Post Brexit intellectual property rights
The Withdrawal Agreement Implementation Bill has been passed into legislation by the UK government, and the UK left the EU on 31 January 2020.
A transition period, during which the UK will abide by EU legislation, has begun and is likely to end on 31 December 2020. There is an option to extend the transition period for a further two years but the UK Government has already indicated that it has no desire to do so; indeed, it has legislated for a commitment not to agree to any extension.
During the transition period there are no changes regarding the filing, scope and protection of EU trade marks and EU design rights.
The UK Government has put in place legislation that will guide how intellectual property rights affected by the UK’s departure from the EU will be dealt with from the end of the transition period. Full details of these are published below.
D Young & Co’s services will remain unaffected by the UK’s departure from the EU with offices in both the UK and Germany. If you have any queries about your intellectual property rights either pre or post Brexit please do not hesitate to get in touch with your usual D Young & Co contact or email us on email@example.com.
This guide was last reviewed 04 February 2020.
Post Brexit: trade marks
During the transition period there are no changes regarding the filing, scope and protection of EU trade marks.
After the transition period UK businesses can still apply for and hold EU trade marks in the same way they can apply for and hold trade marks for other overseas jurisdictions, however EU trade marks will be valid in EU member states only and will no longer be protected in the UK. The Withdrawal Agreement ensures that, after the end of the transition period, EU trade marks will continue to be protected and to be enforceable in the UK by providing an equivalent trade mark registered in the UK.
EU trade mark registrations
All registered EUTMs will be cloned into new UK registrations at the end of the transition period. The new registered trade mark will be referred to as a comparable trade mark (EU), and will be created automatically and at no cost to the registered owner. The trade mark will have the same legal status as if it had been applied for and registered under UK law. The registration will retain the filing date recorded against the corresponding EUTM and will also inherit any priority and/or seniority dates. The registration will retain its existing EUTM registration number but will be prefixed with UK0009…. so it is easily identifiable as a comparable trade mark (EU). To identify UK rights created in respect of international registrations, the number allocated to the comparable trade mark will be the last 8 characters of the international trade mark (EU) prefixed with "UK008". No certificate of registration will be issued but owners of this new right will be able to access the information online. The “comparable trade mark (EU)” will be a fully independent UK trade mark which can be challenged, assigned, licensed or renewed separately from the corresponding EUTM.
EU trade mark registration opt out
There is a provision to opt out if the EU trade mark owner does not wish to own a comparable trade mark (EU), however it is not possible to opt out if the mark has been put to use in the UK by the registered owner or with their consent; if the mark is subject to an assignment, licence, security interest or other agreement or document; or if there are pending proceedings based on the comparable trade mark (EU). The UKIPO has created a new notice template to use for this purpose.
Opt-out requests can only be made after the transition period. Any requests made before the end of the transition period will not be valid. A form relating to this request will be available after the transition period. It is a legal requirement to advise interested third parties for the opt out to have effect. You must confirm that such action has been taken.
If an opt out has been exercised in circumstances where it was not permitted, the comparable trade mark may be reinstated.
EU trade mark applications
EUTM applications which are pending at the end of the transition period can be re-filed as a new UK trade mark application within a period of nine months from the end of the transition period, maintaining the filing date, priority date or seniority date. The trade marks must be identical and seek protection for the same goods and services to the EUTM or contained within the corresponding EUTM application. It will be subject to the usual application processes in the UK. The UKIPO has confirmed that current official filing fees will apply: £170 for one class of goods/services and an extra £50 for each additional class.
Be aware that if you file a UK trade mark application that does not correspond to a pending EUTM application in the nine months after the end of the transition period a third party could file a UK application after yours and claim the date of an earlier corresponding EUTM application that was pending at the end of the transition period. Where this happens the later-filed UK application will take precedence.
International trade mark registrations designating the EU
All international trade marks which have designated the EU will be protected in the UK as comparable trade marks (EU). These rights will be the equivalent of a UK national trade mark registration and will not be treated as a trade mark designated under the Madrid Protocol System.
EU trade mark registrations – renewals
The comparable trade mark (EU) will retain the same renewal date as the corresponding EUTM. Once the comparable trade mark (EU) has been created a separate renewal fee will be due in both the EU and UK.
Where the comparable trade mark (EU) is due for renewal in the six months after the transition period, a renewal reminder from the UKIPO will be sent to the holder on the renewal date (or as soon as possible thereafter). Holders will be provided with a further six month period (running from the date of the reminder letter) for the comparable trade mark (EU) to be renewed in the UK. Standard official renewal fees will apply: £200 for one class and £50 for each additional class. No late renewal fee will be charged by the UKIPO during this six-month period.
Where an EUTM is due for renewal after the transition period, early payment of the fee with the EUIPO, prior to the end of the transition period will have no effect and renewal fees will still be payable at the UKIPO.
EU trade marks which have expired before the end of the transition period
A comparable trade mark (EU) will be created in the following scenario:
- The EUTM was due for renewal in the six months prior to the end of the transition period.
- The EUTM has not been subject to a late renewal action at the EUIPO.
- The EUTM is still within its six month late renewal period.
In the above scenario the comparable trade mark (EU) will hold an expired status and its continued effect in the UK will be dependent upon late renewal of the corresponding EUTM at the EUIPO. Where the EUTM is subsequently renewed as a late renewal the comparable trade mark (EU) will automatically be renewed in the UK and no renewal fees will need to be paid to the UKIPO.
If the EUTM is not renewed at the EUIPO, the comparable trade mark (EU) will be removed from the UK register after the original EUTM’s late renewal period, but with effect from the end of the transition period.
EU certification and collective marks
The UKIPO will create comparable rights before the end of the transition period. The regulations governing use of the EU mark at the time of creating the comparable mark will not be automatically imported onto the UK Register. The UKIPO will only contact the holder to provide an English translation of the regulations relating to the comparable right when needed, for example, if the comparable mark is subject to proceedings. In this instance, an English language version of the regulations will be required. Failure to provide a translation of the regulations requested may result in loss of the right.
Pending EU trade mark oppositions
Oppositions that have already been filed against a pending EU application will continue before the EUIPO. However if earlier UK rights are the only basis of your opposition and the proceedings are not decided by the end of the transition period, the opposition will be unsuccessful and you will need to consider filing a fresh UK opposition against any later filed UK trade mark. We understand that this position is currently being challenged and will update you if this position changes.
In contrast, the UKIPO will ensure that all actions before it which rely on a EUTM which are ongoing after the transition period will continue to be heard and will be decided on the basis of the law as it stood prior to the end of the transition period.
EU trade mark cancellation proceedings
Where an EUTM is subject to revocation and/or invalidity proceedings which are ongoing on the last day of the transition period, the UK comparable trade mark (EU) will ultimately suffer the same fate as the EUTM, that is, if the EUTM is held to be invalid then the UK comparable trade mark EU will also be held to be invalid and the date of effect of the declaration of cancellation in the UK will be the same as in the EU.
Use of an EUTM, whether inside or outside of the UK, which has been made prior to the end of the transition period will count as use of the comparable trade mark (EU).
Where the relevant period for use includes time prior to the end of the transition period, use in the EU will be considered. However, where the relevant five-year period includes time after the end of the transition period, use of the “comparable trade mark (EU)” in the UK will also have to be shown.
In all cases, the five-year period of suspended use is activated by last use of the corresponding EUTM registration or comparable trade mark. Where that use was made in the EU before the end of the transition period (whether inside or outside the UK), it will count for the purposes of the comparable trade mark.
A similar approach is being adopted in relation to reputation. The reputation of the corresponding EUTM in the EU prior to the end of the transition period (but not necessarily the UK) will be considered for the purposes of the comparable trade mark (EU).
Where an EUTM is the subject of an assignment prior to the end of the transition period which has not been recorded on the EUTM Register the comparable trade mark (EU) will be created in the name of the assignor. Both the assignor and assignee will have the right after the transition period to apply to the UKIPO for recordal of the assignee as owner of the comparable trade mark (EU) to stand.
Licenses and security interests
EUTMs which are the subject of a licence or security interest which authorise actions in the UK will continue to have effect in the UK. The licence or security interest will be treated as if it applies to the comparable trade mark (EU). However, the recordal of these rights will not be automatic. Where a license or security interest is already registered at the EUIPO before the end of the transition period the UKIPO will extend the period within which such transactions must be recorded on the UK Register for a comparable trade mark (EU) to 12 months from the end of the transition period. If you have any licences recorded against your EUTM that should be re-recorded against the comparable trade mark (EU), please contact us.
Any licensee should be notified of the new comparable trade mark (EU) and checks should be made to ensure the creation of the new comparable trade mark (EU) does not breach any existing agreement.
EU trade mark registrations and applications reinstated after the end of the transition period
These trade marks will not automatically be cloned into comparable trade marks (EU). The holder of these trade marks will need to make a specific request to the UKIPO to create a comparable trade mark (EU). Reinstatement of EU rights will only be considered if an application is made to the EUIPO within 12 months of the missed deadline.
If an EUTM registration is reinstated after the end of the transition period and you have not been granted a comparable trade mark (EU), the UKIPO needs to be informed within six months.
If you have a pending EUTM application which was reinstated after the end of the transition period and holds a filing date before the end of the transition period, you may submit a UK trade mark application claiming the earlier EU filing or priority date. This must be actioned within nine months of the date the corresponding EUTM application was restored.
EU trade mark registration – conversion
Eligible EUTMs which are in the three month period to request conversion into a national right at the end of the transition period will not be included in process of cloning into a comparable trade mark (EU). However, their entitlement to convert into a UK trade mark will be respected. Applications for conversion after the transition period should be made to the UKIPO within the usual three month period.
EUTM injunctions granted before the end of the transition period
Pan-EU injunctions granted by the UK courts on the basis of EUTMs prior to the end of the transition period will remain in place and be effective in the UK and the remaining EU member states. The position is likely to be the same in relation to registered Community designs.
EUTM injunctions post-Brexit
After the transition period there are likely to be a small number of ongoing cases relating to EUTMs before the UK courts. These cases will continue to be heard as if the UK were still an EU member state, however, the UK courts will not be able to grant pan-EU injunctions (or other pan-EU relief) Similarly courts in member states of the EU will not be able to grant injunctions and/or other relief that extends to the UK. The position is likely to be the same in relation to registered Community designs.
Customs applications for action (AFAs)
UK national and EU Customs AFAs granted by the Customs authorities in the UK will continue to remain in place in relation to the UK only. Any EU AFAs granted by the Customs authorities of another EU member state will no longer cover the UK. Importantly, EU AFAs granted by the UK Customs authorities will no longer cover remaining member states of the EU after the transition period.
Post Brexit: designs
To help businesses prepare, the UK Parliament has passed legislation (The Designs and International Trade Marks (Amendment etc) (EU Exit) Regulations 2019) that will ensure that EU designs will continue to be protected and to be enforceable in the UK by providing an equivalent design registered in the UK. The legislation will come into force at the end of the transition period.
Registered Community designs
The UK Government has confirmed through the legislation that it will ensure that an equivalent enforceable registration will be provided for existing registrations which are fully published. The legislation will also apply to international (Hague) design registrations after the transition period, which designate the EU, and which are published and deemed accepted by the EUIPO. The creation of the equivalent design registration in the UK will be at minimal administrative burden, and seemingly without cost to the registered owner. The registered owner will be informed that a UK right has been granted, but will have the option to opt out.
Pending registered Community designs
For Community designs which are pending at the time of the end of the transition period, or which are registered but not yet published (as a result of deferred publication), the UK Government will provide an option for the applicants to apply for the same protection in the UK within a period of nine months after the end of the transition period, maintaining the date of filing (and priority) of the EU application. This re-application process will also apply to international (Hague) design registrations after the end of the transition period, which designate the EU, and which are either unpublished; still at the application stage; or which are not yet deemed accepted by the EUIPO.
Unregistered Community designs
The UK Government has confirmed that any unregistered Community design right arising before the end of the transition period will continue to be valid for the remaining period of protection. In addition, the UK is creating a supplementary unregistered design right which mirrors the features of the unregistered Community design; this is welcome as it should mean that design features including surface decoration (for example, 2D logos) can be protected under unregistered design law in the UK going forward.
New UK registered designs
It has been made clear that the filing of a new UK trade mark or design application, in the designated nine month period, will be at the usual cost and subject to the usual application processes in the UK.
UK registered design numbering system
For UK registered designs that are re-registered from an existing EU registered design, the UK registered design number will consist of the full 13-digit number assigned to the EU registered design, but prefixed with the digit “9”.
|Existing EU design number||Re-registered UK design number|
For existing international registered designs that designate the EU, the number allocated to the corresponding UK registered design will consist of the full international design number prefixed with the digit “8”.
|Existing international design number||Re-registered UK design number|
|D069640-0001 (DM/069 640)||806964000010000|
|D069629-0001 (DM/069 629)||806962900010000|
|D069629-0002 (DM/069 629)||806962900020000|
Registered Community designs – renewals
The re-registered UK design registration will retain the same renewal date as the corresponding EU registered design. Once the re-registered UK design registration has been created a separate renewal fee will be due in both the EU and UK.
Where the re-registered UK design registration is due for renewal in the six months after the end of the transition period, a renewal reminder from the UKIPO will be sent to the holder on the renewal date (or as soon as possible thereafter). Holders will be provided with a further six month period (running from the date of the reminder letter) for the re-registered UK design registration to be renewed in the UK. Standard official renewal fees will apply and we understand no late renewal fee will be charged by the UKIPO during this six month period.
Where an EU registered design is due for renewal after the end of the transition period, early payment of the fee with the EUIPO, prior to the end of the transition period will have no effect and renewal fees will still be payable at the UKIPO in respect of the re-registered UK design registration.
EU registered designs which have expired before the end of the transition period
A re-registered UK design registration will also be automatically created in the following scenario:
- The EU registered design was due for renewal in the six months prior to the end of the transition period.
- The EU registered design has not been subject to a late renewal action at the EUIPO.
- The EU registered design is still within its six month late renewal period.
In the above scenario the re-registered UK design registration will hold an expired status and its continued effect in the UK will be dependent upon late renewal of the corresponding EU registered design at the EUIPO. Where the EU registered design is subsequently renewed as a late renewal the re-registered UK design registration will automatically be renewed in the UK and no renewal fees will need to be paid to the UKIPO.
If the EU registered design is not renewed at the EUIPO, the re-registered UK design registration will be removed from the UK register after the original EU registered design’s late renewal period.
EU registered design invalidity proceedings
Where an EU design is subject to invalidity proceedings which are ongoing on the last day of the transition period, the new UK registered design will ultimately suffer the same fate as the EU design, that is, if the EU design is held to be invalid then the new UK registered design will also be held to be invalid and the date of effect of the declaration of invalidity in the UK will be the same as in the EU.
Customs applications for action (AFAs)
UK national and EU Customs AFAs granted by the Customs authorities in the UK will continue to remain in place in relation to the UK only. Any EU AFAs granted by the Customs authorities of another EU member state will no longer cover the UK. Importantly, EU AFAs granted by the UK Customs authorities will no longer cover remaining member states of the EU after the transition period.
Post Brexit: exhaustion of rights
Currently, IP rights are considered “exhausted” once goods have been placed on the market by the IP owner or with the owner’s consent anywhere within the European Economic Area (EEA), namely the member states of the European Union plus Iceland, Liechtenstein and Norway.
IP rights in relation to goods which are being imported into the UK from an EEA country will continue to be considered as exhausted during the transition period, and it seems, at least for a temporary period after the transition period. The UK Government is considering options for what exhaustion regime should apply after the end of such temporary period. The position relating to exports from the UK may well be different after the transition period, if the UK and EU fail to reach agreement during the transition period. Therefore, there could be restrictions when the transition period ends on the parallel import of goods from the UK into the EEA.
Post Brexit: geographical indications
The UK Government has confirmed that it will set up its own GI schemes which will be WTO TRIPS compliant, broadly mirror the current EU regime and be no more burdensome to producers. This will apply from the end of the transition period.
A public consultation has been held to include the UK GI logo and appeals process. The protections will be similar to those enjoyed now by UK GI producers, with all 86 UK GIs given new UK GI status automatically. There are two issues for UK producers of GI products to consider:
- the use of a new UK logo on products marketed in the UK
- the preparation of an application for GI status in the EU, or other steps that producers may wish to take in order to protect product integrity – for example, applying for trade mark protection.
On this second point the UK Government guidance anticipates that all current UK GIs will continue to be protected by the EU’s GI schemes. If that does not occur producers might consider protecting their products by applying for EU collective marks or EU certification marks.
A further point is that the UK would no longer be required to recognise EU GI status. EU producers would be able to apply for UK GI status. This particular point has been highlighted by the EU negotiators as being very important and requires a clear resolution before a final deal is reached. We assume there is a concern, for example, that without a deal, in theory, "British Champagne" may be a possibility.
The guidance advises that “We aim to give businesses and individuals as much certainty as possible as soon as we can, and to ensure that any new requirements are not unduly burdensome.”
Post Brexit: .eu domain names
Having published advice in the event of a no-deal scenario during 2019, EURid (the registry responsible for the day-to-day running of the .eu top level domain) issued an update on 16 January 2020 stating its “entire plan outlined below is on hold.” EURid has indicated that it will issue an update upon receipt of further instructions from the European Commission. We are monitoring the situation and will update this guide as and when this information is made available.
As of 19 October 2019, only (i) EU citizens (independently of where they live), (ii) EU and EEA residents, and (iii) organisations, businesses and undertakings established within the EU or EEA are allowed to register or hold a .eu domain name. Holders of .eu domains are therefore strongly advised to check whether they meet the above eligibility criteria as soon as possible.
EURid has set out the following steps for UK registrants in the event of a "no deal" scenario:
Before exit day
You will receive an email notification from EURid one week prior to exit day and again the day after exit day notifying you that your .eu domain name will soon no longer be compliant with the .eu regulatory framework.
Your .eu domain name will remain active and can continue to be used for a period of two months from exit day (the “grace period”). This will give you an opportunity to demonstrate compliance with the .eu regulatory framework. During this grace period, you will not be able to register a .eu domain name, or extend the term of your current .eu domain name if you are not compliant.
If you have failed to demonstrate eligibility within the grace period, your .eu domain name will be withdrawn and will become inoperable (meaning you will not be able to access your .eu websites or emails thereafter).
Exit day + one year
All affected domain names will become available for general registration one year after exit day.
If you are eligible: you are strongly advised to contact your domain name registrar in order discuss whether you will need to provide proof of eligibility. If proof of eligibility is required, this should be completed by no later than the expiry of the grace period as it is currently unclear whether it will be possible to do so after this date.
If you are not eligible: you are strongly advised to:
1. check your domain name expiry date and consider whether to renew it ahead of exit day if the domain name is due to expire within the grace period;
2. discuss the possibility of transferring your internet presence to another top level domain (such as .com, .co.uk, .uk, etc.);
3. consider seeking advice from your local domain name registrar on whether the terms of your contractual agreement provide for any recourse in the event of withdrawal or revocation of a .eu registration;
4. consider developing a migration plan for services and functions that your .eu domain name, website or associated email address is linked to or supports, such as:
a. .eu email addresses that access critical business processes, including online banking services, online payment providers, government services like HMRC online, or payment verification systems,
b. .eu email addresses that access services that use an email and password for registration, including membership organisations and clubs, social media, and two-factor authentication services,
c. .eu email addresses used to communicate with customers, clients, internal communications or to distribute mailing lists,
d. .eu websites or email accounts that holds data that you need to transfer before any loss of access,
e. virtual private network (VPN) or other services that use your .eu domain name, and
f. trade mark or intellectual property rights impacted by the loss of your .eu domain name; and
5. seek legal advice.
Similar eligibility restrictions may apply to EU member state country code top level domains such as .fr or .it.
Please also note that following Brexit, with the exception of "well known marks" (as defined under Article 6bis of the Paris Convention), IP rights holders will no longer be able to rely on their UK registered or unregistered rights when seeking to challenge .eu domain names that are subject of speculative and abusive registration.
Post Brexit: patents & the UPC
There is no change to the way patents can be filed and prosecuted. It is business as usual.
The UK will continue to be a member of the European patent system, which is governed by the EPC, a treaty between contracting states to the EPC that is, and will remain, completely separate from the EU.
A number of non-EU members, such as Norway, Switzerland and Turkey, have long been EPC contracting states. Accordingly, the UK's exit from the EU simply means that the UK will join these other EPC contracting states who are not members of the EU. It will not change the EPC in any way.
The UK exit from the EU has no effect on our ability to represent clients before the EPO. There will be no change in our ability to file or prosecute patent applications or our ability to file or defend oppositions to granted patents. The UK Government also explicitly notes that, separate to UK patent matters, European patent attorneys based in the UK, such as D Young & Co, can continue to represent applicants before the European Patent Office (EPO), since it is not an EU body; this has also been confirmed by the EPO itself.
Patent protection in the UK will continue to be available via the EPO by validating granted European patents in the UK after grant, and our European patent attorneys will continue to act in the usual way in all matters before the EPO.
European patent applications may still designate all contracting and extension states and we will continue to be able to secure protection across the EPC.
Unitary patent and Unified Patent Court
The Unified Patent Court will hear cases relating to European patents and the new unitary patent – both administered by the non-EU European Patent Office (EPO). The Unified Patent Court will be an international patent court established through an international agreement (the Unified Patent Court Agreement) between the EU countries.
There is a possibility that the Unified Patent Court will not be fully ratified and never come into effect. In this case there will be no changes for UK and EU businesses at the point that the UK exits the EU.
In the event that the Unified Patent Court comes into force after the UK has left the EU, then UK, EU and third country businesses will still be able to use the Unified Patent Court and unitary patent to protect their inventions within the EU, and they will be able to validate the UK upon grant of an EP application as before. UK business will still be able to use the Unified Patent Court and unitary patent to protect their inventions within the other contracting EU countries.
Correspondence addresses and confidentiality
European patent attorneys based in the UK will continue to represent applicants before the European Patent Office, since it is not an EU body. Conversely meanwhile, although prosecution of UK patents is by UK patent attorneys, it is possible for the owner of a UK patent to have an address for service elsewhere in the EEA.
In light of this, the UK Government has now provided assurance that this will continue, and that there is no plan to change current client-attorney privilege for non-UK attorneys in the EEA.
EU Biotech Directive
The UK Government proposes to retain the existing EU law (EU Biotech Directive) relating to biotech inventions after exit day. Therefore, the legal requirements for patenting biotech inventions will remain in place - these requirements are already implemented in UK national patent law. Patent examiners will continue to apply the same law when examining 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.
Post Brexit: supplementary protection certificates and regulatory protection
The UK will essentially retain the existing EU law relating to SPCs after the transition period. The SPC regime in the UK will continue to operate as before. In particular, the requirements for obtaining an SPC, and the process for applying for an SPC, will be largely unchanged.
D Young & Co will continue to be able to represent clients in relation to SPCs. Although SPCs are based on EU legislation they are national rights, so the filing of SPCs will remain unchanged. There will be no change in our ability to file UK SPCs, nor in other EU countries on which we continue to instruct our trusted network of SPC agents as now.
New SPCs based on UK marketing authorisations
The UK legislation which will take effect after the end of the transition period essentially mirrors the existing EU SPC Regulations. However, after the transition period a UK national marketing authorisation (MA) will be required for both medicinal products and plant protection products in order for the product to be entitled to a UK national SPC. The deadline for applying for an SPC will be unchanged, at six months from the grant of the UK MA, and the same documentation and evidence will be required.
Existing SPCs based on EU marketing authorisations
The EU-wide MAs granted for medicines by the European Medicines Agency (EMA) after the transition period will no longer apply to the UK and will not be available to support UK SPCs filed after the transition period.
As indicated below, all existing granted EMA MAs will be “cloned” into UK MAs after the transition period. For existing pending or granted UK SPCs based on EMA MAs, the applicant may be asked to provide information on the cloned UK MA, so that this can be recorded on the SPC section of the Patents Register. This will not affect the validity of the SPC and we will be able to attend to such a request if the UKIPO issues it.
Duration of SPCs
The duration of SPCs, regardless of whether filed before or after the end of the transition period, will remain the same - based on 15 years from either the UK MA date, or the date of the first MA in an EEA member state, whichever is sooner. The term of the SPC, as now, will be capped at five years from the expiry of the basic patent.
New UK paediatric extensions to SPCs
The six-month extension will remain available after the transition period for SPCs for medicines on which agreed paediatric studies have been carried out. For paediatric extensions filed after the transition period, the requirements will largely be the same as previously, and the process of applying for an extension will remain the same - though existing UK legislation will also apply to the availability of this extension.
Applicants will still be able to make the request at the same time as filing the SPC application, or at any point up to two years before the SPC expires. The main difference is that it will no longer be necessary to show that the product is authorised in all EEA member states: it will only be necessary to show it has an MA in the UK. As now, the six-month paediatric extension will not be available for orphan medicines, which will instead retain the additional two years’ market exclusivity as set out below.
Existing UK Paediatric extensions to SPCs
The existing EU legislation will continue to apply for paediatric extensions to SPCs for medicines which are pending or granted before the end of the transition period. In particular, for such extensions, it will still be necessary to show that the product is authorised in all EEA member states.
SPC manufacturing waiver
EU legislation introduced in 2019 provided for a waiver from SPC protection which allows third party manufacturers to make SPC-protected medicines for export outside the EU. It also allows making and storage of medicines during the last six months of an SPC ready for sale in the EU after the SPC expires.
Under the EU legislation, the waiver will initially only apply to SPCs that are applied for on or after 01 July 2019. From 02 July 2022, it will also apply to SPCs that were applied for before 01 July 2019, but only if they had not taken effect before 01 July 2019. It is also subject to a number of conditions.
This EU legislation will be maintained after the transition period, subject to fixes to confirm it is working correctly as UK legislation. Following a consultation, final legislation on this matter will be passed by the UK Parliament.
Post-Brexit: regulatory-based protection for medicines
After the end of the transition period, there will also be changes in the regulation of human and veterinary medicines and the various forms of regulatory-based protection available. For medicines, existing MAs granted centrally by the EMA will automatically be converted into UK MAs after the transition period. Existing UK MAs based on the mutual recognition or decentralised procedures will be unaffected.
Data and market exclusivity
Regulatory data and market exclusivity will remain available based on UK MAs after the transition period, and the period of “8+2+1” years for this form of regulatory protection will remain unchanged. After the transition period the start of this period will be the date of marketing authorisation in the EU or UK, whichever is earlier.
A dedicated regulatory system for orphan medicines (for the treatment of rare diseases) will continue after the transition period, and a specific UK orphan MA will be granted for such medicines. This will largely mirror the existing EU system, but will also include a number of UK-specific matters such as the prevalence of the disease in the UK, the availability of satisfactory alternative treatment methods in the UK and the significant benefit of the product.
The 10 year market exclusivity for orphan medicines will remain after the transition period. This will also begin on the date of authorisation in the EU or UK, whichever is earlier. Orphan medicines for which agreed paediatric studies have been carried out will, as now, be entitled to an additional two years’ market exclusivity. However, the pre-marketing EU orphan designation for medicines will not be replicated in the UK: orphan status will be decided upon at the time marketing authorisation is granted.
Post-Brexit: exemptions from patent infringement for clinical trials
The UK will retain the existing “EU Bolar” law which exempts from patent infringement trials carried out on generic medicines in order to obtain regulatory approval, for marketing after the patent expires. Existing legislation which exempts from patent infringement the various studies, trials and tests carried out on a pharmaceutical product in order to gain regulatory approval anywhere will also remain in force.
Post Brexit: copyright
With regard to copyright, the UK Government explains that, as a result of the UK’s membership of the main international treaties on copyright (which will not be affected by Brexit), the scope of protection will remain largely unchanged. Further, the EU Regulations and Directives on copyright and related rights will be “ported” into UK law under the EU Withdrawal Act 2018. It explains, therefore, that the immediate issue will primarily be one of reciprocity of those EU Regulations and Directives.
It identifies, among others, the following issues:
Sui generis database rights
Currently, businesses in European Economic Area (EEA) member states (such as the UK) are eligible for database rights in each member state (broadly, these rights do not arise in relation to databases created by non-EEA businesses).
At the end of the transition period, database rights currently in existence will continue to exist in the UK and the EEA for the rest of their duration. However, only UK citizens, residents and businesses will be eligible for new database rights in the UK. Similarly EEA member states will be under no obligation to grant new database rights to UK businesses in those member states. In light of this the UK Government recommends reviewing existing licensing arrangements and, where possible, imposing licensing terms which mitigate this potential loss of rights.
Portability of online content service
Before and during the transition period, UK consumers can access their online content services (for example, Netflix) when they temporarily travel to another EU member state. The same is true for EU customers temporarily visiting the UK. Portability of online content services between the UK and EU will cease at the end of the transition period. Consequently UK customers visiting the EU and EU customers visiting the UK may see restrictions to the content ordinarily available to them when in their home state.
Country-of-origin principle for copyright clearance in satellite broadcasting
Currently, if a satellite broadcaster clears the copyright requirements in its “home” member state it can broadcast into any other EEA member state. This will cease to apply to broadcasts from the UK after the end of the transition period and UK-based satellite broadcasters that currently rely on the country-of-origin copyright clearance rule when broadcasting into the EEA may need to clear copyright in each member state to which they broadcast. The UK will continue to apply the country-of-origin principle to broadcasts from any country. Wider issues regarding broadcasting and video on demand are addressed in the UK government’s specific guidance on this issue.
Prior to and during the transition period, cultural heritage institutions established in a member state of the EEA are entitled to digitise orphan works in their collection and make them available online across the EEA without the permission of the right holder. The UK Government explains that UK-based cultural heritage institutions that continue to do this may be infringing copyright.
Therefore, except for those in specialised industries (such as broadcasting) or with specific copyright portfolios (such as those with database rights), businesses are unlikely to be significantly affected, at least immediately, following the transition period.
Post Brexit: plant variety rights and marketing of seed and propagating material
Any community plant variety rights (CPVR) which have been granted, including those held by UK business, will be automatically recognised in the remaining 27 EU member states and will be automatically recognised and given protection under the UK Plant Varieties Act.
CPVR applications which have not been granted by the end of the transition period will not be extended to cover the UK. To obtain protection in the UK, a separate application for rights in the UK will need to be made following the usual process for UK plant variety rights, using the same priority date and distinctiveness, uniformity and stability (DUS) test.
For new varieties after the transition period, two separate applications – a CPVR and a UK PVR - will need to be made to achieve the same geographical coverage which is presently achieved by one application. The cost implications for breeders are being reviewed by the Animal and Plant Health Agency (APHA). It appears that DUS tests from the EU may be accepted by the UK but that the Community Plant Varieties Office will not accept the results of UK DUS testing.
Marketing seed and propagating material
Business wishing to market seed and propagating material in both the EU and the UK will need to separately apply for listing in the EU Common Catalogue and the UK National Listing.
The UK will apply for its certification processes to be considered as a “third country recognised by the EU as equivalent for seed certification”.
Varieties that are already registered on the EU Common Catalogue but are not on the UK National Listing, are currently being added to the UK list which will allow them to be marketed for a period of two years after the transition period. Any business wanting to add varieties to the National List in this way should contact APHA. After the two year interim period, businesses will need to comply with the new UK arrangements.