Home > IP Topics Index > Innovation and IP Management: A Contextual Overview > Genomics, Ethics, and Intellectual Property > Editor's Summary, Implications and Best Practices

There are many ethical concerns surrounding the patenting of biological materials. This chapter considers three topics:

1. Are some or all patents for genes and cells unethical per se?
2. How should tissue samples be collected?
3. How are patents used to restrict access to medical and agricultural biotechnological inventions?

Some individuals and organizations have denounced, on ethical grounds, any patents for biotechnological applications, genes, or living organisms. However, there is neither a single articulation of such concerns nor is there a branch of government that can address them. Patent offices, for example, are ill-equipped to address ethical questions. However, any blanket prohibition on patenting genes or other biological materials is generally inconsistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which requires countries to allow IP protection for most biotechnology products. Still, under TRIPS, there are exceptions to this general prohibition. For example, bioengineered animals may be deemed unpatentable. TRIPS also contains a provision that certain unethical inventions or innovations may be denied patents; a similar provision is found in the European Union’s ordre public clause. U.S. patent law, however, does not have this kind of morality provision.

There are also ethical questions surrounding the process of obtaining biological samples. The norm is that people who donate their tissue for research purposes relinquish property rights to the donated cells, genes, and other biological material. Problems can arise, however, when human, animal, and plant materials and specimens are collected in developing countries and subsequently used to create biotechnological inventions that are patented in developed countries; some people have questioned the ethics of what they call “biopiracy.” The chapter explains that ethically questionable situations can usually be avoided if the following principles are followed:

1. Prior informed consent should be obtained from the relevant entities before taking any samples.
2. In benefit sharing, an organization agrees to share with a developing country any economic benefits that result from patented inventions based on biological materials collected in that country. For example, if a shaman provides valuable information on a medicinal plant, and the extract of that plant is subsequently developed into a patented pharmaceutical product, then under benefit sharing, the shaman and his tribe would receive some of the proceeds from the sale of that product.

The above methods help to minimize, but do not eliminate, the ethical quandaries related to the collection of biological materials. Many questions remain: Who is authorized to give prior consent? Should more than one authority give consent (for example, both tribal and government officials)? How much must be disclosed about the proposed research to ensure that the authorities are adequately informed?

Benefit sharing can also be difficult to implement. First, many scientific researchers do not have funding to properly compensate indigenous peoples for their assistance. Second, who decides how benefits will be allocated? Third, if benefits are offered to people who assist researchers, some individuals (particularly those who donate tissue specimens) may “assist” researchers purely for the money they will receive, not unlike blood donors.

Patent owners can keep developing countries from accessing critical technologies if they impose high licensing fees, license their patents exclusively to single licensees, engage in narrow cross-licensing, or refuse to license their patent to anyone. In addition, if critical research tools are also patented, developing countries may have difficulty obtaining the rights to use all of the technologies they need to conduct research. These problems can be overcome if patent holders themselves sign nonassertion agreements (promising not to enforce their patents in certain cases), reduce their licensing fees, and possibly even form international R&D partnerships whereby the patents are made available pursuant to the collaboration.

There are few laws that address the ethics of patenting. In the absence of any clear consensus, ethical decisions concerning biotechnological patents will need to be made on a case-by-case basis. The ethics of patenting is an evolving field that currently is more gray than black-and-white.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Ethical concerns about patenting genes and DNA sequences, among others, have not been incorporated into laws, leaving ethical issues largely unresolved. As a result, policymakers, scientists and users of biotechnology need to address these “ethical minefields” on a case-by-case basis to minimize controversy, disruption and opposition, while avoiding the paralysis of inaction.
• The guidelines of the Convention on Biological Diversity (CBD) concerning prior informed consent, benefit sharing, and equitable access can help researchers utilize biological resources. They also encourage the owners of those biological resources to practice conservation, because something of value is worth safeguarding.
• TRIPS allows nations to impose certain restrictions on patenting biologically based inventions, such transgenic animals. However, when considering implementing such restrictions, it is important to consider how they might impact R&D, technology transfer, and collaborative partnerships, as well as impact on the poor who are most in need of appropriate new technologies.

For Senior Management (university president, R&D manager, etc)

• Ethical concerns about patenting genes and DNA sequences, among others, have not been incorporated into laws, leaving ethical issues largely unresolved. As a result, policymakers, scientists and users of biotechnology need to address these “ethical minefields” on a case-by-case basis to minimize controversy, disruption and opposition, while avoiding the paralysis of inaction.
• Public-sector institutions should have ethical guidelines for IP management that are consistent with national laws. An institution’s policies regarding the ethical use of intellectual property should be consistent with the mission of that institution.
• Encourage one and all to discuss the ethical issues surrounding intellectual property. Only in the marketplace of ideas can such complex issues be sorted out.

For Scientists

• Ethical concerns about patenting genes and DNA sequences, among others, have not been incorporated into laws, leaving ethical issues largely unresolved. As a result, policymakers, scientists and users of biotechnology need to address these “ethical minefields” on a case-by-case basis to minimize controversy, disruption and opposition, while avoiding the paralysis of inaction.
• Be aware of the ethical implications of your own research and of any IP protection you might pursue for that research.

For Technology Transfer Officers

• Ethical concerns about patenting genes and DNA sequences, among others, have not been incorporated into laws, leaving ethical issues largely unresolved. As a result, policymakers, scientists and users of biotechnology need to address these “ethical minefields” on a case-by-case basis to minimize controversy, disruption and opposition, while avoiding the paralysis of inaction.
• Be aware of ethical issues in IP management. For example, certain biotechnological inventions might not be patentable, due to national laws or your institution’s policy directives.