Legal protection of biotechnological inventions

Brussels, Oct 2005

By approving on Wednesday a joint resolution on the patenting of biotechnological inventions, Parliament confirmed its support for biotechnology, but only within an appropriate framework guaranteeing the respect of ethical, environmental and health aspects. Although there was consensus on this general principle, political groups were divided on some important aspects, such as therapeutic cloning and the limit of the patent protection. On the question of patents including the use of human DNA, MEPs stressed that germ cells are part of the human body and therefore are not patentable. Moreover, they took up the case of a patent issued by the European Patent Office (EPO) that includes a method of selection of human germ cells. Since this patent could violate the EU Directive on the legal protection of biotechnological inventions, the Parliament asked the Commission to file an objection to the EPO. The question of a correct interpretation of the Directive with regards to the level of protection granted by a patent on DNA was also raised. According to the MEPs, "it is unclear whether a patent on DNA covers only the application in this function or whether other functions are also covered by the patent." During yesterday debate, Commissioner Charlie McCREEVY said, "On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection." Nevertheless, he added that "the restrictive interpretation should not be incompatible with the directive." While the Liberal and Socialist Groups were in favour of not taking a position now and waiting for more research on this issue, Parliament opted for the restrictive interpretation. The approved amendment, tabled by the UEN and the EPP-ED, provides, indeed, that patents can be granted only "in connection with a concrete application" of the invention. Finally, the MEPs addressed the issue of the distinction between therapeutic and reproductive cloning. According to Commissioner McCreevy, the directive is clear that reproductive cloning involving the creation of new human beings is excluded. On the other hand, he said "The term 'therapeutic cloning' covers a wide range of different possibilities and research may be permitted in some Member States and not in others." Again the Parliament was divided. Liberals and Socialists defended therapeutic cloning arguing that there is no ethical reason for a complete ban on patenting of inventions relating to stem cells. This was not the majority view, however, and Parliament instead approved an amendment that explicitly rejects the cloning of the human being in all phases of his life, including research on human embryos.

European Patent EP1257168 - "METHOD OF CRYOPRESERVING SELECTED SPERM CELLS".

European Patent EP695351 - "ISOLATION, SELECTION AND PROPAGATION OF ANIMAL TRANSGENIC STEM CELLS"

EPO Press release: "The EPO follows the EU's Directive on biotechnology patents"

European Parliament
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