I 
(Legislative acts)  
REGULATIONS  
REGULATION (EU) No 386/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
of 19 April 2012 
on entrusting the Office for Harmonization in the Internal Market (Trade Marks and Designs) with 
tasks related to the enforcement of intellectual property rights, including the assembling of public and private-sector representatives as a European Observatory on Infringements of Intellectual 
Property Rights
 
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE 
EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European 
Union, and in particular Article 114 and the first paragraph of 
Article 118 thereof,  
Having regard to the proposal from the European Commission,  
After transmission of the draft legislative act to the national 
parliaments,  
Having regard to the opinion of the European Economic and 
Social Committee (  1 ), 
Acting in accordance with the ordinary legislative procedure (  2 ), 
Whereas:  
(1) The economic well-being of the Union relies on sustained 
creativity and innovation. Therefore, measures for their 
effective protection are indispensable in ensuring its 
future prosperity.  
(2) Intellectual property rights are vital business assets that 
help to ensure that creators and innovators get a fair return for their work and that their investment in 
research and new ideas is protected.  
(3) A sound, harmonised and progressive approach to intel ­
lectual property rights is fundamental in the endeavour to fulfil the ambitions of the Europe 2020 Strategy 
including A Digital Agenda for Europe.
 
(4) The constant increase in infringements of intellectual 
property rights constitutes a genuine threat not only to the Union economy, but also, in many cases, to the health and safety of Union consumers. Therefore, effective, immediate and coordinated action at national, 
European and global levels is needed to successfully 
combat this phenomenon.
 
(5) In the context of the overall intellectual property rights 
strategy envisaged by the Council Resolution of 
25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan (
 3 ), the Council 
called on the Commission to set up a European 
Observatory on Counterfeiting and Piracy. The Commission therefore formed a network of experts 
from the public and the private sectors and described 
the tasks of that network in its Communication entitled ‘Enhancing the enforcement of intellectual property rights in the internal market’. The name of the European Observatory on Counterfeiting and Piracy should be changed to the European Observatory on Infringements of Intellectual Property Rights (‘the Observatory’).EN 16.5.2012 Official Journal of the European Union L 129/1  
( 1 ) OJ C 376, 22.12.2011, p. 62. 
( 2 ) Position of the European Parliament of 14 February 2012 (not yet 
published in the Official Journal) and decision of the Council of 
22 March 2012 (not yet published in the Official Journal).  (  3 ) OJ C 253, 4.10.2008, p. 1.(6) That Communication stated that the Observatory should 
serve as the central resource for gathering, monitoring and reporting information and data related to all infringements of intellectual property rights. It should be used as a platform for cooperation between represen ­
tatives from national authorities and stakeholders to 
exchange ideas and expertise on best practices and make recommendations to policymakers for joint 
enforcement strategies. The Communication specified 
that the Observatory would be hosted and managed by the services of the Commission.
 
(7) In its Resolution of 1 March 2010 on the enforcement of 
intellectual property rights in the internal market (  1 ), the 
Council invited the Commission, the Member States and industry to provide the Observatory with available reliable and comparable data on counterfeiting and piracy and to jointly develop and agree, in the context of the Observatory, on plans to collect further information. The Council also invited the Observatory to publish each year a comprehensive annual report covering the scope, scale and principal characteristics of counterfeiting and piracy as well as its impact on the 
internal market. That annual report should be prepared 
using the relevant information provided in that regard by the authorities of the Member States, the Commission and the private sector within the limits of data protection law. The Council also recognised the importance of 
developing new competitive business models enlarging 
the legal offer of cultural and creative content and at the same time preventing and combating infringements of intellectual property rights as necessary means for fostering economic growth, employment and cultural diversity.
 
(8) In its Conclusions of 25 May 2010 on the future revision 
of the Trade Mark system in the European Union (  2 ), the 
Council called on the Commission to establish a legal 
basis for the involvement of the Office for Harmon ­
ization in the Internal Market (Trade Marks and Designs) (‘the Office’) in enforcement-related activities, including the fight against counterfeiting, in particular through fostering its cooperation with the national trade mark offices and the Observatory. In that respect, Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (
 3 ) provides, inter alia, for 
certain measures to promote cooperation, including the exchange of information, among Member States and 
between Member States and the Commission.
 
(9) In its Recommendation of 26 March 2009 on 
strengthening security and fundamental freedoms on 
the internet (  4 ), the European Parliament recommended 
that the Council preserve full and safe access to the 
internet while encouraging private/public cooperation in 
enhancing law enforcement cooperation.  (10) In its Resolution of 22 September 2010 on enforcement 
of intellectual property rights in the internal market (  5 ), 
the European Parliament called on the Member States and the Commission to extend the cooperation between the Office and national intellectual property offices so as to include the fight against infringements of intellectual property rights.
 
(11) In its Resolution of 12 May 2011 on unlocking the 
potential of cultural and creative industries (  6 ), the 
European Parliament urged the Commission to take into account the specific problems encountered by small and medium-sized enterprises when it comes to asserting their intellectual property rights and to promote best practice and effective methods to respect 
those rights.
 
(12) In its Resolution of 6 July 2011 on a comprehensive 
approach on personal data protection in the European Union (
 7 ), the European Parliament called on the 
Commission to ensure full harmonisation and legal certainty, providing a uniform and high level of protection of individuals in all circumstances.
 
(13) In view of the range of tasks assigned to the Observatory, 
a solution is needed to ensure an adequate and sustainable infrastructure for the fulfilment of its tasks.
 
(14) Council Regulation (EC) No 207/2009 of 26 February 
2009 on the Community trade mark (  8 ) provides for 
administrative cooperation between the Office and the courts or authorities of the Member States, and the exchange of publications between the Office and the 
central industrial property offices of the Member States. 
On that basis, the Office has established cooperation with national offices that are active in the field of protection of intellectual property rights. Consequently, the Office 
already possesses, to a considerable extent, the necessary 
experience and expertise to provide an adequate and sustainable infrastructure in the field of the Observatory’s tasks.
 
(15) The Office is therefore well placed to be entrusted with 
carrying out those tasks.  
(16) Those tasks should relate to all intellectual property 
rights covered by Directive 2004/48/EC, since in many cases, infringing acts affect a bundle of intellectual property rights. Furthermore, data and the exchange of best practices are needed on the entire abovementioned range of intellectual property rights, in order to obtain a complete picture of the situation and to enable compre ­
hensive strategies to be devised with a view to reducing 
infringements of intellectual property rights.EN L 129/2 Official Journal of the European Union 16.5.2012  
( 1 ) OJ C 56, 6.3.2010, p. 1. 
( 2 ) OJ C 140, 29.5.2010, p. 22. 
( 3 ) OJ L 157, 30.4.2004, p. 45. Corrected version in OJ L 195, 
2.6.2004, p. 16. 
( 4 ) OJ C 117 E, 6.5.2010, p. 206.  ( 5 ) OJ C 50 E, 21.2.2012, p. 48. 
( 6 ) Not yet published in the Official Journal. 
( 7 ) Not yet published in the Official Journal. 
( 8 ) OJ L 78, 24.3.2009, p. 1.(17) The tasks that the Office should carry out can be linked 
to the enforcement and reporting measures laid down by Directive 2004/48/EC. Thus, the Office should provide services to national authorities or operators which affect, in particular, the homogenous implementation of the Directive and which are likely to facilitate its appli ­
cation. The Office’s tasks should therefore be considered as closely linked to the subject matter of acts approxi ­
mating the laws, regulations and administrative 
provisions of the Member States.
 
(18) Assembled by the Office, the Observatory should become 
a centre of excellence on information and data relating to 
infringements of intellectual property rights, by bene ­
fiting from the Office’s expertise, experience and resources.
 
(19) The Office should offer a forum that brings together 
public authorities and the private sector, ensuring the 
collection, analysis and dissemination of relevant 
objective, comparable and reliable data regarding the value of intellectual property rights and infringements of those rights, identifying and promoting best practices and strategies to enforce intellectual property rights, and raising public awareness of the impact of infringements of intellectual property rights. Furthermore, the Office should fulfil additional tasks, such as improving the understanding of the value of intellectual property rights, fostering the exchange of information on new competitive business models which enlarge the legal 
offer of cultural and creative content, enhancing the 
expertise of persons involved in the enforcement of intel ­
lectual property rights by appropriate training measures, increasing knowledge of techniques to prevent counter ­
feiting, and improving cooperation with third countries and international organisations. The Commission should 
be associated with the activities undertaken by the Office 
under this Regulation.
 
(20) The Office should thus facilitate and support the activities 
of national authorities, the private sector and the Union 
institutions relating to the enforcement of intellectual 
property rights and in particular their activities in the fight against infringements of those rights. The exercise by the Office of its powers under this Regulation does not prevent Member States from exercising their com ­
petences. The Office’s tasks and activities under this Regulation do not extend to participation in individual 
operations or investigations carried out by the competent 
authorities.
 
(21) In order to fulfil those tasks in the most efficient manner, 
the Office should consult and cooperate with other auth ­
orities at national, European and, where appropriate, international levels, create synergies with the activities carried out by such authorities and avoid any duplication 
of measures.
 
(22) The Office should implement the tasks and activities 
relating to the enforcement of intellectual property 
rights by making use of its own budgetary means.  (23) With regard to representatives of the private sector, the 
Office should, when assembling the Observatory in the context of its activities, involve a representative selection of the economic sectors — including the creative industries — most concerned by or most experienced in the fight against infringements of intellectual property rights, in particular representatives of right holders, including authors and other creators, as well as 
internet intermediaries. Also, a proper representation of 
consumers and of small and medium-sized enterprises should be ensured.
 
(24) The information obligations imposed by this Regulation 
on the Member States and on the private sector should not create unnecessary administrative burdens and should endeavour to avoid duplication as regards data already provided by Member States and private-sector represen ­
tatives to Union institutions under existing Union reporting requirements.
 
(25) Since the objective of this Regulation, namely to entrust 
the Office with tasks related to the enforcement of intel ­
lectual property rights, cannot be sufficiently achieved by 
the Member States and can therefore, by reason of its 
effect, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of 
proportionality, as set out in that Article, this Regulation 
does not go beyond what is necessary in order to achieve that objective,
 
HAVE ADOPTED THIS REGULATION:  
Article 1  
Subject matter and scope  
This Regulation entrusts the Office for Harmonization in the 
Internal Market (Trade Marks and Designs) (‘the Office’) with 
tasks aimed at facilitating and supporting the activities of national authorities, the private sector and the Union insti ­
tutions in the fight against infringements of the intellectual property rights covered by Directive 2004/48/EC. In carrying out these tasks the Office shall organise, administer and support the gathering of experts, authorities and stakeholders assembled under the name ‘European Observatory on Infringements of Intellectual Property Rights’ (‘the Observatory’).  
The tasks and activities of the Office under this Regulation do 
not extend to participation in individual operations or investi ­
gations carried out by the competent authorities.  
Article 2  
Tasks and activities  
1. The Office shall have the following tasks:  
(a) improving understanding of the value of intellectual 
property;EN 16.5.2012 Official Journal of the European Union L 129/3(b) improving understanding of the scope and impact of 
infringements of intellectual property rights; 
(c) enhancing knowledge of best public and private sector 
practices to protect intellectual property rights;  
(d) assisting in raising citizens’ awareness of the impact of 
infringements of intellectual property rights; 
(e) enhancing the expertise of persons involved in the 
enforcement of intellectual property rights; 
(f) enhancing knowledge of technical tools to prevent and 
tackle infringements of intellectual property rights, 
including tracking and tracing systems which help to distinguish genuine products from counterfeit ones;  
(g) providing mechanisms which help to improve the online 
exchange, between Member States’ authorities working in 
the field of intellectual property rights, of information relating to the enforcement of such rights, and fostering cooperation with and between those authorities;  
(h) working, in consultation with Member States, to foster 
international cooperation with intellectual property offices in third countries so as to build strategies and develop tech ­
niques, skills and tools for the enforcement of intellectual property rights.  
2. In the fulfilment of the tasks set out in paragraph 1, the 
Office shall carry out the following activities in accordance with 
the work programme adopted pursuant to Article 7, and in line 
with Union law:  
(a) establishing a transparent methodology for the collection, 
analysis and reporting of independent, objective, comparable and reliable data relating to infringements of intellectual property rights;  
(b) collecting, analysing and disseminating relevant objective, 
comparable and reliable data regarding infringements of intellectual property rights;  
(c) collecting, analysing and disseminating relevant objective, 
comparable and reliable data regarding the economic value of intellectual property and its contribution to economic growth, welfare, innovation, creativity, cultural 
diversity, the creation of high-quality jobs and the devel ­
opment of high quality products and services within the Union;  
(d) providing regular assessments and specific reports by 
economic sector, geographic area and type of intellectual property right infringed, which evaluate, inter alia, the impact of infringements of intellectual property rights on society and the economy, including an assessment of the effects on small and medium-sized enterprises, as well as 
on health, the environment, safety and security; 
(e) collecting, analysing and disseminating information 
regarding best practices between the representatives meeting as the Observatory, and, if applicable, making recommendations for strategies based on such practices;  
(f) drawing up reports and publications to raise awareness 
amongst Union citizens of the impact of infringements of intellectual property rights and to that end, organising conferences, events and meetings at European and inter ­
national levels as well as assisting national and Europe- wide actions, including online and offline campaigns, prin ­
cipally by providing data and information;  
(g) monitoring the development of new competitive business 
models which enlarge the legal offer of cultural and creative content, and encouraging the exchange of information and raising consumer awareness in this respect;  
(h) developing and organising online and other forms of 
training for national officials involved in the protection 
of intellectual property rights;  
(i) organising ad hoc meetings of experts, including academic 
experts and relevant representatives of civil society, to support its work under this Regulation;  
(j) identifying and promoting technical tools for professionals 
and benchmark techniques, including tracking and tracing systems which help to distinguish genuine products from counterfeit ones;  
(k) working with national authorities and the Commission to 
develop an online network facilitating the exchange of information on infringements of intellectual property rights between public administrations, bodies and organi ­
sations in the Member States dealing with the protection 
and enforcement of those rights;  
(l) working in cooperation with, and building synergies 
between, the central industrial property offices of the 
Member States, including the Benelux Office for Intellectual 
Property and other Member States’ authorities working in the field of intellectual property rights, with a view to 
developing and promoting techniques, skills and tools 
relating to the enforcement of intellectual property rights, including training programmes and awareness campaigns;  
(m) developing, in consultation with the Member States, 
programmes for the provision of technical assistance to third countries as well as developing and delivering specific training programmes and events for officials from third countries who are involved in the protection of intel ­
lectual property rights;EN L 129/4 Official Journal of the European Union 16.5.2012(n) making recommendations to the Commission on issues 
falling within the scope of this Regulation, on the basis of a request from the Commission;  
(o) carrying out similar activities necessary in order to enable 
the Office to fulfil the tasks set out in paragraph 1. 
3. In carrying out the tasks and activities referred to in para ­
graphs 1 and 2, the Office shall comply with existing provisions of Union law on data protection.  
Article 3  
Financing  
The Office shall at all times ensure that the activities entrusted 
to it by this Regulation are carried out by making use of its own budgetary means.  
Article 4  
Meetings of the Observatory  
1. In order to carry out the activities referred to in 
Article 2(2), the Office shall at least once per year invite to meetings of the Observatory representatives from public admin ­
istrations, bodies and organisations in the Member States 
dealing with intellectual property rights and representatives from the private sector, for the purpose of their participation in the Office’s work under this Regulation.  
2. Private-sector representatives invited to meetings of the 
Observatory shall include a broad, representative and balanced range of Union and national bodies representing the different economic sectors, including the creative industries, most concerned by or most experienced in the fight against 
infringements of intellectual property rights.  
Consumer organisations, small and medium-sized enterprises, 
authors and other creators shall be properly represented.  
3. The Office shall invite each Member State to send at least 
one representative from its public administration to meetings of the Observatory. In that context, Member States shall ensure continuity in the Observatory’s work.  
4. The meetings referred to in paragraph 1 may be comple ­
mented by working groups within the Observatory made up of representatives from Member States and representatives from the private sector.  
5. Where appropriate, and in addition to the meetings 
referred to in paragraph 1, the Office shall organise meetings 
consisting of:  
(a) representatives from the public administrations, bodies and 
organisations in the Member States; or (b) private-sector representatives.  
6. Members or other representatives of the European 
Parliament and representatives from the Commission shall be invited to any of the meetings covered by this Article, either as participants or observers, as appropriate.  
7. The names of the representatives attending, the agenda 
and the minutes of the meetings referred to in this Article shall be published on the Office’s website.  
Article 5  
Information obligations  
1. As appropriate, in accordance with national law, including 
the law governing the processing of personal data, Member States shall, at the request of the Office or on their own initi ­
ative:  
(a) inform the Office of their overall policies and strategies on 
the enforcement of intellectual property rights and any changes thereto; 
(b) provide available statistical data on infringements of intel ­
lectual property rights; 
(c) inform the Office of important case-law.  
2. Without prejudice to the law governing the processing of 
personal data and to the protection of confidential information, private-sector representatives meeting as the Observatory shall, when possible, at the request of the Office:  
(a) inform the Office of policies and strategies in their field of 
activity on the enforcement of intellectual property rights 
and any changes thereto;  
(b) provide statistical data on infringements of intellectual 
property rights in their field of activity.  
Article 6  
The Office  
1. The relevant provisions of Title XII of Regulation (EC) 
No 207/2009 shall apply to the carrying-out of the tasks and 
activities provided for under this Regulation.  
2. Using the powers conferred by Article 124 of Regulation 
(EC) No 207/2009, the President of the Office shall adopt the internal administrative instructions and shall publish the notices that are necessary for the fulfilment of all the tasks entrusted to the Office by this Regulation.EN 16.5.2012 Official Journal of the European Union L 129/5Article 7  
Content of the work programme and of the management 
report  
1. The Office shall draw up an annual work programme that 
appropriately prioritises the activities under this Regulation and for the meetings of the Observatory, in line with the Union’s policies and priorities in the field of protection of intellectual 
property rights and in cooperation with the representatives 
referred to in point (a) of Article 4(5).  
2. The work programme referred to in paragraph 1 shall be 
submitted to the Office’s Administrative Board for information.  
3. The management report provided for in point (d) of 
Article 124(2) of Regulation (EC) No 207/2009 shall contain at least the following information concerning the Office’s tasks and activities under this Regulation:  
(a) a review of the main activities carried out during the 
preceding calendar year; 
(b) the results achieved during the preceding calendar year, 
accompanied, where appropriate, by sectoral reports analysing the situation in the different industry and 
product sectors;  
(c) an overall assessment of the fulfilment of the Office’s tasks 
as provided for in this Regulation and in the work 
programme drawn up in accordance with paragraph 1; 
(d) an overview of the activities that the Office intends to 
undertake in the future;  
(e) observations on the enforcement of intellectual property 
rights and potential future policies and strategies, including on how to enhance effective cooperation with and between Member States;  (f) an overall assessment of the proper representation in the 
Observatory of all the actors mentioned in Article 4(2).  
Before submitting the management report to the European 
Parliament, the Commission and the Administrative Board, the President of the Office shall consult the representatives referred 
to in point (a) of Article 4(5) on the relevant parts of the report.  
Article 8  
Evaluation  
1. The Commission shall adopt a report evaluating the appli ­
cation of this Regulation by 6 June 2017.  
2. The evaluation report shall assess the operation of this 
Regulation, in particular as regards its impact on the enforcement of intellectual property rights in the internal market.  
3. The Commission shall, when preparing the evaluation 
report, consult the Office, the Member States and the represen ­
tatives meeting as the Observatory on the issues referred to in 
paragraph 2.  
4. The Commission shall transmit the evaluation report to 
the European Parliament, the Council and the European Economic and Social Committee and shall undertake a broad consultation among stakeholders on the evaluation report.  
Article 9  
Entry into force  
This Regulation shall enter into force on the twentieth day 
following that of its publication in the  Official Journal of the 
European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Strasbourg, 19 April 2012.  
For the European Parliament 
The President
 
M. SCHULZ  For the Council 
The President  
M. BØDSKOVEN L 129/6 Official Journal of the European Union 16.5.2012