Directive on the legal protection of biotechnological inventions
|European Union directive:|
|Directive on the legal protection of biotechnological inventions|
|Made by||European Parliament & Council|
|Made under||Art. 100a|
|Came into force||1998-07-30|
|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.
|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 (as legally defined) and human genes.
The Directive is divided into the following five chapters:
- Patentability (Chapter I)
- Scope of Protection (Chapter II)
- Compulsory cross-licensing (Chapter III)
- Deposit, access and re-deposit of biological material (Chapter IV)
- Final Provisions (entering into force) (Chapter V)
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.
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. 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.
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 '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. 
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.
Examples of lobby
According to SmithKline Beecham lobbyist Simon Gentry, the company allocated 30 million ECU from the start for a pro-Directive campaign. Part of this campaign was direct support of patient charities and organizations. On the day of the July 1997 vote, a number of people in wheelchairs from these 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 may have only been a minority of vocal groups co-opted by industry to present their message. The Genetic Interest Group (GIG) and the European Alliance of Genetic Support Groups (EAGS) were both against the patenting of genes initially. This changed when SmithKline Beecham began making donations to GIG and they organized an information event on human gene-patenting in Strasbourg in January 1997, which was presented as an event of patient organisations.
As of January 15, 2007, all of the 27 EU member states had implemented the Directive.
- Biological patent
- Patent law of the European Union
- G 2/06, 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.
- "EUR-Lex - 100993 - EN - EUR-Lex". Ec.europa.eu. Retrieved 2015-02-24.
- "Part 1 : Proceedings of the sitting". Europarl.europa.eu. Retrieved 24 February 2015.
- "EUR-Lex - 11643 - EN - EUR-Lex". Ec.europa.eu. Retrieved 2015-02-24.
- [dead link]
- "intellectual property (TRIPS) - agreement text - contents". WTO. Retrieved 2013-08-18.
- [dead link]
- "legal texts - Marrakesh agreement". WTO. Retrieved 2013-08-18.
- "EUR-Lex - 170903 - EN - EUR-Lex". Ec.europa.eu. 2002-01-14. Retrieved 2015-02-24.
- 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
- Simpson, Alan (1997-09-01). "No Patents on Life". The Corner House. Retrieved 2015-02-24.
- "State of Play of the Implementation of Directive 98/44/EC" (PDF). Ec.europa.eu. Retrieved 24 February 2015.
- EU Legislation summary
- Text of the directive (pdf)
- Text of directive with headers (html)
- 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, 2005-07-14
- FAQ from the Commission Directorate-General for the Internal Market
- Reports and other documents concerning European Commission activities in the area of biotechnological inventions from the Commission Directorate-General for the Internal Market
- Issues from the UK Intellectual Property Office
- Some biotechnological inventions registered at the European Patent Office (unofficial site)
- Baruch Brody, 2007. “Intellectual Property and Biotechnology: The European Debate,” Kennedy Institute of Ethics Journal 17(2): 69-110.