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

UKIPO launches ‘AI and IP Call for Views’

The UK Intellectual Property Office has published its call for views on artificial intelligence (‘AI’) and intellectual property (‘IP’). The IPO is interested in understanding the implications that AI might have for IP policy, and vice versa, in the near to medium future.

To respond, email before 11:45 pm on 30 November 2020.


In this call for views, the IPO recognises that “AI and machine learning are enabling. They are transforming the global economy and already an integral part of our lives. They impact our workplace, our homes, our transportation, and our healthcare”, and wants to understand “the commercial, economic, legal and social implications of AI and how the IP framework can incentivise the development and adoption of AI technologies”.

The call for views asks a number of questions in relation to how the IP framework currently relates to AI and the future of AI and IP policy.

It contains five sections covering the below IP rights and themes:

  • Patents (including in relation to AI inventorship, patentability of AI inventions, and infringement of patents by AI systems);
  • Copyright and related rights (including in relation to use of copyright works by AI systems and copyright protection of AI-generated works);
  • Designs (including in relation to AI ownership and authorship, and infringement by AI systems);
  • Trade marks (including how current trade mark law would apply to AI technology and infringement by AI systems); and
  • Trade secrets (including the advantages and disadvantages of using trade secrets in the AI sector).

A full list of the questions asked across all of the IP rights above can be accessed here.


Priyanka Madan

Priyanka Madan
Associate - London
+44 20 7466 2986

Laura Adde

Laura Adde
Associate - London
+44 20 7466 7491

Brompton Bicycle – far from folded

CJEU follows Cofemel in allowing copyright protection where designs are not exclusively dictated by technical function

The CJEU has decided in the Brompton Bicycle case C-833/18 (11 June 2020) that to qualify for copyright, a design must be original – that is, the subject matter must reflect the personality of its author (the creator or designer), as an expression of her/his free and creative choices.  This requirement cannot be fulfilled where the design “has been dictated by technical considerations, rules or other constraints which have left no room for creative freedom or room so limited that the idea and its expression become indissociable“.  Therefore any design satisfying the condition of originality may be eligible for copyright protection, even if its creation has been dictated in part by technical considerations, provided those technical design choices have not prevented the creator from reflecting her/his personality in the design.


The case confirms that technical designs may benefit from copyright, dependent upon the extent to which creative freedom is possible. In situations where there is none and the design is solely dictated by the function, there will not be copyright protection. The CJEU left it to the local court to decide whether this was the case with the Brompton bicycle designs.  In order to establish whether the product concerned falls within the scope of copyright protection, the referring Belgian court must now decide on the facts whether, through the choice of the shape of the product, its author has expressed her/his creative ability in an original manner (by making free and creative choices) in such a way that it reflects her/his personality. The CJEU said that the question of the potential existence or not of other possible shapes which can achieve the same technical result is not decisive in assessing the factors which influenced the choice made by the creator. Likewise, the intention of the alleged infringer is irrelevant in such an assessment. Significantly, the fact that a patent over the bicycle had recently expired was held not to be a relevant consideration; the individual copyright issues were considered independently of any history of protection by other IPRs.


This decision will have an important impact in the design sector, because it has confirmed that a design can also have copyright protection if the design  reflects the personality of its creator, as an expression of their free and creative choices, even if the shape of that product is in part necessary to obtain a technical result. Where there is no creative freedom in the development of the design copyright will not apply.

Since copyright protection is one of the longest lasting IP rights, this will make it an attractive option for protection and enforcement, in particular where other rights such as registered designs or patent rights in the product have expired. Whilst the existence of such latter rights was seen by the CJEU as potentially relevant to any assessment of the creative freedom of the author and technical functionality of a design, it was not fatal to a finding that copyright could exist.

As copyright has a much longer term than other IP rights (lifetime of creator plus 70 years for UK copyright, as opposed to 3 years for EU unregistered design rights or 10-15 years for unregistered UK design rights or 20 years for a patent), the decision will be welcomed by some in the design world who seek to maintain rights over key designs.  Others who would wish to get inspiration from designs, the protection in which would otherwise have expired, will find today’s decision more challenging.  We will undoubtedly see other designers seek to rely upon copyright to protect iconic designs, even if mass produced, given the advantages of copyright protection.  Another advantage of copyright is that there are no registration requirements, unlike registered designs or patents. However, designs remain a valuable form of protection, as they do protect a wider category of industrial designs, including those that have functional elements.

We saw the CJEU in Cofemel (September, 2019) endorse the EU test for subsistence of copyright, as being the artist’s own intellectual creation (consistent with Infopaq and Levolo).  This differs from the old UK test of for originality, of sufficient skill and labour test, i.e. sweat of the brow.  However, Cofemel also suggested that the categories of copyright protection were not limited, so could include designs.  However, the Cofemel judgment suggested that the scope for cumulative protection was limited for designs under both EU copyright and design law (also established in Flos).  It rejected the notion of a requirement of aesthetic appeal for copyright protection, but equally suggested that technical considerations may preclude exclusively functional designs from being eligible for copyright protection.

In the Brompton Bicycle case, the CJEU followed Cofemel in the view that a design whose shape is dictated by technical considerations, that do not leave room for the exercise of creative freedom, is not eligible for copyright protection.  It is analogous to the reasoning given in some of the trade mark cases on protecting 3D shapes (such as Lego).  It suggests that there does need to be something creative for a work to qualify for copyright protection, not driven by purely functional concerns or perhaps the technical output from a machine.

Until the repeal of section 52 Copyright, Designs and Patents Act 1988 (CDPA), the UK law limited the use of copyright to protect industrially manufactured designs to 25 years. Since that repeal, the industrial manufacture of a design does not have a limiting effect on the copyright term in the designs for that object. However, under section 51 CDPA, where any article is made to a design embodied in a design document or model, the copyright in that design document or model recording the design cannot be enforced (unless the design or model itself was an artistic work). This section must now be likely to come under review, either by the UK courts or legislature, in light of the Brompton and Cofemel decisions.  The UK Courts have already imported the test for originality, as being the author’s own intellectual creation, as recently seen in the Response Clothing decision of His Honour Judge Hacon in January 2020. This decision recognises the tension between section 51 of the Copyright, Designs and Patents Act 1988 which limits copyright protection for designs to works of artistic craftsmanship and the judgment in Cofemel.  In Response Clothing, the Judge acknowledged the tension, but found he was not constrained by earlier English law from finding that a machine-made fabric design was a work of artistic craftsmanship and followed Cofemel to find that it was entitled to copyright protection. This latter case left English law tipping its hat towards the important EU decision in Cofemel, but not fully importing its full effect.  There is scope for divergence by the Courts in post-Brexit UK in the important area for protection of designs, which is key to many product designs.

Notwithstanding that the UK has left the EU, the Brompton Bicycle case (coming within the transition period) will bind the UK courts, unless the Supreme Court (or Parliament through legislation) decides subsequently to depart from it or Ministers make regulations under the European Union (Withdrawal Agreement) Act 2020 about the judicial treatment of the decision.   Realistically, this is extremely unlikely in the short to medium term, given that Cofemel has already been endorsed and applied by the courts in the UK in the Rapid Clothing v Edinburgh Woollen Mill case.  That does mean that the conundrum of section 51 needs resolving, through primary legislation or the courts striking it down as ultra vires.  That leaves the UK with the prospect of enhanced protection for designs through copyright, including the potential for some designs to gain retrospective protection, when protection from unregistered design rights (UK or Community) might well have expired.

Further, additional changes will also come into effect on 1 January 2021 to recognise equivalent UK rights to Community design rights (both registered and unregistered).  See our Guide to the impact of Brexit upon IP here.


Key contacts and authors

Joel Smith

Joel Smith
Partner, London
+44 20 7466 2331

Rachel Montagnon

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

Tech Disputes webinar series (Episode 2: The evolution of copyright in the digital world)

Webinar: The evolution of copyright in the digital world

Wednesday 3 June, 10am – 10:45am

A review of the key points to consider in dealing with digital copyright, including the communication to the public right and issues around the use of material on the internet, together with a look at how copyright may change, both in the EU with the implementation of the Directive on Copyright in the Digital Single Market, and in the UK, post Brexit without the Directive.

Register here to access a recording of this webinar on-demand. 

Pietro Pouche

Pietro Pouche
Of Counsel, IP, Milan
+39 02 0068 1359

Heather Newton

Heather Newton
Senior Associate, IP, London
+44 20 7466 2984

Laura Adde

Laura Adde
Associate, IP, London
+44 20 7466 7491


The CJEU held that the hiring out of motor vehicles equipped with radio receivers did not constitute a “communication to the public” within the meaning of Art 3(1) of the Directive 2001/29/EC (the “InfoSoc Directive“). The decision in Föreningen Svenska Tonsättares Internationella Musikbyrå u.p.a. (Stim) and Svenska artisters och musikers intresseorganisation ek. för. (SAMI) v Fleetmanager Sweden AB and Nordisk Biluthyrning AB (Case C-753/18) reinforces the distinction between providing a physical facility, which is not a “communication to the public” and actively engaging in the act of communication itself. Continue reading

Herbert Smith Freehills’ IP Podcasts – Episode 3: Architects’ copyright

In episode three of our IP podcast series ‘Architects’ copyright’, Rachel Montagnon and Joanna Silver discuss the problems associated with the use of architects’ designs where specific permissions are not in place, and the impact on development projects, including:

  • What sort of works attract copyright?
  • How could these copyright works be infringed?
  • Who owns copyright in architects’ designs?
  • What licences can be implied if no agreement is in place?
  • Termination of engagement and insolvency situations
  • Escrow and collateral warranties
  • Moral rights
  • What relief can architects claim?

Listen and subscribe here:

Joanna Silver

Joanna Silver
Senior Associate
+44 20 7466 2315

Rachel Montagnon

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

Previous episodes in our Intellectual Property Podcast series…

Episode 1: An introduction to FRAND

The UK Supreme Court is soon expected to hand down its judgment in the appeals of Unwired Planet v Huawei and ZTE v Conversant, concerning FRAND, which were heard together. In advance of the decision itself, this podcast provides a reminder of what FRAND is all about (fair, reasonable and non-discriminatory terms required in the licensing of standard essential patents) and what issues are before the Court, as well as some background to the individual disputes. Presented by David Webb and Rachel Montagnon.

Listen and subscribe here –

Episode 2: ‘Plausibility’ in patent law

Andrew Wells (one of the winners of the 2019 AIPPI prize for UK AIPPI Group’s study questions for his contribution on the plausibility question) and Rachel Montagnon discuss:

  • The concept of ‘plausibility’ in patent law
  • The EPO approach to inventive step and plausibility
  • How plausibility arises in insufficiency arguments
  • The approach of the English courts
  • The future for the concept of plausibility in patent law
  • Practical implications for innovators and patentees

Listen and subscribe here –

EU Copyright Directive published in the EU Official Journal

The Directive on Copyright in the Digital Single Market (the “Directive“) has been published in the EU Official Journal and enters into force on 7 June 2019. Member States then have 24 months, until 7 June 2021, to transpose the Directive into national laws.

The Directive was supported by 19 Member States during its vote in the European Council on 15 April 2019. The UK supported the legislation whilst Poland, Italy, Finland, Sweden, Luxembourg and the Netherlands opposed it. Poland stated that its reason for objection was that the Directive could pave the way to internet censorship. The Directive was finally approved by the European Parliament on 26 March 2019, marking the end of lengthy negotiations and delays.

For further detail on the Directive, please see our previous blog post here. The final text provided the following changes to the numbers:

  • Article 17 (previously Article 13 in the draft) – online content-sharing service providers’ liability for copyright infringing content;
  • Article 15 (previously Article 11 in the draft) – ancillary copyright for press publishers

Further provisions were also added relating to: exceptions and limitations for text and data mining;  collective licensing, and recall, transparency, and fair remuneration rights for owners of copyright.

Articles 17 and 15 proved to be controversial throughout the approval process as we discussed in our earlier blog post here.  The EU Commission is now required to issue guidelines to Member States on the application of “best efforts” requirements, as well as on cooperation with rights holders.

Whether the UK transposes the Directive into national law remains to be seen given the country’s imminent departure from the EU. It will be interesting to see how stakeholders manage the implementation process following the biggest shake up of copyright legislation in decades.


Joel Smith

Joel Smith
+44 20 7466 2331

Elena Hogg

Elena Hogg
+44 20 7466 2590