Genomic resource centre

Executive Summary: Genetics, genomics and the patenting of DNA

Part 2: Analysis

Ethical Issues
Legal Issues
Ways in which the patent system may affect access to genetics and genomics

Ethical Issues

Despite the fact that patent offices in the United States have been granting patents on DNA, there continues to be wide debate about the acceptability of this practice, both on ethical and legal ground.

There are arguments against patenting DNA that rely on an inherent objection to the practice.

  • Commodification. There are two objections to DNA patents based on the idea of commodification: one is in relation to the commodification of organisms or their tissues, and the other is in relation to the commodification of information or raw data. The first kind of objection tends to be based on moral grounds, whereas the second links with legal arguments addressed below.

  • Common heritage of mankind. On this view, DNA has a special character, beyond that of ordinary biological molecules. It is somehow foundational, imbued not only with biological, but also historical and even moral significance. UNESCO's 1997 Declaration on the Human Genome and Human Rights, supports this view, stating that the human genome underlies the fundamental unity of all members of the human family and, in a symbolic sense, it is the heritage of humanity. Others argue that this view borders on "genetic essentialism", a kind of reductionism that exaggerates the value of the contribution of genetics to human behaviour, identity and culture.

There are other arguments against patenting DNA that rely on the consequences of patenting.

  • Public good. A public good is one that is non-rivalrous and inappropriable, and some have claimed that DNA has this character. To call something a "public good" is not simply to describe how it is; it is also to make a normative claim about what would be in the public's interest. Air, for example, is a public good because its appropriation (were it possible) would make everyone worse off. To say that genomics, or more specifically genomic data, is a public good is to claim that people would be better off if everyone had access to it. Accepting that genomics is a public good means accepting placing certain limits on its appropriation for private gain.

  • Benefit sharing. Some have argued that patenting DNA supports the misappropriation of goods from those who were their rightful owners. In most cases, the rightful owners are a community whose members share various genetic traits in common, whose DNA is tapped for scientific, clinical or commercial gain. In essence, such arguments express concern about the distribution of benefits of research. The question of ownership, and therefore patenting, is used as a means of highlighting that those with unequal power but desirable genetic resources often do not gain access to benefits of research.

Legal Issues

A number of commentators have argued that DNA, at least in certain instances, does not meet the legal criteria of patentability.

  • DNA as information. One set of concerns turns on the view that DNA's value lies principally in its information content, rather than its material qualities, and should therefore not be eligible for patenting. According to some critics, current DNA patenting trends represent a departure not only from patent practice, but from patent doctrine, which is based on an agreement to disclose information in exchange for giving the inventor rights over the material invention.

  • Criteria for patentability.A second set of concerns relates more specifically to the application of the criteria for patentability by patent offices. A general worry is that these criteria have been interpreted loosely in some jurisdictions in the context of DNA. There has been concern that DNA does not meet the requirement of an inventive step, given that the sequencing of DNA has become a highly automated and routine part of laboratory practice. Additionally, there has been concern regarding the granting of patents for sequences of limited or questionable utility. In the United States, this concern gave rise to the USPTO's 2001 guidelines on expressed sequence tags (ESTs), which tighten the specifications regarding what constitutes utility. Finally, some concerns relate to the traditional distinction between inventions and discoveries. This dichotomy typically amounts to a distinction between what exists "in nature", and what is the product of human labour, or at a minimum, human intervention. The invention/discovery dichotomy is principally relevant to the novelty standard of patentability. Patenting in biotechnology presents particular challenges to this distinction, because the subject matter in question consists of "natural" entities.

Ways in which the patent system may affect access to genetics and genomics

DNA patents may improve incentives to develop useful products. The patent system is designed to encourage innovation, by encouraging the investment of time, creativity and capital necessary to bring about socially useful technological advances. However, firms have little incentive to invest in diseases that affect poor populations, because the local market is unlikely to offer high financial gains for the products of research. In this context, patents do hinder access, but fail to provide incentive for relevant research and development.

DNA patents may also adversely affect access in at least two ways: by hindering access to the products of genomic innovation in the short term; and by hindering genomics innovation, particularly in areas relevant to developing countries, by creating barriers to research.

Hindering access to the products of genomic innovation:

  • Increasing the cost of available services: There are high-profile examples of patents on diagnostic tests resulting in the increased cost of existing services. Genetic tests for Canavan disease, familial breast cancer, Alzheimer's disease and haemochromatosis are among those that have received publicity because of the outcry by patients and clinicians that patents, combined with exclusive licensing practices, have put the price of diagnostics beyond the reach of many. There is little evidence to date that this has had a direct impact on developing countries, though it could indirectly affects costs by making technology transfer more complex or expensive.

Hindering genomics innovation by creating barriers to research:

  • Imposing transaction costs and inconvenience on research and development: Researchers need to use a large number of different research tools, and in biotechnology there is evidence of the cumulative nature of scientific development such that later innovation depends heavily on prior iterative advancements. The concern is therefore that the existence of patents on research tools could slow or even block many subsequent research efforts as researchers are forced to pay high fees to a large number of patent holders before even commencing their projects. Or, worse still, that research might be denied permission for use of the existing research tools. The cost of basic research could increase due to the increasing number of patented basic research tools, slowing down biomedical innovation. This scenario has been referred to as the "tragedy of the anti-commons". A recent report by the U.S. National Research Council examines the changes in patenting and licensing in recent years and their effect on innovation in pharmaceuticals and related biotechnology industries. The report highlights evidence that many institutions in the United States have developed workable solutions that allow them to carry on with research, in the face of widespread patenting of research tools. However some barriers remain, in both particular fields of research and for particular types of research institutions. These include the fact that there is a finite number of genes, and therefore a limited number of tools, for researchers to employ in gene-based research. Furthermore, challenging patents in court is not feasible for firms with limited capital (including the majority of those in developing countries), or for research institutions and universities. The bottom line is that these constraints may create disincentives for the pursuit of certain lines of research for example, diagnostics. Diagnostics is a field in which the raw materials of genomics may translate more easily into useful health applications for developing countries. What's more, these disincentives will chiefly affect institutions that have relatively limited capital, such as research centres and public-private operations, which are often those groups most concerned with research in areas relevant to developing countries.

  • Impeding the transfer of existing tools and technologies: Patents are national in application, but research is increasingly global, particularly emerging technologies like genomics. So while it may be true that patent protection has not been obtained for genetic inventions in many countries in the developing world, it does not necessarily follow that patents do not affect access to health products and services in these countries. Most genetic research is performed in industrialized countries, and is predictably directed towards health needs of markets in these countries. With few exceptions, developing countries lack facilities required to adapt existing tools and technologies to their own needs or access non-patented know-how associated with the use of patented DNA sequences. This is the identical challenge faced in the context of pharmaceutical research and development, a challenge acknowledged by the "paragraph 6 problem" of the Doha Declaration. Though patents are rarely filed in developing countries, patents could block the ability of potential supplier countries to export patented goods to other countries. For example, patents are often filed in South Africa, but not in other African countries, because South Africa has relatively strong manufacturing capacities and is therefore a potential supplier to poorer countries in the region.