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Legal protection of biotechnological inventions

Clear and effective legal protection in the field of biotechnology is essential for both techno-scientific research and economic development in Europe. That is the purpose of this Directive which also specifically bans human cloning and any modifications to germ line genetic identity. The ethical aspects are handled by an independent committee which has been given the task of advising the European Commission on these matters.

ACT

European Parliament and Council Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions.

SUMMARY

The objective of the Directive is to clarify the distinction between what is patentable and what is not. It particularly seeks to confirm that the human body at the various stages of its formation and development, and processes for cloning human beings and for modifying the germ-line genetic identity of human beings, may not be regarded as patentable inventions.

In order to protect biotechnological inventions, Member States must ensure that their national patent laws conform to the provisions of the Directive.

Patentability

Inventions which are new, involve an inventive step and are susceptible of industrial application are patentable even if they concern a product consisting of or containing biological material *. Biological material which is isolated from its natural environment or produced by means of a technical process may also be the subject of an invention.

The following are not patentable:

  • plant and animal varieties;
  • essentially biological processes for the production of plants or animals, such as crossing or selection. This exclusion from patentability does not, however, affect the patentability of inventions which concern a microbiological process *;
  • the human body and the simple discovery of one of its elements, including the sequence or partial sequence of a gene.

However, an element isolated from the human body or produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention.

The following inventions include those that are unpatentable where their exploitation would be contrary to public policy or morality:

  • processes for cloning human beings;
  • processes for modifying the germ-line genetic identity of human beings;
  • uses of human embryos for industrial or commercial purposes;
  • processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

Ethical aspects

The Commission's European Group on Ethics in Science and New Technologies is to evaluate all ethical aspects of biotechnology.

Extent of protection

The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention extends to any biological material derived from that biological material through propagation or multiplication and possessing those same characteristics.

The protection conferred by a patent on a product containing genetic information extends to all material in which the product is incorporated.

The protection referred to in points 8 and 9 does not, however, extend:

  • to biological material obtained from the propagation or multiplication of biological material, where the multiplication or propagation necessarily results from the application for which the material was marketed by the holder of the patent or with his consent, provided that the material obtained is not subsequently used for other propagation or multiplication;
  • to plant-propagating material or breeding stock sold to a farmer by the holder of the patent or with his consent, provided that the farmer uses the biological material or livestock for his own agricultural purposes.

Compulsory cross-licensing

Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he may apply for a compulsory licence for non-exclusive use of the invention protected by this patent, subject to payment of an appropriate royalty.

This also applies where the holder of a patent concerning a biotechnological invention cannot exploit it without infringing a prior plant variety right.

Procedures for depositing biotechnological inventions

The application for a patent must meet a certain number of conditions (the biological material has been deposited no later than the date on which the patent application was filed with a recognised depositary institution, transmission of information on the characteristics of the biological material deposited, etc.).

Key terms used in the act
  • Biological material: any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.
  • Microbiological process: any process involving or performed upon or resulting in microbiological material.

REFERENCES

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 98/44/EC 30.7.1998 30.7.2000 OJ L 213 of 30.7.1998
Last updated: 04.07.2011
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