPCs that were applied for before 1 July 2019, but only if they had not taken effect before 1 July 2019.

The maker must meet certain requirements to use the exception. These include notifying the SPC holder of the information required by the legislation. The maker must also notify the Intellectual Property Office of the same information. Notifications must be made at least three months before any relevant activity occurs. The maker must use a paper version of the standard form when notifying the Intellectual Property Office. At present, there is no fee for filing these notifications at the Office.

Further information and the standard form are available in the legislation (https://eur-lex.europa.eu/eli/reg/2019/933/oj) (Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products) on the EUR-Lex website.