No-deal Brexit: The legal rights of patent holders
Brexit is imminent, and it is still not clear whether the UK and the EU will manage to secure a Brexit agreement prior to 29 March 2019, when according to the plans the UK leaves the EU. Consequently, to address the uncertainties, the UK government has published guidance on the legal rights of the patent holder in case the parties do not reach an agreement. In general, the patent holders can breathe again; in case of a no-deal scenario, the rules and systems will basically be the same as now.
According to the UK government, a no-deal scenario would affect the legal rights of patent holders in three ways:
1. The UK patent legislation and the rules on supplementary protection certificates (SPCs)
All existing patents, including national UK patents and European patents, remain in force, and the application process stays the same. European patents are issued by the European Patent Office (EPO) on the basis of the European Patent Convention (EPC). The convention is independent of EU legislation and therefore not affected by Brexit.
According to the UK European Union (Withdrawal) Act 2018 (here), national legislation originating in EU legislation, including national legislation based on directives, will remain in force. At the same time, the relevant EU regulations will be retained in UK law. This means that:
- The SPC rules as stipulated in Regulation 469/2009 are retained; meaning that all valid SPCs remain in force in the UK, and it will be possible to apply for and obtain SPCs as well. Additionally, it will be possible to obtain paediatric extensions to SPCs in accordance with Regulation 1901/2006. However, it is uncertain to which extent the proposed amendments to the SPC rules on "manufacturing waiver" will be incorporated into UK law. Please read Plesner's previous article on the amendments here (in Danish).
- The rules on data exclusivity for innovative medicinal products will continue to apply in UK legislation pursuant to the rule in Article 10 of the directive on medicinal products for human use (Directive 2001/83/EC, implemented in the UK Human Medicines Regulations 2012).
- The Bolar exemption in the UK Patents Act 1977, which implements the directive on medicinal products for human use, regarding the access to obtain marketing authorisations on the basis of patented medicinal products, will also still apply.
- The rules on the patenting of biotechnological inventions in Directive 98/44 (implemented into UK law by the Patents Regulations 2000) as well as the special rules on the protection of plant variety rights (breeding techniques) in Regulation 2100/94 continue under UK law without change.
- The rules on compulsory licences in connection with patented medicine for export to meet a specific health need in a developing country will continue to apply as well.
Accordingly, the patent rules will apply independently of the EU; however, their contents remain the same. In other words, patent holders do not have to take any special precautions in preparation for a no-deal situation. The UK government recommends, however, that SPC holders familiarise themselves with any changes to the rules. Please read about the changes here.
It is important to make note of the fact that the relevant EU legislation is retained as national, UK law. This entails that the UK in principle can decide to alter the rules as any other national legislation.
2. The Unified Patent Court and unitary patent
It is unclear whether the Unified Patent Court will start before Brexit on 29 March 2019. The reason is that the German constitutional question on this has not been decided yet, and Germany is one of the three counties that must ratify the UPC agreement before it can take effect. Please read Plesner's previous article on the German constitutional case here (in Danish). Additionally, a new report from the Max Planck Institute raises questions about the legality of the Unified Patent Court. Please read our previous mention of this report here (in Danish).
If the German case leads to the German ratification of the UPC, the UK government will explore whether it would be possible to remain within the Unified Patent Court and unitary patent systems in a no-deal situation.
If the UK cannot remain within the Unified Patent Court in a no-deal situation, businesses cannot use the Unified Patent Court and the unitary patent to protect their inventions within the UK. Instead, they will have to use the patent protection stipulated under the UK legislation.
However, already issued unitary patents will have the same national protection in the UK, and the right holder does not have to take any action in this regard. UK business will also be able to use the Unified Patent Court and unitary patent to protect their inventions in the other contracting EU member states (within the EU).
3. Correspondence addresses and confidentiality for patents
European Patent Attorneys based in the UK will continue to be able to represent applicants before the European Patent Office (the EPO). Please read the notice published by the EPO here. The UK government believes that the rules on correspondence addresses and confidentiality (legal professional privilege) will continue to apply regardless of a no-deal scenario.
It would seem that the patent holder's legal rights in case of a no-deal scenario remain very much the same, while the question of the Unified Patent Court and the unitary patent is the big joker.
Plesner will follow the further developments closely and will continue to supply information on the subject.
Please read the guidance on the legal rights of patent holders in case of a no-deal situation here.
You can read more about Plesner's Brexit Task Force and other Brexit news here.
Plesner's UPC feature page can be found here.