EU - Directive on Patents for Biotechnology

Newsletters and Bulletins / March 1999 / United States

As noted in our July 1997 Newsletter (N.S. 187), after failure of its first attempt to adopt a directive relating to biotechnology, the Commission proposed a revised version. This has now been adopted. The major features are summarized below.

Inventions that meet the EPC's definition of invention are patentable "even if they concern a product consisting of or containing biological material or a process" for producing such a material even if the material previously existed in nature as long as the patent is directed to the material isolated from the natural environment or the material was produced by means of a technical process. Additionally although the EPC's prohibition on the patenting of plant and animal varieties remains intact, "inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety".

Genes and partial sequences thereof are patentable only if the specification discloses an industrial application for the gene or sequence, the introductory recitals to the directive stating "a mere DNA sequence without indication of a function does not contain any technical information and is therefore not patentable".

Neither the human body at any stage of its formation and development nor the discovery of one of its elements, such as a gene, is patentable. However, once isolated from the body or otherwise produced by means of a technical process, a gene that otherwise meets the criteria for patentability may be patented even though its structure is identical with that of a natural element.

Certain inventions are excluded from patentability on the basis that they infringe the EPC's prohibition on patents for inventions whose exploitation is contrary to ordre public or morality, namely:

cloning of human beings;

modifying the germ line genetic identity of human beings;

use of human embryos for industrial or commercial purposes; and

processes for modifying the genetic identity of animals which are likely to cause them suffering without substantial medical benefit to man or animals and animals resulting from such processes.

Protection granted by a patent on a biological material possessing specific characteristics or on a process for production of such material extends to biological material produced by propagation or multiplication of an identical or divergent form possessing the same specific characteristics as the patented material and also to any other biological material into which the patented material is incorporated as long as the genetic information of the patented material continues to perform its function. However, such provisions do not apply to material produced by propagation or multiplication of material placed on the market within the EU by the patentee or with his consent if the propagation or multiplication "necessarily results from the application for which the biological material was marketed, provided that the material is not subsequently used for other propagation or multiplication". Additionally certain farmer's rights are created. These are similar to those given in the Plant Variety Rights Directive and limit the powers given to the patentee insofar as they apply to certain specified species of fodder plants, cereals, potatoes and oil and fiber plants. For these types of plants, farmers may, except when the variety in question is a hybrid or synthetic, have a right to use harvested products for propagating purposes in the field on their own holdings. However, farmers other than "small farmers", will have to pay for this privilege although the amount charged shall be "sensibly lower than the amount charged for the licensed production of propagating material of the same variety in the same area". So far as animals are concerned, the farmer's rights include the use of a patented animal "for an agricultural purpose" but not sales "within the framework or for the purpose of a commercial reproduction activity".

Where a patent cannot be exploited without a license under a plant variety right or vice versa, the Directive provides for compulsory cross-licensing. Before such a license is granted, however, the applicant for the license will have to show that he has been unable to negotiate a license from the dominant right holder and that the plant variety right or invention for which he seeks the compulsory license is one constituting "significant technical progress of considerable economic interest compared with" the dominant right.

The Directive codifies the practice of depositing biological materials with a suitable depositary so as to meet the description requirements for patent applications relating to biological materials that are not available to the public and are unable to be described in words in such manner as to enable one skilled in the art to put the invention into practice.

Editor's note: See the related discussions in our August 1999 Newsletter (N.S. 191) and in our June 2000 Newsletter (N.S. 192).

March 1999 Index

[Home] [About Ladas & Parry LLP] [Contact Us] [Search]
[Trademarks] [Domain Names & E-Commerce] [Patents & Copyrights]
[Litigation] [IP Rights Maintenance] [IP as Property] [News & Bulletins]