Directive on the patentability of biotechnological inventions

The European Union Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions required two legislative procedures to be adopted. It was intented to harmonize the laws of the Member States on patents relating to biotechnological inventions, including plant varieties and human genes.

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 March 1 1995 so the first directive process did not yield a directive [1].

On December 13, 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 July 12, 1998 in its second reading and adopted the Common Position of the Council, so in the second legislative process, the directive was adopted [2] [3]. 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 July 6, 1998, a final version was adopted [4] . Its code is 98/44/EC.

On January 14, 2002, the Commission submitted an assessment of the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable as required under Article 16(b) of this directive [5].

See also

• Codecision procedure
• Directive on the patentability of computer-implemented inventions
• Directive on the enforcement of intellectual property rights

External links

• Short summary of the Commission (Scadplus)
• FAQ from the Directionate General for the internal Market
• The Directionate's page about its laws on biological inventions
• comprehensive paper by an LLM Candidate at Cornell University
• The UK Patent Offics on the directive
• Biological inventions at the EPO
• Paper from the IPR Helpdesk