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Directive on the patentability of biotechnological inventions

Directive 98/44/EC
European Union directive
Title Directive on the legal protection of biotechnological inventions
Made by European Parliament & Council
Made under Art. 100a
Journal reference L213, 30 July 1998, pp. 13–21
History
Date made 1998-07-06
Came into force 1998-07-30
Implementation date 2000-07-30
Preparative texts
Commission proposal C296, 1996-10-08, p. 4.
C311, 1997-10-11, p. 12.
EESC opinion C295, 1996-10-07, p. 11
EP opinion C286, 1997-09-22, p. 87.
C167, 1998-06-01
Reports COM(2002) 2
COM(2002) 545
COM(2005) 312
Other legislation
Replaces
Amends
Amended by
Replaced by
Current legislation

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions is a European Union directive in the field of patent law, made under the internal market provisions of the Treaty of Rome. It was intended to harmonise the laws of Member States regarding the patentability of biotechnological inventions, including plant varieties (as legally defined) and human genes.

The Directive is divided into the following five chapters:

The original proposal was adopted by the European Commission in 1988. The procedure for its adoption was slowed down by primarily ethical issues regarding the patentability of living matter. The European Parliament eventually rejected the joint text from the final Conciliation meeting at 3rd reading on 1 March 1995 so the first directive process did not yield a directive.

On 13 December 1995, the Commission adopted a new proposal was nearly identical to the rejected version, was changed again, but the Parliament put aside its ethical concerns on patenting of human genes in on 12 July 1998 in its second reading and adopted the Common Position of the Council, so in the second legislative process, the directive was adopted. The drafts person of the Parliament for this second procedure was Willi Rothley and the vote with the most yes votes was Amendment 9 from the Greens which got 221 against 294 votes out of 532 members voting with 17 abstentions but 314 yes votes would have been required to reach the required an absolute majority to adopt it.

On 6 July 1998, a final version was adopted. Its code is 98/44/EC.

The Kingdom of the Netherlands brought Case C-377/98 before the European Court of Justice against the adoption of the directive with six different pleas but the Court granted none of them.


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