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Directive on the legal protection of biotechnological inventions

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335:'inventions'. The directive, however, provides that "biological material which is isolated from its natural environment ... may be the subject of an invention even if it previously occurred in nature." It is clearly arguable that merely isolating a human gene or protein from its natural environment is not an activity that can come within the meaning of the word 'invention'. The Danish Council of Bioethics in its Patenting Human Genes and Stem Cells Report noted that "In the members' view, it cannot be said with any reasonableness that a sequence or partial sequence of a gene ceases to be part of the human body merely because an identical copy of the sequence is isolated from or produced outside of the human body." TRIPS applies to the European Community as it is a member of the World Trade Organization (WTO) in its own right and accordingly must ensure "the conformity of its laws, regulations and administrative procedures with obligations as provided" by the WTO. 47: 317:, 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. 334:
Nevertheless, the ECJ decision does not preclude a further test of the validity of the directive on the ground that it is inconsistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Art. 27.1 TRIPS provides that patents are only to be granted with respect to
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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
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On 14 January 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.
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for a pro-Directive campaign. Part of this campaign was direct support of patient charities and organisations. On the day of the July 1997 vote, a number of people in wheelchairs from these groups demonstrated outside the main hall in
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Report from the Commission to the Council and the European Parliament, Development and implications of patent law in the field of biotechnology and genetic engineering
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Baruch Brody, 2007. "Intellectual Property and Biotechnology: The European Debate,” Kennedy Institute of Ethics Journal 17(2): 69–110.
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Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions
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Reports and other documents concerning European Commission activities in the area of biotechnological inventions
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Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organisations
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against the adoption of the directive with six different pleas but the Court granted none of them.
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meeting at 3rd reading on 1 March 1995 so the first directive process did not yield a directive.
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The Big Mirage: The Misuse of the Patient with Hereditary Diseases Before the EP's Vote in 1997
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As of 15 January 2007, all of the 27 EU member states had implemented the Directive.
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in 1988. The procedure for its adoption was slowed down by primarily
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On 6 July 1998, a final version was adopted. Its code is 98/44/EC.
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Deposit, access and re-deposit of biological material (Chapter IV)
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Directive on the legal protection of biotechnological inventions
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Directive on the legal protection of biotechnological inventions
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from the Commission Directorate-General for the Internal Market
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from the Commission Directorate-General for the Internal Market
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Directive on the patentability of biotechnological inventions
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The Directive is divided into the following five chapters:
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Paris Convention for the Protection of Industrial Property
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issues regarding the patentability of living matter. The
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lobbyist Simon Gentry, the company allocated 30 million
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Société des Produits Nestlé S.A. v. Cadbury UK Limited
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Directive on the re-use of public sector information
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Directive on Copyright in the Digital Single Market
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European Union directive in the field of patent law
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European Commission. 14 January 2002 720: 661:Text of directive with headers (html) 251:plant varieties (as legally defined) 531:"legal texts – Marrakesh agreement" 24: 814:Electronic Commerce Directive 2000 599:Simpson, Alan (1 September 1997). 91:L213, 30 July 1998, pp. 13–21 25: 1200: 1067:Traditional speciality guaranteed 644: 363: 327:brought Case C-377/98 before the 1174:Patent law of the European Union 693:Some biotechnological inventions 553:"EURLex – 170903 – EN – EUR-Lex" 409:"EURLex – 100993 – EN – EUR-Lex" 383:Patent law of the European Union 275:Scope of Protection (Chapter II) 45: 1062:Protected designation of origin 1038:Regulation on Community designs 688:UK Intellectual Property Office 615: 592: 453:"EURLex – 11643 – EN – EUR-Lex" 567: 545: 523: 506: 484: 467: 445: 423: 401: 13: 1: 820:Information Society Directive 790:Satellite and Cable Directive 394: 161:C286, 1997-09-22, p. 87. 139:C311, 1997-10-11, p. 12. 856:Customs Regulation 1383/2003 808:Conditional Access Directive 796:Copyright Duration Directive 150:C295, 1996-10-07, p. 11 137:C296, 1996-10-08, p. 4. 7: 778:Computer Programs Directive 656:Text of the directive (pdf) 371: 288: 10: 1205: 1184:1998 in the European Union 748:Intellectual property laws 325:Kingdom of the Netherlands 263: 1100: 1075: 1052: 1016: 967: 948:European Union trade mark 930: 865: 768: 759: 329:European Court of Justice 272:Patentability (Chapter I) 216: 208: 200: 192: 184: 179: 167: 154: 143: 130: 125: 117: 109: 101: 96: 83: 75: 61: 53: 44: 37: 1054:Geographical indications 844:Copyright Term Directive 343:Campaigning and lobbying 228:European Union directive 39:European Union directive 826:Resale Rights Directive 517:10 October 2006 at the 1189:Life sciences industry 697:European Patent Office 651:EU Legislation summary 478:19 August 2007 at the 1169:Biological patent law 1138:WIPO Copyright Treaty 953:Trade Marks Directive 838:Enforcement Directive 628:. European Commission 455:. European Commission 433:. European Parliament 411:. European Commission 1003:Unified Patent Court 601:"No Patents on Life" 581:29 June 2006 at the 998:European patent law 303:European Parliament 295:European Commission 217:Current legislation 118:Implementation date 66:European Parliament 34: 802:Database Directive 695:registered at the 603:. 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Index

Directive on the patentability of biotechnological inventions
European Union directive
European Parliament
Council
Journal
L213, 30 July 1998, pp. 13–21
Commission
EESC
EP
European Union directive
internal market
Treaty of Rome
patentability
biotechnological
inventions
plant varieties (as legally defined)
human
genes
European Commission
ethical
European Parliament
Conciliation
Council
Kingdom of the Netherlands
European Court of Justice
SmithKline Beecham
ECU
Strasbourg
Biological patent
Patent law of the European Union

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