The Finnish Patent Act and Plant Varieties Act are set to be amended in response to the EU Biotechnology Directive. To a large extent, the Patent Act already corresponds to the provisions of the Biotechnology Directive. However, certain clarifications and additions to the relevant statutes are considered necessary. The proposed amendments to the Patent Act include:
- replacing references to micro-organisms or cultures with the term 'biological material' used in the Biotechnology Directive. The Patent Act would state that a patent can be granted for an invention involving a product consisting of, or containing, biological material, or a process for producing, processing or using biological material;
- clarification of the provisions on the patentability of inventions involving plants and animals. The prohibition on patenting plant and animal varieties would remain. But, for the sake of clarity, the Patent Act would state that plants and animals can be patented if the technical feasibility of the invention is not confined to a particular variety of plant or animal;
- clarification of the distinction between an invention and a discovery, particularly with respect to inventions relating to humans. The proposed wording would correspond to the relevant provision in the Biotechnology Directive. The Patent Act would state that an element of the human body, including a sequence or a partial sequence of a gene, would as such be regarded as a discovery, which is not patentable. However, where isolated from the human body or otherwise produced by a technical process, such an element is patentable, even if its structure is identical to the natural occurring form. The industrial applicability of the claimed sequence must be disclosed in the patent application;
- an amendment to the current provision of the Patent Act excluding inventions that are contrary to public order or morality from patent protection. The amended provision will list the classes of inventions that are considered to fall within this excluded category. These include processes for cloning human beings; processes for 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 any substantial medical benefit to man or animal;
- an extension to the patent protection of biological material to include any biological material, possessing the same characteristics, derived from that biological material through propagation or multiplication;
- the introduction of a 'farmer's privilege' into the Patent Act, that is, an implied authorization for a farmer to use the product or offspring of protected plants or livestock for agricultural purposes. As the proposed legislation would restrict patent holders' rights, it will only apply to applications submitted after the new legislation has entered into force;
- the introduction of provisions to establish compulsory mutual licensing in situations where the exploitation of a patented biotechnological invention is dependent on the exploitation of a protected plant variety and vice versa. A compulsory licence could be granted where the plant variety or the invention constitutes significant technical progress of considerable economic interest and the applicant has first attempted to obtain a contractual licence. The Helsinki District Court would be the authority responsible for granting the necessary licence. The provisions on compulsory licensing would only apply to applications submitted after the new legislation has entered into force.
The proposed amendments are expected to enter into force on July 30 2000.
For further information on this topic please contact Tanja Liljeström at Roschier Holmberg, Attorneys Ltd by telephone (+358 8 5513304) or by fax (+358 8 5513320) or by e-mail ([email protected]).
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