Is it possible to extend the term of a patent in the UK and Europe?

The following are required to get an SPC for a pharmaceutical or a plant protection product:

 

• A patent covering the product. This must cover the product itself (rather than a use of the product or a process to make the product), and must be in force in the relevant country when the application for the SPC is submitted.

 

• A valid Marketing Authorisation in the relevant country. This must be the first authorisation to market the product as a medicinal or plant protection product. In the EU (and Switzerland), that means the first authorisation to market the product as a medicinal or plant protection product anywhere in the EEA. In the UK, it is the first authorisation to market the product as a medicinal or plant protection product in the UK.

 

The application for an SPC must be filed within six months of the date of grant of the patent or within six months of the date of grant of the Marketing Authorisation, whichever is later.

 

Only one SPC per product is allowed, and so a final requirement for the grant of an SPC is that the product has not already been the subject of an SPC.

 

The duration of the SPC is determined using the following calculation:

 

(Date of first Marketing Authorisation in the EU or UK – Filing date of patent) – 5 years

 

• If the result of the calculation is five years or less, then that is the duration of the SPC
• If the result of the calculation is more than five years, then the duration of the SPC is five years

 

The exception to this is that if a pharmaceutical product was tested in compliance with an approved paediatric investigation plan, a six month extension of the SPC may be granted, resulting in the maximum SPC duration being five and a half years.

 

SPCs are a complex and specialist area of significant commercial importance. If you have any questions on this topic, please contact Anthony Ball or your usual Keltie advisor to discuss further.