30.7.98 Official Journal of the European Communities L 213/13 DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998 on the legal protection of biotechnological inventions THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), (1)  Whereas biotechnology and genetic engineering are playing an increasingly important role in a broad range of industries and the protection of biotechnological inventions will certainly be of fundamental importance for the Community’s industrial development; (2)  Whereas, in particular in the field of genetic engineering, research and development require a considerable amount of high-risk investment and therefore only adequate legal protection can make them profitable; (3)  Whereas effective and harmonised protection throughout the Member States is essential in order to maintain and encourage investment in the field of biotechnology; (4)  Whereas following the European Parliament’s rejection of the joint text, approved by the Conciliation =~ Committee, for a  European Parliament and Council Directive on the legal (Y OJ C 296, 8.10.1996, p. 4 and O] C 311, 11.10.1997, p. 12. (%) OJ C 295, 7.10.1996, p. 11. (%) Opinion of the European Parliament of 16 July 1997 (O] C 286, 22.9.1997, p. 87). Council Common Position of 26 February 1998 (OJ C 110, 8.4.1998, p. 17) and Decision of the European Parliament of 12 May 1998 (O] C 167, 1.6.1998). Council Decision of 16 June 1998. protection of biotechnological inventions (*), the European Parliament and the Council have determined  that the legal protection of biotechnological inventions requires clarification; (5)  Whereas differences exist in the legal protection of biotechnological inventions offered by the laws and practices of the different Member States; whereas such differences could create barriers to trade and hence impede the proper functioning of the internal market; (6)  Whereas such differences could well become greater as Member States adopt new and different legislation and administrative practices, or whereas national case-law interpreting such legislation develops differently; (7)  Whereas uncoordinated development of national laws on the legal protection of biotechnological inventions in the Community could lead to further disincentives to trade, to the detriment of the industrial development of such inventions and of the smooth operation of the internal market; (8)  Whereas legal protection of biotechnological inventions does not necessitate the creation of a separate body of law in place of the rules of national patent law; whereas the rules of national patent law remain the essential basis for the legal protection of biotechnological inventions given that they must be adapted or added to in certain specific respects in order to take adequate account of technological developments involving biological material which also fulfil the requirements for patentability; (9)  Whereas in certain cases, such as the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals, certain concepts (*) OJ C 68, 20.3.1995, p. 26.