Introduction to Supplementary Protection Certificates (SPCs)

An SPC is an extension to the term of a patent for a human or veterinary medicine, or a plant protection product (pesticide), which requires a marketing authorisation (that is, regulatory approval) before it can be marketed. The purpose of SPCs is to compensate the patent holder for the patent term lost due to the need to obtain regulatory approval.

In the UK and the EU, a product must meet the following requirements to be granted an SPC:

• Protected by a basic patent in force.
• A marketing authorisation (MA) as a medicine or plant protection product – this must be the first such MA for that product.
• Not already be protected by an SPC.

The deadline for filing a UK SPC is:

• 6 months from the grant date of the relevant MA (EMA or MHRA – see Brexit section below), or
• 6 months from the grant date of the basic patent,
• whichever is later.

There are no extensions allowed to this deadline – so we recommend getting in touch with our SPC experts to discuss SPCs once the product is in late-stage development and an MA application is close to being filed.

Once filed, the UKIPO takes about three to five years before the SPC is examined. This examination will be accelerated if the basic patent is nearing the end of its normal twenty-year term.

A UK SPC expires on the earliest of the following dates:

• 15 years from the UK MA date,
• 15 years from the first MA date in an EEA member state, or
• 5 years from the expiry date of the basic patent.

For medicines, this term can be extended by six months if paediatric studies are carried out on the medicine as indicated below.

In order to file an SPC application at the UKIPO, we need the following details:

• The basic patent – together with information explaining how it protects the authorised product.
• The MA (EMA or MHRA) being relied upon.

Our SPC experts will prepare the official forms and file the SPC application.

The specialist SPC examiners at the UKIPO will check whether the above requirements for SPC protection are met and that the formal matters are complied with. Once any objections are attended to, the SPC will proceed to grant.

In order to bring a UK SPC into force, it is necessary to pay the accumulated renewal fees for the entire term of the SPC, before the expiry date of the basic patent. These must all be paid together – it is not possible to pay them annually like renewal fees on the basic patent.

Most other countries require renewal fees on SPCs to be paid annually, treating them as if they were further years on the basic patent.

SPCs are still available in the UK, under national UK law, following Brexit. However, there are some important changes.

The UK has four constituent parts: England, Scotland and Wales (together Great Britain) and Northern Ireland. Under the Northern Ireland protocol, EU law on goods, including medicines and plant protection products, still applies to Northern Ireland following Brexit.

This means that regulatory approval for medicines in the UK is now split – national MAs granted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) cover only Great Britain, whereas EU-wide MAs granted by the European Medicines Agency (EMA) cover only Northern Ireland.

As a consequence of this UK SPCs will similarly be split. It will be necessary to apply for a UK SPC based on whichever MA is granted first, but it will only cover either Great Britain or Northern Ireland. Once the second MA has been granted, it will then be necessary to apply to extend the SPC to the rest of the UK.

In addition to the UK, SPCs and similar forms of patent term extension are available in all EU and EEA countries, as well as in some other countries including the US, Canada, Korea, Japan, Australia and Switzerland. However, there are still many countries, such as China and India, which have no provision for SPCs.

We work with a trusted network of foreign agents with specific experience in SPCs to enable us to coordinate the filing and prosecution of SPCs both in Europe and worldwide.

UK and EU law permits a six-month extension to SPCs for medicines for which paediatric studies have been carried out in accordance with an agreed paediatric investigation plan (PIP).

The deadline for filing the request to extend the SPC in the UK and in EU countries is two years before the expiry of the SPC – so any plans for agreeing the PIP with the regulatory authority and carrying out the paediatric studies must begin many years in advance. Our SPC experts can advise and assist on this matter.