To get a marketing authorization for a new pharmaceutical, a set of detailed experiments is needed to make sure that the product is safe and efficient. This takes plenty of time, which can take up a considerable portion of the patent term because the patent application has to be made before the invention can be published.
Supplementary Protection Certificate (SPC) has been established to compensate the time needed for getting a marketing authorization. Furthermore, SPC gives companies that develop new pharmaceuticals time to get back at least a part of the, typically substantial, development costs so that the companies will keep investing in drug development in the future.
What are the requirements for getting an SPC?
SPC is granted to the active ingredient or to the combination of active ingredients of a pharmaceutical or a plant protection product if:
- the product has a valid patent
- the product has a marketing authorization
- the product has not previously been granted an SPC
What is the scope of protection?
SPC does not determine the scope of protection but the scope of protection is based on the patent and the marketing authorization. SPC covers the product, for which the marketing authorization has been granted, as disclosed in the patent. SPC therefore does not typically cover the whole patent but only the part that has gotten the marketing authorization.
For most parts, SPC gives the same rights as a patent and it comes with the same responsibilities and limitations. For example, annual payments have to made just like for a patent.
In 2019 a new regulation was adopted which allows the manufacture of an SPC protected product six months before the SPC expires if the product is exported outside the EU or it is produced for storage. This regulation aims at strengthening competitiveness of companies within the EU in comparison to third-country companies.
How long is the SPC valid?
SPC becomes valid after the patent term expires and the maximum duration is 5 years. The SPC term is affected by the time it takes from filing the patent application to receiving a marketing authorization in the EU in following manner:
- 0-5 years: SPC is not granted
- 5-10 years: SPC is valid for 0-5 years
- over 10 years: SPC is valid for 5 years
In addition, a 6-month extension can be applied for if the pharmaceutical product has been studied in children according to Pediatric Investigation Plan. This is to encourage companies to test new medicine also in children.
How to apply for an SPC?
SPC application is submitted to the Finnish Patent and Registration office with a specific form. The application must be filed within six months from the date the product was granted its first marketing authorization in Finland or within six months from the grant of the patent, if the patent has been granted after the marketing authorization.