Nature 407, 934 (26 October 2000), News Germany gives green light to gene patents QUIRIN SCHIERMEIER [MUNICH] The German cabinet last week endorsed the patenting of humangenes, when it approved a European Union (EU) directive on the legalprotection of biotechnological inventions.The move is a significant step towards the directive’s adoption acrossEurope. It was approved at the European level in 1998 after almost tenyears of preparation, and is intended to harmonize biotechnology patentsin the EU (see Nature 388, 314; 1997). But ethicists and scientists stillobject to some clauses albeit on different grounds.Controversy surrounds a clause stating that patents can be granted on an”element isolated from the human body or otherwise produced by means of atechnical process . . . even if the structure of that element is identicalto that of a natural element”. The clause says that such elements caninclude “the sequence or partial sequence of a gene”.Some say this violates the human right to freedom and protection of thebody from ownership. The Netherlands has filed a complaint against thedirective at the European Court of Justice on these grounds.”In its current form [the directive] would lead inexorably to thecommercialization of genetic knowledge,” says Jean-Franois Mattei, aMarseilles-based geneticist and member of the French parliament. Matteiwill submit a petition calling for a moratorium to President JacquesChirac next month.Although EU members are legally obliged to adopt the directive and, wherenecessary, adapt their legislation to fit it, France and several othermember states have yet to do so. Those that have include Denmark, theRepublic of Ireland, Finland and Britain.Discussion is particularly heated in France, because the directive goesagainst its national patent laws. These state that “the human body, itsparts and products, and knowledge of entire or partial structure of thegene as such” cannot be patented.Many scientists’ concerns centre on the breadth of gene patents. Some havewarned that the development of drugs and therapies could be blocked, orprices increased, if gene patents could cover all possible functions of asequence (see Nature 406, 111; 2000).The ministerial comments accompanying the German bill, which are intendedto guide its implementation, address this concern. They say that theGerman and European patent offices should “restrict a patent to thoseparts of a gene substantial for the function described in theapplication”. Applicants would need to give a concrete description of the function of agene, and protection would generally be awarded on smaller sequences. Thiswould minimize cases where additional patentable functions are assigned toalready protected gene sequences.But Axel Kahn, director of the INSERM Laboratory of Research on Geneticsand Molecular Pathology at the Cochin Institute of Molecular Genetics inParis, doubts that national comments will solve the problem.”I regret that the directive contains no unambiguous clause saying thatthe use of DNA sequences for everything that was not initially describedremains free,” he says. Kahn points out that there is no reason for theEuropean Patent Office to follow the guidelines in the German law.But Joseph Straus, head of the department for European patent law at theMax Planck Institute for Foreign and International Patent, Copyright andCompetition Law in Munich, is confident that European patent offices willrespect the research community’s desire for narrow gene patents.The biotechnology industry in Germany and abroad has welcomed thegovernment’s decision. “Those European governments that have agreed on thedirective are now reluctant to adopt it,” says Bo Hammer Jensen, whochairs the intellectual property rights panel at EuropaBio, theassociation of European bioindustries. “We are happy that Germany hasfinally decided to take it on.”첨부 파일과거 URLhttp://www.ipleft.or.kr/bbs/view.php?board=ipleft_5&id=77