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Convention for the Protection of Industrial Property of 20 March 1883, as revised (the Paris Convention) and the Patent Cooperation Treaty, Washington, 19 June 1970, (the PCT) which makes it possible to seek patent protection for an invention simultaneously in each of a large number of countries by filing an international patent application; and (ii) European level in the form of the European Patent Convention (Munich) 1973, as revised (the EPC).286 Moreover in December 2012 the European Parliament and the Council adopted the ‘EU patent package’, which provides for a unitary EU patent, language regime and unified EU patent court. The general requirements for patentability at European level are set out in the EPC, which states that European patents should be ‘granted for any new inventions, in all fields of technology which are susceptible of industrial application, which are new and which involve an inventive step’. Similar tests for patentability are found in other jurisdictions287. That biotech inventions may be subject to patents is clear established at the EU level by Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions288 which provides in article 3(1) that new inventions that involve an inventive step and which are susceptible of industrial application are patentable ‘even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used’. Article 3(2) goes on to provide that; ‘(b)iological 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’. Under Article 6 of the directive, inventions are to be considered un-patentable where their commercial exploitation would be contrary to public order or morality. Patent law is obviously fundamental to the development of the Blue Biotechnology sector: without patent protection the enormous costs and effort required for the creation of biotech products could not be justified. New genes, proteins and processes resulting from research and development may all be subject to patent protection provided they meet the necessary criteria for patentabilty. As noted above, patents like other types of IPR are subject to certain limitations in terms, for example, of their duration. In Europe, the United States, Russia, China and Japan patents typically last for 20 years from the date of application. Moreover as part of the patent application process an inventor must adequately disclose the patented invention to the public. Nevertheless patent law also raises a number of issues as regards biotechnology in general and blue biotechnology in particular. First of all there is the question as to precisely what may be patented in terms of sequenced genomes. Secondly as patents are a form of property right the owner may chose to use them - or not. The deliberate acquisition of patents can therefore be used to block competitors in a particular field. Moreover in some biotechnology sectors, although apparently not at present in the marine biotechnology sector, the sheer number of patents issued with regard to genomic information has created what are known as ‘patent thickets’, which in turn have the potential to hinder future research. The next question to consider, therefore, is the basis on which IPR may be used. 286 The EPC sets out the patentability requirements for all Member States (currently 38) of the European Patent Organisation, but patent enforcement remains a matter for national law. 287 As reflected by Article 27 of TRIPs, which provides that ‘patents shall be available for any inventions, whether products or processes, in all field of technology, provided that they are new, involve an inventive step and are capable of industrial application’. 288 OJ L 213, 30.7.1998, p. 13 Study in support of Impact Assessment work on Blue Biotechnology 205

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