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Biotechnological inventions: legal protection

Biotechnological inventions: legal protection


Directive 98/44/EC — legal protection of biotechnological inventions



It harmonises national patent laws regarding biotechnological inventions.

It specifies those inventions which are patentable on ethical grounds and those which are not.


  • Inventions which concern a product consisting of, or containing, biological material* or a process for the production of such biological material may be patented if they are new, involve an inventive step and can be applied industrially.
  • The following are not patentable:
    • plant and animal varieties
    • essentially biological processes* for producing plants and animals
    • the human body at the various stages of its formation and development.
  • However, an element isolated from the human body or produced by a technical process may be a patentable invention.
  • Inventions may not be patented where their commercialisation would be immoral or against public order. In particular, the following are not patentable:
    • processes for cloning human beings
    • processes that modify the human germ line genetic identity
    • use of human embryos for industrial or commercial purposes
    • processes that may cause suffering to animals when modifying their genetic identity.
  • The protection granted by a patent also extends to any biological material derived from the original biological material.
  • Where a plant breeder cannot use a plant variety without infringing a patent, they may apply for a compulsory licence for non-exclusive use of the invention, subject to payment of an appropriate royalty.
  • The European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology.

In 2012, the European Commission set up an expert group to examine the technical development and implications of patent law in the field of biotechnology and genetic engineering. The group assists the Commission with its reporting obligations under Directive 98/44/EC.


It has applied since 30 July 1998. EU countries had to incorporate it into national law by 30 July 2000. Nowadays, the rules are implemented in the legislation of all EU countries.


Protection of biotechnological inventions


* Biological material: any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

* Biological process: a process for the production of plants and animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.


Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, pp. 13–21)

last update 21.03.2016