Synthetic biology and patents

The patent system has evolved over many centuries and is considered, by and large, to have successfully promoted innovation. Patents help to stimulate investment in research and development through the provision of a limited monopoly to the inventor, while ensuring full disclosure of the invention to the public. One of the reasons for the long-lasting success of the patent system is its nondiscriminatory character. The same basic patentability criteria apply to all fields of technology: novelty, inventive step and industrial application. This provides legal certainty to the applicant and third parties because the criteria applied during examination at the patent office—and in courts— are largely independent of the nature of the invention. The World Trade Organization (WTO; Geneva, Switzerland) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which was negotiated in 1994, includes a provision that underlines this technology-neutral character of patents: Article 27(1) states that “[...] patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application”. Nevertheless, the emergence of new technologies regularly raises the question of whether the patent system, which was historically designed to protect mechanical inventions, and was only later extended to chemical products and processes, is suitable to protect inventions in fields as new as synthetic biology. Perhaps more importantly, it also raises the issue of whether the patent system is, or has been, able to promote the advancement of these new technologies. Similar questions were also raised some years ago, as the patenting of biotechnology and computer-implemented inventions— that is, software—gathered momentum. The European Parliament (Strasbourg, France), after a 10-year debate, concluded Directive 98/44/EC on the legal protection of biotechnological inventions; this was later implemented in the regulations of the European Patent Convention (EPC), which is an intergovernmental treaty that establishes a common legal framework for patents in 36 European member states. The provisions in this directive specify further requirements for biotechnological inventions in order to be patentable and define subject matter that can not be patented— such as processes for the cloning of human beings or the industrial and commercial use of human embryonic stem cells. A similar attempt to adopt a directive for the protection of computer-implemented inventions failed in 2005 after vigorous debate in the European Parliament.