Directive on the legal protection of biotechnological inventions
European Union directive in the field of patent law,
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 harmonise the laws of Member States regarding the patentability
of biotechnological inventions, 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 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 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 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).
“Directive on the legal protection of biotechnological inventions” enters the record as european Union directive in the field of patent law,. Crown Archives preserves that source wording while asking what Directive, legal and protection can confirm, complicate or overturn.
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The record creator and administrative purpose are central evidence, because official documentation reflects both action and institutional priorities. The source revision retrieved here is dated Mar 20, 2026. The linked authority identifier is Q3029646. 1 of 1 selected statements include explicit references; 0 carry qualifiers and 0 use preferred rank. The first chronological checks are 1998, 1988 and 1995.
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This entry incorporates text from “Directive on the legal protection of biotechnological inventions” on English Wikipedia. Contributors are listed in the page history. Text is available under the Creative Commons Attribution-ShareAlike 4.0 License. Selected authority identifiers and statements are retrieved from Wikidata under CC0; their references and qualifiers remain part of the verification path.