ARCHIVED — The United States and European Experiences
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On April 12, 1988 the U.S. Patent and Trademark Office (PTO) issued its first patent on a living animal: the Harvard mouse or Onco-Mouse.(1) This announcement marked a turning point in a debate about the patenting of living organisms that had gone on for some years, beginning with a 1974 application for a patent on a genetically engineered bacterium capable of "digesting" crude oil. The Patent and Trademark office initially rejected the application, on the grounds that "micro-organisms are `products of nature'" and that "as living things, micro-organisms are not patentable subject matter" under the relevant sections of U.S. patent law.(2) The patent applicant, microbi ologist Ananda Chakrabarty, appealed this ruling all the way to the U.S. Supreme Court, which ruled in 1980 that life forms were indeed patentable.(3) There followed an expansion of patent activity in a number of areas related to micro-organisms and cells: one such patent, "covering the process for producing biologically functioning molecular chimeras" (the Cohen-Boyer patent) became Stanford University's "top earning patent".(4) However, until 1987 biotechnology-related U.S. patents applied only to microorganisms, to processes involving them, and to tissue and cell culture processes and products. Among the most controversial patents in this latter category was one issued to the Regents of the University of California for a cell line originating in the diseased spleen of a surgical patient named John Moore. After patents had been granted for both the cell line and the methods of producing several products from it, Moore sued the University seeking a share of the proceeds.(5) His lawsuit was ultimately rejected by the California Supreme Court, based on legal reasoning that at least some commentators find strongly suspect.(6)
In April 1987, as the result of a ruling by an internal review board (the Board of Patent Appeals and Interferences), PTO announced that it subsequently would consider "nonnaturally occurring nonhuman multicellular living organisms, including animals, to be patentable subject matter ...."(7) The announcement provoked a moral maelstrom. Typical of the reaction was a petition by a coalition of animal rights groups and an organization known as the Foundation on Economic Trends (FET) asking the PTO to reverse its policy because it is "morally reprehensible."(8) Jeremy Rifkin, the founder of FET, remarked that "the new patent policy raises moral and ethical issues that are mind-boggling."(9) In response to such criticisms, the PTO imposed a moratorium on animal patents until September 30, 1987.(10) Shortly after the end of that moratorium period, the Harvard mouse patent was granted. It is indicative of the biotechnology research community's interest in patenting animals that as of late 1991, 120 animal patent applications were pending in the United States.(11) As of early 1994, only three additional animal patents have been granted.(12) This may be read either as a consequence of the backlog of applications for biotechnology patents in general,(13) or as a consequence of PTO's reluctance to fuel the political controversy surrounding patenting of higher organisms by, for instance, providing patent protection to genetically engineered farm animals as well as to animals used in laboratory experiments.
The flavour of the controversy about patenting animals is described by Sheldon Krimsky, who has investigated and written about biotechnology and public policy for almost 20 years:(14) "The decision to patent a mammal brought many of the advocacy groups that opposed the patented bacterium into the latest policy fray. It also attracted another formidable constituency, animal rights groups. The concept of a patented animal signalled to these groups that society was regressing to an extreme Cartesian view of animals as soulless, unfeeling creatures that may be treated like machine parts."(15) Legislators acted on these interest group concerns even before the 1988 patent decision was issued. A subcommittee of the House of Representatives' Committee on the Judiciary held hearings on proposed legislation to impose a moratorium on the patenting of animals in 1987,(16) and on essentially the same legislation in 1989.(17) In neither case was the proposed legislation passed.(18)
This discussion of U.S. policy on patenting higher life forms is necessarily incomplete; it does not, for example, include legislative activity in the area of plant patenting or the related field of plant breeders' rights. However, it does indicate quite effectively that the high-profile actors have fallen into three categories: an administrative agency (PTO) with a restricted statutory mandate; the courts; and interest group leaders and individual legislators. The key actors in this last category are best described as "policy entrepreneurs." The most prominent among these entrepreneurs is Rifkin, who established FET in 1977 "to pursue his campaign against what he saw as an unreflective headlong rush for scientific progress at the expense of other values."(19) Like other advocacy groups in the United States, FET has made aggressive and often successful use of litigation to advance its policy positions.(20) Most notably, a lawsuit filed by FET led to a 1984 federal court injunction that temporarily prohibited approval of field tests of genetically engineered microorganisms, on the grounds that the U.S. National Institutes of Health (NIH), the agency responsible for issuing such approvals, had failed to meet the environmental impact assessment requirements imposed by federal legislation. Although the tests were eventually approved, the litigation resulted in years of delay.(21) FET subsequently used litigation to oppose other field trials.(22)
Additional interest groups opposed to patenting of higher life forms participated in the 1987 legislative hearings. They included farmers' organizations worried that expansion of patenting would lead to intensified corporate control of agriculture, and would thereby threaten the already tenuous viability of the family farm. The National Council of Churches and a variety of animal rights organizations were concerned about the potential for a "shift in how humanity relates to the natural environment."(23) To this list of actors one must add, of course, the biotechnology industry itself and the expanding number of academic researchers with a direct or indirect economic stake in the fortunes of that industry.(24) Two observers of the 1987 hearings do not, however, see the controversy as predominantly economic:
The dispute reflected in part the concerns of those with direct economic interests. But opposition to the patenting decision was mainly driven by values and beliefs--about the moral rights of animals, the threat to democratic values, the repugnance of commodifying living things, and the ethics of tampering with life.(25)
Similar conflicts have unfolded in the European Union (EU). In most EU countries, although not all, patenting decisions are broadly governed by the provisions of the European Patent Convention (EPC), to which some non-EU countries are signatories as well. Decisions about patentability under the EPC are made by the European Patent Office (EPO). Once again, the Harvard mouse is a central character in the story. The application for a patent on the mouse was originally rejected by the Examining Division of EPO, on the grounds that animal varieties were excluded from patentability under Article 53(b) of the EPC.(26) On appeal to the EPO's Technical Board of Appeal, an internal tribunal roughly analogous to the PTO Board of Appeals in the United States, the case was returned to the Examining Division with the finding that animals per se were not excluded from patentability by the EPC prohibition on patenting of animal varieties. In addition, according to one of the lawyers for the patent applicants, "in differing from the Examining Division, the Appeal Board took the view that use of oncogenes in the Harvard animals does raise questions of animal suffering which make it critically important to reconsider the morality issue.... This issue was thus also remitted to the Examining Division for reassessment."(27)
As a result of that reassessment, the Examining Division decided that the Onco-Mouse was patentable, at least partly on the basis that granting the patent would not offend against the ethical exclusion in Article 53(a) of the EPC. That exclusion provides that patents shall not be granted on "inventions the publication or exploitation of which would be contrary to ordre public or morality, provided that the exploitation shall not be deemed to be so contrary, merely because it is prohibited by law or regulation in some or all of the Contracting States...." According to one of the lawyers for the patent applicants, "hundreds of moral objections" to granting the Harvard mouse patent were received by the EPO's examining division.(28) Canadian patent legislation provides no analogous exclusion from patentability based on considerations of morality or public policy.(29) In addition, under Article 99(1) of the EPC, notices of opposition may be filed for up to nine months after a patent is granted. There is no comparable procedure for objections to be registered in Canada — a point emphasized by the Canadian Intellectual Property Office in a recent presentation on patenting life forms,(30) and one we consider extremely important.
The EPO's approach to resolving the ethical questions raised about patenting the Onco-Mouse involved identifying the relevant values and balancing them. According to Rudolf Teschemacher of EPO:
[T]he Division identified three different interests which were involved and required balancing: there is the basic interest of mankind to remedy widespread and dangerous diseases, on the other hand the environment has to be protected against the uncontrolled dissemination of unwanted genes and, finally, cruelty to animals should be avoided. The latter two considerations may well justify regarding an invention as immoral and therefore unacceptable, unless the advantages, i.e. the benefit to mankind, outweigh the negative aspects.
On overall balance the Examining Division concluded that the invention cannot be considered immoral or contrary to "ordre public". The provision of a type of test animal useful in cancer research and giving rise to a reduction in the amount of t esting on animals together with a low risk connected with the handling of the animals by qualified staff can generally be regarded as beneficial to mankind.(31)
This conclusion was in keeping with the reasoning of the patent applicants, who argued that:
Although some animal subject matter may be `immoral,' our position has always been that the Harvard mouse is the essence of a moral invention because it offers the possibility of more expeditious development of potential new cancer treatments (surely a desirable aim), and allows overall for a reduction in the amount of animal testing and the extent of animal suffering.... Using animals for testing purposes (in a strictly controlled manner) is a `necessary evil,' given the requirements of drug clearance authorities. The provision of a type of animal which might actually reduce the amount of experimentation has, we feel, rightly to be regarded as moral.(32)
The EPO decision clearly left the door open to denying patents in situations where different values were involved or different weights were attached to those values. Indeed, the EPO "recently opposed a similar mouse patent designed to study hair growth because the study was not deemed to be sufficiently important to outweigh animal suffering."(33)
Even before the initial rejection of the Harvard mouse patent application by the EPO's Examining Division, the Commission of the European Communities had proposed a draft Directive that would have provided for expansive patent protection of biotechnol ogical innovations within the nations of the European Union.(34) An amended proposal was released in December 1992, after consultations with the European Parliament.(35) According to the amended draft:
Parliament concentrated mainly on the ethical dimension of biotechnological inventions. As the discussions progressed, it became clear that a mere reference to the concepts of public policy ("ordre public") and morality was not enough and that this traditional framework for exclusion from patentability needed to be supplemented by more precise guidelines for national patent offices and courts.(36)
A number of elements of the amended draft resulted from tensions between the European Commission and the European Parliament.(37) Of these, two are of particular importance as background for our study of ethical issues.
First, "the vast majority" of the members of the European Parliament supported adding to the directive a section on "farmer's privilege,"(38) which would enable farmers to use seeds from crops grown from patent-protected seeds, and to breed patent-protected livestock, without incurring a further financial obligation to the patent-holder. However, such use would be for their own purposes only, and not for resale.(39) Second, the amended Draft Directive explicitly excluded from patentability, "inter alia,":
- the human body or parts of the human body per se;
- processes for modifying the genetic identity of the human body for a non-therapeutic purpose which is contrary to the dignity of man;
- processes for modifying the genetic identity of animals which are likely to inflict suffering or physical handicaps upon them without any benefit to man or animal.(40)
This exclusion is ambiguous in several respects. For instance, it is not clear how it will be determined whether a particular non-therapeutic purpose is contrary to the dignity of man. In addition, although the amended Draft Directive prohibits patents on parts of the human body, this provision "means parts of the human body as found inside the human body" and clearly was not intended to preclude patenting "certain products or parts of the human body which are already covered by patents granted in connection with the development of medicinal products."(41)
A revised (yet again) version of the Draft Directive was adopted by the EU Council of Ministers in February 1994.(42) The Council of Ministers, "the supreme decision-making body of the Community,"(43) accepted some but by no means all of the revisions proposed by the European Parliament. A number of minor modifications were made to the exclusions from patentability mentioned in the preceding paragraph. At least one of these modifications would expand the range of biotechnological inventions excluded from patentability by requiring that genetically modified animals and processes for carrying out such modification offer "substantial benefit to man or animal" before they are considered patentable.(44) On the other hand, the Council extended farmer's privilege only to seeds and not to livestock,(45) arguing that although farmer's privilege is already provided for in forthcoming Community regulations on plant breeders' rights, there is no justification for creating an exception from "the fundamental principle of patent law according to which the holder of a patent may prohibit any third party from using the protected invention."(46) In other words, the reasoning is that farmers do not deserve special treatment simply because of the distinctive nature of the economic activity in which they engage.
This is not the end of the issue, for two reasons. First, the Council of Ministers adopted what is referred to as a "Common Position adopted by qualified majority," rather than a unanimous position, which means the proposed Directive must now be returned to the European Parliament for approval. (Ministers from Denmark, Spain and Luxembourg voted against the Directive.) "If Parliament rejects the `common position,' the Council must act unanimously."(47) Since elected members of the European Parliament are not necessarily committed to the policies of their respective national governments, such approval is by no means a foregone conclusion. Second, although Directives are binding on EU member nations, they "lay down the ends but not the means," and must be implemented by the adoption of legislation or regulations by each member state.(48) Given the widespread opposition to various provisions of the Directive, political conflict over some of its key provisions is likely to intensify rather than abate at the national level within at least some EU nations.
The coalition opposing patenting of higher life forms in Europe is similar to that in the United States. Farmers' organizations are concerned about the possible economic impacts of patents on higher life forms. Although studies on the topic are not available, it is probable that the intense politicization of this issue is at least loosely related to the tension between protectionist agricultural policies in the EU and the trade-liberalizing objectives of the recently concluded General Agreement on Tariffs and Trade (GATT) negotiations.(49) In many European countries, new advocacy organizations have been formed specifically to support more restrictive biotechnology policies, and have been joined by some existing organizations such as Greenpeace. Among their key activities at the European level has been a "No Patents for Life!" campaign organized in response to the EPO decision on the Harvard Mouse.(50) The political issues include not only patenting, but also regulation of biotechnological research and applications. Efforts to achieve a unified regulatory framework at the Community level have come into conflict with sharply differing national approaches and attitudes. Germany, for instance, has enacted a regulatory regime the stringency of which has provoked considerable complaint from academic researchers and industry, and apparently has led to decisions by at least two chemical firms to locate new plants outside Germany.(51)
A crucial difference between the North American and European situations is the existence in Europe of vocal and strategically influential Green or ecology parties, not only at the national level but also in the European Parliament.(52) Whereas in the United States opponents of patenting are limited to the courts and to asserting influence through policy networks and communities that exist largely outside formal legislative institutions, ecology parties provide an additional conduit through which European policy outcomes can be influenced. Superimposed on these political dynamics is the "democratic deficit" created by the increased authority acquired by the European Commission as part of the process of European integration; according to some critics, that increased authority has not been accompanied by increased accountability.(53) The effect has been to create a relatively high-profile public debate that highlights a number of the key conflicts surrounding the patenting of biotechnological innovations, in a way that has not happened in Canada.(54)