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
A directive is a legal act of the European Union that requires member states to achieve a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before thei ...
in the field of patent law, made under the
internal market
provisions of the
Treaty of Rome. It was intended to harmonise the laws of Member States regarding the
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. By extension, patentability also refers to the substantive conditions that must be met fo ...
of
biotechnological
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used ...
inventions, including
plant varieties (as legally defined) and
human
Humans (''Homo sapiens'') are the most abundant and widespread species of primate, characterized by bipedalism and exceptional cognitive skills due to a large and complex brain. This has enabled the development of advanced tools, cultu ...
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 Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body ...
in 1988. The procedure for its adoption was slowed down by primarily
ethical
Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns ma ...
issues regarding the patentability of living matter. The
European Parliament
The European Parliament (EP) is one of the legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it adopts ...
eventually rejected the joint text from the final
Conciliation meeting at 3rd reading on 1 March 1995 so the first directive process did not yield a directive.
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
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 6 July 1998, a final version was adopted. Its code is 98/44/EC.
The
Kingdom of the Netherlands
, national_anthem = )
, image_map = Kingdom of the Netherlands (orthographic projection).svg
, map_width = 250px
, image_map2 = File:KonDerNed-10-10-10.png
, map_caption2 = Map of the four constituent countries shown to scale
, capital = ...
brought Case C-377/98 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). 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 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.
Campaigning and lobbying
According to
SmithKline Beecham
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the tent ...
lobbyist Simon Gentry, the company allocated 30 million
ECU 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
Strasbourg, chanting the pharmaceutical industry's slogan, "No Patents, No Cure" in an emotional appeal to Parliamentarians to vote for the Directive.
Implementation
As of 15 January 2007, all of the 27 EU member states had implemented the Directive.
See also
*
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 25 November 2008, relating to (non-patentability of) inventions involving the use and destruction of human embryos.
References
External links
EU Legislation summaryText 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
from the Commission Directorate-General for the Internal Market
from the Commission Directorate-General for the Internal Market
from the
UK Intellectual Property Office
The Intellectual Property Office of the United Kingdom (often referred to as the UK IPO) is, since 2 April 2007, the operating name of The Patent Office. It is the official government body responsible for intellectual property rights in the UK ...
Some biotechnological inventionsregistered at the
European Patent Office
The European Patent Office (EPO) is one of the two organs of the European Patent Organisation (EPOrg), the other being the Administrative Council. The EPO acts as executive body for the organisation (''unofficial site'')
Paper*Baruch Brody, 2007. "Intellectual Property and Biotechnology: The European Debate,” Kennedy Institute of Ethics Journal 17(2): 69–110
{{DEFAULTSORT:Directive On The Legal Protection Of Biotechnological Inventions
Biological patent law
Patent law of the European Union
1998 in law
1998 in the European Union
Life sciences industry