3. Ethics in genetic research and practice

3.5 Patenting human genes and proteins
The patenting or 'biopiracy' of human genes and proteins is foremost a commercial issue. Patents are in essence a limited-period monopoly. The implications in the field of genetic research and practice are profound. In commercial terms a patent means revenue for the owner from licensing arrangements, product development, manufacture and sale. Profit becomes the incentive for research and development. The question is whether the price paid for the contribution to knowledge is not too high. Apart from concerns over the transactional costs of patenting human biological material, there is another response to such patenting, which posits that a human body cannot be the subject of property rights. Some base the objection on human rights' theories related to human integrity and dignity, while others base it on religious or spiritual values and beliefs. The heart of the objection is a concern that human beings should not be objectified.

Historically, patents over living organisms or phenomena of nature were disallowed, as these were not seen to comply with the requirements of novelty and innovation.41,^o This changed after the ruling by the US Supreme Court in the case of Diamond v Chakrabarty (447 U.S. 303, 1980) where a patent was granted for a genetically engineered living organism that was designed to digest and break down crude oil. Since that time, multiple patents have been registered over plant, animal and human genetic material, subject to the requirement that the subject matter be novel and innovative.

A cell-line derived from the cells of individuals is one form of 'altered human genetic material' that may be the subject matter of a patent. However, the registration of such patents is highly controversial as the applicant's proprietary rights to the cell-lines are contested by the donors of the genetic material used to create the cell-line.^p In this regard, the Supreme Court of California has held that "as biotechnology has an enormous potential benefit for humanity, giving the human source of genetic material property rights would drastically curtail the free distribution of biological samples for scientific research, thereby doing a great disservice to society."⁴¹ Ironically, the Court went on to permit the granting of proprietary rights in human genetic material on the basis that patenting is the best motivation for innovative research. The irony lies in the fact that there was no cost/benefit analysis in the determination of the Court. It is not a certainty that the commercial enticements offered for scientific research have, in fact, benefited the community. It cannot simply be taken for granted that the granting of monopolies is the best method of ensuring the greatest benefit to consumers. This has particular application in South Africa, where the majority of our community is economically under-privileged. The price of granting patents is, for the majority of the population, reduced access to potentially essential medical products, albeit for only a limited period.

The most objectionable aspect of patent, as evidenced in the US patent system and in the European Union,q is that it encourages research work which does not require time, effort and innovation which should be rewarded. The reference is to the permissible patenting of expressed sequence tags that involve automated sequencing technology. The research really begins with finding full-length cDNA and genomic sequences, and "the task of identifying biological functions of a gene is by far the most important step in terms both of its difficulty and its social benefit. It therefore merits the most incentive and protection."⁴² It is anomalous that straightforward processes be rewarded so substantially when the real work only begins after a patent has been granted. In effect, the patent is used to protect a future investment, which may or may not result in product development, and is not a reward for undertaking publicly useful research.

The profit-motive theory for permitting patents is therefore inapplicable, because the reward is not for the development of beneficial products, but is an incentive to spend time and money on potentially profitable research. This is not to say that tools used for the development of useful products are not patentable. However, it is queried whether an expressed sequence tag is such a tool. The sequence seems to fall more neatly into the category of 'raw material'.

Patenting becomes problematic when the patent owner imposes licence fees or restrictions on the research of other organisations, particularly where the patent owner has built on the work of others to develop the subject matter of the patent claim. Previously viable research becomes too expensive under a licence system, or is prohibited altogether. This has important implications for private patents of work that is largely indebted to publicly funded research. The public bears a double burden; first, in funding the research, and second, in paying monopolistic prices for products developed from that research. The resultant monopolistic prices impact also on the ability of public health agencies to offer free or low-cost services to the public, thus removing the economically under-privileged even further from access to beneficial medical products.

The argument in favour of patents does have some validity. What incentive exists for research where competitors can 'piggy-back' on the innovations of a product developer? Taking away incentives may cause research to become a largely publicly funded activity, guided (or stifled) by the mores (and agenda) of the incumbent government and subject to political approvals. Privatisation of research allows greater independence from political intervention. In defence of private companies it is said that the desire to make profits is not devoid of reasoning. Logic dictates that products must be priced at an affordable price for profits to be realised. The debate, however, is not merely one of price, but of public utility. Affordability does not mean utility. A product that has a cost price of R1 may still be affordable at R10, ten times the cost price. There is no dispute that development must be rewarded; the controversy rests on the question of how much development deserves reward and how much reward is sufficient.

In summary, the present incentive is for researchers to patent sequences or partial sequences of human genes. Further, the focus of substantive research has become profit driven. The patenting system grants to one entity the control of all future research and medical development with respect to the subject matter of the patent, in some instances for undertaking nothing more than a mechanical procedure.⁴³ This cannot be to the public benefit, while it promotes secrecy and hinders the exchange of scientific information, resulting in duplication of efforts, inefficiency in research and greater costs to the public for access to the resultant medical products.

It is evident that the patent system does not offer a donor much protection. However, an individual donor or donor community is not completely vulnerable. While the process of registering a patent does not involve an investigation of the proprietary rights to the subject matter of the claim, there are laws and practices with regard to informed consent, regulating the use of human tissue for research. Donors of the material must give consent to the use of their tissues for the purposes of research and development, and further, consent must be given to the patenting of isolated genetic material gleaned from the donor samples. Any possible financial or other benefit by anyone should be disclosed to the donor.

Unfortunately, levels of informed consent are at present dubious or largely absent. Informed consent acknowledges that a subject's privacy is breached by the activity to be undertaken, and it seeks to absolve the breaching party of responsibility by requiring the subject to permit the carrying out of the activity. Lack of consent affects the legality of the activity. Thus, in a paradigm of informed consent, subjects are able to protect their rights and interests by clearly defining the ambit of the consent. This does not necessarily invalidate the patent application, but lays the applicant open to claims for damages. Further, a donor has rights of privacy over his medical records. No analysis of donor samples may be commercialised without the donor's informed consent in respect of the records (see 6.7 and 7.2.4 in Book 1). There should not be exploitation of individuals nor communities (see 11 in Book 1).