The Trade and Cooperation Agreement and its impact on IP, Pharma and Medical Devices

The final Brexit agreement, the Trade and Cooperation Agreement (the “TCA”) was agreed between the UK and the EU on 24 December 2020. Within this agreement are provisions that set out the standards expected to be recognised (mutually) between the EU and the UK in relation to intellectual property (including SPCs and trade secrets). There are some provisions concerning pharmaceutical regulation and product standards, but overall there is a lack of mutual recognition, with the consequence that, for both pharmaceuticals and medical devices, there are now effectively two separate regimes for the EU and the UK.

Intellectual Property

The provisions on IP match or exceed those for IP set out in the various treaties to which the UK and EU have acceded (such as WIPO, WTO and TRIPS agreements).  These IP standards are to be maintained as a minimum. The cited objectives and scope in relation to intellectual property (see Title V) indicate the aims behind these provisions which are to:

(a) facilitate the production, provision and commercialisation of innovative and creative products and services between [the UK and the EU] by reducing distortions and impediments to such trade, thereby contributing to a more sustainable and inclusive economy; and

(b) ensure an adequate and effective level of protection and enforcement of intellectual property rights.

The provisions are intended to “complement and further specify the rights and obligations of each [of the UK and the EU] under the TRIPS Agreement and other international treaties in the field of intellectual property to which they are parties” and do not “preclude either [the UK or the EU] from introducing more extensive protection and enforcement of intellectual property rights than required under [this section of the TCA] provided that such protection and enforcement does not contravene [those provisions]”. However, there are aspects of current UK and EU IP law, such as the dilution provisions in trade mark law, to which the agreement does not refer, instead referring to the Paris Convention provisions on the protection of well known marks. Whether this will be a point of future divergence remains to be seen.

Both the UK and the EU also have the ability to develop their own exhaustion regimes. The provisions on geographical indications (“GIs”) indicate that a mutual future scheme has not be agreed although a review clause on GIs has, which provides that the UK and EU may (if both parties agree it is in their interests) use reasonable endeavours to agree rules for the protection and domestic enforcement of their GIs.

The UK Government’s Summary document that accompanies the TCA (see here) states that the agreement “includes mechanisms for cooperation and exchange of information on IP issues of mutual interest” and “retains regulatory flexibility for each [of the UK and the EU], enabling the UK to develop an IP system in line with [its] domestic priorities“, thus enabling the UK to diverge where it so requires.

We have already commented on the changes to the UK IP regime in the firm’s guide to Brexit here (see the IP section).

The Regulation of Medical Devices and Medicinal Products

Medical devices: The TCA has a chapter (4) (under Trade – Title I) on eliminating unnecessary technical barriers to trade which deals with conformity of standards. However, this only provides for an approach under which each party can agree that its standards bodies (including those relating to medical devices) will conform with international standards and will work together to influence those and to “foster bilateral cooperation with the standardising bodies of the other Party“.

For medical devices, it had been hoped that there would be at least mutual recognition of conformity assessment under which each of the EU and the UK would recognise the other’s certification bodies. However, as things stand, although Great Britain will continue to accept CE marked medical devices until 30 June 2023 those devices certified by the UK and marked as UKCA (standing for UK Conformity Assessed, as discussed in more detail in our post here), will not mutually recognised by the EU.

Medicinal Products: For medicinal products there is a dedicated annex in the TCA, Annex TBT-2 – Medicinal Products (the “Medicinal Products Annex”), which applies to all medicinal products listed in its Annex C, namely:

  • marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use,
  • advanced therapy medicinal products,
  • active pharmaceutical ingredients for human or veterinary use,
  • investigational medicinal products,

with this list being subject to amended by the UK-EU Partnership Council (the main governing body for the agreement and supplementing agreements).

The aim of the Medicinal Product Annex is to “facilitate availability of medicines, promote public health and protect high levels of consumer and environmental protection in respect of medicinal products”.  To help achieve this aim, the Annex provides for:

  • the mutual recognition of Good Manufacturing Practice (“GMP”) inspections and certificates, meaning that manufacturing facilities do not need to undergo separate UK and EU inspections;
  • the individual inspection, on notice, by the EU or UK of each other’s facilities); and
  • for the suspension of the mutual recognition arrangements.

Further, the TCA also states that the EU and the UK should work together to implement agreed international guidelines and that any changes to either the UK or the EU’s regulation regime should be on 60 days’ notice and be subject to discussion by a Working Group on Medicinal Products, which will be established to enable mutual consultation. This Working Group on Medicinal Products will be under supervision of the Trade Specialised Committee on Technical Barriers to Trade, and will monitor and review implementation and ensure the proper functioning of the Medicinal Products Annex. It is noteworthy that the Medicinal Products Annex is specifically excluded from the TCA’s disputes mechanism, however, through its role in facilitating discussions and functioning as an appropriate forum for issues relating to Medicinal Products, it is hoped that it will be a sufficient mechanism to deal with any concerns.

When considering the confidentiality of information supporting applications for marketing authorisations (“MAs”), regulatory protection of pharmaceutical products, and Supplementary Protection Certificates (“SPC”) it is noteworthy that this is not included in the Medicinal Products Annex, but is included in the IP section (Title V) of the TCA.

  • In relation to regulatory data protection generally, the TCA requires that both the UK and the EU ensure that commercially confidential information submitted to obtain an MA is protected against disclosure to third parties, unless there is an overriding public interest or steps are taken to ensure the data is protected from unfair commercial use.
  • For the regulatory protections of data and market exclusivity, the TCA provides that, subject to any international agreement to which both the EU and the UK are party, and without prejudice to any additional periods of protection which either party may wish to provide for in its domestic law, these regulatory protections will be “for a limited period of time to be determined by domestic law”. This allows each of the UK and the EU to determine the length of such regulatory exclusivities under their own regulatory regimes.
  • For SPCs, the TCA records the agreement of both the UK and the EU to provide for further patent protection to compensate for the impact of regulatory administrative procedures but, again, the length of time is not stipulated.

The effect of these provisions is that they provide some comfort that these valuable forms of protection for medicinal products will be maintained by both the UK and the EU.

For detailed commentary on the new regulatory position for Pharma in the UK, and the impact on IP rights generally, see our series of posts on the HSF Intellectual Property Notes blog here.

Other provisions relevant to the pharmaceutical and medical device industry

The TCA also has provisions relating to the UK’s continued participation in EU programmes and on UK / EU cooperation on “serious cross-border threat[s] to health that are relevant for the pharmaceutical industry.

  • Subject to the UK making financial contributions, Part 5 of the TCA includes agreement on the UK’s continued participation in EU programmes, including the EU’s research and innovation funding programme, Horizon Europe.
  • UK / EU cooperation on serious cross-border threat[s] to health is covered by the TCA including agreement between the UK and the EU on emergency relief in relation to importation requirements, tax and road transport exemptions, and agreement to cooperate in relation to international health security systems.

Future developments

Although tariff free and quota-free trade has been agreed, there is little mutual recognition of regulatory provisions. This may not be the end of negotiations, with automatic reviews every 5 years written into the TCA and termination possible on 12 months’ notice.  See the HSF Brexit blog for further information, and our initial comments here.

Key contacts and authors

Jonathan Turnbull

Jonathan Turnbull
Partner, London
+44 20 7466 2174

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

George McCubbin

George McCubbin
Senior Associate, London
+44 20 7466 2764

Priyanka Madan

Priyanka Madan
Associate - London
+44 20 7466 2986

The European Commission considers the future of health in Europe with new Pharmaceutical Strategy and Action Plan on IP

The European Commission has this week published a wide-ranging and ambitious Pharmaceutical Strategy for Europe, and an Action Plan on Intellectual Property.

Pharmaceutical Strategy for Europe

The new pharmaceutical strategy for Europe is a key pillar of the European Health Union, which President von der Leyen called for in her 2020 State of the Union speech. It covers the full lifecycle of a medicine including R&D, clinical trials, marketing authorisation, manufacturing, pricing and reimbursement, access and IP protection.

The aims of the strategy are to promote accessibility and affordability of medicines, and to ensure the European pharmaceutical sector remains innovative and world-leading. The coronavirus pandemic has brought the health sector into sharp focus this year, and a goal of the strategy is to help to establish a crisis-resilient EU pharmaceutical system.

The strategy sets out four main objectives:

  • Ensure access to affordable medicines and address unmet medical needs (e.g. in the area of cancer)
  • Support innovation, competitiveness and sustainability of the EU’s pharma industry and the development of high quality, safe, effective and greener medicines
  • Enhance crisis response mechanisms and address security of supply
  • Ensure a strong EU voice in the world by promoting a high level of quality, efficacy and safety standards

In term of next steps:

  • The strategy will be discussed at political level at the EPSCO (Employment and Social Affairs Council) meeting of 2 December 2020.
  • Implementation will start immediately after adoption and will include legislative and non-legislative actions.
  • The actions will be rolled out gradually starting with the first proposals in the coming months, including the revision of the legislation on rare diseases (Orphans and Paediatric Regulations).
  • An EU Health Emergency Response Authority is proposed for 2021.
  • Depending on the evaluation process, the strategy plans a proposal for revision of the basic pharmaceutical acts (i.e. Directive 2001/83/EC relating to medicinal products for human use; and Regulation 726/2004 laying down EC procedures for the authorisation and supervision of medicinal products) in late 2022.

The strategy is mostly focussed on IP and regulatory issues, but notes that the proposed policies will be accompanied by enforcement of the EU competition rules. In particular, it refers to the 2019 Report on competition enforcement in the pharmaceutical sector.

Action Plan on Intellectual Property

The new Intellectual Property Action Plan aims to build on the EU’s strengths in the IP sector by “upgrading the EU’s framework, where needed, and putting in place well-calibrated IP policies to help companies capitalise on their inventions and creations, whilst at the same time ensuring that inventions and creations are serving economy and society at large“. It identifies 5 current challenges and 5 key focus areas, with specific proposals for action to:

  • upgrade the system for IP protection,
  • incentivise the use and deployment of IP, notably by SMEs,
  • facilitate access to and sharing of intangible assets while guaranteeing a fair return on investment,
  • ensure better IP enforcement, and
  • improve fair play at global level.

Within these 5 key focus areas, some highlights of what the action plan discusses are:

  • supporting the launch and rapid roll out of the unitary patent system in 2021. It also floats the possibility of introducing “a unified SPC grant mechanism and/or create a unitary SPC title
  • new licensing tools and a system to coordinate compulsory licensing (20212022)
  • revising the EU legislation on design protection (Q4 2021)
  • a new approach to the way geographical indications (GIs) are protected, and the possibility of an EU protection system for non-agricultural GIs (Q4 2021)
  • evaluating the plant variety legislation (Q4 2022)

The wider picture

Both the strategy and action plan are in synergy with the new Industrial Strategy for Europe and the priorities outlined in the European Green DealEurope’s Beating Cancer Plan, and the European Digital Strategy.

 

Emily Bottle

Emily Bottle
Senior Associate, London/Milan
+44 207 466 2525/+39 02 3602 1402

Dafni Katrana

Dafni Katrana
Senior Associate, Brussels
+32 2 518 1846

Martina Maffei

Martina Maffei
Senior Associate, Milan
+39 0236021388

Herbert Smith Freehills’ global Trade Marks Practice lauded a ‘formidable force’ in WTR 1000 rankings

Herbert Smith Freehills has been lauded a ‘class act’, after it was ranked highly in the 2019 edition of World Trademark Review (WTR) 1000.

Now in its ninth year, the WTR 1000 highlights firms and individuals that are deemed outstanding in this area of practice.

Herbert Smith Freehills has been showcased in the research directory as being ‘a formidable force within the trademark sphere’ and a ‘prestigious commercial outfit’, after it was highlighted for having particularly strong trademark experience globally in WTR 1000. The firm’s practices in the UK, Australia, France and Italy were all highly ranked in the directory.

The publication singles out the firm for being “packed to the rafters with world-class talent that consistently exceeds the expectations of clients”.

WTR cites the “hands-on leadership”  of Joel Smith, UK Head of IP as crucial to the side’s recent growth and success and goes on to highlight Joel as “a brilliant strategic thinker” flagging his work for major brands alongside much-praised Paris Partner Alexandra Neri on cross-border trade mark disputes.

Global Head of IP Mark Shillito is lauded as an “exquisite complex problem solver and litigator” and Laura Orlando has also been showcased, after she helped set up our growing Milan office in late 2017. She is flagged for her, “super pragmatic and business oriented” approach, which makes her one of the “best IP lawyers in Italy”.

Celia Davies, who heads Herbert Smith Freehills’ Trademarks prosecution group in Australia, is “a true leader in the trademark market”. Melbourne Partner Shaun McVicar has also been held up as possessing a “commercial and strategic outlook on litigation” which means that brands are in “good hands when he is on a case.” Partner Sue Gilchrist is also singled out as being a “top-flight litigator” and Kristin Stammer as an “eminent adviser with terrific technical trademark knowledge”.

In its write-up of the firm’s trade mark practice, WTR comments, “Herbert Smith Freehills isn’t about being the biggest in trademarks; it focuses, instead, on quality and adding strategic value for blue-chip international rights holders – and routinely surpasses expectations in both regards.”

As with previous editions, to arrive at the 2019 rankings, WTR undertook an exhaustive qualitative research project to identify the firms and individuals that are deemed outstanding in this critical area of practice. The publication says that when identifying the leading firms, factors such as depth of expertise, market presence and the level of work on which they are typically instructed were all taken into account, alongside positive peer and client feedback.

To view the full write-up, please visit: https://www.worldtrademarkreview.com/directories/wtr1000

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:

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Brexit “no deal” technical notices published on Patents, Trade marks, Designs, Copyright, GIs, and Exhaustion of rights

The latest tranche of “no deal” technical notices was released yesterday afternoon by the UK Government. Amongst them are several notices that highlight the Brexit issues faced by intellectual property right owners and, in some cases, confirm the Government’s approach to resolving them. The Government also released this news story today which comments on the guidance given in the technical notices and comments on the Government’s longer term aims for IP protection.

Key announcements, in the context of no deal, are:

  • Provision of a new right to replace unregistered Community design rights, to be known as “the supplementary unregistered design right“.
  • Existing EUTMs and Community registered designs will be replaced with new, equivalent rights in the UK at the end of the implementation/transition period, “with minimal administrative burden“.
  • The SPC, compulsory licensing, pharmaceutical product testing exception and patenting of biotechnological inventions regimes will remain unchanged at least initially.
  • If the UPC comes into force the UK will replace unitary patent rights with equivalent rights if the UK needs to withdraw from the new system, although the UK “will explore whether it is possible to remain within it“. The Government’s news story states that “The UK intends to stay in the Unified Patent Court and unitary patent system after we leave the EU.”
  • UK originating sui generis database rights will no longer be enforceable in the EEA; “UK owners may want to consider relying on other forms of protection (e.g. restrictive licensing agreements or copyright where applicable) for their databases
  • The UK will set up its own GI schemewhich will be WTO TRIPS compliant“. The new rights “will broadly mirror the EU regime and be no more burdensome to producers“.  Since the UK would no longer be required to recognise EU GI status, EU producers would be able to apply for UK GI status. Those wishing to protect UK GIs in the EU will need to submit applications on a third country basis.
  • The UK will continue to accept the exhaustion of IP rights in products put on the market in the EEA by, or with the consent of, the rights holder. However, the EU will likely not consider that goods placed on the UK market are exhausted in the EEA, and thus permission may need to be sought from the rights holder to transfer goods to the EEA that have legitimately been put on the market in the UK. The Government news story says that “The UK looks forward to exploring arrangements on IP cooperation that will provide mutual benefits to UK and EU rights holders and we are ready to discuss issues the EU wishes to raise in the negotiations on our future relationship, including exhaustion of IP rights”.

Links to the notices:

  1. Patents
  2. Trade marks and designs
  3. Copyright
  4. Geographical Indications
  5. Exhaustion of IP rights

More detail on each of these is provided below. For those with an interest in Life Sciences please also see our blog post on the notices related to that sector that were released last month.

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HSF Legal Guide to Brexit – an update on provision for intellectual property rights

IP rights which are designated as applying across the EU (EU trade marks, Community plant variety rights, Community registered designs and Community unregistered designs) and those, qualification for which involves activity within the EU (such as database rights), are all at risk of termination in relation to the territory of the UK once the definition ‘EU’ no longer includes the UK. However, the Commission and the UK Government have agreed at negotiator level (as published on 19 March 2018 and subsequently, 19 June 2018) certain sections in the withdrawal agreement including provision of replacement rights for those registered rights thus affected and for the UK Government to provide replacement rights for UK registered rights.

The UK Government’s White Paper detailing its proposal for the future relationship between the UK and the EU (published on 12 July 2018) includes a limited number of proposals relating to intellectual property as follows:

• The UK intends to explore staying in the Unified Patent Court (UPC) and Unitary Patent system post-Brexit. The UK will work with the member states that have signed up to the UPC Agreement to ensure that the UPC Agreement can continue on a firm legal basis;

• Arrangements on future co-operation on intellectual property are recognised as important to provide confidence and security to rights holders operating in and between the UK and the EU;

• The UK will establish its own Geographical Indications (GIs) scheme to provide continuous protection for UK GIs in the UK and protection for new GIs applied for by UK and non-UK applicants

In our detailed briefing, we review the proposals for the treatment and protection of intellectual property rights in the UK at Brexit: see Intellectual Property and Brexit (part of the HSF Brexit Legal Guide 2018).

See also the Herbert Smith Freehills Brexit Hub and Brexit Blog.

Authors

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

UK Government agrees elements of the European Commission’s proposals for post-Brexit protection of EU-wide IP rights in the UK in the latest draft of the Withdrawal Agreement

In the latest draft of the Withdrawal Agreement (19 March 2018) the UK Government and European Commission negotiators appear to have agreed text providing for the replacement of EU-wide IP rights having effect in the UK with equivalent UK rights at the end of the transition period post-Brexit (until 31 December 2020). Further, during the transition period, EU-wide rights will still apply to the UK due to the effect of Article 122 which provides that EU law will be applicable to the UK during the transition period and that it will produce the same legal effects in respect of and in the UK as those which is produces within the EU and its Member States and shall be interpreted and applied in accordance with the same methods and general principles, and that during the transition period, any reference to Member States in EU law shall be understood as including the UK.

Other IP related measures include provision for dealing with: exhaustion of rights, pending applications, international registrations designating the EU and the effect of invalidity proceedings that are “on foot” at the end of the transition period, (see Articles 50-57).  Certain provisions (highlighted in green) are now listed as agreed between negotiators, whilst others are still just proposals from the Commission (those un-highlighted) including those on GIs, SPCs and who pays the administration costs involved.

There are still unresolved issues for those who hold IP rights in the EU and those who license (in or out) EU-wide IP rights or have agreements linked to the “EU” as territory, which we discuss below.

Despite the areas of current agreement, there remains the possibility of a “no deal” scenario in relation to the whole agreement, in which case none of the areas agreed would stand (although the UK Government could make separate arrangements to create equivalent rights at the moment of Brexit). Anything agreed between the Commission and the UK under the Withdrawal Agreement needs European Council approval and then European Parliament approval. Thus, although a good start has been made on agreeing the post-Brexit fate of EU-wide IP rights currently having effect in the UK, the final arrangements are still far from certain. Indeed, if the Withdrawal Agreement is not accepted then there will be no transition period at all and a “hard” Brexit will come into effect on 30 March 2019, with all that implies for IP rights (see our comments from January 2017 here).

In summary, the proposals in the revised Withdrawal Agreement, and problems associated with them, are:

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BREXIT AND IP – LAW SOCIETY NOTE CALLS FOR GOVERNMENT ACTION

The exact mechanics of how Brexit will materialise and what it would mean for intellectual property rights in the UK is still unclear. However, time is now running short and the main representative bodies for IP practitioners have become concerned that IP rights (which are some of the assets most likely to be adversely impacted by Brexit – indeed in some cases at risk of being lost without specific provision being made by the UK Government prior to Brexit) have not been receiving the attention they require.

On 22 December, a note was sent to the UK Government by the Law Society which had been contributed to and signed by representatives of the IP Committee of the Law Society of England and Wales, and of the IP Bar Association, the Chartered Institute of Patent Attorneys (CIPA), the Chartered Institute of Trade Mark Attorneys (ITMA) and the IP Federation (whose website also carries a copy of the note).

The note makes the case for the UK as a key IP forum and identifies “a short list of the biggest areas where Government action is necessary to ensure continuity and certainty of IP law and to prevent disruption both to undertakings which use IP services and IP service providers“.

The following are some of the key recommendations made by the note:

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“PORT CHARLOTTE” Whisky does not infringe the EU protected designation of origin (PDO) “PORTO” or “PORT” – Consideration needed urgently for protection of PDOs and GIs, UK and EU-wide, post-Brexit

The CJEU has confirmed that “Port Charlotte”, registered as an EU trade mark for whisky, does not evoke (infringe) the protected designation of origin (PDO) for “porto” or “port”. The decision will be significant for consumer products businesses as it confirms that EU (not national) law applies to enforcement of Protected Designations of Origin (PDO) and highlights the importance of ensuring continued protection of UK PDOs post-Brexit.

Interestingly, the CJEU did not find that the use of “Port Charlotte” as a brand for whisky would have a detrimental impact upon the PDO for port (and the port producers protected by this designation). Yet we await the outcome in a not dissimiliar dispute before the CJEU between the Champagne wine producers and Aldi over the sale of champagne flavoured sorbet (see our report of the Aldi case here ).

Business Impact

·         The CJEU’s ruling that Regulation1234/2007 (which sets out the rules on PDOs for wine) (the “Regulation”) exclusively and exhaustively lays down the legal rules in the EU applicable to the protection of PDOs, to the exclusion of any national laws which seek to provide additional protection, confirms that the system for PDO protection is entirely as set out in the relevant EU law, and cannot be supplemented at a national level.

·         Assessing consumer perception of the meaning of a mark, throughout the EU, will be relevant to the assessment of whether that mark “evokes” in the mind of the consumer the PDO in question.  The impact of this point will be fact specific, in each case.  The likelihood that a PDO is evoked may also be affected by the similarity, or otherwise, of the features of the products in question.

·         In a post-Brexit world, the UK will need to give thought to the interaction of PDOs granted under the EU system and what level of protection would be offered going forwards to existing PDOs in the UK and whether the UK continues with its own system of protected designations and geographical indications for distinctive UK foods (such as cheeses and pork pies) and beers/wines (such as ales and bitters).

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Commission paper on IPR post-Brexit highlights the importance of resolving key issues prior to withdrawal

The European Commission has published a “Position paper transmitted to EU27 on Intellectual property rights (including geographical indications)” (7 September 2017) which proposes that the (Brexit) Withdrawal Agreement should ensure that:

  • The protection enjoyed in the United Kingdom on the basis of Union law by both UK and EU27 (the remaining EU states) holders of intellectual property rights having unitary character within the Union before the withdrawal date is not undermined by the withdrawal of the United Kingdom from the European Union. The paper suggests there should be automatic recognition of an IP right in the UK on the basis of the existing, unitary character IP right i.e. that, for example, any EU trade mark rights applying in the UK prior to Brexit should be automatically replaced by UK rights post-Brexit. Further, the fact that use may not be in the UK should not be able to form a basis for revocation of the rights. The implementation should be not result in any financial cost for the IPR holders and any administrative burden should be kept to a minimum.  The paper also requires that the UK Government put in place a system to continue the protection of Geographical Indications (GIs) and protected designations of origin (PDOs) which are currently legislated for under EU law and for which there is no current domestic legislation in the UK. However there is no suggestion of a reciprocal recognition of UK-based PDOs or GIs post-Brexit.
  • Procedure-related rights (e.g. right of priority) in relation to an application for an intellectual property right having unitary character within the Union still pending on the withdrawal date are not lost when applying for an equivalent intellectual property right in the United Kingdom ie. that where an application is in progress at the point of the UK’s withdrawal from the EU, the applicant should be entitled to keep the benefit of any priority date when applying after the withdrawal date for an equivalent IPR in the UK.
  • Applications for supplementary protection certificates or for the extension of their duration in the United Kingdom on-going before the withdrawal date are completed in accordance with the conditions set out in Union law (and any certificate so granted or extended should provide for protection equivalent to that provided for by Union law.
  • Databases protected in the EU27 and the UK before the withdrawal date continue to enjoy protection after that date. This involves waiving the requirements of Article 11(1) and (2) in the EU27 Member States in respect of UK nationals and UK companies and firms; and the UK should not exclude EU27 nationals and EU27 companies and firms from legal protection of databases in the UK on nationality or establishment grounds. No provision for any continuing mutual recognition of database rights is referred to however.
  • Exhaustion before the withdrawal date within the Union of the rights conferred by intellectual property rights is not affected by the withdrawal of the United Kingdom from the European Union. The conditions for exhaustion of each IPR should be those defined by Union law.

These points highlight the key areas that have concerned IP stakeholders since the Brexit referendum and serve as a timely reminder to the UK Government that these issues need to be dealt with prior to Brexit, in one way or another.

Joel Smith, Head of IP at Herbert Smith Freehills, commented,Whilst it is reassuring that the Commission recognises that there are important issues for continuity of IP protection to be addressed upon Brexit, this paper only begins to scratch the surface for the number of issues that need examining by UK Government”.

Author

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217