Proposal for a Council Regulation amending Regulation (EC) No 2100/94 on Community plant variety rights
Date: 2003-11-11
Institutions: European Commission
Subjects: Community Plant Variety Office, patent law, patents licence, plant variety right, transgenic plant

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 11.11.2003
COM(2003)456 final

2003/0161 (CNS)

Proposal for a

COUNCIL REGULATION

amending Regulation (EC) No 2100/94 on Community plant variety rights

(presented by the Commission)

EXPLANATORY MEMORANDUM

Article 29 of Regulation (EC) No 2100/94 on Community Plant Variety Rights is inconsistent
with  Article  12  of  the  Biotechnology  Patents  Directive  98/44/EC  on  the  legal  protection  of
biotechnological inventions.

In February 1998 the Council called on the Commission to examine this inconsistency and to
submit an appropriate proposal to amend Regulation (EC) No 2100/94.

A plant variety may be protected by a plant variety right but may also contain one or several
biotechnological inventions which are themselves protected by a patent, e.g. patented genetic
components. These intellectual property rights may be owned by different persons.

In the case of disagreement between the various intellectual property owners, both legislations
provide that compulsory measures (exploitation rights or cross licencing) may be granted to
ensure that the plant variety or patent may be exploited, but only when justified.

Under Regulation (EC) No 2100/94 this may be done only on the grounds of ‘public interest’.
Under  Directive  98/44/EC,  a  compulsory  exploitation  right  can  be  granted  if  it  would
constitute  a  ‘significant  technical  progress  of  considerable  economic  interest’,  but  not  a
general ‘public interest’.

The proposed amendment to Regulation (EC) No 2100/94 will resolve this inconsistency:

1.

2.

3.

It will provide coherence of the system  of  compulsory  cross-licencing  provided  for
by  Regulation  (EC)  No  2100/94  on  Community  plant  variety  rights  and  Directive
98/44/EC on biotechnological inventions.

To enable the exploitation of a patented biotechnological invention, the Community
Plant Variety Office can grant to the patent holder a compulsory licence for the use
of a protected plant variety containing his invention. Applicants for the compulsory
licences must demonstrate that;

– 

– 

they  have  applied  unsuccessfully  to  the  holder  of  the  plant  variety  right  to
obtain a contractual licence; and

the  biotechnological  invention  constitutes  a  significant  technical  progress  of
considerable economic interest compared with the protected plant variety.

The  holder  of  the  patent  can  be  granted  a  cross-licence  to  exploit  the  plant  variety
containing  his  biotechnological  invention,  if  the  holder  of  a  plant  variety  right  has
been  granted  a  compulsory  licence  for  the  use  of  this  patented  invention  under
Directive 98/44/EC.

The proposal has no new financial implications for the Community budget.

The proposal will have no impact on small or medium sized undertakings.

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2003/0161 (CNS)

Proposal for a

COUNCIL REGULATION

amending Regulation (EC) No 2100/94 on Community plant variety rights

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
308 thereof,

Having regard to the proposal from the Commission1,

Having regard to the opinion of the European Parliament2,

Whereas:

(1) 

(2) 

(3) 

(4) 

(5) 

Regulation  (EC)  No  2100/943  creates  a  Community  regime  for  plant  varieties,  co-
existing with national regimes, which allows for the grant of industrial property rights,
valid throughout the Community (“Community plant variety rights”).

The  implementation  and  application  of  this  regime  are  carried  out  by  a  Community
Office  with  legal  personality,  known  as  the  Community  Plant  Variety  Office  (“the
Office”),

Only the Office is entitled to grant a compulsory exploitation right for a plant variety
which is protected by a Community plant variety right,

The Community’s legal framework for the protection  of biotechnological inventions,
established in Directive 98/44/EC of the European Parliament and of the Council of 6
July 1998 on the legal protection of biotechnological inventions4 lays down in Article
12  rules  for  the  grant  of  non-exclusive  compulsory  licences  where  protected  plant
varieties incorporate patented inventions, and vice versa,

Article  29  of  Regulation  (EC)  No  2100/94  provides  in  general  for  the  grant  of
compulsory  exploitation  rights  for  Community  plant  varieties  on  grounds  of  public
interest, whereas Article 12 of Directive 98/44/EC does not impose such a requirement
in  relation  to  a  compulsory  cross-licencing  between  an  invention  patent  and  a  plant
variety right.

1

2

3

4

OJ C , , p. .
OJ C , , p. .
OJ L 227, 1.9.1994, p. 1.
OJ L 213, 30.7.1998, p. 13.

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(6) 

(7) 

Considering the need to ensure coherence of the system of compulsory cross-licencing
in the different  fields of industrial and commercial property,  the  rules  established by
Regulation  (EC)  No  2100/94  should  be  aligned  with  those  provided  for  in  Directive
98/44/EC.

Considering the national scope of the protection for biotechnological inventions under
Directive 98/44/EC and the need to ensure that the national patent holder be granted a
cross-licence for a plant variety right only in the Member State(s) where he can claim
a patent for a biotechnological invention,

(8) 

For the adoption of this Regulation, the Treaty does not provide for powers other than
those conferred by Article 308,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 2100/94 is hereby amended as follows:

Article 29 shall be replaced by the following:

"Article 29

Compulsory  exploitation  right  and  compulsory  cross  licencing  where  a  variety  incorporates
an invention protected by patent

1.

2.

3.

Compulsory  exploitation  rights  shall  be  granted  to  one  or  more  persons  by  the
Office, on application by that person or those persons, but only on grounds of public
interest and after consulting the Administrative Council referred to in Article 36.

On application by a Member State, by the Commission or by an organisation set up
at  Community  level  and  registered  by  the  Commission,  a  compulsory  exploitation
right may be granted, either to a category of persons satisfying specific requirements,
or to anyone in one or more Member States or throughout the Community. It may be
granted  only  on  grounds  of  public  interest  and  with  the  approval  of  the
Administrative Council.

The Office shall, when granting the compulsory exploitation right under paragraphs
1,  2  or  5,  stipulate  the  type  of  acts  covered  and  specify  the  reasonable  conditions
pertaining thereto as well as the specific requirements referred to in paragraph 2. The
reasonable  conditions  shall  take  into  account  the  interests  of  any  holder  of  plant
variety  rights  who  would  be  affected  by  the  grant  of  the  compulsory  exploitation
right. The reasonable conditions may include a possible time limitation, the payment
of  an  appropriate  royalty  as  equitable  remuneration  to  the  holder,  and  may  impose
certain obligations on the holder, the fulfilment of which are necessary to make use
of the compulsory exploitation right.

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4.

5.

6.

7.

8.

On the expiry of each one-year period after the grant of the compulsory exploitation
right  under  paragraphs  1,  2  or  5,  and  within  the  aforementioned  possible  time
limitation,  any  of  the  parties  to  proceedings  may  request  that  the  decision  on  the
grant  of  the  compulsory  exploitation  right  be  cancelled  or  amended.  The  sole
grounds  for such  a request shall be that the circumstances determining  the decision
taken have in the meantime undergone change.

On  application,  a  compulsory  exploitation  right  shall  be  granted  to  the  holder  in
respect of an essentially derived variety if the criteria set out in paragraph 1 are met.
The reasonable conditions referred to in paragraph 3 shall include the payment of an
appropriate royalty as equitable remuneration to the holder of the initial variety.

The  implementing  rules  pursuant  to  Article  114  may  specify  certain  cases  as
examples of the public interest referred to in paragraphs 1 and 2, and moreover lay
down details for the implementation of the provisions of the above paragraphs.

Compulsory exploitation rights may not be granted by Member States in respect of a
Community plant variety right.

The following rules shall apply by way of derogation from paragraphs 1 to 7:

(a) Where  the  holder  of  a  patent  for  a  biotechnological  invention  applies  to  the
Office for a compulsory licence for the non-exclusive use of a protected plant
variety under article 12(2) of Directive 98/44/EC, the Office shall grant such a
licence, subject to payment of an appropriate royalty, provided that the patent
holder demonstrates that

(i)

(ii)

he  has  applied  unsuccessfully  to  the  holder  of  the  plant  variety  right  to
obtain a contractual licence; and

the  invention  constitutes  significant  technical  progress  of  considerable
economic interest compared with the protected plant variety.

(b) Where,  in  order  to  enable  him  to  acquire  or  exploit  his  plant  variety  right,  a
holder has been granted a compulsory licence under article 12(1) of the above
Directive for the non-exclusive use of a patented invention, the Office shall, on
application by the holder of the patent for that invention, grant to him a non-
exclusive cross-licence on reasonable terms to exploit the variety.

(c) On granting a licence or cross-licence to a patent holder under sub-paragraph
(a)  or  (b)  respectively,  the  Office  shall  restrict  the  territorial  scope  of  the
licence or cross-licence to the part or parts of the Community  covered  by  the
patent.”

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

Article 2

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Council
The President

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