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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EPO publishes 2018 revision of Guidelines for Examination directed to computer-implemented inventions

The EPO has recently published the 2018 revision to its Guidelines for Examination, which are generally updated annually to take into account developments in patent law and practice. For a complete list of sections that have been amended this year, please see the EPO’s website here. These new Guidelines will come into effect on 1 November 2018.

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

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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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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.

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EU Digital Copyright Directive – European Parliament adopts amended text

In the second reading of the Digital Copyright Directive by the European Parliament on 12 September 2018, the controversial Articles 11 and 13 were adopted but with amendments.

These articles provide for:

  • a specific right of digital reproduction for the press in relation to their publications under Article 11, which includes the right to prevent others from reproducing their material (amendments shown here in italics):  “Member States shall provide publishers of press publications with the rights provided for in Article 2 and Article 3(2) of Directive 2001/29/EC so that they may obtain fair and proportionate remuneration for the digital use of their press publications by information society service providers“.  These rights would not be retrospective and would expire 5 years from publication (calculated from the first day of January of the year following the date of publication).  Personal, non-commercial use is not to be caught by this provision and mere hyperlinking is to be allowed). However,”Member States shall ensure that authors receive an appropriate share of the additional revenues press publishers receive for the use of a press publication by information society service providers“.
  • protection of the interests of rights-holders in protected material which is communicated to the public via online content sharing services under Article 13: The providers of these services store and give access to large amounts of works and other subject-matter uploaded by their users and the amended text requires them to ensure its integrity and security and agree licence terms for such use or to prevent works being made available if requested by the rights-holders. Complaints procedures must also be provided for, including “human review”.

However, since the adopted text is not the same at the European Parliament’s first reading, the text now needs to go through the informal trialogue negotiations procedure. This involves discussions of the text between the European Parliament, Council and Commission in order to establish an agreed text, which may take some time The negotiation of these provisions will be followed with great interest by the major online platforms, content industry and publishers.

The adopted text can be viewed here.

Author

Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, London
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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

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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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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
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+44 20 7466 2217

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THE TASTE OF FOODS CANNOT BE PROTECTED BY COPYRIGHT, SAYS THE AG

On 25 July 2018, Advocate General Wathelet issued his opinion in an interesting case pending before the Court of Justice of the EU (CJEU) (C-310/17) concerning copyright over the taste of a food product.

The AG took the view that EU law precludes the taste of food from being protected by copyright, essentially because:

  • the notion of “literary and artistic works” in the Berne Convention includes only subject-matter that can be perceived through sight or hearing, therefore implicitly excluding those perceivable through other senses like taste, smell or touch; and
  • artistic works should be identified in a precise and objective manner in order to allow third parties to understand their scope of protection. This is not the case for the taste of food products.

Business impact

This case is particularly interesting as it is the first time that the CJEU will rule on the copyright of the taste of a food product and, more generally, on the notion of copyright work which is not defined under Directive 2001/29/EC (“InfoSoc Directive”).

Food scientists in major food businesses may be disappointed not to obtain a new layer of protection for creating new tastes.

The opinion of the AG confirms the difficulty of ensuring copyright protection for the taste of a food product, as well as for perfumes, as observed in the field of trade marks.  Even though the new EU Trade Mark Regulation does not require a sign (any longer) to be capable of being graphically represented in order to be registered as a trade mark, in practice it is not yet possible to register a taste or a smell as a trade mark as the subject-matter of protection cannot be determined with clarity and precision with generally available technology.

If the CJEU were to follow the opinion of the AG in its Judgment, many producers of food products and perfumes will remain disappointed that their creative efforts are not recognised by legal protection through copyright. Continue reading

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