Draft Withdrawal Agreement Approved by UK Cabinet - IP and Marketing Authorisation Provisions Summarised

As was widely reported yesterday evening, the Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (the Draft Withdrawal Agreement (14 November 2018)), detailing the arrangements for the UK to leave the EU has now been agreed by the UK Cabinet. The draft is as agreed between the UK and the EU's negotiators. As stated in HSF's Brexit Withdrawal Agreement webinar invitation here, a special European Council, anticipated to be held on 25 November 2018, will be asked to approve the Draft Withdrawal Agreement and the full text of the political declaration. The deal will also have to pass through the European Parliament. However, the main challenge to a deal being ratified is the requirement for approval by the UK Parliament. The first vote by the UK Parliament is expected within two weeks of the European Council.

We set out below a summary of the Draft Withdrawal Agreement's provisions on intellectual property. The situation is not much changed from the previous draft issued in March 2018 although the provision for geographical indications has now been agreed: EU-wide rights will be replaced or recognised in the UK and provision has been made for pending applications, including for supplementary protection certificates (SPCs). The sharing of information for assessment of marketing authorisations between the MHRA and the EMA and vice versa is also provided for.

The Draft Withdrawal Agreement provides for an implementation/transition period from the date the UK leaves the EU (29 March 2019) to end of 31 December 2020. If the Draft Withdrawal Agreement is agreed, this transition period will mean that effectively the UK will continue to be treated as part of the EU from a legislative point of view. As the Commission's press release puts it,"During this period, the entire Union acquis will continue to apply to and in the UK as if it were a Member State". IP registrations and enforcement will carry on as normal during this period. Until the end of the transition period you will still be able to acquire/register and maintain EU-wide IP rights that will have effect in the UK. See the detail in our summary section below.  However, "as of the withdrawal date (i.e. including during the transition period), the UK, having left the EU, will no longer be part of EU decision-making. It will no longer be represented in the EU institutions, agencies and bodies, and persons appointed, nominated, or representing the UK, and persons elected in the UK, will no longer take part in the EU institutions, agencies, and bodies".

The accompanying political agreement document "Outline of the political declaration setting out the framework for the future relationship between the European Union and the United Kingdom" (currently a summary version, with a fuller version to follow) looks to the future relationship between the UK and the EU post-transition. There is mention of IP in the section on Economic Partnership, but all that is said is: "Protection and enforcement of intellectual property rights beyond multilateral treaties to stimulate innovation, creativity and economic activity".  Under 'Basis for cooperation', the political agreement states that "Terms for the United Kingdom’s participation in Union programmes, subject to the conditions set out in the corresponding Union instruments, such as in science and innovation, culture and education, development, defence capabilities, civil protection and space". There is also mention of "Cooperation in matters of health security".  For more on the impact of no deal on the pharma industry see our post on the UK Government's "no deal technical notices" published on 23 August 2018.

Summary of the Draft Withdrawal Agreement's provision for IP and marketing authorisations:

IP is dealt with under Title IV in Articles 54 to 61 (pages 89-103 of the 585 page agreement). Most of this draft is the same as was previously agreed in the draft in March/June 2018. Replacement of EU trade marks, Community registered and unregistered design rights and Community plant variety rights in the UK are covered, along with database protection and provision for geographical indication recognition. There is no mention of the UPC or unitary patents nor any specific provisions on pharmaceutical regulatory arrangements other than on marketing authorisations (see below). Pending applications for SPCs are covered (as in previous drafts).

• The holder of any of the following intellectual property rights which have been registered or granted before the end of the transition period shall, without any re-examination, become the holder of a comparable registered and enforceable intellectual property right in the United Kingdom under the law of the United Kingdom (Art 54.1):
  • An EU trade mark (EUTM) holder shall become the holder of a UKTM for same sign for the same goods or services
  • A Community registered design (CRD) holder shall become the holder of a registered design right in the United Kingdom for the same design
  • A Community plant variety right (CPVR) holder shall become the holder of a plant variety right in the United Kingdom for the same plant variety
• Invalidity proceedings: If one of these rights above is declared invalid or revoked, or, in the case of a CPVR, is declared null and void or is cancelled, in the EU as the result of an administrative or judicial procedure which was ongoing on the last day of the transition period, the corresponding right in the UK shall also be declared invalid or revoked, or declared null and void, or be cancelled (as of the same date). nb: The UK will not be obliged to declare invalid or to revoke the corresponding right in the UK where the grounds for the invalidity or revocation of the EUTM or CRD do not apply in the UK. (Art 54.3)
• Renewal: The first renewal date will be the renewal date of the corresponding intellectual property right registered in accordance with Union law. (Art 54.4)
• Filing dates, priority, seniority, revocation for non-use and reputation (TMs): The replacement UKTM will have the date of filing or the date of priority of the EUTM and where appropriate seniority. The new UKTM will not be liable for revocation on the ground that the corresponding EUTM had not been put into genuine use in the territory of the United Kingdom before the end of the transition period. It will be possible to use reputation in the EU acquired by the end of the transition period as reputation as required under s.10(3) TMA; thereafter reputation will be based on use of the mark in the UK. (Art 54.5)
• Term, date of filing/priority (CRDs and CVPRs): For replacements for CRDs and CPVRs, the term of protection under UK law will be at least equal to the remaining period of protection under EU law of the corresponding EU right, and the date of filing or date of priority will be that of the corresponding EU right. (Art 54.6)
• Fees, administration, surrender: There will be no fees charged for the replacement rights. It will all be carried out free of charge by the relevant entities in the United Kingdom, using the data available in the registries of the European Union Intellectual Property Office, the Community Plant Variety Office and the European Commission. Holders will not be required to introduce an application or to undertake any particular administrative procedure and no correspondence address in the UK will be required for 3 years after the end of the transition period. Renewal fees will be charged, however. Holders wishing to surrender their rights will be able to do so "in accordance with the relevant procedure" under UK law.
• International registrations (TMs and Designs): The Draft Withdrawal Agreement says that the UK will take measures to ensure that protection obtained before the end of the transition period for internationally registered trade marks or designs designating the EU under the Madrid system for the international registration of marks, or the Hague system for the international deposit of industrial designs, will have protection in the UK for their trade marks or industrial designs in respect of those international registrations. (Art 56)
• Applications and rights of priority (TMs and plant variety rights (pvr)): For  applications that are pending at the end of the transition period, there will be a 9 month period within which an application (for the same mark and goods/services or same pvr) can be filed in the UK and will be given the same filing and priority date as the EU or Community right (and where appropriate seniority) which they replace in the UK. (Art 59)
• Geographical Indications, designation of origin, traditional speciality guaranteed, traditional terms for wine: Where these are protected in the EU on the last day of the transition period, those persons who are entitled to use the geographical indication, the designation of origin, the traditional speciality guaranteed or the traditional term for wine concerned shall be entitled, as from the end of the transition period, without any re-examination, to use them in the UK, and will be granted at least the same level of protection under UK law as under the specific provisions of EU law. Where any of these cease to have protection in the EU after the transition period their protection in the UK shall cease also. Nb Protection will not be given in the UK to such protections which are derived from international agreement to which the Union is party. (Art 54.2)
• Unregistered Community designs (UCDs): The holder of a right in relation to a UCD which arose before the end of the transition period shall in relation to that UCD ipso iure become the holder of an enforceable intellectual property right in the UK, under the law of the UK, with the same level of protection as the UCD and term of protection at least equal to the remaining period of protection of the corresponding UCD. (Art 57)
• Databases: Holders of sui generis database rights in respect of the UK, which arose before the end of the transition period, will maintain an enforceable right in the UK under UK law which affords the same level of protection as that provided under the Database Directive, provided that the right holder continues to comply with the requirements of Art 11 of that Directive. The term of protection shall be at least equal to the remaining period of protection for the sui generis database right. UK nationals and those with habitual UK residence and undertakings established in the UK (provided that where such an undertaking has only its registered office in the United Kingdom, its operations are genuinely linked on an ongoing basis with the economy of the United Kingdom or of a Member State) will be deemed to fulfil the requirements of Art 11. (Art 58)
• Pending applications for SPCs in the UK: Applications for supplementary protection certificates for plant protection products and for medicinal products, and applications for the extension of the duration of such certificates, where such applications were submitted to an authority in the UK before the end of the transition period, in cases where the administrative procedure for the grant of the certificate concerned or of the extension of its duration was ongoing at the end of the transition period, will all be considered using the same process and criteria as set out in the current applicable EU Regulations (Regulations (EC) No 1610/961 and No 469/20092). Any SPC granted shall provide for the same level of protection. (Art 60)
• Exhaustion of rights: Intellectual property rights which were exhausted both in the EU and in the UK before the end of the transition period under the conditions provided for by EU law shall remain exhausted both in the EU and in the UK post-transition. (Art 61)

On marketing authorisations, referred to under Art 45 as "Making available of information in relation to past authorisation procedures for medicinal products", the Draft Withdrawal Agreement provides that the UK should provide marketing authorisation dossiers to the EMA without delay, "upon reasoned request", on medicinal products which have been authorised by the UK before the end of the transition period, where that dossier is necessary for the EMA's assessment of a marketing authorisation application. There is provision for supply to the UK of such dossiers on medicinal products authorised before the end of transition for the purpose of the UK assessing marketing authorisation applications, but ony to the extent that the UK's legislative requirements replicate the circumstances set out in relevant the EU Directives.

For details of the "no deal" position on IP - see our blog post following the UK Government's no deal technical notices in September 2018 here.

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