Ethical issues in patenting scientific research


pp. 173-181 in Proceedings of the International Conference of the Council of Europe on Ethical Issues Arising From The Application of Biotechnology. Volume II. (Council of Europe, 2000).
Author: Darryl R. J. Macer
Summary

This paper is included in the session titled "Research", a topic perhaps more suited to the issue of patenting than that of the session on "Industry" which follows, although this is a sign of the times. We live in the 1990s and not the 1960s. We have seen the growth of patent applications by academic and public sector researchers to a point where they may out number those of industry applicants, especially in the case of biotechnology. The trend towards commercialised science is symbolised by the U.S. Congress which decided that publicly funded science should be commercialised, and during the 1980s intellectual property rights were decentralised from government to research institutions to create commercial incentives. This trend has become world-wide.

Ethically we can start by asking rather simple questions, is the principle of beneficence, or loving good, served more by having research than by not having research, and do we encourage more research into more beneficial areas of science by the incentive system of patents than we would by not having patents? We will also consider whether other ethical principles such as justice and doing no harm are served by systems of intellectual property protection. Ethically can anyone own a product of their mind, a product of nature, a product of a designed process, a discovery or even an invention? Does it make any difference whether the product or process involves living organisms or rocks? Should we expect the practical law to share the same goals as that of ethics, namely can we expect ideal ethical laws or some compromise?
In this paper I will first review intellectual property protection, and secondly, discuss the ethical arguments related to patenting in biotechnology research.

Intellectual Property Protection

There are several systems of intellectual property protection designed to reward inventors. To qualify for a patent an invention must be novel, non-obvious and useful. Industrial competitiveness leads to secrecy, and results may not be published at all if a company does not think they can keep the benefits to themselves from the research costs invested, or the money used to purchase the rights to the use of results of research from a university research team. A patent guaranties the publication of the results and the deposit of the product in a central repository, for use in the future development of research to create better inventions.

The closing of results from other workers is against the principle of scientific openness, but is a common feature of certain forms of industrial research, especially when the process used to create a product may be expected to be kept a secret for some years. However, with biotechnology inventions, once the product is sold, the DNA can be sequenced and reproduced by another team of researchers. Specific techniques, such as nuclear transfer or cell manipulation techniques may be keep secret a little longer, but still tend to be made open through the patent system. Patents can generally be sought either on products or processes used to manufacture the product. It is easier to obtain a process patent, but it has been harder to prove that a competitor is using your process, as access to their production facilities may be restricted.

If the claimed invention is the next, most logical step which is clear to workers in that field, than it cannot be inventive in the patent sense. If a protein sequence is known, than the DNA sequences that code for it will not in general be patentable, unless there is a sequence which is particularly advantageous, and there is no obvious reason to have selected this sequence from the other sequences that code for the protein (Carey and Crawley, 1990). In the case of natural products there are often difficulties because many groups may have published progressive details of a molecule or sequence, so it may have lost its novelty and nonobviousness. These are essentially short pieces of the human genome. However, the genomics companies like TIGR have applied for patents on previously published sequences from databases, and the policy seems to be emerging.

There are also patents on protein molecules which have medical uses. In this case the protein structure is patentable if it, or the useful activity, was novel when the patent was applied for. The invention must also be commercially useful. A new use may be allowed a new patent, although an Australian judge in 1998 rejected such an application. There are patents on short oligonucleotide probes used in genetic screening. If someone can demonstrate a use for a larger piece of DNA than they can theoretically obtain a patent on it. An example of a larger patentable section of genetic material would be a series of genetic markers spread at convenient locations along a chromosome (Saltus, 1986). Another set of genetic markers on the same chromosome can be separately patented if they also meet those criteria.

The question of patenting of genetic material continues to be a contentious issue, despite the global agreement with article 4 of the Universal Declaration on the Human Genome and Human Rights, passed by UNESCO General Assembly in 1997, and adopted by the UN General Assembly in 1998, which states "The human genome in its natural state shall not give rise to financial gain." This is because there are numerous interpretations of what natural state means, given that what is being patented is not a chemical substance but the information included in the sequence. Nelkin and Andrews (1998) asked, like many, what are the limits to commercialisation of the human body, and wonder if we should change the species name to Homo economicus? In 1999 the Helix Research Institute in Japan applied for a patent on 6000 human genes, in a similar way to how US genomics companies have applied for patents on many genes.

The direct use of products, such as therapeutic proteins, is well established. The information may also be used in the study of a particular disease, for example, by the introduction of a gene into an animal to make a model of a particular human disease, and it was for this reason "Oncomouse" was patented. The first patent obtained for a living organism was obtained after the court case Diamond v. Chakrabarty in 1980, and the first patent on an animal was on an oyster in 1987 in the USA. The genetic information can also be used to cure a disease, for example using the technique of gene therapy with a specific gene vector, and this can also be patented. The ethical issues relevant to the debate on patenting life are discussed below.

Ethical issues

There are two basic approaches to applying patent law to biotechnology inventions. One is that the normal patentability criteria shall apply to everything, that is, the invention has the attributes of novelty, non-obviousness, and utility, and the invention should be deposited in a recognised depository. The second is to have a specific exclusion on certain types of invention. Denmark has an exclusion in its national law to patenting of animals for example. This exclusion is based on ethical arguments, and also application of the idea that no application against common morality should be supported.

Some ethical issues in patenting in scientific research include:

Relevant to this discussion of what is morality, is the weight of public opinion. There is public rejection of the idea of patenting animals in many countries, as seen in the International Bioethics Survey I conducted in 1993 in ten countries in Asia-Pacific (Macer, 1994). While there is support for patenting a cure for AIDS, there is less support for patenting genes or living organisms? When we think about this in more detail, which is the least ethical, to patent a medical cure or to patent a seed for a new crop? I will argue that the answer is not so clear.

Some of the ethical arguments that are commonly expressed when supporting patenting of biotechnology inventions are:

* Patent law regulates inventiveness, not commercial uses of inventions

* Patenting promises useful consequences (e.g. new products/research)

* Other countries support patents, so our country needs to if the biotechnology industry is to compete

* If patenting is not permitted, useful information will become trade secrets

* Patenting rewards innovation

The arguments against patenting include:

* Metaphysical concerns about promoting a materialistic conception of life

* Patenting promotes inappropriate human control over information that is common heritage

* Some countries do not permit similar patents

* Patenting produces excessive burdens on medicine (increased costs to consumers, payment of royalties for succeeding generations)

* Increased use of animals means more animal research which may be against animal welfare.

Most of these issues will not be affected by permitting patents, as the issues are similar to those existing prior to the patenting debate (e.g. the distribution of wealth, international competitiveness) (OTA, 1989; Bruce, 1998; Wartburg & Liew, 1999). This issue remains contentious and the fact that different countries have conflicting policy reflects this. The issue is closely related to the commercialisation of biotechnology, but some sort of information protection is already accepted as an incentive to invest in research of benefit to society.

The principle benefit claimed for patents is that rewarding an inventor creates a positive environment for progress of research that leads to the betterment of society. The financial interest in a free market creates more funding for research, and faster overall progress in research in important areas has been the result of the intense research efforts. This issue has been used by industry to oppose moves to block patents on biotechnological inventions that come from other ethical concerns (Ballmaier, 1999; Macer, 1998).

It is less clear to argue that the type of research that people will buy, which supports patenting and the research investment it protects, is the research of most benefit to society. Medical and agricultural products are clearly needed, but not always the most efficient and sustainable processes and products are used, as seen for example in chemical pesticide industry or expensive pharmaceutical alternatives to existing medicines. We can also consider the amount of money people in developed countries spend on luxury products, such as cosmetics, that may be considered a waste of research investment in terms of distributive justice, when compared to life threatening diseases.

The countries most supportive of patenting also appear to have been the most successful at generating research funding and making new products for use in medicine. We can think of the research supported in North America, Japan and Europe, when compared to other regions of the world. However, before accepting the results in terms of a measure of Nobel Prizes, or patent applications, we should consider how products of traditional agriculture and medicine have been applied to provide the introductions for current agricultural and pharmaceutical applications of biotechnology. Overall the contributions of the knowledge that is free access, and seeds which are freely accessible is much greater than the contributions of patented medicines and technologies.

Do the ends justify the means? The end is a product or genome sequence, which is open to all. However, by pursing certain means of achieving this end we may not obtain the same specific end. If we allow more privately funded research there may be more restrictions on the end information, in order to encourage private funding. If restrictions are applied to the general access to information than it is clear that we will have a different short-term end when we use a shared ownership approach compared to that from a private market approach allowing private ownership. After the period of patent exclusion than the direct result is the same, i.e. full knowledge and open use.

The indirect results will be affected by factors such as whether during the period of patent exclusion certain companies have been well established and are able to provide beneficial services or monopolies, and the relative advantages of the open knowledge after patenting compared to industrial secrecy that could occur if patenting was difficult to obtain. More significantly, there may be a greater amount of total knowledge and a more rapid completion date using the approach involving private companies. The means by which these approaches are pursued differs. In one approach the government laboratories spend their resources on the project, at the expense of other projects, but with the cumulative results being openly available to all. In the other approach, the private companies do the research, which would create more total biomedical research knowledge, but certain parts of this would be tied up in patents, though the knowledge would also be available with a small delay.

One ethical problem is that with whole genomic sequencing the knowledge from the private sector, e.g. Celera genomics factory, will be obtained only one year or two in advance of public funded efforts, so should that year in advance be translated to a twenty year period of exclusive patent use? Ethically we may question the length of patents in such tight races by companies with the greatest money, when they have the potential to monopolise numerous genomes. On the other hand, the patent system stimulated them to invest and to speed up the process of genomic sequencing by several years which must deserve some reward.

The DNA could be viewed as a random sequence of bases, and the author is the sequencer, but this is not what we would normally talk of as an author or inventor, rather the sequencers are discoverers. In the days of colonial rule a discoverer could claim a land as their property, but later it was recognised that the pre-existing people had claims to the property no matter how it was developed by the colonisers. The sequencers of DNA are not sequencing un-owned land but rather they are sequencing un-characterised land, the name of mappers is rather suitable for this analogy. Some critics of ownership could go as far as to call those who seek to profit and to control the decisions concerning the human genome project without general consultation, a type of "genomic imperialist" (Macer, 1991). The DNA is not random, it is merely unknown. This is an important difference, in addition to the common possession of the DNA sequence by every member of humanity, the sequencers are not authors. While it may also be unconventional to call the possessor of information the author, they have more claims to that title than the sequencers, in addition they can be called the owners (only in this general way the human sequencers are shared owners because they also possess DNA).

The claim that the function of patents is to regulate inventiveness rather than to regulate commercial uses of inventions is perhaps avoiding the consequences of the system. There have been some controversies regarding the commercial monopoly held by the company which was able to patent AZT, the initial HIV/AIDS treatment, which gained large profits in view of its monopoly. It is all the more questionable whether this should be allowed because of the key roles that government funded research played in developing AZT and showing it was active against AIDS. There are other examples where the commercial monopolies obtained can not be said to be in the best public good, and the existence of patent laws is certainly relevant to the later commercial uses of inventions.

Patenting is said to reward innovation, which is a basis of the successful modern democratic and Asian economic systems. They do recognise property rights in inventions. However, there is an existing difference in the protection of property rights compared with other rights in international law and declarations of human rights. Property rights are not absolutely protected in any society because of the principle of justice, for the sake of "public interest", "social need", and "public utility", societies can confiscate property. In the United Nations Declaration of Human Rights, Article 27 there are two basic commitments that many countries in the world have agreed to observe (in their regional versions of this declaration). These are (1) Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits. (2) Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author (Sieghardt, 1985). This second part could be applied to the shared authorship of the common heritage of the genome (Macer, 1991), and article 4 of the Declaration on the Human Genome and Human Rights.

Therefore there is an existing precedent for exemption from property ownership, which is the point of the exclusiveness of patents, when some property is of great benefit to the public. As for the argument that we should support patents because other countries do, there are certainly many countries that have exemptions for patent protection (Lesser, 1991). The exemption because of social need would apply if there would be more benefit from patent exclusion, which is not necessarily so. It depends on the way information is used. Therefore one answer to the question who should own the results of the genome project is no one in particular.

The patenting of new varieties of plants and animals is subject to some restrictions in different countries, and internationally the concept of farmerfs rights has been accepted under the Commission on Genetic Resources in Food and Agriculture, and the Convention on Biological Diversity. The useful attributes of varieties are the result of long periods of breeding, so the additional insertion of a new gene onto this background is only a further increment to the good characters of the variety. So I might consider a new flower pattern could be patented, and a new property patented, but not a whole flower. The UPOV Convention governs an alternative system of intellectual property called plant variety rights, which allows the breeder to market the crop variety as long as they can provide seed at reasonable price to all. Developing countries are mixed in their reception to intellectual property, for example some countries in Africa support the UPOV Convention, and others want to restrict overase patenting of plant varieties (Masood, 1999).

In the USA the commercialisation of human cells and tissues is generally permissible unless it represents a strong offence to public sensitivity (OTA, 1987). The idea that the human genome sequence should be public trust and therefore not subjected to copyright was also the conclusion of the U.S. National Research Council, and the American Society of Human Genetics. The European Parliament "Human Genome Analysis" program limited contracting parties' commercial gains with the phrase "there shall be no right to exploit on an exclusive basis any property rights in respect of human DNA"

Using a more positive argument, the knowledge gained should be considered as the common property of humanity (Macer, 1991). There is an existing legal concept that things which are of international interest of such a scale should become the cultural property of all humanity. It can be argued that the genome, being common to all people, has shared ownership, is a shared asset, and therefore the maps and sequence should be open to all. Some of the common factors that derive from the shared ownership are that the utilisation must be peaceful, access should be equally open to all while respecting the rights of others, and the common welfare should be promoted.

Biomedical research is performed and funded in many countries. For many years science has not only been the individual pursuit of people with unusual ideas, but rather it involves the funding of research by public or private money, consisting of taxes, charities and business investments. We should not be surprised therefore to hear the justifications for the funding of the project in terms of the business opportunities. All politicians are convinced of the usefulness of funding biotechnology by the opportunity to boost their national biotechnology, the same of almost all science.

Conversely, however, there is an ethical duty to fund science placed on all countries. There are several reasons why research funding should be shared. The basic ethical reason is the principle of justice, that we should all contribute to shared knowledge that we can benefit from. People from every country will be able to benefit from the information, though to different degrees. Many people also believe that the pursuit of knowledge itself is a good, but this is not a ethical reason but a philosophical one, notably the currently popular philosophy of science. There is also the connection between basic research and the standard of University teaching, and if we consider education to be a basic moral good we can claim that to perform research has a positive effect on the teaching standard which may be a more significant benefit in small countries than the direct results of research. Another argument people give to promote research is that of national pride, that people want those of other countries to have a high opinion of their country.

Conclusion

While respect for autonomy suggests some self-interests must be considered for the sake of researchers' autonomy and their future work, most rapid progress will be obtained if data is shared between all researchers. It is unethical by any researcher to withhold information that could provide medical therapy if released. Until now there have been very few medical procedures that have been patented, despite their suitability. Only instruments and products used in diagnosis or treatment have been patented, actual procedures have been left open for all to use free of patent liability in accord with the principle of beneficence. The principle of justice (Rawls, 1971), would argue that new foods, or medical therapy should be available to all at an affordable price, and without discrimination.

Ethically, we can apply the principle of love (Macer, 1998) or beneficence. Does allowing patenting of biotechnology give more benefits than a ban to the most people? Does it work for love of life and the environment, compared to alternatives? The benefits should be in terms of general medical or agricultural development, rather than economic prosperity of one company or country over another. At the same time, love says that no one should be stripped of the respect that others owe to them, and we should work for the benefit of all without ignoring the weak.

Let us reflect further on how a possible further Bioethics Convention could meet the challenges that ethical patenting faces from biotechnology. Despite the acceptance by the European Patent Office of the European Parliamentfs directive on patenting inventions produced through biotechnology, there are ethical issues that require further resolution. The patent situation will also depend upon the relationship between TRIPS, UPOV Convention and the Convention on Biological Diversity, which oversee the international situation.
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