Stem Cell Patents
Stem cell research, like other areas of scientific and biotechnological research, leads to innovations, some of which may be protected by intellectual property rights. In the stem cell research domain, as in most biotechnology, patents are the most prevalent form of intellectual property protection. Patents represent a limited property right that allows the patent holder the right to exclude all others from the use or exploitation of the patentable subject matter. A patent represents a bargain with an inventor in which a time-limited monopoly (usually 20 years) is granted in exchange for public disclosure of the inventor’s creation.
Patenting life forms
Just as there is controversy over classifying human body parts and tissues as property, the classification of living things or products of nature as property is equally controversial, and some would argue that it is simply a mistake – people are not property. Classifying these things as property raises issues of commodification, that is viewing or treating something not traditionally thought of as subject to market forces, as if it was such a commodity. The question arises whether man-made reproductions or isolations of naturally occurring things are patentable. Where applied to human cells or tissues, property notions are often seen as offensive to human dignity.
Patents and Human Stem Cells
Given that non-naturally occurring inventions are patentable subject matter, isolated and purified stem cells are patentable as research tools but patents on human embryonic stem cells (hES) – that is the cells themselves – have been hotly contested. There are significant differences between Europe and the United States and Japan. (Canada has not granted a patent on hES to date).
While patents on hES have been upheld in the United States, the same patents have been denied in Europe. In Europe, the patent office (EPO) may deny patents on ethical grounds, if the commercial exploitation of those patents is against ordre public (public order) or morality. Combined with a legally enshrined principle of non-commercialization of the human embryo, human body and its products this has lead Europe to deny the patentability of hES.
Other ethical issues raised by the patenting of human stem cells include the barriers to access by other researchers that patents can create through either exclusionary practices or expensive licensing fees (user fees charged by the patent holder). Such research barriers can create obstacles to the development of products and processes that have significant medical benefit. In other words, there are real people who may be harmed by not getting timely access to life-saving treatments or technologies if patent protections are too strong. Concerns about how licensing fees would affect pricing of any products or therapies that might be developed also exist.
Distributive Justice
In the context of hES research the question, “Who profits?” applies first to commercial benefits from the lucrative patents that have been awarded on the hES lines and second to who will benefit from the potential medical therapies. Broad intellectual property protections and exclusive licensing agreements can restrict access to benefits of research. Some important steps are being taken by funders of scientific research to ensure that broad access to the fruits of the research is part of a funding agreement. Much of this work is done through managing the intellectual property rights that may result from the research, especially through licensing agreements.
Stem cell research holds the potential to give rise to therapies will be needed in the most and the least developed countries of the world. In many instances these therapies will be beyond the reach of countries that have just pennies to spend on each person for health care every year. Ensuring that the benefits of stem cell research reach as many people as possible is a global ethical imperative.