WHAT IMPACT WILL A BREXIT WITHOUT A

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1 WHAT IMPACT WILL A BREXIT WITHOUT A WITHDRAWAL AGREEMENT AS OF MARCH 30, 2019, HAVE ON YOUR SUPPLEMENTARY PROTECTION CERTIFICATES? By Anne BOUTARIC, Partner, REGIMBEAU Paris, February 1, 2019 UK MPs overwhelmingly rejected the negotiated exit agreement of the EU by 432 votes against 202 on January 15, On Tuesday January 29, MPs approved the amendment that replaced the backstop by an unspecified alternative device by 317 votes to 301. An amendment affirming parliaments opposition to a no deal was also adopted by 318 votes against 310. However, the amendments aiming to postpone the Brexit date or to allow parliamentarians to vote on possible outcomes, including a second referendum, were rejected. In the hours that followed, French President Emmanuel Macron said that the agreement was, however, the best deal possible and not renegotiable. The EU is actively preparing for an exit of the UK on March 30, without a withdrawal agreement. It is therefore now worth considering a possible hard exit of the United Kingdom from the EU. 1 BREXIT is officially scheduled at 23:00 GMT (London time) on March 29, 2019, thus at midnight on March 29, Luxembourg and Paris time. 1

2 On the morning of March 30, 2019, the United Kingdom would wake up as a third country with regard to the European Union. Such an exit, without a transitional period or supervision, in particular re-establishing borders and customs duties, would obviously have substantial effects in some areas, for example regarding the circulation of persons and of products such as drug supplies. Would such a hard exit have effects in terms of supplementary protection certificates? A Supplementary Protection Certificate (SPC) is an independent national title which extends the protection provided by a patent protecting a product for up to 5 years, which, as a medicinal product 2 or as a plant protection product 3, has been subject to an administrative authorization procedure, governed by community regulations, prior to being placed on the market. It should be recalled that BREXIT, with or without an agreement, should not have a direct effect on patents. National patent applications filed in the United Kingdom and national patents granted in the United Kingdom are in no way affected by BREXIT. They will continue to be examined, issued and maintained in force in accordance with the unchanged national rules applicable in the United Kingdom. The exercise of resulting rights is not otherwise affected and will continue to be implemented according to the known rules. European Patents are granted by the European Patent Office (EPO), which is an organ of the European Patent Organization, supranational and independent of the European Union. European patents designating the United Kingdom are therefore also not impacted by a possible BREXIT. They will therefore be examined and granted by the European Patent Office, in accordance with the unchanged provisions of the European Patent Convention. The validation and maintenance in force of European patents granted by the EPO in the United Kingdom and that designate the United Kingdom, will remain subject to national provisions in effect in the United Kingdom. However, SPCs issued in the United Kingdom should be impacted by BREXIT. Indeed, they are currently exclusively governed by the provisions of Regulation (EC) No. 469/ Regulation (EC) No. 469/ Regulation (EC) No. 1610/1996 2

3 concerning the supplementary certificate for medicinal products and Regulation (EC) No. 1610/96 concerning the supplementary certificate for plant protection products. In the absence of a withdrawal agreement, these two regulations will no longer apply to the United Kingdom. According to the IP and Brexit guide of the current UK government, SPCs issued in the UK on the basis of Community regulations will continue to have effect. In addition, the government commits, without providing further details, to introduce the community provisions into national law from the date of exit. We therefore do not yet know the legal provisions that will be introduced into national law, nor the practical details. Two subjects can nevertheless be mentioned at this stage: 1. The effect of BREXIT on community marketing authorizations (MAs) BREXIT would have a direct effect on the marketing authorizations of a medicinal product or plant protection product (MA). Products, medicinal products, or plant protection products covered by a national MA would not be affected by BREXIT. The same should apply to products that benefit from a national MA through the mutual recognition procedure. However, products benefiting from a community MA community according to the centralized procedure, would be directly impacted. In its guide How medicines, medical devices and clinical trials would be regulated if there s no Brexit deal, the current UK government is committed to automatically converting any MA obtained according to the centralized procedure to a national MA no later than March 29, The UK Medicines and Healthcare products Regulatory Agency should write or already have written to each holder of a community MA informing them of the terms and conditions of the conversion process, giving them the opportunity to refuse such a conversion. It is therefore important to inform MA holders that, according to the provisions of Article 14 of each of the above-mentioned regulations, a certificate is extinguished if and as long as the product covered by the certificate is no longer authorized to be placed on the market as a result of the withdrawal of the corresponding marketing authorization(s). 3

4 Thus, holders of SPCs filed in the United Kingdom before March 29, 2019, on the basis of a community MA must ensure the community MA is converted into a UK MA, subject to the extinction of the corresponding SPC in the United Kingdom. For SPC applications in the European Union outside of the United Kingdom filed after March 29, 2019, a marketing authorization issued by UK health authorities will no longer be considered as a marketing authorization for the community and thus cannot be used as a starting point for calculating the duration of the certificate Different interpretations of the provisions of the regulations English judges have clearly stated, in several decisions, that the case law of the Court of Justice of the European Union (CJEU) determining whether a product is protected by a basic patent, within the meaning of Article 3a) of each of the regulations, is not satisfactory. In some of these English decisions, a test has been proposed; a test that the CJEU seems to refuse for the moment. Once the provisions of European regulations have been introduced into British national law, what will be the interpretation of these provisions? Will the judges follow the case law of the CJEU in spite of all its flaws or will they apply the test that they have proposed to interpret the regulations? Or will they simply apply the infringement test 5, which has been ruled out many times by the CJEU? Moreover, studies on the impact of these regulations on the internal market launched in 2017 and 2018 by the European Commission could lead to a more or less significant revision of these regulations. Will these amended provisions always be automatically introduced into UK national law? The first test could be the amendment of Article 4 of Regulation (EC) No 469/2009, introducing an exemption from infringement for manufacturing for the sole purpose of exporting to third party countries, on which the Commission is currently working 4 According to Article 13 of Regulation (EC) No. 469/2009 or Regulation (EC) No. 1610/1996, The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years. 5 The case law of the CJEU on this issue is discussed in our article of October 25, 2018, "Which skilled person should be chosen to define whether a compound is protected by a basic patent in force? 4

5 and which the UK legislator may subsequently decide to introduce into its national law or not. What measures to consider in the immediate future? It is essential to take the time to analyze your portfolio of intellectual property titles, in view of a BREXIT without a withdrawal agreement. For SPCs, it is necessary to identify the MA relied on the basis of SPCs issued in the United Kingdom. In the case of a community MA, it should notably be verified that the UK Medicines and Healthcare products Regulatory Agency has been in contact with regard to its conversion into a national MA, in the event that BREXIT becomes effective on March 30, 2019 without a transition period. Naturally, all of REGIMBEAU s teams follow these questions carefully, and are at your disposal to answer your questions and accompany you on any issues that may arise. Anne BOUTARIC (boutaric@regimbeau.eu) Partner French & European Patent Attorney About REGIMBEAU: REGIMBEAU, a French IP law firm, has been assisting companies and private and public project developers to protect, enhance and defend their innovations (patents, trademarks, designs) for more than 85 years. Fifteen partners head a team of more than 200 people whose skills are put into practice in every strategic aspect of Intellectual Property - business intelligence and information search, license agreements, IP portfolio audits, partnership negotiations, acquisition of industrial property rights, litigation. Thanks to its wide-ranging expertise, REGIMBEAU (present in Paris, Munich, Lyon, Rennes, Grenoble, Montpellier, Toulouse and Caen) can meet its clients' needs for international strategic consulting while preserving personalized relations of the highest quality. 5