Intellectual Property

Overview

Intellectual Property
Last updated: 30 August 2017

Bird & Bird's EU Legislation Tracker highlights Regulations and Directives scheduled to take effect or to be implemented by Member States in the period to the UK's departure from the EU. It does not provide an exhaustive survey. Instead, we have sought to summarise some of the key legislation, both draft and finalised, which we are tracking in the run up to Brexit and which are likely to be of interest to companies which do business in the UK and/or elsewhere in Europe. 

The Tracker includes a short commentary on the substance of each of the measures identified, and a timeline for their known or likely effective dates (for Regulations) or implementation deadlines (for Directives). These are colour coded by reference to the likely date of Brexit.

For the purposes of the Tracker, we have assumed that the UK will exit the EU two years from its service of Article 50 notice (i.e. 29th March 2019). Ultimately the UK's Great Repeal Bill will determine whether the UK will retain, implement, amend or repeal the legislation summarised in our Tracker and the date when this will happen.

Key
Implementation status 
  Implementation deadline/effective date likely to be pre-Brexit
  Implementation deadline/effective date likely to be post-Brexit
 
 Timeline    EU legislation
 

Takes effect: 

[Likely Q2 - Q4 2017?]

 
The Unitary Patent and Unified Patent Court  - Regulation 1260/2012 & 1257/2012

Overview:

The Unitary Patent - Regulation 1260/2012 & 1257/2012
The European patent with unitary effect ("Unitary Patent") was created on 17 December 2012 when the Council of the European Union approved two Regulations (The Unitary Patent - Regulation 1260/2012 & 1257/2012). The aim is to create a single system whereby establishing patent protection across Europe is easier and more effective. Once granted, a unitary patent will provide uniform protection in all participating countries.

The Unified Patent Court (2013/C 175/01)
The Agreement on the Unified Patent Court ("UPC") was signed as an intergovernmental treaty in February 2013 by 25 countries to set up a supranational court. The UPC will have jurisdiction over Unitary Patents (as well as traditional European Patents granted in UPC member states), where a single action will cover all participating countries.

For the Unitary Patent system to enter into force, 13 of the signatories must deposit their instrument of ratification or accession with the General Secretariat of the Council of the EU (including France, Germany and the UK). To date, fourteen member states have ratified; but Germany and the UK have not yet done so. The Agreement on the UPC will enter into force on the 1st day of the fourth month of the last of Germany and the UK to deposit their instrument of ratification; Germany likely to be last following a challenge to Germany's Constitutional Court. In order for the UPC to be fully operational upon the entry into force of the Agreement on the UPC, a Protocol on Provisional Application has been agreed and will come into force the day after Germany (assuming it is Germany that is last) has deposited their instrument of ratification. This allows, amongst other things, for the judges to be appointed. A Protocol on Privileges and Immunities also has to be ratified in order to give the UPC its legal personality. This Protocol has to be ratified by Germany, France, the UK and Luxembourg, being the member states where the central division of the UPC and the Court of Appeal are located. None of these countries has yet ratified this Protocol.

Brexit impact:

Since Article 50 was triggered, the UKIPO has indicated that the UK is on track to ratify the UPC Agreement according to the Preparatory Committee’s timetable (i.e. provisional application in May 2017 and court operational on 1 December 2017) and that they expect the Protocol on Privileges and Immunities to be ready to lay before Parliament after Easter.

Therefore it appears that, at least until the UK leaves the EU, the UK plans to remain a part of the system and the London section of the central division (handling life sciences cases) and the London local division will remain at the premises which has already been secured for them at Aldgate Tower, 2 Leman Street, London. It is currently unknown what will happen when the UK officially leaves the European Union.

Other information:

Link to Regulations:
Agreement on a Unified Patent Court
Regulation 1260/2012
Regulation 1257/2012

Link to Bird & Bird UP and UPC homepage: 
Homepage

Bird & Bird Related Articles:
The Unified Patent Court – back on track again
Brexit: Life Sciences implications

 

Implementation deadline:

9 June 2018

 
Trade Secrets Directive - 2016/943/EC

Overview: 

  • Directive which seeks to harmonise the meaning and protection of trade secrets.
  • It will do this by:
    • creating a common definition of 'trade secret';
    • setting out remedies for holders of trade secrets in the event that they are misused; and
    • granting powers to enable the courts to prevent the disclosure of trade secrets during proceedings.

Brexit impact:

  • The UK government has not indicated whether or not it intends to implement Directive, which in any case is broadly reflected in current UK law but the UK IPO is currently holding round-table meetings with interested parties to discuss the proposed approach to implementation.

Other information:

Directive

Link to relevant EU/ industry commentary:
Commentary - IP Watch Dog
Commentary - BusinessZone

Bird & Bird Related Articles:
European Parliament votes to adopt Trade Secrets Directive 

 

Takes effect: 

2019

 
Clinical Trials Regulation 536/2014

Overview of provisions:

  • The Regulation was adopted on 16 June 2014.
  • It aims is to ensure a greater level of harmonisation of the rules of conducting clinical trials throughout the EU. Features include a single portal for applications for clinical trials, transparency requirements and more detailed safety provisions.
  • For the Regulation to come into effect an EU database and EU portal must be developed and audited. Due to technical difficulties, the original delivery time frame (that the EU Portal and database would be ready by August 2017) has been postponed, and a new delivery time frame will be discussed by the EMA's Management Board in October 2017 once the developer confirms progress. Assuming that it passes the audit, the Regulation should come into effect in 2019.

Brexit Impact:

  • If the Clinical Trials Regulations are implemented by the UK before the UK officially leaves the EU then, subject to amendments and negotiations with EU regulatory bodies, we may see an approach to Clinical Trials that is harmonised with the EU approach.
  • However, if the UK chooses to adopt different legislation to the Regulation post Brexit then this may cause issues for the clinical trials procedure, including costs and administrative burden for the sponsors of trials.

Other information:

Regulation

Link to relevant EU/industry commentary:
Pharmafile Article

Bird & Bird Related Articles:
Brexit: Life Sciences implications

Implementation deadline:

14 January 2019 (for remaining provisions not already in force)

 
Directive 2015/2436/EC of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the member states relating to trade marks

Overview

  • To make trade mark registration in the EU cheaper, quicker, more reliable and more predictable.
  • The provisions includes the removal of graphic representation requirements when filing trade mark applications, and the endorsement of the "literal meaning" approach to class heading coverage.

Brexit impact:

  • Many areas covered by the Directive are already part of the UK law, so to an extent regardless of whether the UK implements the Directive or not, there will be harmonisation to some degree.

Other information:

Directive

Link to relevant EU/ industry commentary:
INTA Bulletin
EUIPO Article

Bird & Bird Related Articles:
EU trade mark law: new legislation published 
Brexit & the Reformed EUTM System 

Implementation deadline:

[Likely 2020?]

 
Draft: A proposal for a Directive of the European Parliament and of the Council on copyright in the Digital Single Market

Overview

  • Part of the Digital Single Market package of legislation.
  • The draft Directive seeks to harmonise copyright law across the EU. Its provisions focus on the granting of greater protection against online exploitation of rights holder's publications. The most controversial aspect of the proposed Directive is the mandatory exceptions under the Directive, particularly with regards to the text and data mining, many educational institutes are asking for the proposed Directive to be amended.
  • The Council put forward a proposal for this Directive on 14 September 2016. Since then it has been undergoing the ordinary legislative procedure in Parliament and on the 2 March 2017 the European Parliament (EP) Committee on Legal Affairs (JURI) published an Opinion on the proposal. The European Parliament Internal Markets and Consumer Protection Committee, European Economic and Social Comittee, and Comittee of the Regions have all adopted opinions on the proposal, with various suggestions made. 

 Brexit impact:

  • It remains to be seen whether the UK will adopt legislation to implement the Directive.

Other information:

Proposed Directive

Link to relevant EU/ industry commentary:
Intellectual Property Watch Article
University World News Article
Legislative Train Article

Bird & Bird Related Articles:
Digital Single Market Strategy - EU to restrict geo-blocking to allow access to media services whilst abroad 

Takes effect:

Spring 2020

 
A Regulation on medical devices, which will replace Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices and Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

Overview

  • A draft Regulation which aims to ensure a high level of health and safety provisions in respect of medical devices and the free and fair trade of products throughout the EU.
  • EC draft originally proposed on 26 September 2012.
  • The Regulation was adopted by the Council at first reading in March 2017 and adopted by the European Parliament on 5 April 2017. A three year transition period will apply from Spring 2020 when the Regulation takes effect.

Brexit impact:

  • Whilst it remains to be seen, it would make sense for the UK to adopt legislation to mirror the European position.

Other information:

Proposed Regulation

Link to relevant EU/ industry commentary:
European Council Article

Takes effect:

Spring 2022

 
A Regulation on in vitro diagnostic medical devices, which will replace Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

Overview

  • A draft Regulation which aims to strengthen patient safety, by ensuring the quality of medical device products and laying down a more transparent regulatory system. It also introduces a new risk-rule classification system that is based on the Global Harmonization Task Force classification rules.
  • The European Commission proposed a new legal framework on 26 September 2012.
    • The Regulation was adopted by the Council at first reading in March 2017 and adopted by the European Parliament on 5 April 2017. A five year transition period will apply from Spring 2022 when the Regulation takes affect.

Brexit impact:

Whilst it remains to be seen, it would make sense for the UK to adopt legislation to mirror the European position.

Other information:

Proposed Regulation

Link to relevant EU/ industry commentary:
MedTech Europe Article


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