Patent on Human Stem Cell: Ethical Issues

AUTHOR'S PROFILE: Suryatanu Dey, student of B.A LL.B (HONS.) with Specialisation in Energy Law, Semester X, School of Law, UPES, DEHRADUN.

STEM CELL RESEARCH- A NEW ERA

Embryonic stem cells of human beings have been the subject of research for a long time because of their versatility like self – renewability. They fall into 3 primary categories:

• Human embryonic stem cells (HESC) are derived from embryos making them non-viable.
• Induced Pluripotent stem cells (IPSC) are derived from adult tissue cells and don’t lead to the destruction of human embryos.
• Human Parthenogenetic stem cells (HPSC) are relatively new developments.

Stem cells from adult human beings can be obtained mainly through three sources i.e., bone marrow, adipose tissue, and blood, and doesn’t involve any ethical issues since there is no destruction involved but the viability of adult stem cells as a research tool has been found to be very limited as compared to that of embryonic stem cells. Therefore, the majority of the therapeutic research involves human embryonic cell lines done to utilize their self-renewable property and develop new cell characteristics in the repair and replacement of tissues and helps in curing various malignant and non-malignant diseases like diabetes, Parkinson’s disease, cancer, etc.

The legal and ethical issues to be considered for each type of stem cell is different and unique in itself as well as the laws of each country governing the subject of patentability of stem cells differ from each other. The therapeutic application of stem cells and their derivatives are unlimited but there are political and moral considerations surrounding the patentability of stem cells and their products.

The approach to stem cell research varies from country to country; some offer full support to researchers to explore this field to its fullest extent, whereas in some others there are no formal policies resulting in the majority of the research being governed by private contributors without the support of the government. The countries’ acceptance of this technology shows their clear preference for the therapeutic benefits of stem cells over the concerning ethical issues.

Countries supporting this technology include the United Kingdom, Belgium, Israel, South Korea, India, Japan, Singapore, China, and Australia; countries like Germany, Austria, and Italy offer stricter policies for stem cell research whereas countries like the United States, Canada, and the European Union, however, have limited opportunities which can be availed only if the research is deemed ethically acceptable. Most research is carried out ethically from stem cells harvested from umbilical cord blood or unsuccessful in-vitro fertilization [i].

PATENTING OF STEM CELLS

The patentability of stem cells differs from country to country. The basic requirements for an invention to become patentable are,

1. Novelty Value
2. Inventiveness and Non-Obviousness
3. Industrial Applicability.

The invention related to stem cell technology generally qualifies these requirements and becomes a patentable subject matter in varying degrees.

PATENTABILITY OF STEM CELLS: THE INTERNATIONAL PERSPECTIVE

In the European Union, patenting of stem cell technology faces resistance on moral and social grounds. Directive 98/44/EC on the Legal Protection of Biotechnological Inventions regulates the legal protection of biotechnological inventions across the EU[ii] known as the Biotech Directive. The Enlarged Board of Appeal (EBOA) of the European Patent Office (EPO) ruled that a product or a process that comes into being by exclusively destroying a human embryo is not patentable. Thus, the definition of the term ‘human embryo’ becomes very important and relevant and was interpreted by the Court of Justice of the European Union in the case of Brustle v. Greenpeace,2011 where it observed that "not only fertilised human ovum but also non-fertilized human ovum whose division and further development had been stimulated by parthenogenesis. Although those organisms have not, strictly spoken been the object of fertilization, due to the effect of the technique used to obtain them, they are as is apparent from the written observations presented to the Court, capable of commencing the process of development of a human being just as an embryo created by fertilization of ovum can do so". When International Stem Cell Corporation (ISCC) applied for two patents where parthenogenesis was used to activate human oocytes but the application was rejected by the UK Patent office citing the Biotech Directive. But this was a new development in stem cell research. On 18th December 2014, the CJEU ruled that the “unfertilized human ovum whose division and further development has been stimulated by parthenogenesis does not constitute a human embryo" [iii]. The narrowing of the definition of the human embryo allowed the patenting of the Human Stem Cell or HPSCs and IPSC as these cells cannot develop into human beings but not HESCs as they will result in the destruction of viable human embryos capable of developing into full-fledged human beings.

Patenting of stem cells is facing serious challenges in the United States Of America but still possesses no “morality” based barrier in comparison to the Europe Union. According to Section 101 of 35 U.S.C “whoever invents or discovers any new and useful process, the machine, manufacturers, or composition of matter, or any new or useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of the title.”But as per the Supreme Court, there are 3 exceptions to Section 101’s broad principles which are Laws of Nature, Physical Phenomena, and Abstract ideas. In the case of Diamond v. Chakraborty, the United States Supreme Court affirmed that just because a subject matter is alive it does not mean its invention cannot be patented[iv] as modern technology can create life and falls under the exceptions of Section 101. But the Leahy – Smith American Invents Act passed in September 2011 and some important Court judgments like the patent of BCRA 1 and BCRA 2 [v] and cell-free DNA have limited the scope of patentability of stem cells in the United States which is the most significant change in Patentability law in the United States In May 2013, the patent eligibility of a subject matter under Section 101 were further redefined by the Supreme Court's verdict on the Myriad Genetics Inc v. Association of Molecular Pathology. It was held that a naturally occurring segment of DNA is natural and cannot be patented just because it has been isolated as it does not constitute an invention and is a mere separation from its surrounding genetic material. On the other hand, cDNA or complementary DNA is synthetically created DNA that does not have any obstacles to patentability. The verdict is also known as the Myriad–Mayo Guidance[vi] which specifically lists organisms like bacteria, plants, and multi-cellular animals but there is no reference to stem cells falling within its purview and so there is no certainty over the application of the guidance to stem cells.

In Australia, Section 18 of the Patent Act, 1990 provides for the same criteria of novelty, usefulness, inventiveness, and “a manner of manufacture” as in other countries. In relation to patent, ‘manufacture’ may be interpreted as a descriptor for the subject matter for which the patent is being applied [vii]. The provisions are general and wide in nature and have to be interpreted in accordance with the technological advancement occurring in this field. The Federal Court Of Australia held in the case of Cancer Voices Australia, 2013 “even if the physical properties of the materials have not changed, the removal of the material from its natural environment and its separation from other cellular components may still give rise to what might reasonably be described as an artificial state of affairs" [viii], However, isolated cells or cell lines can be patented if they can be used for a specific purpose like as a diagnostic tool or for an industrial process.

Section 18(2) explicitly excludes patenting of “human beings and the biological processes for their generations" where the definition of “human being” is ambiguous. IP Australia recognizes "human beings as being in the process of generation from time to time of the process that creates a fertilized ovum up until the time of the birth" [ix]. Hybrids and chimeras are also not patentable as they contain human nuclear DNA and are categorized as human beings. In Australia, stem cell research can be done only by using surplus embryos from assisted reproduction technology with a valid license and is based on adult bone marrow cells that are not controversial.

PATENTABILITY OF STEM CELLS: THE INDIAN CONTEXT

The Indian Patent Act, 1970 stipulates that an invention to be patentable must meet certain criteria given under section 3 which are:

• Absolute Novelty
• Inventive Step
• Non-obviousness
• Industrial Application

But there are limitations prescribed under section 3 of the Act that prohibits patenting under certain conditions. Stem cell technology is categorized u/s 3(b) of the Act, which says “an invention, the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment are not inventions.” There is nothing mentioned in the Patents Act that makes stem cells and related research, not patentable provided ethical ways are used to harvest the stem cells[x]. The Discovery of any living thing occurring in nature is not patentable as there is no invention. Genetically modified multi-cellular organisms also are not patentable in India but microorganisms and microbiological procedures are. Gene sequences and DNA sequences having particular disclosed functions can be patented but methods of medical treatment are prohibited from patenting.

Another objection in stem cell research is under section 3(j) which prohibits from patentability, "plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals". Section 3(c) also bars the patentability of any living thing or non-living object occurring in nature. There is no explanation of what exactly constitutes parts of plants and animals under section 3(j) and any cell or tissue derived from plants and animals is considered a part thereof leading to the refusal of the patent.

In India, the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT) have issued guidelines for stem cell research and therapy in 2007 and has been updating these guidelines from time to time as deemed necessary based on new technological advancement and various breakthrough scientific knowledge in this field. The guidelines were revised in 2013 as the National Guidelines for stem cell research[xi]. The use of stem cells in regenerative medicine has a huge potential to improve human health and well-being. Human embryonic stem cells hold the key to such improvement but cannot be used in research due to moral and ethical reasons. But there is no restriction on the use of pluripotent stem cells derived from sources like bone marrow, and adult blood cells. Stem cell research holds the key to regenerative medicine to treat diseases like Type I diabetes or Parkinson’s disease. At present, ICMR is funding organizations engaged in Human Embryonic stem cell research subject to monitoring by the regulatory board to detect unethical applications and liable for punishments including imprisonment. Many companies are shifting their research back to Malaysia or Singapore because of the lack of a regulatory framework that would be binding for stem cell research.

At present, the status of the embryo is not established under the law. Article 21 of the Constitution of India protects the right to life and states that the killing of a foetus is a crime. The question is whether there would be exceptional cases, cases incorporated to encourage stem cell therapy where the destruction of an embryo for research will be allowed. Presently, HESC can be carried out on surplus embryos or embryos generated specifically for research purposes. The ethical and moral issue of using embryos will always remain as a part of society – the part which will disagree with using embryos for any form of scientific research. India needs to think about the future and cater to the legal framework wherein HESC and research could be conducted without any constraint for the greater good of humanity.

ETHICAL ISSUES IN STEM CELL RESEARCH

Ethics is a term derived from the Greek word Ethos which can mean custom, habit, character, or disposition affecting the behaviour of people. It can be defined as the moral philosophy of society.

Ethically, living beings are creations of nature and cannot be owned by a patent and are vested with the inherent dignity and integrity which is to be protected. Genetic manipulation of organisms and their protection by the system of patents, therefore, raises moral and ethical issues due to developments in Biotechnology. The capability of isolating, removing, suppressing, or incorporating genes from and into a living organism has developed substantially, and patenting of human genetic material like DNA or genes amounts to the trespassing of private property. Research in genetics has made it possible to grow human organs for transplantation to those suffering from organ failure but such research has given rise to serious concerns over ethics. It leads to the destruction of embryos which causes moral and ethical issues as such embryos are capable of developing into complete human beings. This gave rise to global recognition and the Declaration of Human Genome and Human Rights Convention endorsed on 11th November 1997 [xii]. The complexity of stem cell research and its patenting is due to the involvement of many stakeholders and many arenas which include National and International political systems, legal and healthcare systems, research efforts, various views of multiple religious groups, and a basic philosophical understanding of when life begins and the dignity of life.

Research on stem cells and their applications is taking place all over the world and every country has its own moral code and ethics and guidelines are dependent on those parameters.

Micro-organisms and other living inventions produced by the microbiological, non-biological, or biotechnological processes are now patentable. Thus, it is now mandatory for India to grant a patent to inventions through the amendment made to Patent Act, 2005. A patent was granted on a living process on the directive of the Calcutta High Court and was upheld by the Chief Justice in the Supreme Court of India. A process “which promises to mankind the great blessings of science, should not be stifled by too many restrictive approaches"[xiii]. This was a landmark decision by the Court prior to the 2002 amendment to the Patents Act, 1970, and proved to be a benchmark in the field of microbiological research.

In practice in all countries, ethics groups have been established for ascertaining the ethical and moral aspects of stem cell research. The International Bioethics Committee was created in 1993. The ethics groups ensure that human dignity is maintained and no grant of a patent on the human body and integrity in biomedical research. Each and every country has its own ethical groups or committees that oversee the maintenance of ethics in patenting. In India, the Indian Council of Medical Research issued guidelines to evaluate ethics involved in human genetics such as human genome mapping, genetic recombinant engineering, assisted reproduction technology, and stem cell research involving serious ethical questions. Respect is also shown to international ethical guidelines for biomedical research involving human subjects by the Council for International Organisation of Medical Sciences in 1993 and the general principles of the World Medical Association issued in 1994 in The Helsinki Declaration.

CONCLUSION

The benefits of biotechnology cannot be ruled out by anyone but there lacks uniformity in understanding the ethical issues concerning the subject. Such tampering with life may prove beneficial to society at large but it is at the cost of ethics and morality embedded in the Indian culture. Thus, a balancing approach should be followed with respect to ethical concerns and at the same time encourage advanced biotechnological research. But the line of ethics should not undermine the potential benefits of biotechnological research in the interest of society.

In India, the law relating to the patentability of human embryonic stem cells is at a nascent stage as there is a lack of guidelines and judicial precedents. The approach of the Indian Patent Office is not justified as it is important to encourage innovation. While there has been some change in the [1]approach, still there is a need for a clear and well-defined structure so that patents in stem cells can be granted with adherence to moral and ethical considerations for the greater good of mankind.

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REFERENCES

[i] Patent: stem Cell Patent Debate Never Dies: https;//www.bananaip.com/ip-news-center/stem-cell-patent-debate-never-dies

[ii] Interfacing Science, Medicine, and Law: The Stem Cell Patent Controversy in the US AND EU. By Sonya Davey, Neil Davey, Qian Gu, Na Xu, Rajat Vatsa, Samir Devalaraja, Paul Harris, S. Gannavaram, Raj Dave, and Ananda Chakraborty.

[iii] International Stem Cell Corporation V Comptroller of Patents, CJEU,2014

[iv] Diamond Vs Chakraborty,1980,447US 303(1980)

[v] Myriad Genetics Inc vs. Association of Molecular Pathology,2013

[vi] Mayo Collaborative Services Vs Prometheus Laboratories Inc. (132 s cl 1289)

[vii] National Research Development Corporation (NRDC) Vs. Commission of Patents (1959) (102 CLR252, IA IPR 63)

[viii] Cancer Voices Australia Vs Myriad Genetics Inc (2013) (FCA65)

[ix] Fertilitescentrum AB and Luminous Pty Ltd. (2004) (APO19)

[x] Stem Cell: Patentable? Chesta Sharma/www.iipta.com

[xi] India setting out Guidelines for Stem Cell: the pharmaletter.com

[xii] https://en.unesco.org>themes>29 C/17

[xiii] Dimminaco AG v. Controller General of Patents, Designs and Trademark (2002) I.P.L.R 255(Cal)