Supplementary protection certificates: Diverging interests
What impact will Brexit have on supplementary protection certificates (SPCs)? The question is complicated as SPCs are national rights governed by EU Regulations—specifically, Regulation (EC) No 469/2009 of the European Parliament and of the Council of May 6, 2009, concerning the SPC for medicinal products.
There is also Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of an SPC for plant protection products. Both apply in all the EU and European Economic Area (EEA) member states, and some other countries, such as Macedonia, Albania, Bosnia & Herzegovina and Serbia, offer similar legal protection.
SPCs are essential in the pharmaceutical and plant variety industries because they provide a means to extend patent protection for up to five years to compensate for time spent obtaining a marketing authorisation. They have proved popular since being introduced in Europe: according to a 2017 study by economist Malwina Mejer more than 20,000 SPCs were published between 1991 and April 2016 in the 28 EU member states, Switzerland, Norway and Iceland (but note that Switzerland’s system is somewhat different from that in the EU).
In relation to Brexit, the regulations cease to affect an EU member state once it leaves the union. The excellent news for SPC applicants and proprietors is that the UK government has measures to ensure that very little will change in the short term. However, in the longer term, there is more uncertainty.
The current position
The UK ceased to be an EU member state on January 31, 2020. On that date, it entered into an 11-month transition period that ends on December 31, 2020. During this transition period, EU law continues to apply in the UK, and this includes the SPC Regulations mentioned above.
That is set to change on January 1, 2021. However, the Withdrawal Agreement between the UK and EU provides that any SPC applications pending at the end of the transition period will be examined under the current framework. Any SPC granted from such an application will provide the same protection as existing SPCs (see the commission’s stakeholder notice).
Continuity in the UK
At the end of the transition period, the Patents (Amendment) (EU Exit) Regulations 2019 will come into effect in the UK and will govern any new applications filed from January 1, 2021. The regulations mostly provide continuity regarding SPCs.
In particular, the following will not change on January 1, 2021:
