Patents are used to protect technical inventions and prevent competitors from marketing products or processes, such as medicinal products, covered by the claims of the patent. However, patents only last for a set period of time - typically 20 years from the filing date. While this might be acceptable for products that can be sold as soon as a patent application is filed, medicinal products are subject to rigorous and lengthy regulatory approval procedures before they can be put on the market. Thus, medicinal products are perhaps at a disadvantage in the patent system - by the time the product is authorised to be sold in a particular country, there may be little patent term remaining.
To prevent this from discouraging pharmaceutical research, the European Union (EU) enacted legislation in 2007 whereby the period of protection for a medicinal product can be extended beyond the normal patent term by obtaining a supplementary protection certificate (SPC). SPCs are also available in EEA countries.
An SPC is a national right, available in member states of the European Union (EU). An SPC provides protection in a similar way as a patent, except that the scope is limited to the active ingredient or combination of active ingredients placed on the market as a medicinal product.
How to obtain an SPC for a medicinal product
There are several conditions to fulfil before an SPC can be applied for in an EU Member State of interest.
First, the medicinal product to be the subject of the SPC must be covered by the claims of a granted patent which is in force in the Member State. Second, the medicinal product must have received a marketing authorisation (MA) in the Member State under Directive 2001/83/EC or Directive 2001/82/EC relating to medicinal products for human use or animal use, respectively. Further, said MA must be the first MA to place the medicinal product on the market in the Member State, and the medicinal product must not have been the subject of a previous SPC in the Member State.
Once all the requirements are met, an application for an SPC must be filed with the national patent office of the Member State within six months of the date on which the MA was granted, or within six months of the date on which the patent was granted, whichever is later.
How long does an SPC last?
The duration of an SPC starts from the end of the normal patent term and is equal to the time elapsed between the filing date of the patent and the grant date of the MA, minus five years, although the term of the SPC is capped at five years. In addition, an SPC can be extended by six months if the medicinal product has also received regulatory approval for paediatric use. Thus, the maximum extension of patent term available through an SPC is five and a half years.
Which countries does an SPC cover?
A single SPC gives protection of a medicinal product for a single country - in order to secure extended protection for a medicinal product in multiple countries, multiple SPCs must be obtained.
There are also separate and different provisions for extending market exclusivity for medicinal products in countries outside of Europe, including Australia, Canada, Japan, Korea, Russia, and the USA. However, such provisions are not available in some major markets, such as China and India.
The law surrounding SPCs for pharmaceutical products is ever-changing and complex, and there have been several decisions by the Court of Justice of the European Union (CJEU) in recent years attempting to clarify it. The future SPCs in the UK also faces uncertainty due to Brexit. Therefore, if you or your company are interested in obtaining an SPC for your medicinal product, we strongly recommend seeking the advice of a professional in this field.