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.
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.
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 scheme “which 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:
- Trade marks and designs
- Geographical Indications
- 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.
Filed under Agribio, Consumer, Copyright (and related rights), Designs and Databases, EU, France, Italy, Media and Advertising, Patents and SPCs, Pharma, Trade marks, Passing off, Geographical indications, PDOs, UK
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:
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.
Rachel MontagnonProfessional Support Consultant, LondonEmail
+44 20 7466 2217
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
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.
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.
Rachel MontagnonProfessional Support Consultant, LondonEmail
+44 20 7466 2217
Filed under Consumer, Copyright (and related rights), Designs and Databases, EU, Patents and SPCs, Pharma, Trade marks, Passing off, Geographical indications, PDOs, UK
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.
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