Everyday a lot of new intellectual properties (IP) in biomedicine and biotechnology are flooding into to our world. Although many such IPs are free and available to the public, majority of such IPs have commercial values to human health and our routine life, and the owners of the IPs are frequently adopting different approaches such as trade secrets, trademarks or service marks, copyrights and patents to protect their ownership and distribution rights over their IPs. In biomedicine and biotechnology, IPs include not only biomaterials, and bioprocesses and devices to produce such biomaterials, but also ideas and the expression of ideas 13. In the past, patenting of IPs in biomedicine and biotechnology have drawn a lot of criticisms and debates 3-6,8,9,11,18,20,22-24,27,29-31,33,36,38-40,44,46-50,55,56,58,59,67,69-72,75,76,78.
In present paper, my discussion will be focused on the ethical analysis of the rights and patents of major IPs types such as genetically engineered plants/animals, stem cells, therapeutic genes/proteins, antibodies and vaccines.
Intellectual Property Types and Rights in Biomedicine & Biotechnology
1. Biomedical and Biotechnological Intellectual Property Types
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As is well know, an intellectual property or IP is a unique product or a creation of human mind/intellect with certain amount of commercial value. In the fields of biomedicine and biotechnology, intellectual properties are mainly intangible assets of discoveries, inventions, designs, and ideas 12,13,30,33,62,73. Biomedical and biotechnological discoveries, inventions, and the related designs and ideas can be classified into 3 major types or categories of intellectual properties as follows:
Biomedical and Biotechnological Materials. These may be genetically engineered organisms such as transgenic plants 37,38,77, transgenic animals 21,28,60, genetically engineered viruses, bacteria or yeast 26,41,42,61,64; some tissues or organs of a living organism 5,67; some type of cells or cell lines 7,32,39,45,51,57; special molecules from the cells of a living organism such as proteins and genes 14,17,25,35,65; or products like antibodies and recombinant proteins made by an organism or cultured cells or microorganisms 26,37.
Bioprocesses. These may be any processes adopted to produce any products - such as the biomedical and biotechnological materials as described above, which are useful to human health or our routine life. For example, a unique process to make high effective human insulin for human type-1 diabetes, a unique process to produce a genetically modified viral vaccine against severe acute respiratory syndrome (SARS) 64, and a unique process to do genetic testing (test genes/mutations) for cystic fibrosis, maturity-onset diabetes of the young, long QT syndrome, and hereditary breast cancer 50.
Biomedical and Biotechnological Devices. These may be any specific devices that may be used in healthcare, industry, scientific research or our routine life; or devices used to produce the biomedical and biotechnological materials as described above. For example, a special fermentation device to produce insulin by cultured bacteria, an automatic insulin pump embedded subcutaneously for delivering insulin in diabetic patients, and the MedPulser Electroporation Therapy System for treating cancers1.
2. Biomedical and Biotechnological Intellectual Property Rights
It is well established that just like a tangible property, the owner of an intelletual property or IP has the exclusive rights to control the use of the IP; the exclusive rights to make profit from the IP by renting, selling, transfering, and/or exchanging it; the exclusive rights to destroy the IP; and most critically the exclusive rights to exclude others from doing these same actions involved with the IP.
An owner of a biomedical or biotechnological IP has all such rights of a regular IP as described above. However, such rights can be further classified into two types: leagally protected rights (i.e., legal rights) and legally unprotected rights (i.e. non-legal rights). This is because in the fields of biomedicine and biotechnology, two major forms of intangible assets exist - legal intangibles (such as a special design or formula to make a medicine for treating HIV/AIDS, a copyrighted publication, or a patented insulin pump), and competitive intangibles (such as knowledge activities or know-hows, collaboration activities, leverage activities, or structural activities - which may impact a biomaedical or biotechnological company's effectiveness, productivity, wastage, costs, revenues, customer service, satisfaction, market value to produce a useful product). Legal intangibles are undoutedly considered IPs or intellectual properties with legal IP rights - defensible in a court of law. However it is a controversy whether or not competitive intangibles should be treated or regarded as intellectual property with legal rights - some people believe that they should be considered as IPs while others not - thus with or without legal IP rights. For example, Kowalski et al 38 believed that IP rights involved in a genetically engineered crop such as rice plant, may include: (a) patent rights; (b) rights of plant variety protection certificates; (c) rights of unpublished patent applications; and (d) any inventions, improvements, and/or discoveries that may or may not be legally protectable, including know-how, trade secrets, research plans and priorities, research results and related reports, statistical models and computer programs and related reports, and market interests and product ideas.
Approaches of Protecting Intellectual Property in Biomedicine & Biotechnology
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IP impinges on almost everything scientists in biomedicine or biotechnology do. As scientists are paid to come up with ideas and aspire to patent and/or publish their work, the protection of ideas, inventions, discoveries, designs or written works especially should be of interest and concern to all 13. Although many owners (an individual scientist or a group of scientists or an organization or a group of organizations) of an invention, discovery, design, or idea in biomedicine and biotechnological fields choose to let the public directly use their IPs, some others, like the owners of IPs in fields of music industry and movie industry, may choose to legally protect their IPs with different purposes. Currently all 4 approaches have been used for protecting IPs in biomedicine and biotechnology area: patents, copyrights, trademarks/service marks, and trade secrets. A patent provides legal protection for a new invention, an application of a new idea, discovery, or concept that is useful 13. Copyright provides legal protection from copying for any creative work, as well as business and scientific publications, computer software, and compilations of information 13. A trademark or service mark provides rights to use symbols, particular words, logos, or other markings that indicate the source of a product or service 13. A further method of benefiting from an invention is simply to keep it secret, rather than to disclose it - a trade secret 13.
Ethics of Protecting Biomedical and Biotechnological Intellectual Property by Patents
The range of intellectual properties is very big, and patent protection is widely used in biomedicine and biotechnology. Therefore, I will focus my discussion on the ethics of patent protection of intellectual properties of the following hot areas: Genetically engineered plants/animals, stem cells, therapeutic genes/proteins, antibodies and vaccines using the workable ethic theories -Kantianism, Act/Rule Utilitarianism and Social Contract Theory.
A. Critical Ethical Issues Derived from Patenting Some Hot Biomedical and Biotechnological IPs
1. Genetically engineered organism (plants or animals)
Genetically engineered (GE) organism has special usage in our society and human life. Examples of GE plants are: (1) Planting resistant cultivars is the most effective and economical way to control plant virus diseases while a few genetically engineered (GE) virus resistant (VR) crops have been released in developed countries for cultivation (Note: plant viruses cause severe crop losses worldwide, conventional control strategies, such as cultural methods and biocide applications against arthropod, nematode, and plasmodiophorid vectors, have limited success at mitigating the impact of plant viruses) 54; and (2) Significant potential advantages are associated with the production of vaccines in transgenic plants by the collaborative efforts of both agricultural biotechnology sector and pharmaceutical sector although no commercial product has been produced yet on the market 37. An example of GE animal is promising - transgenic animals as bioreactors to produce the need-growing therapeutic recombinant proteins (Note: The ability of transgenic animals to produce complex, biologically active recombinant proteins in an efficient and economic manner has stimulated a great deal of interest in this area. As a result, genetically modified animals of several species, expressing foreign proteins in various tissues, are currently being developed.) 21.
Shall we patent GE organisms? Many countries have granted patents for GE organisms while some other countries still prevent patenting such organisms. Therefore, the most critical ethical issue regarding GE organism is: Is it right or wrong to protect the IP - GE organism by patenting?
2. Stem Cells
Stem cells have potential therapeutic usage in effectively treating human cancer and human degenerative diseases such as Alzheimer's disease (AD), Parkinson's disease (PD) and Age-Related Macular Degeneration (AMD). For example, human stem cells have become particularly attractive candidates not only to replace damaged tissue in degenerative pathologies, but also to deliver therapeutic molecules in patients with disseminated metastatic cancer, and across the worldwide there have been over 200 patent applications involving human and non-human stem cells - over one third of all stem cell applications and one quarter of all embryonic stem cell applications have been granted (Note: Over the last decade, improvements in cancer therapies have prolonged the lives of cancer patients. Despite dramatic advances in imaging technology, surgical techniques, and adjuvant radio- and chemotherapy, the overall prognosis of this disease remains dismal. In light of this, there is an urgent need for the development of more effective therapies that can target residual disseminated tumor burden. Given the heterogeneity of tumors in general, no one strategy is likely to provide a satisfactory treatment regimen. Until the middle of the 20th century, medical treatments were limited to options like drugs, surgery, antibiotics, and radiation.) 45.
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The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison's intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for ethical reasons 10,15,19. The controversy leads to the critical ethical issue here: Is it right or wrong to patent the IP - stem cells?
3. Therapeutic Genes and Proteins
Therapeutic genes and proteins are those genes and proteins that can be used to treat or cure some specific diseases. One example of therapeutic gene is the cystic fibrosis (CF) transmembrane conductance regulator gene (CFTR), which can be engineered into a vector such as AAV to construct the AAV-CFTR vector system for the possible treatment of CF by gene therapy 66. One example of therapeutic protein is insulin, which can be used to treat type-1 diabetes 74.
Although many countries have granted the patenting of therapeutic genes and proteins, many people still believe that genes or DNAs or proteins should not be patented 9,34,43,74. Therefore, the most critical ethical issue regarding therapeutic genes and proteins: Is it right or wrong to patent therapeutic genes and proteins?
4. Antibodies and Vaccines
Antibodies are immunoglobulin proteins that can react with their corresponding specific antigens while vaccines are specific antigens or immunogens that can induce humans or animals to produce specific antibodies and associated immunity. Both antibodies and vaccines have widely used in scientific research involved with living things, and many existing antibodies and vaccines have been widely used in diagnosing, treating and preventing diseases of living organisms. One example of antibody used in human healthcare is the antibody of HIV, which is used widely to help diagnose AIDS and the pathogen type involved. One example of vaccine used to prevent or even eradicate human diseases is poliovirus vaccine, which has caused almost 100% eradication of human polio disease pandemic or endemic.
A large number of antibodies and vaccines have been granted patenting in the past decades while some people may believe that they should not be patented because of blocking the access by patients that are poor and in bad need of them 2,18,26,32,35,52.. Therefore, the ethical issue regarding antibodies and vaccines still exists: Is it right or wrong to patent antibody and vaccine?
B. Solving the Critical Ethical Issues Derived from Patenting Hot Biomedical and Biotechnological IPs by Analysis Using Workable Ethical Theories
1. Analysis Using Kantianism
Over the past twenty decades, many patents have been claimed in the areas of genes, gene products like native or recombinant proteins, stem cells, vaccines and antibodies, engineered crop species and animals as well as the technical processes or devices to engineer them 16,68,71. Such patent-debatable biomedical and biotechnological products are not human being per se. In other words, patenting genetically engineered plants, animals, stem cells, therapeutic genes and proteins, antibodies and vaccines are not associated with treating people as "products", or treating people as means to an end. On the contrary, patenting such creative and useful bio-products will benefit everyone in our society, i.e., it treat others as ends like treating ourselves in our society (Note: this fits into the second Categorical Imperative of Kantianism). Therefore, from the perspective of Kantianism, it is ethically correct to patent biomaterials such as genetically engineered organisms (except human per se), stem cells, therapeutic genes and proteins, antibodies and vaccines.
2. Analysis Using (Act & Rule) Utilitarianism
Resnik in his paper of 2003 had evaluated the potential benefits and harms of DNA patenting for biomedical research and medical practice 56. He concluded that, all things considered, the benefits of patenting DNA outweigh the harms, although societies should adopt policies designed to prevent or mitigate the harms associated with patenting - some of these policies include: (1) reinforcing the research exemption for academic researchers, (2) raising the "bar" for the criteria of patentability, (3) restricting the scope of patents, (4) disclosing conflicts of interest related to DNA patents, (5) sharing the economic benefits of patenting with patients, and (6) providing insurance coverage for some types of genetic tests 56. Therefore, from the Utilitarianism point of view, it is right to patent therapeutic gene and gene products (proteins and antibodies, etc).
Resnik in his paper of 2002 55 argued that it costs a great deal of money to do research, to develop new products, and to implement therapies involved human embryonic stem (ES) cells; and private companies, researchers, and health professionals require returns on investments and reimbursements for goods and services of human embryonic stem cells. He held or defended the following points: (1) It should be legal to buy and sell ES cells and products. (2) It should be legal to patent ES cells, products, and related technologies. (3) It should not be legal to buy, sell, or patent human embryos. (4) Patents on ES cells, products, and related technologies should not be excessively broad. (5) Patents on ES cells, products, and related technologies should be granted only when applicants state definite, plausible uses for their inventions. (6) There should be a research exemption in ES cell patenting to allow academic scientists to conduct research in regenerative medicine. (7) It may be appropriate to take steps to prevent companies from using patents in ES cells, products, and related technologies only to block competitors. (8) As the field of regenerative medicine continues to develop, societies should revisit issues relating to property rights on a continuing basis in order to develop policies and develop regulations to maximize the social, medical, economic, and scientific benefits of ES cell research and product development 55. Therefore, from the Utilitarianism perspective, it is right to patent therapeutic stem cells including embryonic stem cells for regenerative medicine.
Radder in his paper of 2004 discussed the patentability of genes of plants, animals, or humans and of genetically modified (parts of) living organisms 53. He argued that (1) patents of genetically engineered organisms (animals and plants) or their genes are legitimate because they promote socially useful innovation but it may also hamper rather than promote such innovation; (2) product patents are not adequately based on actual technological inventions, as they should be according to the usual criteria of patentability, and product patents tend to reward patentees for inventions they have not really made available 53. However, he failed to weigh the total benefits and harms of patenting genetically engineered animals/plants or their genes. If we add the benefits brought to the whole world, whether to our routine life or healthcare, by genetically engineered plants or animals, the total benefits will outweigh its harms. Therefore, from the Utilitarianism point of view, it is right to patent genetically engineered animals, plants and genes.
In addition, past decades of patenting therapeutic genes and proteins, vaccines, antibodies, stem cells, and engineered crop species and animals, etc., have demonstrated that such patenting has more benefits than harms to our society. Therefore, from the point of Utilitarianism, it is ethically correct to patent such biomedical and biotechnological materials.
3. Analysis Using Social Contract Theory
Shrader-Frechette (2005) argued that patents of genetically engineered seeds (GES) are reasonable, but many patent policies are not - he outlined John Locke's classic account of property rights, and argued that current patent policies must be revised to take account of Lockean ethical constraints 63. Everyone in our society have the moral rights to better life and healthcare but require the society to provide the resources. Patenting genetically engineered animals/plants, stem cells, therapeutic genes/proteins, and antibodies/vaccines, will greatly provide more such resources for such better life or healthcare rights. Therefore, from the Social Contract Theory perspective, it is ethically right to patent these biomedical and biotechnological products.
Taken together, the above analysis using Kantianism, Utilitarianism and Social Contract Theory has helped us to solve the critical ethical issues derived from patenting some critical biological and biomedical products. That is, Kantianism Utilitarianism, and Social Contract Theory all told us that: It is a ethically right action to patent genetically engineered organisms (plants and animals but not humans per se), stem cells, therapeutic genes and proteins, and antibodies and vaccines.