Patenting biotechnologies: the European Union Directive 98/44/EC of the European parliament and of the council of 6th July 1998 on the legal protection of biotechnological inventions.

Forum (Genoa, Italy) Pub Date : 1999-07-01
G Morelli Gradi
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Abstract

Before the Directive 98/44/EC of the European Parliament and the Council of 6th July 1998, notwithstanding some decisions of the European Patent Office (still presently under opposition) and some patents already granted by the Italian Patent Office, the existing legal framework did not allow the patentability of living organisms in the European Community countries. The Directive has dramatically changed the perspectives. It ensures free circulation of patented biotechnological products harmonising the national legal system of each Member State, guaranteeing compliance with the European Patent Convention signed in Munich on 5th October 1973, the Trade-Related Aspects of Intellectual Property Rights agreement of 15th April 1994 and the Rio de Janeiro Convention on Biological Diversity of 5th June 1992. The legal basis of the Directive and the fundamental principles of protection are that discoveries as such are not considered patentable. Plant and animal varieties as such, as well as essentially biological procedures for the production of plants and animals are excluded from protection by patent. On the contrary, the new field of patentability covers plants and parts of animals with new introduced genetic characters. Methods of surgical and therapeutic treatment and diagnostic methods applied to animal bodies are not considered inventions suitable for industrial applications and excluded from protection by patents. Biological materials and material isolated from its natural environment and isolated elements of the human body with technical processes may be patented. Excluded from patentability are inventions that are contrary to law and order or public morality as well as processes for human cloning for reproductive purposes and for modifying the germ-line genetic identity of human beings, as well as the use of human embryos. The processes for modifying the genetic identity of animals without any substantial medical benefit for man (with the exception of studying new medicinal products useful for treating serious diseases such as cancer, hepatitis or AIDS, by means of Oanimal modelsO) are also excluded. The rights of farmers are also guaranteed, by allowing them to re-sow seeds and freely use breeding stock covered by patents on their farms, without paying costly royalties to the holders of patents.

生物技术专利:欧洲议会和理事会1998年7月6日关于生物技术发明法律保护的欧盟指令98/44/EC。
在1998年7月6日欧洲议会和理事会颁布98/44/EC号指令之前,尽管欧洲专利局做出了一些决定(目前仍受到反对),意大利专利局也已经授予了一些专利,但现有的法律框架并不允许欧共体国家的生物体具有专利性。该指令极大地改变了人们的观点。它确保专利生物技术产品的自由流通,协调每个成员国的国家法律体系,保证遵守1973年10月5日在慕尼黑签署的《欧洲专利公约》、1994年4月15日的《与贸易有关的知识产权协定》和1992年6月5日的《里约热内卢生物多样性公约》。该指令的法律依据和保护的基本原则是,这些发现本身不被认为是可专利的。植物和动物品种本身,以及基本上用于生产植物和动物的生物程序,不受专利保护。相反,新的可专利性领域涵盖了具有新引入遗传性状的植物和动物的部分。应用于动物身体的外科治疗方法和诊断方法不被认为是适合工业应用的发明,不受专利保护。生物材料和从其自然环境中分离出来的材料以及用技术方法从人体中分离出来的元素可以申请专利。违反法律和秩序或公共道德的发明,以及为生殖目的克隆人类和修改人类种系遗传特性的过程,以及使用人类胚胎,都被排除在可获得专利的范围之外。对人类没有任何实质性医疗效益的改变动物遗传特性的过程(通过动物模型研究有助于治疗癌症、肝炎或艾滋病等严重疾病的新医药产品除外)也被排除在外。农民的权利也得到保障,允许他们在自己的农场重新播种和自由使用专利所涵盖的种畜,而无需向专利持有人支付昂贵的特许权使用费。
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