Generic Arguments About Patenting Higher Life Forms

[T]he great and costly engine for invention can only be effectively driven with the support from the private sector, motivated to serve a public need.

The patent system offers the only protection available for the intellectual product of this research, and thus, the only hope of a fair return against the great financial risks that investment in biotechnology entails.⁽⁹⁴⁾

Dr. Leder provided some examples. He argued that the Harvard mouse had great potential for public benefit "as a vehicle for the development of further therapies" as well as "an early warning system for the detection of carcinogens and mutagens" in chemical testing,⁽⁹⁶⁾ and he pointed out that:

In the past few weeks, the gene for cystic fibrosis has been identified and the ability to replace this gene, for example, in a mouse, with the defective human cystic fibrosis gene would constitute an extremely powerful model system for the development of an effective treatment.

For individuals and families at risk for this and other diseases, this would represent a priceless asset.⁽⁹⁷⁾

A second argument moves beyond judgments about the social or humanitarian desirability of particular innovations for which the availability of patents provides an incentive to more general economic considerations. In a world where private sector investment, including research support, flows across national borders with increasing ease, those jurisdictions offering weak or limited patent protection can expect to suffer in terms of lost employment opportunities and national income: investors will simply look elsewhere. A patent agent with Allelix Biopharmaceuticals Inc., who has by his own account "experienced the ebb and flow of investor interest," has emphasized the importance of strong and predictable patent protection given the fragile state of the Canadian biotechnology industry.⁽¹⁰¹⁾ In the U.S. context, Patents and Trademarks Commissioner Donald Quigg argued against restrictions on patenting transgenic animals based on anticipated harm to "the competitive position of our industry in this area,"⁽¹⁰²⁾ and a spokesman for the Industrial Biotechnology Association argued against a moratorium on transgenic animal patents by saying: "I can think of no better way to throw a bucket of cold water on America's high-tech industries than to suggest that scientists and inventors cannot count on our patent system until Congress debates whether the new technology should qualify for patent protection."⁽¹⁰³⁾

The ethical weight attached to such claims depends on two factors. First, the flourishing of the biotechnology industry must actually benefit "society," rather than just a select universe of users and promoters. To give an example, the use of bovine somatotropin (BST) to increase the milk production of dairy cattle arguably fails to meet this test, since at present the primary problem facing dairy farmers is that of excess productive capacity rather than excess demand. Second, there must be an unambiguous causal connection between the availability of patent protection and the economic viability of the biotechnology industry. Of course, if one defines what genetic researchers and the biotechnology industry are doing as intrinsically wrong, such a con sequentialist approach will be seen as irrelevant at best, and ethically corrosive at worst.

A third argument is based on considerations of fairness: people deserve the fruits of their intellectual work. To the inventor goes the right to the invention. Just as we are entitled under ordinary circumstances, as a matter of justice, to the products of our physical labour, so we are entitled to the products of our creative and intellectual labour. As Leon Kass writes, "justice requires protecting the labours of the imaginative and industrious against theft by the sly and lazy".⁽¹⁰⁴⁾ This is not a consequentialist argument because fairness or justice is valued in and of itself. It is important to note that although the vocabulary is similar, there is a difference between this argument and Philip Leder's invocation of the beneficial consequences for society that can arise only if inventors and investors retain the "hope of a fair return".

How compelling are these arguments? It seems hard to argue against patenting if it will be conducive to the kinds of outcomes identified by Leder. Nevertheless, some commentators view the accumulation of scientific knowledge through genetic research as a mixed blessing, at best. They are concerned, for instance, that the "geneticization" of human health associated with the accumulation of knowledge about the human genome will be socially destructive.⁽¹⁰⁵⁾ Numerous disturbing ethical questions are raised by the predicted expansion of "molecular medicine, in which the risk of disease can be accurately assessed by DNA-based diagnostic procedures."⁽¹⁰⁶⁾ How would this capability be used? Would it become a basis for subtle, but effective discrimination against the genetically "weak"?⁽¹⁰⁷⁾ The potential for human germ line therapy has provoked even stronger ethical objections. If one regards particular applications of genetic engineering or the basic research that supports it as sufficiently troubling or pernicious to call the social desirability of the entire enterprise into question, then the argument that patenting will facilitate its expansion and commercialization loses its appeal. Indeed, on this view patenting becomes ethically suspect in direct proportion to the strength of the incentive it provides for such research and development.

Further, some recent developments suggest that patenting may in fact hinder the pursuit of lines of inquiry with potentially lifesaving results. Scientists in Australia are reportedly concerned that a patent awarded by the Australian Patent Office covering the hepatitis-C virus as well as any vaccine or product derived from the growth of cells infected with the virus will create a disincentive for research on the disease; one research project has reportedly already been abandoned "after potential investors became nervous because of the uncertainty surrounding the patent."⁽¹⁰⁸⁾ Researchers in the United States are becoming uneasy about restrictions on access to a database of gene sequences compiled by the Institute for Genomic Research (TIGR). TIGR is headed by J. Craig Venter, a former senior scientist with the U.S. National Institutes of Health (NIH), whose work with the Human Genome Project provides the basis for what appears to be a uniquely fast and efficient approach to gene sequencing.⁽¹⁰⁹⁾ Although itself a nonprofit institution, it has contractual and financial links with for-profit firms including Human Genome Sciences Inc. (HGS) and the pharmaceutical firm SmithKline Beecham.⁽¹¹⁰⁾ "TIGR is offering to share much of its data with universities and other nonprofit institutions--if they sign contracts promising to respect TIGR's and HGS's proprietary rights and to provide previews of relevant publications."⁽¹¹¹⁾ U.S. researchers are also being warned about some kinds of conversations at scientific conferences, since they may involve disclosures that compromise subsequent patent applications.⁽¹¹²⁾ These developments suggest that there exists at least the potential for direct conflict between the profit imperative and the pursuit of potentially lifesaving research.

Quite apart from these issues, it can be argued that the national income and employment possibilities associated with a thriving biotechnology industry and with the applications of its various products and processes are prima facie desirable as objectives of public policy, just as are income and employment growth in any other sector. Whenever the welfare of people is at stake, as it is with the prospect of employment and what that means for one's economic and personal well-being, ethical concerns are present. Particularly given the fragility of Canada's position in an increasingly open and interdependent economic world, such arguments should not be dismissed lightly if Canada's biotechnology industry lags well behind that of the United States,⁽¹¹³⁾ and if the economic benefits are as substantial as promoters of the industry would have us believe.

This is a big "if," and two reasons for caution should be kept in mind. First and more obviously, it is one thing to say that the economic benefits associated with the applications of biotechnology have to be taken into account; it is quite another to treat these as the only relevant considerations. Doing so would amount to making employment and income the only values of concern: "jobs at any cost". Claims about economic benefits, even if they stand up to factual scrutiny, are always just one factor among many to be taken into account. There is nothing irrational in a society's deciding that some such benefits are not worth the price in terms of damage to any one of a number of ethical principles.

Second, industry's perception and promotion of the importance of patenting may be inflated by self-interest: attempts to secure subsidies or favourable regulatory treatment from government by promising jobs that never materialize are hardly new in the Canadian context. The pursuit of self-interest is not confined to investors in biotechnology firms; it extends to the careers of individual academic researchers, particularly as they are affected by the status and funding of their university departments.⁽¹¹⁴⁾ Would the industry and the careers of those who provide its scientific basis wither and die without a high level of patent protection, or would they merely not flourish as much as they otherwise might? Is the question really one of national survival in the global marketplace? How strong a claim, in other words, can be defended about the relationship between patenting and the future of a country's biotechnology industry?

According to John Barton, "The empirical evidence that patents actually favour innovation is limited but moderately supportive."⁽¹¹⁵⁾ Economic historian Joel Mokyr, who has specialized in analysing the role of technological innovation in economic growth, reaches a similar conclusion with respect to the role of patents in stimulating technological progress during the Industrial Revolution.⁽¹¹⁶⁾ He does, however, argue that the patent system "encourages ideas that represent radical departures from accepted practice," which he calls "macroinventions," and thus that patenting is important in generating the occasional spectacular breakthrough," one which results from a tremendous investment of resources against a low probability of success.⁽¹¹⁷⁾ Arguably, this describes many current and proposed ventures in genetic research and biotechnology, including not only capital-intensive laboratory research but also the effort to discover wild genetic resources with potential commercial utility.⁽¹¹⁸⁾ In addition, the cost structure of at least some of the industries to which biotechnological innovation may be expected to contribute, such as the pharmaceutical industry, is likely to make patent protection especially significant: research costs are high, potential dead ends are numerous, and lead times before a product can be marketed are long because of the regime of clinical trials necessary to demonstrate safety and efficacy. Conversely, it has been argued that patenting historically has encouraged incremental improvements based on "practical knowledge and mechanical ingenuity,"⁽¹¹⁹⁾ whereas today's emergent industries are increasingly reliant on scientific knowledge generated in different institutional settings within which scientists respond to a different set of incentive structures.⁽¹²⁰⁾

In other words, the empirical status of the connections among patenting, scientific research and social benefits (however defined) is contested and at least sometimes unclear. However, even if claims about the need for patent protection are inflated by considerations of self-interest, within the existing legal framework of intellectual property rights that fact in itself would not justify withholding patent protection for higher life forms as long as they met the standard criteria for patentability. Similarly inflated claims by other science-based industries probably would not be met with proposals to limit the patent protection to which those industries are entitled. Indeed, one of the rationales for patenting--the inherent fairness of compensating those who take risks and invest resources--is logically independent of considerations of socially beneficial consequences.

The argument from the inherent fairness of patent protection seems unproblematic at first. It can be elaborated either on the basis "that man [sic] has a natural property right in his own ideas" or that "justice requires that a man [sic] receive reward for his services in proportion to their usefulness to society," presumably as reflected in the returns from licenses and royalties.⁽¹²¹⁾ However, in at least some cases involving patents on living matter, it has been argued that the intellectual labour in question involves at best collection, cultivation or purification (for instance, of human cell lines or soil microorganisms) rather than invention as conventionally understood by way of analogy with the development of a new mechanical device. Policy director Andrew Kimbrell of FET explained the Foundation's opposition to gene patenting: "when you have a cell, a gene, an organ--if that has not been turned into a therapeutic device, when you are trying to patent the thing in itself what you are basically doing is patenting part of life itself. You are not patenting your own invention. You are patenting something that was discovered. That's like patenting the moon once it was discovered."⁽¹²²⁾

A further ethical issue is rooted in the concern that the economic reward provided by a patent might be out of proportion to the effort expended. It may be unfair. To use a deliberately provocative formulation of the issue, patenting of higher life forms may amount to granting title to the entire iceberg in return for having helped to develop the tip, or even just for having described it with previously unachievable precision (as in the case of BRCA1). In other words, not enough human effort or ingenuity has been involved to justify a potentially far-reaching claim to intellectual property rights in the result: although "[e]very living organism is a product of millions of years of natural evolution," the availability of patents on living organisms has made it possible, "by generating a relatively very small change in an organism ... to gain legal control over the exploitation of the modified organism and all of its progeny ...".⁽¹²³⁾ A similar argument has been made against allowing patents on modifications of genetic material collected in developing countries with a long tradition of plant breeding in response to local conditions.

This situation is admittedly not unique to the products and processes of biotechnology. Most inventions, be they mechanical, chemical or microbiological, rely on an extensive body of earlier innovation which may or may not be covered by patents or other forms of intellectual property rights. For an example in another area of intellectual property law and policy, consider an annotated bibliography. Clearly the work of compiling and annotating the bibliography, however substantial it may have been, pales in comparison to the task of writing all the books, articles and theses. Nevertheless, the producer of the bibliography would not be denied copyright protection on this basis. As noted earlier, radical breakthroughs or macroinventions remain the exce ption rather than the rule, yet is it suggested by opponents of extending intellectual property rights to higher life forms that only such inventions are worthy of patent protection? In addition, at this point in the history of intellectual property law and policy, accepting this objection to the fairness argument would have implications going far beyond higher (multicellular) life forms. It could mean repudiating a body of administrative decisions and case law having to do with the patentability of microorganisms and human cell lines that is now relatively well established. This is not, of course, a conclusive ethical argument; precedent and established practice do not necessarily carry any ethical weight in and of themselves. Finally, it should be pointed out that almost by definition, the value added to a naturally occurring microorganism or cell line by cultivation or purification can hardly be deemed insubstantial, if it represents a step in the absence of which the cell line or organism would not have had commercial utility.

In conclusion, we are sceptical about arguments that rely on the existing principles of intellectual property law to support the conclusion that patents should not issue on higher life forms or biological materials such as human cell lines. However, this is quite different from making an ethical argument that such patents should be available, or should be unrestricted. Indeed, as noted in the remainder of the report, arguments exist to justify a variety of restrictions. Arguments could also be made, based on independent considerations of distributive justice, for restricting or imposing conditions on intellectual property rights in biotechnological innovations. Suppose for the sake of argument that discoveries or innovations leading to drugs that arrest the progress of AIDS or diagnostic tests that predict susceptibility to breast cancer are protected by patents. Might there be an ethical case for combining intellectual property rights in the relevant discoveries or innovations with policy measures that would broaden access to the fruits of those innovations? Such measures could include regulatory control of product pricing or compulsory licensing, among other policy instruments.

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