An SPC can be obtained when a marketing authorization has been granted for a product protected by a patent in force provided that a certificate has not previously been issued for that product.
The duration of the SPC is calculated using as a starting point the time difference between the date when the patent application was filed and the date when marketing approval was obtained for the product in question. The SPC duration can never be more than 5 years.
Since an SPC cannot be obtained until there is an actual product on the market, i.e. when there is a market authorization for the product, it goes without saying that such an extended patent protection is very valuable for the pharmaceutical company selling the product. Each day with a successful pharmaceutical on the market is synonymous with substantial income for the selling company. Before a product can be put on the market, the companies will typically have invested considerable financial resources and time in the research and development leading to the final product, and the possibility to be compensated for that time and effort spent is very attractive. It was to compensate for the time spent, and at the same time to reward the benefits that new pharmaceuticals provide to the public health that the EU directives that govern the obtaining of an SPC were drawn up. However, as the legislation governing SPCs is relatively brief, it is amenable to interpretation. This has led to many questions regarding the interpretation of the SPC legislation having been referred to the CJEU for clarification. An SPC may also be obtained for plant protection products in a similar way as for pharmaceuticals.
If you have any questions regarding SPCs, please contact us.