The following discussion of policy concerns regarding patents on human genetic material is not intended to be exhaustive. Instead, we wish to illustrate here that practical and tangible policy concerns exist that can be separated out from the general debate over the appropriateness of human gene patents. Unlike some of the broader concerns over the commercialization of and definitions of humanity, policy makers can begin to address these concerns through direct and discrete legislative, judicial and regulatory responses. Whether it can be considered to be justifiable or not, a radical alteration in patent law —such as prohibiting the patenting of human genetic material — is unlikely to be tenable, because there are too many forces pushing the patent agenda forward. Moreover, it is far from clear that a wholesale abandonment of gene patents would be desirable. However, we may be able to craft specific responses to specific concerns. Because such an approach would target specific problems, rather than trying to disallow an entire class of patents, it may be a more manageable approach to patent reform. In this section, we discuss a few strategies that could be considered as ways to move this debate forward.
One of the simplest and most obvious ways to mitigate the concerns about the impact of patents on research and the development of genetic products would be to apply current patenting rules more stringently. For example, should we allow patents over any genetic sequence or only for those that the inventor has identified a known, clear and substantive function for? Many groups have argued that only the latter merits the reward of a patent22,35
. If patents are allowed on upstream discoveries, such as expressed sequence tags (ESTs), it might discourage the development of useful downstream inventions, such as genetic tests. Such an approach would also reduce the number of patents granted to those that have been well and narrowly described, thereby diminishing the “overlap and fragmentation of patent claims” that can negatively affect the dissemination of genetic technologies22
. According to some commentators, such an approach is in agreement with existing patent legislation36
. For example, it has been noted that “the courts have applied these standards much more loosely than is required by the statute”. And, because no new legal framework is required, this is a relatively easy strategy for many countries to adopt. Indeed, this is a strategy that is already being considered, as shown by the United Patent Office’s recent interim guidelines that call for a stricter application of the utility requirement37
There are several other policies that could address the problems that patents raise in relation to research and the dissemination of technology. For example, the experimental-use exemption in the United States and Canada could be clarified to allow research to occur on the subject of a patent without fear of patent-infringement litigation. In addition, broader licensing policies that apply to certain subclasses of gene patents (for example, patents on clinically valuable genetic tests) could be considered. This reform would help to ensure that access to useful technologies is not hindered and that costs are not elevated by a monopolization of clinical services. Indeed, some United States physician groups have taken the position that patents on genetic-testing procedures should be broadly licensed, for a reasonable fee, to any lab meeting technical and quality standards2,24
As we briefly noted above, patent law has also been implicated in issues associated with the commercialization process. Although patent law may not be the best forum in which to address ethical and policy concerns associated with the commercialization of genetic information (for example, federal regulation agencies, such as the United States Food and Drug Administration, seem well placed to meet many of the concerns)38
, patents are critical for the commercialization process. Given this, we ought to explore ways of harnessing the powerful economic incentives attached to patents as a means of mitigating the ethical concerns associated with the use of patented genetic inventions, such as the premature or inappropriate implementation of genetic technologies26,29,38–41
. For example, patent holders could be held to be liable for the unethical or negligent use of genetic inventions. Although such an approach would undoubtedly be controversial, it is not beyond the stretch of current negligence law42
. Because the patent holder can use licensing agreements to control access to a given genetic invention, it is arguable that a patent holder could be expected to ensure that a licensee of that invention be required to meet emerging legal and ethical norms associated with the use of the technology, such as the requirement to provide fully informed consent or genetic counselling where appropriate.
Finally, two further strategies seem essential. First, and perhaps most importantly, more research is needed on the actual benefits and harms of human gene patents. Much of the public debate seems to be based on broad assumptions that patents either encourage innovation and product development or that they are bad for society generally. As much as possible, reform initiatives should be based on credible evidence. Second, it is important to encourage an open, continuing and informed dialogue between concerned members of the public, patent law experts, researchers, ethicists and the biotechnology industry.