N.B. Please ensure that your responses to the questions above cover each category of subject matter specified in Article 27.3(b), namely micro-organisms, essentially biological processes for the production of plants or animals, microbiological processes, non-biological processes, plant varieties and other inventions concerning plants or animals.
Following Article 4(2) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions "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".
See the answer to question 1 above.
[Answer A.1: Following Article 4(2) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions "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".]
Article 4 (1) of Directive 98/44/EC indicates that plant and animal varieties are not patentable.
Following Article 6(1) and (2)(d) of Directive 98/44/EC "Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality…" and, in particular, "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" shall be considered unpatentable. Recital 45 of Directive 98/44/EC specifies the "substantial medical benefit in terms of research, prevention, diagnosis or therapy".
Following Article 2(3) of Directive 98/44/EC "The concept of "plant variety" is defined by Article 5 of Regulation (EC) N° 2100/94". Article 5 of Regulation (EC) No.2100/94 reads: "1. Varieties of all botanical genera and species, including, inter alia, hybrids between genera or species, may form the object of Community plant variety rights. "2. For the purpose of this Regulation, "variety" shall be taken to mean a plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be: - defined by the expression of the characteristics that result from a given genotype or combination of genotypes, - distinguished from any other plant grouping by the expression of at least one of the said characteristic, and - considered as a unit with regard to its suitability for being propagated unchanged. "3. A plant grouping consists of entire plants or parts of plants as far as such parts are capable of producing entire plants, both referred to hereinafter as "variety constituents. "4. The expression of the characteristics referred to in paragraph 2, first indent, may be either invariable or variable between variety constituents of the same kind provided that also the level of variation results from the genotype or combination of genotypes." Recital 30 of Directive 98/44/EC reads: "the concept "plant variety" is defined by the legislation protecting new varieties, pursuant to which a variety is defined by its whole genome and therefore possesses individuality and is clearly distinguishable from other varieties". Recital 31 of the Directive 98/44/EC reads: "Whereas a plant grouping which is characterized by a particular gene (and not its whole genome) is not covered by the protection of new varieties and is therefore not excluded from patentability even if it comprises new varieties of plants."
No. Article 4(1)(b) of Directive 98/44/EC reads: "essentially biological processes for the production of plants or animals" are not patentable. Article 2(2) of Directive 98/44/EC reads: "A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection."
Yes. Article 3(2) of Directive 98/44/EC reads. "Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature." Following Article 2(1) of Directive 98/44/EC, "biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system."
Yes. Council Regulation 2100/94/EC on Community Plant Variety Rights provides for a sui generis form of protection for new plant varieties. In addition, and according to the Preamble to Regulation 2100/94/EC, Member States may provide for national legislation that protects plant varieties.
1991 Act (confirmed by UPOV Council).
Yes (if essentially derived from the protected initial variety or from a variety that is itself predominantly derived from that initial variety).
No (for certain agricultural crops).
Yes (in the case of (c) above for farmers other than "small farmers").
Yes (in the case of availability within the Community: 1 year; in the case of availability outside the Community: 4 years or – for trees or vines - 6 years).
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