Herbert Smith Freehills’ Brexit Legal Guide updated – comparison of IP and pharma provisions in the draft Withdrawal Agreement versus the No Deal provisions promised by the UK Government

See the updated IP section of the revised Herbert Smith Freehills Brexit Legal Guide which reviews the IP and pharma elements of the draft Withdrawal Agreement endorsed by the EU Council on 25 November 2018 and the no deal provisions as set out by the UK Government in its technical notices and draft SIs issued towards the end of last year.

Summary

  • 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 sui generis 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 Withdrawal Agreement endorsed by the EU Council on 25 November 2018 (the Draft WA) provides for replacement IP rights to be provided by the UK and for coordination of information between the MHRA and EMA in relation to marketing authorisations.
  • If there is no deal, the UK Government’s own no deal technical notices state that registered rights will be replaced with equivalent rights in the UK and draft statutory instruments have been published confirming this.
  • Should the UK leave the EU with no deal, ie not agree the Draft WA or any other arrangements, the SIs will provide amendments to UK IP law to take account of this, just as they would at the end of the transition period if there were no further agreement in the interim.
  • The Draft WA does not make provision for patents or the UPC, nor for pharmaceutical regulatory issues. These latter were covered in some detail however in a series of no deal technical notices issued by the Government in August 2018 on what the implications of a no deal Brexit would be.

No deal

No deal arrangements for IP rights effectively mirror the provisions set out in the Draft WA in any case, as they provide for replacement of registered rights and the recognition of unregistered rights that are existing in the UK at the date the UK leaves the EU. The main exception is for Geographical Indications. These will no longer be recognised in the UK if originating from the EU. The UK would set up its own geographical indication protection system. In either a no deal or Draft WA situation, UK originating Geographical Indications would not apply in the EU post-Brexit. Similarly the provision made in the Draft WA for the exchange of information between the EMA and the MHRA would not be agreed and would need to be negotiated separately.

The UK Government has said that, in relation to exhaustion, if there is no deal “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”; whereas the Draft WA provides that IP rights that were exhausted both in the EU and in the UK before the end of the transition period under the conditions provided for by EU law shall remain exhausted both in the EU and in the UK post-transition. If there was no deal, this would mean that whilst exhaustion within the EU (as it is then constituted) will continue, the UK courts would be able to exercise local or international exhaustion as they see fit. Historically the UK has taken an international exhaustion approach pre-EU membership.

Read more in the Herbert Smith Freehills Brexit Legal Guide – Intellectual Property and Brexit (including pharmaceutical sector provisions)

Authors

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

Preparations for the UPC continue despite an “unpredictable environment”

The UPC Preparatory Committee has issued a “Status of the Unified Patent Court Project” statement and review of 2018, confirming that there are now 16 states which have ratified the UPC, and that German ratification is still awaited (dependent on the outcome of the complaint pending before the Constitutional Court in Germany) before the project can move into provisional application phase. This latter phase is allows the courts to be prepared and judges to be appointed.

 

Despite the current, somewhat unpredictable environment, the technical and operational preparations are continuing allowing for the project to move at pace in the event of a positive outcome from the German Constitutional Court“.

The press release says nothing more than was already known, but it does confirm that the status of the project is constantly being reviewed, stating that the Chairman of the UPC Preparatory Committee “continues to meet with the Executive Group and the operational team on a monthly basis” and noting that those that have applied for judicial positions in the Unified Patent Court are being contacted separately.

Author

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

Patent and Pharma Update – December 2018

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

This issue reports on several ground-breaking decisions from the UK courts on second medical use patents and skinny labels, infringement by equivalents and the possibility of global FRAND licences for standard essential patents (SEPs).  We also look at some significant decisions from the CJEU on SPCs and reimbursements in relation to medicinal products and a few developments at the European Patent Office. Finally, we provide our usual round-up of the latest UPC developments (this time from Italy) and Brexit-related developments relevant to the pharma sector. Continue reading

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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Patent and Pharma Update – October 2018

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

The CJEU has provided its preliminary ruling in Teva v Gilead on the meaning of Article 3(a) in the context of a medicinal product composed of several active ingredients. It has also clarified principles of IP rights exhaustion applicable to parallel importation of medicinal products from “new” Member States that acceded to the EU after 2003. Closer to home, English courts have handed down some interesting decisions around claim construction, confidentiality clubs and delays in raising new arguments. Finally, as the UK moves closer to the March 2019 Brexit deadline, questions remain as to whether the Unified Patent Court will be set up in time for the UK to participate in the Unitary Patent system. The UK Government has made some progress in setting out its approach to various IP issues in the event of a “no-deal” Brexit by recently publishing several technical notes.

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UK Government launches consultation on role of MHRA post-Brexit and confirms commitment to underwrite Horizon 2020 funding

The UK Government has today launched a consultation on the role of the Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexitseeking views on how the MHRA legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period“. As the consultation closes at 11.45 pm on 1 November 2018, time is short for making a response.

Also today, the Government has released an overview of the UK’s relationship with the EU’s Horizon 2020 science and innovation funding programme including a link to the portal where those with current funding can submit data which will be used to guarantee funding post-Brexit.

MHRA Consultation

  • This consultation was promised in the no-deal technical notice on medicines, clinical trials and medical devices, discussed in our blog post of 29 August 2018. It is expressed to be set in the context of “the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period“, i.e. a “cliff edge” no-deal scenario, with no transitional period. However, if the EU Withdrawal Agreement (which sets out the terms on which the UK leaves the EU and is currently being negotiated between the UK and the Commission) is concluded on the terms that have so far been declared as agreed between the negotiators, then there would be a period until the end of 2020 when the UK would still effectively be part of the EU, despite technically having exited at 11pm on 29 March 2019.
  • A direct link to the consultation can be found here.  More detail on the consultation, including the specific areas being covered, can be found in the Consultation Introduction. As the introduction to states, “the overall approach in no-deal is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level. This would include decisions on Marketing Authorisation (MA) applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities“. The consultation also asks for comments on clinical trials issues.
  • The introduction recommends that you read the Draft Statutory Instrument (SI) text, Impact Assessment and Consultation Annex before responding. The Draft SI text relates to statutory instruments that will be needed to update the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medicines (Products for Human Use) (Fees) Regulations 2016, and the Medical Devices Regulations 2002.
  • Response to the consultation is in the form of an on-line survey. Each section of the survey is optional, so you can limit your response to the sections you are interested in.

Horizon 2020 funding

  • Following on from the no-deal technical notice on Horizon 2020 funding which was issued with the other life sciences related notices in August (here), the UK Government has published an overview of the UK’s relationship with Horizon 2020, followed by a Q&A, which aims to clarify the UK’s eligibility to participate in Horizon 2020 – here. Current UK recipients of Horizon 2020 funding are invited to provide data about their projects on a portal managed by UK Research and Innovation (UKRI) (linked on the same page), so that the UKRI has the information it needs in order to underwrite the guaranteed payments if this becomes necessary.
  • As we previously stated in our blog post: If there is ‘no deal’, the Government says it has taken steps to provide continued support for research and innovation currently being funded through this EU project fund. The Government will guarantee funding in most cases, for the full duration of the project, where the funding relates to successful bids submitted by UK participants before the UK exits the EU. Funding will only be for UK participants however. Where UK participants are leading consortia of non-UK parties and would normally be distributing the Horizon 2020 funds, the Government will seek to discuss with the EU Commission how best to address this. In it’s no-deal notice, the Government said it was considering what other measures may be necessary to support UK research and innovation in the event that the EU’s funding is no longer available. Looking beyond 2020, the notice said that “the UK remains committed to ongoing collaboration in research and innovation and wants to work with the EU on a mutually beneficial outcome“.

Contacts

Jonathan Turnbull
Jonathan Turnbull
Partner
+44 20 7466 2174
Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

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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TRADE SECRETS – SHORT VIDEO ON THE IMPACT OF THE NEW UK REGULATIONS IN IP AND EMPLOYMENT CONTEXTS

Here’s a short video made for Practical Law, in which Herbert Smith Freehills IP and Employment Professional Support Consultants, Rachel Montagnon and Anna Henderson, discuss the impact of the UK’s recent Trade Secrets (Enforcement etc) Regulations 2018 and practical approaches to protecting confidential information and trade secrets.

Key issues discussed are:

  • The new, common definition of a trade secret
  • What constitutes lawful and unlawful acquisition, use and disclosure of a trade secret
  • Practical steps businesses can take to protect confidential information
  • Considerations in relation to whistleblowing
  • Guidance around reverse engineering
  • Bringing a claim under the regulations
  • Remedies and provision for damages.
These new UK trade secrets regulations have implemented the Trade Secrets Directive ((EU) 2016/943) and came into force on 9 June 2018.  Also on our IP Notes blog, see our Milan office’s post on the Italian implementation of this Directive and our previous posting on implementation of the Directive in the UK.

Brexit “No Deal” Technical Notices – lots for the life sciences sector to think about

The UK Government issued the first batch of its Brexit “No Deal” Technical Notices on 23 August 2018. These are designed to provide guidance to businesses and other interested parties on how to deal with the problems that a “no deal” scenario will throw up i.e. if the UK exits the EU at the end of March 2019 with no transitional arrangements in place.

There were 25 notices released in this initial batch (see Herbert Smith Freehills’ general commentary here). Over 50 further technical notices are expected to be published before the end of September.

Of the first notices issues, those that will be of particular interest to life sciences businesses include:

More detail on each of these is provided below. Continue reading

Bulgaria ratifies the Protocol on Provisional Application of the UPC Agreement but delays still in store for the UPC

On 24 July Bulgaria ratified the Protocol on Provisional Application of the UPC Agreement (Protocol). Four more ratifications/declarations are needed, including Germany, for the Protocol to come into effect and allow the practical workings of the Unified Patent Court (UPC) to be established in preparation for the court coming into operation, which will happen once the UPC Agreement (UPCA) itself has been sufficiently ratified.  In both cases, ratification by Germany is a prerequisite. Recently reported comments from the Chairman of the UPC Preparatory Committee have revealed that there may be at least a 6-8 month delay once Germany is ready to ratify the UPCA, given how much needs to be done for the UPC to be ready to open its doors. It therefore looks increasingly unlikely that the UPC will take effect before Brexit unless Germany ratifies the Protocol in the next few months.

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