Patenting and Human Beings

The resulting uncertainty is particularly important because even in North America, NIH is not the only applicant for such patents. At least two private firms involved in human gene sequencing have applied for patents on human gene sequences.⁽²¹²⁾ As noted earlier one such firm, Human Genome Sciences Inc., is attractive to investors because of its relationship with Craig Venter's Institute for Genomic Research (TIGR). In U.S. Congressional hearings on NIH's gene patenting policy held in September 1992, Venter defended the patentability of portions of the human genome on several grounds. First, he argued that in the absence of patent protection academic and industry researchers would seek trade secrecy as an alternative route to intellectual property protection, while "[s]cientists in other countries, who will not be subject to this constraint, will continue to publish their work and reap its benefits."⁽²¹³⁾ In addition:

A moratorium on patents would prevent U.S. companies, but not our foreign competitors, from obtaining the intellectual property protection necessary to raise capital and develop products. The American public would be denied the benefits of pharmaceuticals and other products of the biotechnology industry, and American companies could be forced to move their markets and their operations overseas.⁽²¹⁴⁾


The biotechnology industry must raise enormous amounts of capital to develop products and bring them to market. Developing a new human pharmaceutical typically requires at least five years, costs several hundred million dollars, and involves the very considerable risk that a competitor, either in the U.S. or abroad, will develop and market a competing product. The capital required to develop new products can only be raised if the risks are balanced by adequate patent protection. ... The key starting materials for product development are synthetic copies of human genes. The prospect of all human genes being identified in the course of the Human Genome Project, therefore, emphatically raises the issue of how human genes can be protected so that they will be useful as starting materials for the development of new human therapeutics and other useful products.⁽²¹⁵⁾

(1) Should human beings themselves be patentable? It is taken for granted that they should not. For a variety of ethical reasons, we recoil from the proposition that intellectual property rights should be granted with respect to human beings who have been genetically modified in a particular way. Interestingly, in Canada there is no clear statutory basis for that exclusion, although it is possible that a challenge to such a patent might be successfully mounted under section 7 of the Charter of Rights and Freedoms (security of the person). In the United States, it is widely presumed that patents on human beings are precluded by the Thirteenth Amendment to the Constitution, which provides: "Neither slavery nor involuntary servitude, except as a punishment for crime whereof the party shall have been duly convicted, shall exist within the United States." In the countries of the European Union, the patenting of human beings per se is prohibited by the language of the EU Directive.

But what constitutes a human being for purposes of patent law? Steven Wise, President of the Animal Legal Defense Fund in the United States, argues that "there is no `fixed genetic definition of a human being',"<sup>(218)</sup> and Canadian patent lawyer Stephanie Chong points out that "[e]ach time it is sought to exclude human beings from the scope of patentability, it becomes necessary to come up with a workable definition of `human being' which will clarify what is to be covered by the prohibition."⁽²¹⁹⁾ The U.S. PTO has not yet answered this question, even to its own satisfaction.⁽²²⁰⁾

This lack of clarity may not be significant for policy purposes, at least in the foreseeable future. It seems clear, for instance, that a laboratory animal into which a single human gene has been transferred would not be regarded as human by any definition of the term in common usage, and should not thereby be excluded from patent protection. It seems equally clear that a human being whose somatic cells contain a single non-human gene, or multiple non-human genes, introduced for a therapeutic purpose would not be considered non-human and thereby patentable. On the other hand, technologies that make possible the creation of transgenic higher organisms are now relatively well understood, at least for purposes of laboratory application, and a general characteristic of public policy toward biotechnology is that scientific developments have forced redefinition of concepts and relationships that once seemed relatively clear-cut. The question, "How many characteristics may be transplanted before an animal is considered a `human being,' or a human being considered an animal?"⁽²²¹⁾ could soon become urgent, and between the extremes that seem clear, answers to it will be controversial.

An argument can therefore be made that whatever decisions are reached in other areas of patent law with respect to higher life forms, Canada should (a) adopt a specific statutory exclusion of human beings from patentability, and (b) attempt to arrive at a definition of "human being" for purposes of interpreting this exclusion. Rachel Fishman has suggested such a definition for U.S. patent legislation:

The term "human being" means:
1. any genetically altered animal possessing one or more higher faculties such as: the ability to reason (including, but not limited to, the ability to use facts and argue them, to arrive at conclusions from premises in a logical manner, to explain observed phenomena and to form beliefs based on facts); the ability to evaluate principles and observations to arrive at reasoned decisions; the ability to formulate speech and communicate; the ability to write; the ability to develop meaningful personal relationships with other human beings on the basis of equality; the demonstration of awareness of self as a unique and separate being; the ability to feel concern for others; or any other higher faculty; or

2. any creature born of the ovum and sperm of parents who are human beings, whether or not the union of ovum and sperm was in utero, and whether or not the genetic material of the resulting embryo was scientifically altered.⁽²²²⁾

(2) What about patents on portions of the human genome? Whether patenting portions of the human genome should be permissible depends, in large part, upon a determination of what it is that would be patented. Craig Venter, who supports the granting of patents on portions of the human genome, sees a sharp distinction between genes and human or animal life:

I am strongly against patenting human cells, tissues, organs or any animal. There is, however, a major difference between the patenting of genetic information and the patenting of animals or other life forms. Genetic reductionists argue that genes are life forms or equivalent to life. I strongly believe that we are much more than the sum total of our genetic composition. Genes are merely chemical entities that contain the coded information which is translated into a protein, much in the way that a computer stores the information to print a word.⁽²²⁵⁾

To issue a patent for a new type of living organism does not mean the holder of the patent owns organisms of that type that exist or that might come into existence. The owner does, however, have the right, for a limited time, to prevent other people from making, using or reproducing that organism.⁽²²⁸⁾ The property rights in question are perhaps best understood by analogy with copyright in written works, films or sound recordings: even if someone were granted a patent for "mule," or for a genetically modified mule or mouse, that person would not have rights of ownership over all creatures whose distinctive genome is covered by the patent. But that person would have the right to exclude others from using the distinctive version of the genetic code that constitutes the "program" for that particular creature, and the right to benefit financially from all such uses by way of licensing, royalties and the like. For example, a farmer might own a herd of cattle, but be prohibited from selling the calves to other farmers (at least without a contractual provision requiring sterilization to prevent the possibility of further breeding) because the genotype of the cattle is patented.

Such general concerns are, quite understandably, magnified when the subject of a patent is a portion of the human genome. Among the merits of the decision-making framework and procedural approach we recommend in section XII is that it would provide a context within which an informed public debate about the ethics of human gene patenting could occur.

(3) What about the conditions under which human genetic material is obtained? In at least one case a patent has been sought on a human cell line "collected" in the developing world: a human T-lymphocyte line collected from a Guaymi native woman in Panama. This application, filed by the U.S. Secretary of Commerce, was eventually dropped following protests by native organizations in Panama and by RAFI.⁽²²⁹⁾ Such applications raise issues of informed consent similar to those in the Moore case, but with the additional elements of language problems and North-South power differentials. According to a RAFI report: "U.S. officials who took the cell line reported that they had her `oral informed consent,' but Guaymi leaders doubt that she was told that her cell line would be taken out of Panama, or that it would be patented. Panamanian medical doctors who participated in the drive to collect Guaymi cell lines have told Prof. Acosta," the President of the Guaymi General Congress, "that they were unaware of the patent claim."⁽²³⁰⁾ The commercialization of human genetic material obtained from indigenous people is likely to arise as an ethical issue with increasing frequency because of the Human Genome Diversity Project, associated with the NIH's Human Genome Project, whose aim is to collect genetic materials from more than 700 indigenous communities and store these materials in the ATCC.

More than matters of informed consent are involved in determining whether the collection and development of human genetic material is morally permissible, though. Four distinct questions need to be asked. First, should human biological material be patentable under any circumstances at all? Second, should human biological material be patentable in the absence of evidence of informed consent to both the collection and the subsequent commercial use of those materials? Third, how meaningful is informed consent when there are wide disparities of wealth and power, such as exist between scientists from industrialized countries and aboriginal women in Panama? Fourth, assuming that the answers to the first three questions do not preclude patenting human cell lines or other biological materials, what constitutes an equitable arrangement for sharing the returns from the commercialization of human cell lines or other biological materials?

In Canada the first question has been answered affirmatively, at least with respect to cell lines,⁽²³¹⁾ although in specific cases there is still room for debate about whether enough human ingenuity or intervention has been exercised to justify conferring intellectual property rights. Our answer to the second question is unequivocally negative: the principle of informed consent is widely accepted and deeply entrenched in scientific research and medical inte rventions involving human subjects,⁽²³²⁾ and there seems no justification for departing from it here. To implement the principle of informed consent in this context, however, requires new institutional mechanisms because the procedures used to collect genetic materials might not have undergone the ethics review normally conducted in clinical or university settings. The third and fourth questions, in our view, cannot be answered except on a case-by-case basis. They therefore lead to the same conclusion implied by the answer to the second question: an institutional mechanism is needed to ensure that minimum ethical standards have been adhered to in situations involving patents on human genetic material. An outline of such a mechanism is suggested in section XII. There should, however, be a basic presumption that free and fully informed consent and clearly equitable arrangements are essential conditions for the acceptability of any scheme involving commercialization or patenting of materials of human origin. It is important to note that neither requisite was present in the landmark Moore case.

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