Directive on the patentability of biotechnological inventions
Encyclopedia
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 law
s of Member States regarding the patentability
of biotechnological
invention
s, including plant varieties (as legally defined) and human genes.
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 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=100993.
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 patent
ing 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 http://www.europarl.europa.eu/omk/omnsapir.so/calendar?APP=PDF&TYPE=PV1&FILE=19980512EN.pdf&LANGUE=EN http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=11643. 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 http://www.curia.europa.eu/en/actu/activites/act01/0125en.htm#ToC1 before the European Court of Justice
against the adoption of the directive with six different pleas but the Court granted none of them.
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). http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm 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 http://www.etiskraad.dk/sw475.asp 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. http://www.wto.org/english/docs_e/legal_e/04-wto_e.htm
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 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=170903.
from the start for a pro-Directive campaign.
Part of this campaign was direct support of patient charities and organizations and using that to actively manipulate and instrumentalise patient interest group
s 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.
is a European Union directive
European Union directive
A directive is a legislative act of the European Union, which requires member states to achieve a particular result without dictating the means of achieving that result. It can be distinguished from regulations which are self-executing and do not require any implementing measures. Directives...
in the field of patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
law, made under the internal market
provisions of the Treaty of Rome
Treaty of Rome
The Treaty of Rome, officially the Treaty establishing the European Economic Community, was an international agreement that led to the founding of the European Economic Community on 1 January 1958. It was signed on 25 March 1957 by Belgium, France, Italy, Luxembourg, the Netherlands and West Germany...
. It was intended to harmonize the law
Law
Law is a system of rules and guidelines which are enforced through social institutions to govern behavior, wherever possible. It shapes politics, economics and society in numerous ways and serves as a social mediator of relations between people. Contract law regulates everything from buying a bus...
s of Member States regarding the patentability
Patentability
Within the context of a national or multilateral body of law, an invention is patentable if it meets the relevant legal conditions to be granted a patent...
of biotechnological
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
invention
Invention
An invention is a novel composition, device, or process. An invention may be derived from a pre-existing model or idea, or it could be independently conceived, in which case it may be a radical breakthrough. In addition, there is cultural invention, which is an innovative set of useful social...
s, including plant varieties (as legally defined) and human genes.
Content
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)
Timeline
The original proposal was adopted by the European CommissionEuropean Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
in 1988. The procedure for its adoption was slowed down by primarily ethical
Ethics
Ethics, also known as moral philosophy, is a branch of philosophy that addresses questions about morality—that is, concepts such as good and evil, right and wrong, virtue and vice, justice and crime, etc.Major branches of ethics include:...
issues regarding the patentability of living matter. The European Parliament
European Parliament
The European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...
eventually rejected the joint text from the final Conciliation
Conciliation
Conciliation is an alternative dispute resolution process whereby the parties to a dispute agree to utilize the services of a conciliator, who then meets with the parties separately in an attempt to resolve their differences...
meeting at 3rd reading on March 1, 1995 so the first directive process did not yield a directive http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=100993.
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 patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
ing 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 http://www.europarl.europa.eu/omk/omnsapir.so/calendar?APP=PDF&TYPE=PV1&FILE=19980512EN.pdf&LANGUE=EN http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=11643. 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
Kingdom of the Netherlands
The Kingdom of the Netherlands is a sovereign state and constitutional monarchy with territory in Western Europe and in the Caribbean. The four parts of the Kingdom—Aruba, Curaçao, the Netherlands, and Sint Maarten—are referred to as "countries", and participate on a basis of equality...
brought Case C-377/98 http://www.curia.europa.eu/en/actu/activites/act01/0125en.htm#ToC1 before the European Court of Justice
European Court of Justice
The Court can sit in plenary session, as a Grand Chamber of 13 judges, or in chambers of three or five judges. Plenary sitting are now very rare, and the court mostly sits in chambers of three or five judges...
against the adoption of the directive with six different pleas but the Court granted none of them.
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). http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm 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 http://www.etiskraad.dk/sw475.asp 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. http://www.wto.org/english/docs_e/legal_e/04-wto_e.htm
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 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=170903.
Examples of lobby
According to SmithKline Beecham lobbyist Simon Gentry, the company allocated 30 million ECUECU
ECU may refer to:Automotive terms* Electronic control unit, a generic term for any embedded system that controls one or more of the electrical systems or subsystems in a motor vehicle...
from the start for a pro-Directive campaign.
Part of this campaign was direct support of patient charities and organizations and using that to actively manipulate and instrumentalise patient interest group
Patients Not Patents
Patients Not Patents is a patient advocacy group whose primary activity is challenging the validity of medical patents before the United States Patent and Trademark Office . Its founder and Executive Director is Jeffrey Light....
s which have been by far the most influential lobby groups active on the Directive. Many MEPs
Member of the European Parliament
A Member of the European Parliament is a person who has been elected to the European Parliament. The name of MEPs differ in different languages, with terms such as europarliamentarian or eurodeputy being common in Romance language-speaking areas.When the European Parliament was first established,...
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.
Implementation
As of January 15, 2007, all of the 27 EU member states had implemented the Directive.See also
- Patent law of the European Union
- G 2/06G 2/06G 2/06 is a decision of the Enlarged Board of Appeal of the European Patent Office , which was issued on November 25, 2008. The Enlarged Board of Appeal decided that, under the European Patent Convention , a patent cannot be granted for an invention which necessarily involves the use and...
, 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. - Baruch Brody, 2007. “Intellectual Property and Biotechnology: The European Debate,” Kennedy Institute of Ethics Journal 17(2): 69-110. http://muse.jhu.edu/journals/kennedy_institute_of_ethics_journal/v017/17.2brody.pdf
External links
- 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 OfficeEuropean Patent OrganisationThe European Patent Organisation is a public international organisation created in 1977 by its contracting states to grant patents in Europe under the European Patent Convention of 1973...
(unofficial site) - Paper