Directive on the legal protection of biotechnological inventions

From Wikipedia, the free encyclopedia

You have new messages (last change).
Flag of the European Union Directive 98/44/EC
Title: Directive on the legal protection of biotechnological inventions
Made by: European Parliament & Council
Made under: Art. 100a
Official Journal reference: L213, 1998-07-30, pp. 13–21
Dates
Made: 1998-07-06
Came into force: 1998-07-30
Implementation date: 2000-07-30
Preparative texts
Proposal from the Commission: C296, 1996-10-08, p. 4.
C311, 1997-10-11, p. 12.
Opinion of the Economic and Social Committee: C295, 1996-10-07, p. 11
Opinion of the European Parliament: 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: —
Status: 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 harmonize the laws of Member States regarding the patentability of biotechnological inventions, including plant varieties and human genes.

Contents

[edit] Timeline

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. Its code is 98/44/EC.

The Kingdom of the Netherlands brought Case C-377/98[4] before the European Court of Justice against the adoption of the directive with six different pleas but the Court granted none of them.

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].

[edit] Examples of lobby

 The neutrality of this section is disputed.
Please see the discussion on the talk page.

According to SmithKline Beecham lobbyist Simon Gentry, the company allocated 30 million ECU from the start for a pro-Directive campaign. [1]

Part of this campaign was direct support of patient charities and organizations and using that to actively manipulate and instrumentalise patient interest groups which have been by far the most influential lobby groups active on the Directive. Many MEPs voted in favour of the Directive under strong pressure from these interest groups in what was described as "the largest lobby campaign in the history of the EU." On the day of the July '97 vote, a number of people in wheelchairs from some patient interest groups demonstrated outside the main hall in Strasbourg, chanting the pharmaceutical industry's slogan, "No Patents, No Cure" in an emotional appeal to Parliamentarians to vote for the Directive.

Thus, MEPs perceived a strong and unified position in favour of gene-patenting from the patient interest groups, but it has been said that the majority of patient interest groups were not expressed because of industry-supported lobbying co-opted the vocal groups and made them present their message. While most patient interest groups did not buy in to the corporate dream, some rather influential groups have been co-opted.

The Genetic Interest Group (GIG) and the European Alliance of Genetic Support Groups (EAGS) were both against the patenting of genes initially. However, this changed when SmithKline Beecham began making donations to GIG. In January '97, the head of both organisations organized an information event on human gene-patenting in Strasbourg in January 1997, which was presented as an event of patient organisations.

[edit] Notes

  1. ^ Industry and the EU Life Patent Directive, Corporate Europe Observer, Issue 1, May 1998, citing ECOBP, "The Big Mirage: The Misuse of the Patient with Hereditary Diseases Before the EP's Vote in 1997" an ECOBP Background Paper, March 1998, page 4

[edit] See also

[edit] External links


Flag of the European Union Patent law of the European Union Flag of the European Union
Directives Biotechnology (98/44/EC) • Civil enforcement (2004/48/EC)
Also:Regulation (EC) No 1383/2003 (Customs enforcement)
Treaties Paris Convention • Patent Cooperation Treaty • European Patent Convention • Budapest Treaty • TRIPS
Community Patent  
National laws Austria • Belgium • Cyprus • Czech Republic • Denmark • Estonia • Finland • France • Germany • Greece • Hungary • Ireland • Italy • Latvia • Lithuania • Luxembourg • Malta • Netherlands • Poland • Portugal • Slovakia • Slovenia • Spain • Sweden • United Kingdom
EEA Countries Iceland • Liechtenstein • Norway
Retrieved from "http://en.wikipedia.org../../../d/i/r/Directive_on_the_legal_protection_of_biotechnological_inventions.html"
In other languages