Plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

Tabled by Martin Häusling

Added: Article37a Amendments to Directive 98/44/EC 1. Article 4 of Directive 98/44/EC1a on the legal protection of biotechnological inventions is amended as follows: (a) In paragraph 1, the following points are added: ‘(ba) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [O.J. please insert the number of this Regulation]; (bb) plants, plant material, parts thereof, genetic information and process features they contain that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.’ (b) the following paragraph is added: ‘3a. Paragraphs 2 and 3 shall be without prejudice to the exclusions from patentability covered in paragraph 1.’ 2. In Article 8, the following paragraph is added: ‘2a. By way of derogation from paragraphs 1 and 2, the protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall not extend to biological material possessing the same characteristics that is obtained independently of the patented biological material and from essentially biological processes, or to biological material obtained from such material through propagation or multiplication.’ 3. In Article 9, the following paragraphs are added: ‘1a. By way of derogation from paragraph 1, a plant product containing or consisting of genetic information obtained by a patentable technical process shall not be patentable if it is not distinguishable from plant products containing or consisting of the same genetic information obtained by an essentially biological process. 1b. By way of derogation from paragraph 1, the protection conferred by a patent on a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process. 1c. The protection conferred by a patent on a technical process that enables the production of a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process.’ 1a Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 13).

Wording as published by the EP, in English. PE783.371