Explanatory Memorandum to COM(2003)456 - Amendment of Regulation (EC) No 2100/94 on Community plant variety rights

Please note

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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. 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.

2. 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.

3. 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.