Supplementary Protection Certificates

A supplementary protection certificate (SPC) is a special form of intellectual property (IP) that extends the protection of a patented active ingredient or combination of active ingredients present in a pharmaceutical or plant protection product after the expiry of the patent.

What does an SPC do?

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

  • a marketing authorization
  • or product licence

If your patent protects the active ingredients used in these products, this requirement can delay you using the patent. An 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 authorized, and any use of the active ingredient in an authorized 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.

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). This is further explained in the Supplementary Protection Certificates Guide For Applicants PDF document(278Kb).

What protection does an SPC provide?

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.

Do you meet SPC requirements?

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

Apply for an SPC

To apply, you must ask us to examine your SPC application to see if you can obtain a certificate.