# EUR-Lex - 52011PC0215 - EN

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# 52011PC0215

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL implementing enhanced cooperation in the area of the creation of unitary patent protection /* COM/2011/0215 final - 2011/0093 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

1.1.
History of the proposal

In the European Union (EU), patent
protection currently can be obtained either through the national patent offices
of the Member States, which grant national patents, or through the European
Patent Office (EPO) in the framework of the European Patent Convention (EPC)[1]. However, once a European
patent is granted by the EPO, it must be validated in each Member State where
protection is sought. For a European patent to be validated in a territory of a
Member State, national law may inter alia require that the patent
proprietor files a translation of the European patent into the official
language of that Member State[2].
Therefore, the current patent system in the EU, in particular in terms of
translation requirements, involves very high costs and complexity. The overall
cost of validation of an average European patent reaches 12 500 EUR
if validated only in 13 Member States and over 32 000 EUR if
validated in the whole EU. It is estimated that the actual validation costs are
around 193 million EUR per year in the EU.

Both the Europe 2020 Strategy[3] and the Single Market Act[4] identified the creation of an
economy based on knowledge and innovation as a priority. Both initiatives seek
to improve the framework conditions for business to innovate by creating
unitary patent protection in the EU Member States together with a unified
European patent litigation system.

Despite of broad recognition of the
competitive disadvantage European business faces in the absence of unitary
patent protection, the Union has not been able to establish unitary patent
protection. The Commission first proposed a Council Regulation on the Community
patent in August 2000[5].
In 2002, the European Parliament adopted a Legislative Resolution[6]. In 2003, the Council adopted a
common political approach[7],
but a final agreement could not be reached. Discussions on the proposal were
re-launched in the Council after adoption by the Commission of the
Communication "Enhancing the patent system in Europe" in April 2007[8]. The Communication confirmed
the commitment to the creation of a single Community patent.

The Lisbon Treaty introduced a more
specific legal basis for the creation of European intellectual property rights.
According to Article 118(1) of the Treaty on the Functioning of the European
Union (TFEU), measures for the creation of European intellectual property
rights are to be established by the European Parliament and the Council acting
under the ordinary legislative procedure. Article 118(2) TFEU, however, sets
out a specific legal basis for the language arrangements for European
intellectual property rights, which are to be established under a special
legislative procedure by the Council acting unanimously after consulting the
European Parliament. Therefore, the translation arrangements for any unitary
patent system in the EU must be established by a separate regulation.

In December 2009, the Council adopted
conclusions on an "Enhanced patent system for Europe"[9] and a general approach on the
proposal for a Regulation on the EU Patent[10].
Translation arrangements, however, were not covered due to the abovementioned
change in the legal basis.

On 30 June 2010 the Commission adopted a
proposal for a Council Regulation on the translation arrangements for the EU
patent[11].
The proposal was accompanied by an Impact Assessment report[12] analysing various options for
the possible translation arrangements. Regardless of the significant efforts
made by the Presidency of the Council, it was recorded at the Competitiveness
Council meeting of 10 November 2010 that no unanimous agreement on the
translation arrangements could be reached[13].
It was confirmed at the Competitiveness Council meeting on 10 December 2010[14] that insurmountable
difficulties existed, making a decision requiring unanimity impossible now and
in the foreseeable future. It follows that the objectives of the proposed
Regulations to establish unitary patent protection in the entire European Union
can not be attained within a reasonable period by applying the relevant
provisions of the Treaties.

On the basis of the request of twelve
Member States (Denmark, Estonia, Finland, France, Germany, Lithuania,
Luxembourg, the Netherlands, Poland, Slovenia, Sweden and the United Kingdom)
the Commission submitted a proposal[15]
to the Council for authorising enhanced cooperation in the area of unitary
patent protection. All Member States specified in their requests that the
Commission's legislative proposals within the enhanced cooperation should be based
on the recent negotiations in the Council. Following the adoption of the
proposal, Belgium, Austria, Ireland, Portugal, Malta, Bulgaria, Romania, the
Czech Republic, Slovakia Hungary, Latvia, Greece and Cyprus also requested to
join the cooperation. The proposal for the authorising decision was adopted by
the Council, after obtaining the consent of the European Parliament, on 10
March 2011. The present regulation implements the enhanced cooperation in the
area of the creation of unitary patent protection as authorised by Council
Decision 2011/167/EU[16].

1.2.
Legal approach

In comparison to the Commission's proposal
in 2000, this proposal builds on the existing system of European patents by
providing unitary effect to European patents granted for the territories of the
participating Member States. The unitary patent protection will be optional and
co-exist with national and European patents. The proprietors of European
patents granted by the EPO, may submit a request to the EPO within one month
after the publication of the mention of the grant of the European patent,
asking for the registration of the unitary effect. Once it is registered, the
unitary effect will provide uniform protection and will have equal effect
throughout the territories of all participating Member States. European patents
with unitary effect may only be granted, transferred, revoked or may lapse in
respect of those territories as a whole. The participating Member States shall
give the task of the administration of European patents with unitary effect to
the EPO.

2.           CONSULTATIONS WITH THE INTERESTED
PARTIES

In January 2006, the Commission launched a
broad consultation on the future patent policy in Europe[17]. More than 2500 replies were
received from a variety of stakeholders, including businesses in all sectors of
the economy, business and SME associations, patent practitioners, public
authorities and academics. Respondents were asking for a European patent system
that provides incentives for innovation, ensures the diffusion of scientific knowledge,
facilitates technology transfer, is available to all players in the market and
is legally certain. The replies clearly showed stakeholders' disappointment
with the lack of progress in the Community patent project. In particular,
nearly all respondents (the users of the patent system) rejected the
translation arrangements included in the Council's 2003 common political
approach which laid down that the patent holder would have to supply a
translation of the claims (having legal effect) into all official Community
languages.

Stakeholders expressed an overall support
for a "unitary, affordable and competitive" Community patent. This
message was repeated at a public hearing held on 12 July 2006, where a large
variety of stakeholders stated their support for the creation of a truly
unitary high quality patent. They, however, underlined that political
compromises should not undermine the usefulness of the project. In particular,
the representatives of small and medium-sized enterprises (SMEs) highlighted the
importance of moderate patenting costs.

The issue of unitary patent protection was
also addressed extensively in the consultation on the Small Business Act for
Europe, which consisted of a range of initiatives targeted to help European
SMEs[18].
Small and medium-sized businesses identified the high level of patent fees and
the legal complexity of the patent system as major obstacles[19]. In their submissions to the consultation, businesses in general and
SME representatives in particular requested a significant reduction of the
costs of patenting for a future unitary patent[20].

Recent position papers from various
stakeholders refer to the unitary patent protection. European business
associations, such as BusinessEurope[21],
UEAPME[22]
and Eurochambres[23]
confirm that businesses, both large and small, want simplified, cost-effective
and accessible patent protection. National business organisations in many
Member States and across industry sectors have raises identical issues[24]. Stakeholders underlined that
any solution for the unitary patent protection should build on the existing
mechanisms for granting patents in Europe and necessitate no revision of the
European Patent Convention.

3.           IMPACT ASSESSMENT

This proposal is accompanied by an impact
assessment which identifies the main problems in the current European patent
system: (i) high costs related to translation and publication of European
patents, (ii) differences in the maintenance of patents in the Member States
(annual renewal fees have to be paid each year in each country where the patent
is validated); and (iii) administrative complexity of registering transfers,
licences and other rights related to patents. As a consequence, access to
comprehensive patent protection in Europe is so costly and complex that it is
inaccessible to many inventors and companies.

The impact assessment analyses the impacts
of the following options:

Option 1 (Base-line
scenario) – the Commission takes no action,

Option 2 – the Commission continues to work with the other institutions towards
an EU patent covering 27 Member States,

Option 3 - the Commission presents
proposals for regulations implementing enhanced cooperation:

Sub-option 3.1 - the Commission proposes
translation arrangements applicable in the area of unitary patent protection that
correspond to its proposal of 30 June 2010, or

Sub-option 3.2 – the Commission proposes
translation arrangements applicable in the area of unitary patent protection
based on its proposal of 30 June 2010 and incorporating elements of a
compromise proposal discussed by the Council.

The analysis carried out in the impact
assessment has demonstrated that option 3 with sub-option 3.2 is the preferred
option.

These problems can only be addressed at EU
level, as without an EU legal instrument Member States would not sufficiently
be able to establish legal effects attached to patents that are uniform in
several Member States.

4.           LEGAL ELEMENTS OF THE PROPOSAL

Council Decision 2011/167/EU authorised the
Member States listed in its Article 1 to establish enhanced cooperation in the
area of the creation of unitary patent protection.

Article 118 (1) TFEU provides for the legal
basis for creating European intellectual property rights providing uniform
protection throughout the Union by means of a regulation adopted by the
European Parliament and the Council, acting in accordance with the ordinary
legislative procedure.

5.           BUDGETARY IMPLICATIONS

This proposal has no impact on the Union
budget.

6.           DETAILED DESCRIPTION

Article 1 – Subject matter

This Article defines the subject-matter of
this Regulation which implements the enhanced cooperation in the area of the
creation of unitary patent protection authorised by Council Decision
2011/167/EU. It is made clear that this Regulation constitutes a special
agreement within the meaning of Article 142 of the EPC.

Article 2 - Definitions

This Article provides for definitions of
the main terms used in this Regulation.

Article 3 - European patent with unitary
effect

This Article provides that European patents
may benefit from unitary effect in the participating Member States provided
that their unitary effect has been registered in the Register for unitary
patent protection. In addition, the main features of the European patent with
unitary effect are laid down: unitary character, providing uniform protection
and having equal effect in all participating Member States. It follows that, as
a general rule, a European patent with unitary effect may only be limited,
licensed, transferred, revoked or lapse in respect of all the participating
Member States. Finally, the unitary effect of a European patent shall be deemed
not to have arisen to the extent that the European patent has been revoked or
limited.

Article 4 - Date of effect

A European patent with unitary effect shall
take effect in the participating Member States on the date of the publication
by the EPO of the mention of the grant of the European patent. In case unitary
effect has been registered, it is specified that the participating Member
States shall take the necessary measures to ensure that a European patent is
deemed not to have taken effect as a national patent in their territory on the
date of the publication of the mention of the grant in the European Patent
Bulletin.

Article 5 - Prior rights

In
the event of limitation or revocation on the ground of lack of novelty pursuant
to Article 54(3) EPC, the limitation or revocation of a European patent with
unitary effect shall take effect only in respect of the participating Member
State(s) designated in the earlier European patent application as published.

Article 6 - Right to prevent the direct
use of the invention

This Article lays down the right of the
proprietor of a European patent with unitary effect to prevent third parties
not having his consent from making, offering, placing on the market or using a
product which is the subject matter of the patent, or importing or storing the
product for these purposes. In addition, the patent proprietor can prevent
third parties from using a process which is the subject matter of the patent
or, when a third party knows or should have known that the use of the process
is prohibited without the consent of the proprietor, from offering the process
for use within the participating Member States. Finally, the proprietor can
prevent third parties from offering, placing on the market, using, importing or
storing for those purposes a product obtained directly by a process which is
the subject matter of the patent.

Article 7 - Right to prevent the
indirect use of the invention

This Article lays down the right of the
proprietor of a European patent with unitary effect to prevent third parties
not having his consent from supplying or offering to supply within the
participating Member States any person, other than a party entitled to exploit
the patented invention, with means, relating to an essential element of that
invention, for putting it into effect therein, when the third party knows, or
should have known, that those means are suitable and intended for putting that
invention into effect. This shall not apply, however, where the means are
staple commercial products, except when the third party induces the person
supplied to commit acts prohibited by Article 6.

Article 8 - Limitation of the effects of
the European patent with unitary effect

This Article provides a number of
limitations of the effects conferred by the European patent with unitary
effect. In particular, such effects shall not extend to acts done privately and
for non-commercial purposes, to acts done for experimental purposes relating to
the subject-matter of the patented invention or to the extemporaneous
preparation for individual cases in a pharmacy of a medicine in accordance with
a medical prescription. Other acts allowed under Union law, in particular
relating to veterinary medicinal products, to medicinal products for human use,
to plant variety rights and to the legal protection of computer programs by
copyright and of biotechnological inventions, are also not prohibited. Finally,
the effects conferred by the European patent with unitary effect shall not
extend to the use of the patented invention on board vessels, aircrafts or land
vehicles of countries other than participating Member States, when such
vessels, aircrafts or vehicles temporarily or accidentally enter the waters of
participating Member States and to the use by a farmer of protected livestock
for farming purposes, on condition that the breeding animals or other animal
reproductive material was sold or otherwise commercialised to the farmer by the
patent proprietor or with his consent.

Article 9 - Exhaustion of the rights
conferred by the European patent with unitary effect

The rights conferred by a European patent
with unitary effect shall not extend to acts concerning
the product covered by that patent which are carried out within the territories
of the participating Member States after that product has been put on the
market in the Union by the proprietor of the patent or with his consent, unless
there are legitimate grounds for the proprietor to oppose further commercialisation
of the product.

Article 10 - Treating a European patent
with unitary effect as a national patent

A European patent with unitary effect as an
object of property shall be dealt with in its entirety, and in all the
participating Member States, as a national patent of the participating Member
State in which, according to the European Patent Register, the proprietor of
the patent had his residence or principal place of business on the date of
filing of the application for the patent. Where this does not apply, the
European patent with unitary effect as an object of property shall be dealt
with as a national patent of the participating Member State in which the
proprietor had a place of business on that date. Special rules are provided for
in case of joint proprietors. Where no proprietor has his residence or a place
of business in a participating Member State, the European patent with unitary
effect as an object of property shall be dealt with as a national patent of the
State where the European Patent Organisation has its seat.

The creation of unitary patent protection
has to be accompanied by appropriate jurisdictional arrangements responding to
the needs of the users of the patent system. In order for the unitary patent
protection to work properly in practice, appropriate jurisdictional
arrangements should allow for patents to be enforced or revoked throughout the
territory of the participating Member States and at the same time should ensure
high quality judgements and legal security for companies. Specific
jurisdictional arrangements will be proposed as soon as possible, taking also
into account the recent opinion of the Court of Justice of the European Union
(A-1/09) on the compatibility of the draft agreement on the European and EU
Patents Court with the Treaties.

Article 11 - Licenses of right

This Article enables the proprietor of a
European patent with unitary effect to file a statement with the EPO that he is
prepared to allow any person to use the invention as a licensee in return for appropriate
compensation (contractual license).

Article 12 - Implementation by the
participating Member States

This Article lays down the tasks, within
the meaning of Article 143 EPC, which the participating Member States entrust
to the EPO. The EPO shall carry out these tasks in conformity with its internal
rules. The EPO shall administer requests for unitary effect, include and
administer in the European Patent Register entries relating to European patents
with unitary effect, receive and register statements on licensing, ensure the
publication of the translations required during the transitional period,
collect and administer the renewal fees (as well as additional fees), the
distribution of a part of the collected renewal fees to the participating Member
States and administer a compensation scheme of translation costs for applicants
filing European patent applications in one of the official languages of the
Union that is not an official language of the EPO.

The participating Member States shall
ensure that requests by the patent proprietor for unitary effect are submitted
in the language of the proceedings as defined in Article 14(3) of the EPC no
later than one month after the
mention of the grant is published in the European Patent Bulletin. The participating
Member States shall also ensure that the unitary effect
is indicated in the Register for unitary patent protection, where the relevant
conditions are fulfilled. The EPO shall be informed of limitations and
revocations of European patents with unitary effect.

This Article also lays down that the
participating Member States shall set up a Select Committee within the
framework of the Administrative Council of the European Patent Organisation in
order to ensure the governance and supervision of the tasks entrusted to the
EPO. Finally, the participating Member States shall ensure effective legal
protection before a national court against the administrative decisions of the
EPO in carrying out the tasks entrusted to it.

Article 13 – Principle

This Article provides
the principle that the expenses incurred by the EPO in carrying out the
additional tasks shall be covered by the fees generated by European patents
with unitary effect.

Article 14 –
Renewal fees

Renewal fees in
respect of European patents with unitary effect shall be paid to the European
Patent Organisation. If a renewal fee is not been paid in due time, the
European patent with unitary effect shall lapse.

Article 15 –
Level of renewal fees

This Article
sets out a number of rules and conditions to be taken into account when
determining the level of renewal fees. In particular, it provides that renewal
fees for European patents with unitary effect shall be progressive throughout
the term of the patent and shall be sufficient not only to cover all costs
associated with the grant and administration of the unitary patent protection
but also, together with the fees to be paid to the European Patent Organisation
during the pre-grant stage, to ensure a balanced budget of the Organisation.

Finally, the Article lays down that the
Commission is empowered to adopt delegated acts concerning the fixing of the
level of the renewal fees for European patents with unitary effect.

Article 16 – Distribution

The share for distributing 50 percent of
the amount of the renewal fees paid for European patents with unitary effect
minus the costs associated with the administration of the unitary patent
protection among the participating Member States shall be set by the Commission
on the basis of fair, equitable and relevant criteria listed in this Article. The participating Member States shall use the amount of the renewal
fees allocated to them for patent-related purposes.

The Commission is empowered to adopt
delegated acts concerning the distribution of the renewal fees between the
participating Member States.

Article 17 –
Exercise of the delegation

This Article provides particulars relating
to the power conferred on the Commission to adopt delegated acts. The
delegation is made for an indeterminate period of time and may be revoked at
any time by the European Parliament (EP) or by the Council. Any delegated act
must be notified to the EP and to the Council that may express their objection
within a period of 2 months.

Article 18 - Cooperation between the
Commission and the European Patent Office

This Article provides that the Commission
shall establish close cooperation with the EPO in the fields covered by this
Regulation.

Article 19 - Application of competition
law and the law relating to unfair competition

This Article provides that the Regulation
is without prejudice to the application of competition law and the law relating
to unfair competition.

Article 20 - Report on the operation of
this Regulation

Every six years the Commission shall
present to the Council a report on the operation of this Regulation and where
necessary make appropriate proposals for amending it.

Article 21 – Notification by the
participating Member States

The Article requires the participating
Member States to inform the Commission of the measures they adopt under
Articles 4(2) and 12.

Article 22 - Entry into force and
application

This Article provides that this Regulation
shall enter into force on the twentieth day after its publication in the Official
Journal of the European Union. However, since the language arrangements
applicable to European patents with unitary effect would be governed Council
Regulation .../... while the substantive provisions applicable to such patents are
governed by this Regulation, these two Regulations should be applied jointly as
of one specific date. The participating Member States shall ensure that the
rules referred to in Articles 4(2) and 12 are in place prior to or on the date
of application. Finally, it is laid down that unitary patent protection may be
requested for any European patent granted on or after the date on which this
Regulation applies.

2011/0093 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

implementing enhanced cooperation in the
area of the creation of unitary patent protection

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the
Treaty on European Union and the Treaty on the Functioning of the European
Union and in particular Article 118(1) thereof,

Having regard to
Council Decision 2011/167/EU of 10 March 2011 authorising enhanced cooperation
in the area of the creation of unitary patent protection[25],

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       In accordance with Article
3(3) of the Treaty on European Union, the Union shall establish an internal
market, shall work for the sustainable development of Europe based on balanced
economic growth and shall promote scientific and technological advance. The
creation of the legal conditions enabling undertakings to adapt their
activities in manufacturing and distributing products across national borders
and providing them with more choice and opportunities contributes to attaining
these objectives. Uniform patent protection within the internal market, or at
least a significant part thereof, should feature amongst the legal instruments
which undertakings have at their disposal.

(2)       Unitary patent protection
should foster scientific and technological advance and the functioning of the
internal market by making access to the patent system easier, less costly and
legally secure. It should improve the level of patent protection by providing
the possibility to obtain uniform patent protection in the territories of the
participating Member States and eliminate costs and complexity for undertakings
throughout the Union. It should be available to patent applicants from both
participating Member States and other States, regardless of nationality,
residence or place of establishment.

(3)       Pursuant to Article 118(1)
of the Treaty on the Functioning of the European Union (hereinafter
"TFEU"), measures foreseen in the context of the establishment and
functioning of the internal market include the creation of uniform patent
protection throughout the Union and the establishment of centralised Union-wide
authorisation, coordination and supervision arrangements.

(4)       On 10 March 2011, the
Council adopted Decision 2011/167/EU authorising enhanced cooperation between
Belgium, Bulgaria, the Czech Republic, Denmark, Germany, Estonia, Ireland,
Greece, France, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, the
Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Finland,
Sweden and the United Kingdom (hereinafter "participating Member
States") in the area of the creation of unitary patent protection.

(5)       The Convention on the
Grant of European Patents (European Patent Convention), as amended (hereinafter
"EPC"), established the European Patent Organisation and entrusted it
with the task of granting European patents. This task is carried out by the
European Patent Office. European patents granted by the European Patent Office
under the rules and procedures laid down in the EPC should, on request by the
patent proprietor, benefit from unitary effect by virtue of this Regulation in
the territories of the participating Member States (hereinafter "European
patents with unitary effect").

(6)       It is foreseen in Part IX
of the EPC that a group of Member States of the European Patent Organisation
may provide that European patents granted for those States have a unitary
character. This Regulation constitutes a special agreement within the meaning
of Article 142 of the EPC, a regional patent treaty within the meaning of
Article 45(1) of the Patent Cooperation Treaty of 19 June 1970 and a special
agreement within the meaning of Article 19 of the Convention for the Protection
of Industrial Property, signed in Paris on 20 March 1883 and last revised on 14
July 1967.

(7)       The
creation of unitary patent protection should be achieved by giving unitary
effect to European patents in the post-grant phase by virtue of this Regulation
and in respect of the participating Member States. The main feature of European
patents with unitary effect should be their unitary character, i.e. providing
uniform protection and having equal effect in all participating Member States.
Consequently, a European patent with unitary effect should only be limited,
licensed, transferred, revoked or lapse in respect of all the participating
Member States. To ensure the uniform substantive scope of protection conferred
by unitary patent protection, only European patents that have been granted for
all the participating Member States with the same set of claims should benefit
from unitary effect. However, to ensure legal certainty in the event of a
limitation or revocation on the ground of lack of novelty pursuant to Article
54(3) EPC, the limitation or revocation of a European patent with unitary
effect should take effect only in respect of the participating Member State(s)
designated in the earlier European patent application as published. Finally,
the unitary effect attributed to a European patent should have an accessory
nature and should cease to exist or be limited to the extent that the basic
European patent has been revoked or limited.

(8)       In
accordance with the general principles of patent law and Article 64(1) of the
EPC, unitary patent protection should take effect retroactively in the
territories of the participating Member States as of the date of the
publication of the mention of the grant of the European patent in the European
Patent Bulletin. Where unitary effect takes effect, the participating Member
States should ensure that the European patent is deemed not to have taken
effect on their territory on the date of the publication of the mention of the
grant as a national patent to avoid any duplication of patent protection on
their territories stemming from the same European patent granted by the
European Patent Office.

(9)       In matters not covered by
this Regulation or Council Regulation .../... [translation arrangements], the
provisions of the EPC and national law including rules of private international
law shall apply.

(10)     The
rights conferred by the European patent with unitary effect should enable the
patent proprietor to prevent any third party not having his consent from the
direct and indirect use of the invention on the territories of the participating
Member States. However, a number of limitations of the patent proprietor's
rights should enable third parties to use the invention, for instance for
private and for non-commercial purposes, for experimental purposes, for acts
allowed specifically under Union law (in the area of veterinary medicinal
products, medicinal products for human use, plant variety rights, the legal
protection of computer programs by copyright and the legal protection of
biotechnological inventions) under international law and for the use by a
farmer of protected livestock for farming purposes.

(11)     In
accordance with the case law of the Court of Justice of the European Union, the
principle of the exhaustion of rights should be applied also in relation to
European patents with unitary effect. Therefore, rights conferred by a European
patent with unitary effect should also not extend to acts concerning the
product covered by that patent, which are carried out within the territories of
the participating Member States after that product has been put on the market
in the Union by the proprietor of the patent.

(12)     As
an object of property, a European patent with unitary effect should be dealt
with in its entirety, and in all the participating Member States, as a national
patent of the participating Member State in which, according to the European
Patent Register, the proprietor of the patent had his residence or principal
place of business on the date of filing of the patent application. If the
proprietor of the patent did not have his residence or a place of business in
any of the participating Member State, the European patent with unitary effect
should be dealt with as a national patent of the Member State where the
European Patent Organisation has its headquarters.

(13)     In
order to promote and facilitate the economic exploitation of inventions
protected by European patents with unitary effect, the patent proprietor should
be able to offer its patent to be licensed to anyone complying with the terms
and conditions set out by the patent proprietor in return for appropriate
compensation. To that end the patent proprietor may file a statement with the
European Patent Office that he is prepared to grant a license in return for
appropriate compensation. In that case, the proprietor should, after receipt of
that statement, benefit from a reduction of the renewal fees.

(14)     The group of Member States
making use of Part IX of the EPC may give tasks to the European Patent Office
and set up a Select Committee of the Administrative Council of the European
Patent Organisation (hereinafter "Select Committee").

(15)     The participating Member
States should give the European Patent Office certain administrative tasks
relating to European patents with unitary effect, in particular as regards
administration of requests for unitary effect, the registration of unitary
effect and of any limitation, licence, transfer, revocation or lapse of
European patents with unitary effect, the collection and redistribution of
renewal fees, the publication of translations for information purposes during a
transitional period and the administration of a compensation scheme of
translation costs for applicants filing European patent applications in a
language other than one of the official languages of the European Patent
Office. The participating Member States should ensure that requests for unitary effect are filed with the European Patent
Office within one month of the date of the publication of the mention of the
grant in the European Patent Bulletin and that they are submitted in the
language of the proceedings before the European Patent Office together with the
translation prescribed for, during a transitional period, by Council
Regulation.../... [translation arrangements].

(16)     Patent proprietors should
pay one common annual renewal fee for European patents with unitary effect.
Renewal fees should be progressive throughout the term of the patent protection
and, together with the fees to be paid to the European Patent Organisation
during the pre-grant stage, should cover all costs associated with the grant of
the European patent and the administration of the unitary patent protection.
The level of the renewal fees should be fixed with the aim of facilitating
innovation and fostering the competitiveness of European businesses. It should
also reflect the size of the market covered by the patent and be similar to the
level of the national renewal fees for an average European patent taking effect
in the participating Member States at the time where the level of the renewal
fees is first fixed by the Commission.

(17)     In order to determine the
appropriate level and distribution of renewal fees and to ensure that all costs
of the tasks in relation to the unitary patent protection entrusted on the
European Patent Office are fully covered by the resources generated by the
European patents with unitary effect and that, together with the fees to be
paid to the European Patent Organisation during the pre-grant stage, the
revenues from the renewal fees ensure a balanced budget of the European Patent
Organisation.

(18)     Renewal fees should be paid
to the European Patent Organisation. 50 percent thereof minus expenses incurred
by the European Patent Office in carrying out tasks in relation to the unitary
patent protection shall be distributed among the participating Member States,
which should be used for patent-related purposes. The share of distribution
should be set on the basis of fair, equitable and relevant criteria namely the
level of patent activity and the size of the market. The distribution should
provide compensation for having an official language other than one of the
official languages of the European Patent Office, having a disproportionately
low level of patenting activity and having acquired membership of the European
Patent Organisation relatively recently.

(19)     In order to ensure the
appropriate level and distribution of renewal fees in compliance with the
principles set out in this Regulation, the power to adopt acts in accordance
with Article 290 of the Treaty on the Functioning of the European Union should
be delegated to the Commission in respect of the level of the renewal fees for
European patents with unitary effect and the distribution of such fees between
the European Patent Organisation and the participating Member States. It is of
particular importance that the Commission carry out appropriate consultations
during its preparatory work, including at expert level. The Commission, when
preparing and drawing-up delegated acts, should ensure a simultaneous, timely
and appropriate transmission of relevant documents to the European Parliament
and Council.

(20)     An Enhanced partnership
between the European Patent Office and central industrial property offices of
the Member States should enable the European Patent Office to make regular use,
where appropriate, of the result of any search carried out by central
industrial property offices on a national patent application the priority of
which is claimed in a subsequent European patent application. All central
industrial property offices, including those which do not perform searches in
the course of a national patent granting procedure, can have an essential role
under the enhanced partnership, inter alia by giving advice and support to
potential patent applicants, in particular small and medium-sized enterprises,
by receiving applications, by forwarding applications to the European Patent
Office and by disseminating patent information.

(21)     This Regulation should be
complemented by Council Regulation .../... implementing enhanced cooperation in
the area of the creation of unitary patent protection with regard to the
applicable translation arrangements, adopted by the Council in accordance with
Article 118(2) of the TFEU.

(22)     This Regulation should be
without prejudice to the right of Member States to grant national patents and
should not replace Member States' laws on patents. Patent applicants should
remain free to obtain either a national patent, a European patent with unitary
effect, a European patent taking effect in one or more of the Contracting
States to the EPC or a European patent with unitary effect validated in
addition in one or more other Contracting States to the EPC which are not among
the participating Member States.

(23)     Since the objective of this
Regulation, namely the creation of uniform patent protection, can, by reasons
of the scale and effects of this Regulation, be better achieved at Union level,
the Union may adopt measures by means of enhanced cooperation where
appropriate, 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 this objective,

HAVE ADOPTED THIS REGULATION:

CHAPTER I
GENERAL PROVISIONS

Article 1
Subject matter

This Regulation implements the enhanced cooperation in the area of the creation of unitary patent
protection authorised by Council Decision 2011/167/EU.

This Regulation constitutes a special
agreement within the meaning of Article 142 of the Convention on the Grant of
European Patents (European Patent Convention), as amended (hereinafter
"the EPC").

Article 2
Definitions

For the purposes of this Regulation the
following definitions shall apply:

(a)
"Participating Member State" means a
Member State which participates, at the time when the request for unitary
effect as referred to in Article 12 is made, in enhanced cooperation in the
area of the creation of unitary patent protection by virtue of Council Decision
2011/167/EU, or by virtue of a decision adopted in accordance with the second
or third subparagraph of Article 331(1) of the TFEU;

(b)
"European patent"
means a patent granted by the European Patent Office under the rules and
procedures laid down in the EPC;

(c)
"European patent with unitary effect"
means a European patent which benefits from unitary effect in the territories
of the participating Member States by virtue of this Regulation;

(d)
"European Patent
Register" means the register kept by the European Patent Office under
Article 127 of the EPC;

(e)
"European Patent Bulletin" means the
periodical publication provided for in Article 129 of the EPC.

Article 3
European patent with unitary effect

1.           European patents granted
with an identical scope of protection in respect of all participating Member
States shall benefit from unitary effect in the participating Member States
provided that their unitary effect has been registered in the Register for
unitary patent protection referred to in Article 12(1)(b).

European patents that were granted with
different sets of claims for different participating Member States shall not
benefit from unitary effect.

2.           A European patent with
unitary effect shall have a unitary character. It shall provide uniform protection
and shall have equal effect in all participating Member States.

Without prejudice to
Article 5, a European patent with unitary effect may only be limited, licensed,
transferred, revoked or lapse in respect of all the participating Member
States.

3.           The unitary effect of a
European patent shall be deemed not to have arisen to the extent that the
European patent has been revoked or limited.

Article 4
Date of effect

1.           A European patent with
unitary effect shall take effect in the territories of the participating Member
States on the date of the publication, by the European Patent Office, of the
mention of the grant of the European patent in the European Patent Bulletin.

2.           The participating Member
States shall take the necessary measures to ensure that, where the unitary
effect of a European patent has been registered, the European patent is deemed
not to have taken effect as a national patent in their territory on the date of
the publication of the mention of the grant in the European Patent Bulletin.

Article 5
Prior rights

In the event of a
limitation or a revocation on the ground of lack of novelty pursuant to Article
54(3) of the EPC, the limitation or revocation of a European patent with
unitary effect shall take effect only in respect of the participating Member
State(s) designated in the earlier European patent application as published.

CHAPTER II
EFFECTS OF THE EUROPEAN PATENT WITH UNITARY EFFECT

Article 6
Right to prevent the direct use of the invention

The European patent with unitary effect shall
confer on its proprietor the right to prevent any third party not having the
proprietor's consent from the following:

(a)
 making, offering, placing on the market or
using a product which is the subject matter of the patent, or importing or
storing the product for those purposes;

(b)
 using
a process which is the subject matter of the patent or, where the third party
knows, or should have known, that the use of the process is prohibited without
the consent of the proprietor of the patent, from offering the process for use
within the participating Member States;

(c)
 offering,
placing on the market, using, importing or storing for those purposes a product
obtained directly by a process which is the subject matter of the patent.

Article 7
Right to prevent the indirect use of the invention

1.           The European patent with
unitary effect shall confer on its proprietor the right to prevent any third
party from supplying or offering to supply within the participating Member
States any person without the proprietor's consent, other than a party entitled
to exploit the patented invention, with means, relating to an essential element
of that invention, for putting it into effect therein, when the third party
knows, or should have known, that those means are suitable and intended for
putting that invention into effect.

2.           Paragraph 1 shall not
apply when the means are staple commercial products, except where the third
party induces the person supplied to perform any of the acts prohibited by
Article 6.

3.           Persons performing the
acts referred to in Article 8(a) to (d) shall not be considered to be
parties entitled to exploit the invention within the meaning of
paragraph 1.

Article 8
Limitation of the effects of the European patent with
unitary effect

The rights conferred by
the European patent with unitary effect shall not extend to any of the
following:

(a)
 acts done privately and for non-commercial
purposes;

(b)
 acts
done for experimental purposes relating to the subject matter of the patented
invention;

(c)
 acts
carried out solely for the purpose of conducting the necessary tests and trials
in accordance with Article 13(6) of Directive 2001/82/EC[26] or Article 10(6)
of Directive 2001/83/EC[27]
in respect of any patent covering the product within the meaning of either of
those Directives;

(d)
 the
extemporaneous preparation for individual cases in a pharmacy of a medicine in
accordance with a medical prescription nor acts concerning the medicine so
prepared;

(e)
 the
use on board vessels of countries other than participating Member States of the
patented invention, in the body of the vessel, in the machinery, tackle, gear
and other accessories, when such vessels temporarily or accidentally enter the
waters of participating Member States, provided that the invention is used
there exclusively for the needs of the vessel;

(f)
 the
use of the patented invention in the construction or operation of aircraft or
land vehicles or other means of transport of States other than participating
Member States, or of accessories to such aircraft or land vehicles, when these
temporarily or accidentally enter participating Member States;

(g)
 the
acts specified in Article 27 of the Convention on International Civil Aviation
of 7 December 1944[28],
where these acts concern the aircraft of a country other than a participating
Member State;

(h)
 acts
as covered by the farmers privilege pursuant to Article 14 of Regulation
(EC) No. 2100/94[29]
which applies mutatis mutandis;

(i)
 the
use by a farmer of protected livestock for farming purposes, on condition that
the breeding animals or other animal reproductive material were sold or
otherwise commercialised to the farmer by the patent proprietor or with his/her
consent. Such use includes the provision of the animal or other animal
reproductive material for the purposes of his/her agricultural activity, but
not the sale in the framework of or for the purpose of commercial reproductive
activity;

(j)
the acts and the use of the obtained information
as allowed under Articles 5 and 6
of Council Directive 91/250/EEC[30],
in particular, by its provisions on decompilation and interoperability; and

(k)
 the
acts allowed pursuant to Article 10 of Directive 98/44/EC of the European
Parliament and of the Council[31].

Article 9
Exhaustion of the rights conferred by the European patent with unitary effect

The rights conferred by
a European patent with unitary effect shall not extend to acts concerning the
product covered by that patent which are carried out within the territories of
the participating Member States after that product has been put on the market
in the Union by the proprietor of the patent or with his/her consent, unless
there are legitimate grounds for the proprietor to oppose further
commercialisation of the product.

CHAPTER III
A EUROPEAN PATENT WITH UNITARY EFFECT AS AN OBJECT OF PROPERTY

Article 10
Treating a European patent with unitary effect as a national patent

1.           A European patent with
unitary effect as an object of property shall be treated in its entirety and in
all the participating Member States as a national patent of the participating
Member State in which, according to the European Patent Register:

(a)
the patent proprietor had his/her residence or
principal place of business on the date of filing of the application for the
patent; or

(b)
where subparagraph (a) does not apply, the
proprietor had a place of business on that date.

2.           Where two or more persons
are mentioned in the European Patent Register as joint proprietors, paragraph
1(a) shall apply to the joint proprietor indicated first. Where this is not
possible, paragraph 1(a) shall apply to the next joint proprietor indicated in
the order of entry. Where paragraph 1(a) does not apply to any of the joint
proprietors, paragraph 1(b) shall apply accordingly.

3.           Where no proprietor has
his/her residence or a place of business in a participating Member State for
the purposes of paragraphs 1 or 2, the European patent with unitary effect as
an object of property shall be dealt with in its entirety and in all the
participating Member States as a national patent of the State where the
European Patent Organisation has its headquarters in accordance with Article
6(1) of the EPC.

4.           The acquisition of a right
may not be dependent on any entry in a national patent register.

Article 11
Licenses of right

1.           The proprietor of a
European patent with unitary effect may file a statement with the European
Patent Office that he/she is prepared to allow any person to use the invention
as a licensee in return for appropriate compensation.

2.           A license obtained under
this Regulation shall be treated as a contractual license.

CHAPTER IV
INSTITUTIONAL PROVISIONS

Article 12
Implementation by the participating Member States

1.           The participating Member
States shall give, within the meaning of Article 143 of the EPC, the European
Patent Office the following tasks to be carried out in conformity with the
internal rules of the European Patent Office:

(a)
the administration of requests for unitary
effect by proprietors of European patents;

(b)
the inclusion and administration of a Register
for unitary patent protection registering unitary effect as well as any
limitation, license, transfer, revocation or lapse of a European patent with
unitary effect, within the European Patent Register;

(c)
receiving and registering statements on
licensing referred to in Article 11, their withdrawal and licensing commitments
undertaken in international standardisation bodies;

(d)
the publication of the translations referred to
in Article 6 of Council Regulation .../... [translation arrangements] during the
transitional period referred to in that Article;

(e)
the collection and administration of renewal
fees for European patents with unitary effect, in respect of the years
following the year in which the Register referred to in point b) mentions their
grant; the collection and administration of additional fees paid in cases of
late payment of renewal fees within six months of the due date, as well as the
distribution of a part of the collected renewal fees to the participating
Member States; and

(f)
the administration of a compensation scheme of
translation costs for applicants filing European patent applications in one of
the official languages of the Union that is not an official language of the
European Patent Office.

For the purposes of point a), the participating
Member States shall ensure that requests by the patent proprietor for unitary effect
for a European patent are filed in the language of the proceedings as defined
in Article 14(3) of the EPC no later than one month after the mention of the grant is published in the
European Patent Bulletin.

For the purposes of point b), the participating
Member States shall ensure that the unitary effect is indicated in the Register
for unitary patent protection, where a request for unitary effect has been
filed and, during the transitional period provided for in Article 6 of Council
Regulation .../... [translation arrangements], has been submitted together with the
translations referred to in that Article; and that the European Patent Office
is informed of limitations and revocations of European patents with unitary
effect.

2.           In their capacity as
Contracting States to the EPC, the participating Member States shall ensure the
governance and supervision of the activities related to the tasks referred to
in paragraph 1 by the European Patent Office. To that end they shall set up a
Select Committee of the Administrative Council of the European Patent
Organisation within the meaning of Article 145 of the EPC.

3.           The participating Member
States shall ensure effective legal protection before a national court against
the decisions of the European Patent Office in carrying out the tasks referred
to in paragraph 1.

CHAPTER V
FINANCIAL PROVISIONS

Article 13
Principle

The expenses incurred by the European
Patent Office in carrying out the additional tasks given, within the meaning of
Article 143 of the EPC, by Member States to the European Patent Office shall be
covered by the fees generated by the European patents with unitary effect.

Article 14
Renewal fees

1.           Renewal fees and
additional fees for the late payment of renewal fees for European patents with
unitary effect shall be paid to the European Patent Organisation by the patent
proprietor. Those fees shall be due in respect of the years following the year
in which the European Patent Register mentions the grant of the European patent
which benefits from unitary effect by virtue of this Regulation.

2.           A European patent with
unitary effect shall lapse if a renewal fee and, where applicable, any
additional fee have not been paid in due time.

3.           In the case of Article
11(1), renewal fees for the patent which fall due after receipt of the
statement shall be reduced.

Article 15
Level of renewal fees

1.           Renewal fees for European
patents with unitary effect shall be

(a)
progressive throughout the term of the unitary
patent protection, and

(b)
sufficient not only to cover all costs
associated with the grant of the European patent and the administration of the
unitary patent protection but also,

(c)
sufficient together with the fees to be paid to
the European Patent Organisation during the pre-grant stage, to ensure a
balanced budget of the European Patent Organisation.

2.           The level of the renewal
fees shall be fixed with the aim of

(a)
facilitating innovation and fostering the
competitiveness of European businesses,

(b)
reflecting the size of the market covered by the
patent and

(c)
being similar to the level of the national
renewal fees for an average European patent taking effect in the participating Member States at the time
where the level of the renewal fees is first fixed by the Commission.

3.           In order to reach these
objectives set out in this Chapter, the Commission shall set the level of
renewal fees at a level that

(a)
 is equivalent to the level of renewal fee to be
paid for the average geographical coverage of current European patents,

(b)
reflects the renewal rate of current European
patents, and

(c)
the number of requests for unitary protection.

4.           The Commission shall be
empowered to adopt delegated acts in accordance with paragraphs 1-3 and Article
17 concerning the fixing of the level of the renewal fees for European patents
with unitary effect.

Article 16
Distribution

1.           The part of the collected
renewal fees to be distributed to the participating Member States referred to
in Article 12(1)(e) shall be 50 percent of the renewal fees referred to in
Article 14 paid for European patents with unitary effect minus the costs
associated with the administration of the unitary patent protection referred to
in Article 12.

2.           In order to reach these
objectives set out in this Chapter, the Commission shall set the share of
distribution of renewal fees referred to in paragraph 1 among the participating
Member States on the basis of the following fair, equitable and relevant
criteria:

(a)
the number of patent applications,

(b)
the size of the market expressed in the number
of population,

(c)
provision of compensation to Member States for
having an official language other than one of the official languages of the
European Patent Office, having a disproportionately low level of patenting
activity and having acquired membership of the European Patent Organisation
relatively recently.

3.           The participating Member
States shall use the amount allocated to them in accordance with paragraph 1 to
patent-related purposes.

4.           The Commission shall be
empowered to adopt delegated acts in accordance with paragraphs 1-3 and Article
17 concerning the setting of the distribution of renewal fees between the
participating Member States.

Article 17
Exercise of the delegation

1.           The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article.

2.           The delegation of power
referred to in Articles 15 and 16 shall be conferred for an indeterminate
period of time from the [date of entry into force of this Regulation].

3.           The delegation of powers
referred to in Articles 15 and 16 may be revoked at any time by the European
Parliament or by the Council. A decision of revocation shall put an end to the
delegation of the power specified in that decision. It shall take effect the
day following the publication of the decision in the Official Journal of the European
Union or at a later date specified therein. It shall not affect the validity of
any delegated acts already in force.

4.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.

5.           A delegated act adopted
pursuant to Articles 15 and 16 shall enter into force only if no objection has
been expressed either by the European Parliament or the Council within a period
of 2 months of notification of that act to the European Parliament and the
Council or if, before the expiry of that period, the European Parliament and
the Council have both informed the Commission that they will not object. That
period shall be extended by 2 months at the initiative of the European
Parliament or the Council.

CHAPTER VI
FINAL PROVISIONS

Article 18
Cooperation between the Commission and the European Patent Office

The Commission shall establish a close
cooperation through a working agreement with the European Patent Office in the
fields covered by this Regulation. This cooperation shall include regular
exchanges of views on the functioning of the working agreement and in
particular on the issue of renewal fees and the impact on the budget of the
European Patent Organisation.

Article 19
Application of competition law and the law relating to unfair competition

This Regulation is without prejudice to the
application of competition law and the law relating to unfair competition.

Article 20
Report on the operation of this Regulation

1.           Not later than six years
from the date on which the first European patent with unitary effect takes
effect in the territories of the participating Member States, the Commission
shall present to the Council a report on the operation of this Regulation and,
where necessary, make appropriate proposals for amending it. Subsequent reports
on the operation of this Regulation shall be presented by the Commission every
six years.

2.           The Commission shall
submit reports regularly on the functioning of the renewal fees referred to in
Article 14 with particular emphasis on the continued compliance with the
principles set out in Article 15.

Article 21
Notification by the participating Member States

The participating Member States shall
notify the Commission of the measures adopted in accordance with Articles 4(2)
and 12 by the date set in Article 22(2).

Article 22
Entry into force and application

1.           This Regulation shall
enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.

2.           It shall apply from [a
specific date will be set and it will coincide with the date of application of
Council Regulation .../... on the implementation of enhanced cooperation in the
area of the creation of unitary patent protection with regard to the applicable
translation arrangements].

3.           The participating Member
States shall ensure that the rules referred to in Articles 4(2) and 12 are in
place prior to or on the date set in paragraph 2.

4.           Unitary patent protection
may be requested for any European patent granted on or after the date set out
in paragraph 2.

This Regulation shall be binding
in its entirety and directly applicable in the participating Member States in
accordance with the Treaties.

Done at Brussels,

For the European Parliament                       For
the Council

The
President                                                 The President

[1]               http://www.epo.org

[2]               In order to reduce the costs caused by validation
requirements, in 2000 the EPC Contracting States adopted the so-called
"London Agreement" (Agreement on the application of Article 65 EPC,
OJ EPO 2001, 550) which is currently in force in eleven EU Member States and
results in reduced translation requirements.

[3]               COM(2010) 2020.

[4]               COM(2010) 608 final/2.

[5]               COM(2000) 412.

[6]               European Parliament legislative resolution on the
proposal for a Council regulation on the Community patent (COM(2000) 412 -
C5-0461/2000 - 2000/0177(CNS)) (OJ C 127 E, 29.5.2003, p. 519–526).

[7]               Council document 7159/03.

[8]               COM(2007) 165.

[9]               Council document 17229/09.

[10]             Council document 16113/09 Add
1. The terminology changed (from the
"Community" to "EU" patent) due to
the entry into force of the Lisbon Treaty.

[11]             COM(2010) 350.

[12]             SEC(2010) 796.

[13]             Press Release of the
Extraordinary Council meeting "Competitiveness (Internal Market, Industry,
Research and Space)", 16041/10, 10.11.2010.

[14]             See press release 17668/10.

[15]             COM(2010) 790.

[16]             Council Decision 2011/167/EU of 10 March 2011
authorising enhanced cooperation in the area of the creation of unitary patent
protection (OJ L 76, 22.3.2011, p. 53).

[17]             The consultation document, replies from stakeholders
and a report on the preliminary findings of the consultation are available at http://ec.europa.eu/internal_market/indprop/patent/consultation_en.htm.

[18]             COM(2008) 394.

[19]             http://ec.europa.eu/enterprise/policies/sme/small-business-act/

[20]             UEAPME Expectations on the Proposal for a European
Small Business Act, available at www.ueapme.com.
Response to the Consultation on a Small Business Act for Europe, available at http://www.eurochambres.eu

[21]             Views on key issues of the patent reform debate in
Europe, available at http://www.businesseurope.eu

[22]             Position on the recent policy developments on the
European Community patent, available at http://www.ueapme.com

[23]             Position paper on the European Patent System, available
at http://www.eurochambres.eu

[24]             Position
papers from BDI (Bundesverband der Deutschen Industrie), DIHK (Deutscher
Industrie- und Handelskammertag), CBI (Confederation of British Industries),
CCIP (Chambre de commerce et d'industrie de Paris), CGPME (Confédération
générale des petites et moyennes entreprises), Unioncamere, DigitalEurope,
Orgalime, ACT (Association for Competitive Technology), Cefic and others.

[25]             OJ L 76, 22.3.2011, p. 53.

[26]             Directive 2001/82/EC of the
European Parliament and of the Council of 6 November 2001 on the
Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001,
p. 1), as amended.

[27]             Directive 2001/83/EC of the
European Parliament and of the Council of 6 November 2001 on the Community code
relating to medicinal products for human use (OJ L 311, 28.11.2001,
p. 67), as amended.

[28]             International Civil Aviation Organization (ICAO), "Chicago
Convention", Document 7300/9 (9th edition, 2006)

[29]             Council Regulation (EC) No
2100/94 of 27 July 1994 on Community plant variety rights (OJ
L 227, 1.9.1994, p. 1).

[30]             Council Directive 91/250/EEC
of 14 May 1991 on the legal protection of computer programs (OJ L 122,
17.5.1991, p. 42).

[31]             Directive 98/44/EC of the
European Parliament and of the Council of 6 July 1998 on the legal
protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 13).