The importance of being inventive

119 In Summer 2003, the European Commission referred eight EU member states—Germany, Austria, Belgium, France, Italy, Luxembourg, The Netherlands and Sweden—to the European Court of Justice for their failure to implement the European Directive (98/44/EC) on the legal protection of biotechnological inventions (European Commission, 2003). The German government recently published its proposal to implement the Directive, but the German parliament still has to debate and adopt the law in question. There are several reasons for this delay, but the public debate about the patentability of inventions in biotechnology has certainly had an important role. Here we outline the most important legal provisions for the patenting of nucleic acids and polypeptides in Europe and explain how these influence the examination and granting of patents. In addition we discuss the most prominent arguments brought forward in the public debate. Some legal scholars regard patents as a ‘natural’ property right that an inventor holds over his invention—comparable to the copyright on literature, music or artwork. More often, patents are seen as a means of promoting research activity by granting the inventor a restricted monopoly in exchange for the complete disclosure of his invention. A patent thus gives the patent owner only the right to exclude others from commercially using—producing, selling or licensing—the patented subject. In many cases additional provisions, such as the approval of pharmaceuticals, have to be fulfilled before the invention can be used commercially. The exclusive right conferred by a patent is restricted in time and is valid only in those countries where the patent was granted. After the expiry of the patent, which is usually 20 years from the date of filing, the invention becomes a public resource, free for everyone to use. Patents therefore provide an incentive for research and development by conferring a limited monopoly on the patent owner. For the pharmaceutical industry this aspect is particularly important, because the investment needed to develop a new medicine is estimated at about €895 million over an average period of 12–13 years (European Federation of Pharmaceutical Industries and Associations, 2003). A patent puts its proprietor in a better position to recoup these costs. Patents also represent a highly valuable source of information because they must be published—in Europe, 18 months after filing—and everything needed for the invention has to be made available, including sequence information, cell lines and bacterial strains (Cook-Deegan & McCormack, 2001). Patent laws have been constantly refined and adapted to new technologies and developments, but critics claim that the The importance of being inventive