Part II – Implementing Regulations to Part II of the Convention
Chapter V – Biotechnological inventions
(1) For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the Convention shall be applied and interpreted in accordance with the provisions of this Chapter. Directive 98/44/EC of 6 July 199836 on the legal protection of biotechnological inventions shall be used as a supplementary means of interpretation.
(2) "Biotechnological inventions" are inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
(3) "Biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.
(4) "Plant variety" means any 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:
(a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes,
(b) distinguished from any other plant grouping by the expression of at least one of the said characteristics, and
(c) considered as a unit with regard to its suitability for being propagated unchanged.
(5) A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.
(6) "Microbiological process" means any process involving or performed upon or resulting in microbiological material.