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309: 471: 31: 565:(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. 545:
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
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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
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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
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Art. 27.1 TRIPS provides that patents are only to be granted with respect to '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
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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.
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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
454:, 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 441:
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.
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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).
631:, decision of the Enlarged Board of Appeal of the European Patent Office (EPO) of November 25, 2008, relating to (non-patentability of) inventions involving the use and destruction of human embryos. 730: 641: 647:
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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Strasbourg, chanting the pharmaceutical industry's slogan, "No Patents, No Cure" in an emotional appeal to Parliamentarians to vote for the Directive.
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Part of this campaign was direct support of patient charities and organizations and using that to actively manipulate and instrumentalise
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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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against the adoption of the directive with six different pleas but the Court granted none of them.
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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 January 15, 2007, all of the 27 EU member states had implemented the Directive.
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which have been by far the most influential lobby groups active on the Directive. Many
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http://ec.europa.eu/internal_market/indprop/docs/invent/state-of-play_en.pdf
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fr:Directive sur la brevetabilité des inventions biotechnologiques
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Deposit, access and re-deposit of biological material (Chapter IV)
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Thus, MEPs perceived a strong and unified position in favour of
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Directive on the legal protection of biotechnological inventions
594:, Corporate Europe Observer, Issue 1, May 1998, citing ECOBP, " 531: 464: 368:
1995 so the first directive process did not yield a directive
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in its second reading and adopted the Common Position of the
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The Directive is divided into the following five chapters:
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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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It was intended to harmonize the 14: 692:Some biotechnological inventions 624:Patent law of the European Union 469: 307: 291:Scope of Protection (Chapter II) 29: 687:UK Intellectual Property Office 257:of Member States regarding the 1: 496:conditions to do so are met 746: 420:Kingdom of the Netherlands 364:meeting at 3rd reading on 427:European Court of Justice 288:Patentability (Chapter I) 227: 28: 21: 239:European Union directive 23:European Union directive 539:patient interest groups 696:European Patent Office 559:Genetic Interest Group 78:, pp. 13–21 642:Text of the Directive 422:brought Case C-377/98 386:of human genes in on 676:from the Commission 667:from the Commission 245:law, made under the 660:European Commission 483:of this section is 358:European Parliament 346:European Commission 228:Current legislation 108:Implementation date 50:European Parliament 18: 694:registered at the 528:SmithKline Beecham 319:. You can help by 249:provisions of the 17:Directive 98/44/EC 524: 523: 516: 461:Examples of lobby 337: 336: 232: 231: 191:Other legislation 118:Preparative texts 737: 719: 713: 611: 605: 599: 587: 519: 512: 508: 505: 499: 473: 472: 465: 332: 329: 311: 304: 263:biotechnological 241:in the field of 98:Entry into force 33: 32: 19: 745: 744: 740: 739: 738: 736: 735: 734: 717: 711: 700:unofficial site 638: 620: 615: 614: 606: 602: 588: 584: 579: 571: 520: 509: 503: 500: 489: 474: 470: 463: 342: 333: 327: 324: 317:needs expansion 282: 270:plant varieties 247:internal market 185: 183: 170: 134: 30: 12: 11: 5: 743: 741: 709: 708: 703: 689: 680: 671: 662: 653: 644: 637: 636:External links 634: 633: 632: 626: 619: 616: 613: 612: 600: 581: 580: 578: 575: 570: 569:Implementation 567: 561:(GIG) and the 551:gene-patenting 522: 521: 477: 475: 468: 462: 459: 341: 338: 335: 334: 314: 312: 302: 301: 298: 295: 292: 289: 281: 278: 251:Treaty of Rome 230: 229: 225: 224: 221: 217: 216: 213: 209: 208: 205: 201: 200: 197: 193: 192: 188: 187: 180: 176: 175: 163: 156: 155: 148: 141: 140: 127: 120: 119: 115: 114: 109: 105: 104: 99: 95: 94: 89: 85: 84: 80: 79: 72: 65: 64: 61: 57: 56: 47: 43: 42: 39: 35: 34: 26: 25: 13: 10: 9: 6: 4: 3: 2: 742: 733: 732: 728: 727: 724: 720: 716: 707: 704: 701: 697: 693: 690: 688: 684: 681: 679: 675: 672: 670: 666: 663: 661: 657: 654: 652: 648: 645: 643: 640: 639: 635: 630: 627: 625: 622: 621: 617: 609: 604: 601: 597: 593: 592: 586: 583: 576: 574: 568: 566: 564: 560: 555: 552: 547: 544: 540: 535: 533: 529: 526:According to 518: 515: 507: 504:December 2007 497: 493: 487: 486: 482: 476: 467: 466: 460: 458: 456: 453: 449: 444: 443: 439: 435: 430: 428: 424: 421: 416: 414: 409: 406: 405:Willi Rothley 402: 400: 397: 393: 389: 385: 381: 377: 372: 370: 367: 363: 359: 355: 351: 347: 339: 331: 322: 318: 315:This section 313: 310: 306: 305: 299: 296: 293: 290: 287: 286: 285: 279: 277: 275: 271: 267: 264: 260: 259:patentability 256: 252: 248: 244: 240: 236: 226: 222: 218: 214: 210: 206: 202: 198: 194: 189: 186:COM(2005) 312 184:COM(2002) 545 181: 177: 174: 169:, p. 87. 168: 164: 161: 157: 153: 149: 146: 142: 139:, p. 12. 138: 132: 128: 125: 121: 116: 113: 110: 106: 103: 100: 96: 93: 90: 86: 81: 77: 73: 70: 66: 62: 58: 55: 51: 48: 44: 40: 36: 27: 24: 20: 729: 721: 718:}} 712:{{ 710: 699: 603: 595: 590: 585: 572: 556: 548: 536: 525: 510: 501: 479: 445: 431: 417: 410: 373: 362:Conciliation 343: 325: 321:adding to it 316: 283: 268:, including 234: 233: 154:, p. 11 133:, p. 4. 425:before the 376:December 13 274:human genes 220:Replaced by 182:COM(2002) 2 651:2005-07-14 481:neutrality 448:January 14 328:March 2007 266:inventions 212:Amended by 173:1998-06-01 167:1997-09-22 152:1996-10-07 137:1997-10-11 131:1996-10-08 124:Commission 112:2000-07-30 102:1998-07-30 92:1998-07-06 76:1998-07-30 60:Made under 685:from the 658:from the 492:talk page 384:patenting 88:Date made 71:reference 63:Art. 100a 618:See also 485:disputed 340:Timeline 196:Replaces 126:proposal 656:Summary 396:Council 388:July 12 366:March 1 354:ethical 280:Content 223:— 215:— 207:— 199:— 179:Reports 162:opinion 147:opinion 83:History 69:Journal 54:Council 46:Made by 715:IPL-EU 683:Issues 629:G 2/06 413:July 6 243:patent 204:Amends 171:C167, 165:C286, 150:C295, 135:C311, 129:C296, 74:L213, 52:& 706:Paper 577:Notes 237:is a 38:Title 557:The 543:MEPs 478:The 452:2002 418:The 392:1998 380:1995 350:1988 272:and 255:laws 145:EESC 665:FAQ 532:ECU 446:On 411:On 374:On 348:in 323:. 261:of 649:, 457:. 450:, 390:, 378:, 371:. 276:. 160:EP 702:) 698:( 517:) 511:( 506:) 502:( 498:. 488:. 330:) 326:(

Index

European Union directive
European Parliament
Council
Journal
1998-07-30
1998-07-06
1998-07-30
2000-07-30
Commission
1996-10-08
1997-10-11
EESC
1996-10-07
EP
1997-09-22
1998-06-01
European Union directive
patent
internal market
Treaty of Rome
laws
patentability
biotechnological
inventions
plant varieties
human genes

adding to it
European Commission
1988

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