To be sold in the UK, pharmaceutical and plant protection products must receive regulatory approval, which requires either a marketing authorisation or a product licence. This approval process can delay the commercial sale of the product.

If your patent protects the active ingredients used in these products you may apply for a Supplementary Protection Certificate (SPC) which helps compensate for this delay.  An SPC does not extend the term of your patent, but it does provide similar protection for a period of up to five years after your patent expires. In some circumstances, this five-year period can be extended by a further six months.

Requirements for an SPC

To apply for an SPC in the UK, you must hold a valid UK patent that protects the active ingredient in a pharmaceutical or plant protection product. For instance, the patent may protect:

• The active ingredient
• A process to produce the active ingredient
• An application of the active ingredient

A marketing authorisation for the pharmaceutical or plant protection product must also have been granted.

The marketing authorisation may be 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, or
• an authorisation issued through the European Agency for the Evaluation of Medicinal Products

The marketing authorisation must also be the first authorisation granted to place the active ingredient on the UK market.

When to file an application for an SPC

An SPC application should typically be filed within six months of the grant of the marketing authorisation. However, if a patent is obtained after the grant of the marketing authorisation, then the six month deadline for filing the application runs from the patent grant date.

Where are SPCs available?

SPCs for medicinal and plant protection products can be obtained in the UK, all member states of the EU as well as Norway, Iceland and Switzerland. Patent term extensions are also available in limited circumstances in other jurisdictions around the world.

SPCs and similar patent term extension certificates are available in a number of countries worldwide, highlighting this specialist area of commercial importance.

Determining whether a product is entitled to an SPC can be complex, and so if you believe that your product may be entitled to an SPC, or other patent term extension, please do not hesitate to contact us.