SCIENCE AND THE LAW Time to abandon Brussels' bid on patents Gary Moss and Simon Cohen

After six years of debate, the European Commission's attempts to harmonize biotechnology legislation still face opposition over the patenting of genes. Recent legal experience suggests that its efforts are unnecessary.

NEXT week, a critical meeting takes place both the US National Institutes of Health problem in the field. In addition, the in Brussels which could well determine and Britain's Medical Research Council invention must also be industrially applic­ the fate of the European commission's six­ for sequences of genes whose functions able. And the patent must not be "con­ year attempt to harmonize legislation on had not been determined. trary to 'ordre public' or morality". biotechnology patents among the 12 - But the effect of the proposed amend­ All three requirements already give soon to be expanded - members of the ment would be devastating. In particular, patent offices and the courts the scope European Union (EU). it would preclude patents on many types either to refuse applications, or to revoke The meeting is of the conciliation com­ of therapeutic proteins which have only patents such as those relating to gene mittee, a body established under the become available as a result of the efforts sequences with no determined functions Maastricht Treaty in order to resolve dif­ of scientists who have successfully cloned (as in the NIH applications), should they ferences between the European Parlia­ the relevant gene and expressed the pro­ choose to do so. ment and the Council of Ministers. The tein in a suitable host. The new directive, in the form now main difference to be resolved in this If approved, the Parliament's proposal proposed by the commission, is not signifi­ instance relates to the extent to which could cause major damage to the biotech­ cantly different from the existing law as individual genes can be patented. As such, nology industry. For it would remove the promulgated by the European Patent it goes to the heart of the future of the incentive to the pharmaceutical compa­ Offices and the national courts. As all EU biotechnology industry. nies which support these scientists to con­ member states are signatories to the EPC, Article 2 of the draft directive specifies tinue to back their search for effective it can be argued the laws of those states three particular categories of inventions therapeutic treatments for the many gene­ on this issue are already harmonized. which are unpatentable: the human body based illnesses. Indeed, the Parliament's All the commission's efforts appear to or "parts of the human body as such"; recommendation raises the question of have done is to provide a platform for processes for modifying the genetic identi­ whether we need the directive at all. We lobby groups to mount a fierce attack on ty of the human body "contrary to the dig­ would argue that we do not. the whole principle of patenting the nity of man"; and processes for modifying Current patent law across Europe con­ results of genetic research. If changes are the genetic identity of animals which are forms with the European Patent Conven­ required in the future, this could be done likely to cause them suffering or physical tion (EPC), a pan-European agreement through an amendment to the EPC. handicaps "without any substantial benefit drawn up in 1973 and now signed by all There would be no need for the commis­ to man or animal", and animals resulting member states of the European Union (in sion to get involved. from such processes. their individual capacities) as well as some Moreover, European patent law is The phrase "parts of the human body non-EU countries (Austria, Sweden and dynamic, constantly evolving to deal with as such" is intended to mean parts of the Switzerland). new issues and developing technologies. human body as they are found inside the Inventors wishing patent protection in Last month, for example, Britain's Court body. According to language elsewhere in EPC countries can either apply to the of Appeal set a controversial precedent the directive, this reaffirms the general European Patent Office (EPO) in when it handed down a judgment on a principle that no-one should, by obtaining Munich, designating the individual signa­ challenge from Medeva pic to Biogen a patent, be able to claim ownership of, tory states in which they want the patent Inc.'s patent on a hepatitis B vaccine pro­ for example, a gene, protein or cell in its protected, or make individual applications duced by recombinant DNA technology. natural state in the human body. to national patent offices. The EPO route Although the Appeal Court found In May, however, the European Parlia­ is usually preferred, as it involves a single against Biogen, its decision is widely seen ment passed a proposed amendment to application covering many states. as being out of line with established Euro­ this section which would also bar patents Many challenges have already been pean patent law, and Biogen is likely to on genes, proteins or cells that have been made to biotechnology patents which have attempt to appeal the decision to the isolated from the body. The Parliament led to hearings before the EPO's Opposi­ House of Lords. But whatever the out- wants an explicit and unambiguous state­ tion Division and Board of Appeal. In come, no-one is suggesting that new legis­ ment that no part of the human body can addition, both the EPO and national lation is required. The argument is over be patented -whether or not it has been courts have handed down numerous judg­ the interpretation of existing legislation. isolated. In addition, it has proposed an ments dealing with such patents. It is far better to give courts the scope absolute ban on patenting human genes Neither has felt the need for new legis­ to rule on the desirability of biotechnology and gene therapies. lation to deal with issues raised by patents in this area under the existing pro­ The European Parliament is apparently genetic engineering, even though the tech­ visions, rather than seek to place them in concerned that the term 'as such' may be nology has progressed enormously since a straightjacket, with little room for ambiguous, and might permit the type of the EPC was drawn up. This is primarily manoeuvre. patent application for gene sequences because the convention provides an ade­ The biotechnology directive in its cur­ made (but subsequently withdrawn) by quate framework for courts to apply exist­ rent form is certainly unhelpful. Even ing patent law to a particular case. more importantly, the directive is not It This is the second of an occasional series For an invention to be patentable, vari­ needed. should be shelved without of articles on intellectual property rights ous hurdles need to be overcome. One is further ado. C and the law. The first article appeared in that it must involve an inventive step. The Nature 369, 589; 1994. EPO usually evaluates this by deciding The authors are solicitors at Taylor whether an invention solves a technical Joynson Garrett, London EC4Y ODX, UK. 384 NATURE · VOL 372 · 24 NOVEMBER 1994