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Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions.

Type of law

This Directive lays down provisions for the legal protection of biotechnological inventions with a view to encouraging investment and research in the field of biotechnology. The Directive is divided into the following five Chapters: (I) Patentability; (II) Scope of protection; (III) Compulsory cross-licensing; (IV) Deposit, access and re-deposit of a biological material; (V) Final provisions. Inventions shall be patentable in so far as they are new, involve an inventive step and are susceptible of industrial application. Biological material may be the subject of an invention, even if it previously occurred in nature, as long as it has been isolated from its natural environment or produced by means of a technical process. The following shall not be patentable: (a) plant and animal varieties; (b) essentially biological processes for the production of plants or animals. Article 12 concerns compulsory licences to be granted to breeders when they cannot acquire or exploit a plant variety right without infringing a prior patent. Such patents shall be granted upon application and previous payment of an appropriate royalty. Lastly, article 16 refers to the reports to be elaborated and forwarded by the Commission to the European Parliament and to the Council.
Date of text
Entry into force notes
This Directive came into force on 30 July 1998.
Serial Imprint
Official Journal L 213, 30 July 1998, pp. 13-21
Source language


Legislation status
in force
Legislation Amendment