101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 70 Business: Patents Purpose If the UK leaves the EU in March 2019 without a deal, find out in this notice how this would affect:  the UK patent system and supplementary protection certificates  the Unified Patent Court and unitary patent  correspondence addresses and confidentiality for UK patents Patents and supplementary protection certificates Before 29 March 2019 Only a few areas of UK patent law come from EU legislation (supported by, or implemented via, UK domestic legislation such as the Patents Act 1977). One important area relates to patented pharmaceutical products and agrochemicals where EU law provides for an additional period of protection after a patent has run out. This is called a supplementary protection certificate. Additionally, EU law:  sets out legal provisions on the patenting of biotechnological inventions. This includes exceptions from patenting, the scope of any protection, and a compulsory licensing regime between overlapping patents and plant variety rights  provides processes for a compulsory licence to be granted for UK manufacture of a patented medicine for export to a country with a public health need  sets out an exception that certain studies, trials and tests can be carried out using a patented pharmaceutical product without there being an infringement of the patent A broader exception to infringement is also set out in UK law which allows for other activities to be carried out to meet regulatory requirements for medicines. This exception relies on references to relevant EU law. After March 2019 if there’s no deal The relevant EU legislation (or its domestic implementation) will be retained in UK law under the EU Withdrawal Act 2018. The existing systems will therefore remain in place, operating independently from the EU regime, with all the current conditions and requirements. Any UK legislation supporting the existing systems will also continue to function as normal. This means that the EU’s legislation on supplementary protection certificates will be kept in UK law. This law, along with the existing supporting provisions in UK patents legislation, will form the UK’s own supplementary protection certificate regime on exit. Likewise, all other EU legislation relevant to patents and supplementary protection certificates will be kept in UK law. This will ensure UK law continues to work in respect of biotechnology patents and applications, compulsory licensing arrangements, and exceptions from infringement for the testing of pharmaceutical products. Issues relating to the unitary patent are covered elsewhere in this notice. Implications Any existing rights and licences in force in the UK will remain in force after March 2019. For UK, EU and third country businesses there will be no significant change to the legal requirements or the application processes. In particular, pending applications for patents and for supplementary protection certificates will continue to be assessed on the same basis, and new applications can continue to be filed. If legal proceedings involving these rights or licences are underway, they will continue unaffected. The supplementary protection certificate regime in the UK will continue to operate as before for UK, EU and third country businesses. The conditions for patenting biotechnological inventions will remain in place. UK, EU and third country businesses as patent holders, third parties and applicants can continue to make decisions on the basis of the current legislation. Patent examiners will continue to apply the same law when scrutinising patent applications in this area. Third parties who wish to challenge the validity of a patent will be able to do so on the same grounds as at present. For compulsory licensing, UK, EU or third country businesses as holders of patents or plant variety rights which are valid in the UK will continue to be able to apply for a compulsory licence, where there is an overlap between the rights. UK, EU and third country businesses will continue to be able to obtain a compulsory licence for manufacturing a patented medicine to meet a specific health need in a developing country. For pharmaceutical product testing, UK, EU or third country businesses can continue to rely on the exceptions from patent infringement provided for various studies, trials and tests carried out on a pharmaceutical product.