Q178 draft report.pdf - SFIR

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4 The harmonisation of European patent law has lead to a situation where the definition of patentable subject matter does not differ between the European countries. The requirements in the EPC are prevalent. The object of patent protection is an invention. An invention must have technical character, i.e. present a technical solution to a problem. Do different definitions apply in various fields of technology? If so, what are the differences? The Swedish Group understands that there is no difference as to the patentabillity requirements between various fields of technology. However, the distinction between inventions and discoveries has been questioned within the area of biotechnology, as many of the inventions patented contains biological material existing in nature. It is therefore stated in Article 3.2 of the Directive that “biological 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”. Thus, natural biological material that is either “isolated” or “produced by the means of a technical process” may fulfil the basic criterion of technical character. In theory, difference definitions are not applied between various fields of technology. However, in the opinion of the Swedish Group, there is a practical difference between biotechnology patents and patents in other fields. We believe that the application of the patentability criteria (i.e. inventive step) in biotechnology patenting has not been as strict as required, compared to traditional fields of inventions. 2.2 What are exemptions/exceptions from patentability? As indicated supra, the exemptions from patentability in Swedish law are the same as in the EPC. Some subject matter is never regarded as inventions according to Swedish and European patent law. Discoveries, scientific theories and mathematical methods, aesthetic creations, schemes, rules and methods for performing mental acts, playing games or doing business, programs for computers, and presentations of information are not 4
5 patentable subject matter. A common characteristic of this subject matter is that it is not perceived to have technical character and can therefore not be regarded as inventions from a patent law perspective. Hence, it is not patentable subject matter as such. Other subject matter may be regarded as inventions and fulfil the necessary patentability criteria, but nevertheless be expressly excepted from patentability on other grounds. The following are the exceptions found in EPC and in Swedish law: * Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods. This exclusion does not apply to products, in particular substances or compositions, for use of any of these methods. * Inventions whose commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. * Plant or animal varieties. * Essentially biological processes for the production of plants of animals. 2.3 What is the reasoning behind those exemptions/exceptions? The Swedish Group believes that most of the exemptions have policy grounds, and can be seen in an historical perspective. * Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods. These methods are excluded from patentability for policy reasons. It has been regarded as unethical that medical or veterinarian personnel should be affected by the effects of the patent system when carrying out such methods as part of treatments of human or animals. * Inventions whose commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. 5
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Q178 draft report.pdf - SFIR

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