Research ethics and patents

What is a patent?

The patent right is a part of intellectual property rights, which also include e.g. copyrights, brand rights and design rights. A patent gives a time-limited monopoly on the commercial use of an invention. The patent does not give the right to actually use the invention commercially; it only gives exclusive rights to commercial use. The right only enters into force if there are no other obstacles to commercial use. In other words, the patent only gives a monopoly, and in a sense is hypothetical (if X is permitted, it is the patent holder who has exclusive rights to X).

Patent protection is appealing because it may attract investors and provide a basis for sales and licensing agreements. The patent right is an important incentive scheme because, by attracting investors with the promise of a patent, it makes it possible to conduct research which otherwise would be difficult to finance.

What are patents issued for?

Patents are issued for inventions, not discoveries. The invention must comprise a technical solution to a technical problem. Vague ideas cannot be patented. In contrast, products, processes, devices and applications may all be patented. The invention must also be new. Any publication of the invention prior to a patent application will be an obstacle to patent protection. (A discussion of research ethics related to this appears below in the paragraph on "ethical issues related to patents".) When an invention is made public via the media, journals, conferences or the like, it essentially becomes joint property, unless patent protection has already been issued. In addition, the invention must be substantially different from previously known technology in the area, known as "inventive merit".

Norwegian patents

Patents may be sought in Norway via the Norwegian Industrial Property Office. These patents are only valid in Norway. In addition, as from 1 January 2008, when Norway became a signatory state of the European Patent Convention (EPC), it is possible to apply for a patent via the European Patent Office (EPO). Patents issued by the EPO are valid in all countries that have ratified the EPC, as well as in all EU member states.

The "ethics paragraph" in the Patents Act

Both the EPO's regulations and the Norwegian Patents Act contain a paragraph on patent ethics. Accordingly, patent applications may be denied on ethical grounds. Section 1b, first paragraph, of the Patents Act states that "Inventions shall be considered unpatentable where their commercial exploitation would be contrary to public order or morality". Section 1b, second paragraph, states that "Such exploitation shall not be deemed so contrary merely because it is
prohibited by law or regulation". Further, Section 1b, third paragraph, states that "On the basis of the first paragraph the following, in particular, shall not be patentable: (1) processes for cloning human beings, (2) processes for modifying the genetic identity of human sex cells, (3) use of human embryos for industrial or commercial purposes, and (4) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, including animals resulting from such processes".

The Ethics Committee in Patent Cases

Section 15a, cf. Section 25, third paragraph, of the Patents Act, requires the Norwegian Industrial Property Office to consult with the Ethics Committee in Patent Cases if the Norwegian Industrial Property Office is uncertain whether commercial exploitation of an invention is consistent with Section 1b of the Patents Act regarding public order and morality, i.e. the fundamental ethical norms of Norwegian society. The ethics committee scheme is peculiar to Norway, but Section 1b of the Patents Act is identical to the wording in the EU Directive on the protection of biotechnological inventions (98/44/ EC, Article 6) and the European Patent Convention (EPC, Article 53).

Ethical relevance of the patent right

What is the ethical relevance of the patent right? As already mentioned, a patent does not give the right to exploit an invention commercially, in research or for general use. Commercialisation, research and use are all regulated by other statutes. On this basis, critics have argued that the ethics paragraph, and especially the specific provisions on exceptions, do not actually concern patent ethics at all. Obtaining a patent on processes for cloning human beings cannot it itself be an ethical problem. If it is unethical to clone human beings, it is the research that should be prevented, not the patent. The research may upset public order and morality; likewise, making a certain product available on the market may be ethically problematic (e.g. harmful effects), but the actual patent protection, which only gives an exclusive right to use, can hardly be said to upset the public perception of morality. When discussing patent ethics, it therefore seems appropriate to isolate the particular issue that is ethically problematic in respect of the actual patent issuance, rather than the research or general use. It can nonetheless be argued that a patent has a symbolic function, that patent issuance signals that commercialisation (as well as research and general use) is acceptable, and the patent gives legitimacy.

"Patent on life"

When the EU directive was introduced in Norway in 2003 allowing patents on biotechnological inventions, an intense debate on "patent on life" ensued. Although this debate did not always make a clear distinction between opposition to patentability and opposition to biotechnological research as such, it nonetheless raised an interesting point related to the concept of "patent on life". The underlying concern is whether living material can be made the object of exclusive right of ownership at all, or whether such material cannot be privatised. One side of the debate involves the moral intuition that there are certain types of objects that should not be made the object of commercial exploitation at all, either wholly or partially. Certain types of inventions can appear not to have commercial potential, in an ethical sense, because something is thus conceptualised as a commodity that should not be regarded as a commodity. Fertilised eggs may be a type of object which should not be regarded as a commodity, and which therefore (regardless of what one may believe about research on fertilised eggs or the moral status of such eggs) should not be regarded as patentable. That said, denial of a patent does not prevent commercialisation. (See also Research Biobanks.)

Right to monopoly as an ethical problem

It is useful to distinguish between patentability issues that revolve primarily around the ethical aspects of research, use and commercialisation on the one hand, and issues related particularly to exclusive rights on the other hand. Since the former is covered by legislation and also raises questions about research ethics in itself, we will focus here on exclusive rights.

Exclusive rights (a monopoly) have two ethical dimensions:

1. Public availability (Will a patent prevent the invention from benefitting potential users?)
2. Legitimate ownership (Does the inventor deserve exclusive ownership rights to a given invention?)

Questions related to the last point are (a) how the invention has come into being and (b) whether the invention should be regarded as being part of humankind's collective heritage.

In which fields do issues related to patent ethics arise?

The question whether certain types of inventions are of such a nature that a monopoly on commercial exploitation of them should not be given is especially relevant in relation to biotechnological inventions and inventions related to humans' (and animals') living conditions, such as medications and nutrients, but this may also generate debate on copyrights and patent protection for other products that the general public should have free access to (e.g. software products).

While general patent ethics concerns the public at large, issues related to research ethics will primarily address the research community. What are the relevant ethical issues regarding patents? Researchers or research groups that develop processes, products or something else that may qualify for patent protection must assess whether they should apply for a patent. The advantages of a patent may seem obvious. What could be the objections to seeking patent protection? What is the responsibility of researchers who are considering applying for a patent?

A possible answer is of course that researchers may leave the decision up to the relevant agencies, and apply for a patent when it seems expeditious. However, this seems to be an abdication of responsibility. The research community has a responsibility to society; especially when the research has been made possible through public funding, the research community has a duty to give something back. In addition, researchers have a responsibility to support intellectual freedom, open debate and critical peer review within the community which leads to good, sound research. The patent requirements indicate competition rather than collaboration, secrecy over transparency. Researchers must assess whether this serves research or whether it is in conflict with it. Two considerations regarding research ethics may be tied to the two dimensions of exclusive rights mentioned above: We can call these external considerations of research and international considerations of research, respectively.

External considerations of research/social responsibility

NENT's Guidelines for Research Ethics in Science and Technology state that the overriding obligations of research are, among other things, that "(4) Research must promote and take part in the development of democracy," and "(5) Research must promote greater global justice in the distribution of wealth through the spread of information". Of all the overriding objectives for the social responsibility of research, these two are especially relevant in relation to patents. The text under point (4) states further that "Research must promote a collective expansion of knowledge", and point (5) states that "Research results and their usage must be shared in their entirety with society at large, both nationally and internationally and with developing countries in particular. Information about research must in principle be made accessible to all."

The patent systems is neither clearly positive nor negative from the perspective of social responsibility. Positive arguments that generally promote patent and other intellectual rights include, for example, that intellectual property rights encourage investments in research that may benefit society at large, provide effective incentives to research that may benefit society at large, and lead to scientific and technological advances and create jobs.

Nonetheless, researchers have a responsibility to assess the social consequences of obtaining a patent on an invention, in other words, which considerations affect external parties outside the research community. The relevant question related to external considerations of research is: Does our responsibility to society suggest that we should/should not apply for a patent? How can our research be made available to the largest possible number of relevant users? Does patenting or other instruments to protect intellectual property rights promote or prevent the capacity of our research to give something back to society? Are there other solutions?

In other words, researchers must assess how research's social responsibility can be safeguarded as much as possible. Of course, this depends on the specific science and technology, and which issues are relevant will vary widely from one area to another. Potential issues that may need to be taken into account are consequences of the patent with a view to, for example:

• Does the patent contribute to biopiracy? (i.e. taking resources from poor countries without returning them)
• Do we have an unfair monopoly on humankind's collective heritage? (e.g. a patent on genes)
• Does the monopoly exclude others from important knowledge? (knowledge protectionism)
• Does the monopoly result in reduced access to medicine or other essential benefits for poor people?
• Does the monopoly prevent feeding back the findings to the contributors?

The individual research environment is responsible for identifying relevant considerations in its area with regard to the consequences of a potential patent.

Internal considerations of research

High-quality research requires an open research community. Free discussion, peer review and a critical perspective on science are essential for quality assurance of research, including innovation. (See Research values.) One of the arguments in favour of intellectual property rights is precisely that such protection advances scientific and technological development. However, because a patent will not be issued if an invention has already been made public, there is a risk that researchers, as they await a patent, will be sitting on vital knowledge instead of publishing or presenting their findings for their colleagues. Researchers also risk the interruption of long-term research projects or that knowledge they have acquired cannot be used because others are issued a patent that prevents them from completing their project.

Therefore, the question arising from internal considerations of research is: Do patents and other intellectual property rights prevent an open research community and research freedom? Do patents encourage secrecy and intellectual protectionism? Does intellectual protectionism harm research quality and development?

Who owns knowledge?

The Human Genome Project (HGP, concluded in 2003) documented and patented large segments of the human genome. Although it would seem such patents are impossible to obtain since genes are not inventions but occur naturally and must therefore be regarded as discoveries, genes may be patented in practice, cf. Article 5 of the EU directive on the legal protection of biotechnological inventions: "(2) An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element." To illustrate, if researchers have discovered which protein a gene codes for and how this can be used in medical treatment, they are considered to have found a solution to a technical problem. The isolated gene is thus patentable, although nobody owns the gene in its natural occurrence in the human body. The HGP has made this knowledge available in public databases, but the patent protection nonetheless places tight restrictions on what other researchers can do with this knowledge without risking a breach of one of the HGP's many patents. Who owns knowledge about our genes?

The question of who "owns" knowledge entails more than just giving back to society, sharing knowledge with the global research community, or the groups that will benefit and profit from the research results. It is also a question of who has contributed on the front end. For example, John Locke based his support of individual property rights on the argument that each person has a right to the fruits of his/her own labour, which is an extension of the right to decide over one's own body. "If I built the house, it is mine." There is good reason to ask whether objects of intellectual property – knowledge – may be understood in the same way. Neither ideas nor researchers arise in a vacuum, but rather within a research community. A person become a researcher by gaining experience through research-related practice, in a social process facilitated through research groups within an institutional framework. Acknowledgement of this fact is part of the reason that it is not possible to obtain a patent or request a copyright for ideas only. Science is not patentable, only the technology is – at least ideally. However, as the Human Gene Project shows, drawing the boundaries between invention and discovery, between technology and knowledge, is a difficult and controversial exercise. Moreover, there are a relatively large number of co-owners in an invention, if one is looking at the contribution side. Donors provide tissue for research, peers offer input, the local population shares its knowledge about plants with healing properties, to give just a few examples. Researchers who are thinking about applying for monopolistic protection of their work should therefore give thorough consideration to whether they are the legitimate owners of the product, and assess this in relation to the social benefit the patent may nonetheless have.