This article is written by Swapna Gokhale who is pursuing a Diploma in Intellectual Property, Media and Entertainment Laws from LawSikho.
As it is rightly said “Just one living cell in the human body is, more complex than New York City.”, by Linus Paulin, the Nobel Prize-Winning Biochemist from the USA. As we are moving towards advancing technologies in medical sciences, there is still a decrease in life expectancy rate. With a surge in number of people rushing in an out of hospitals dealing with multiple physical and mental issues it is a fact that the quality of life is deteriorating over the period of time. According to the National Cancer Institute of USA it is estimated that in 2020, approximately 1,806,590 new cases of cancer will be diagnosed in the United States and 606,520 people will die from the disease.
In a world where such significant number of people are struggling with various diseases including some deadly and still incurable ones, there is a huge need of new advancements in the current medical diagnostic procedures, therapy, pharmaceutical drugs and research. More and more pharmaceutical companies are coming up with unique and advanced methods to cure diseases. Stem cell research and regenerative medicines are one such advancement wherein world’s top pharmaceutical companies like Pfizer, Miltenyi Biotec, AstraZeneca and Mesoblast Limited are conducting researches. Stem cell research, therapy and regenerative medicines are currently considered to be a path-breaking phenomenon in medical sciences. It thus becomes important to understand about their Intellectual Property rights and how these companies can protect their innovations legally.
Stem cells are responsible for the growth and development of human beings. They have the potential to develop into many other different types of cells and recreate functional tissues in the body including organ-specific cells, muscle tissues and bone marrow cells. Unlike other cells in the body, they can divide as well as renew themselves over a long time. They have a potential to become specialized cells. The two types of stem cells are embryonic stem cells and adult stem cells. Due to these unique characteristics, the pharmaceutical companies worldwide are keen to embrace stem cells as tools in drug discovery and are investing their R&D for curing various diseases by introducing various stem cell drugs. As a rapidly growing field, it is estimated that within few years of time stem cells may be used to make tissues that can be used to cure diseases like Alzheimer’s and cancer (as stated in US Library of Medical Sciences).
Unlike the current clinical strategy that focuses on treating the symptoms or curing the dysfunctional tissue or organ, Regenerative Medicines are used to replace organs or tissues that are damaged due to disease or damage by way of cellular therapy, tissue engineering and artificial organs. Regenerative medicines as the name suggests have a capability to induce the regeneration/growth of organs and tissues in laboratory and implant them in the body which has failed to do so by itself. It is a new technique that brings together experts in biology, chemistry, genetics, medicine, and other fields to find solutions to some of the most challenging issues.
As discussed above, the application of stem cell therapy and regenerative medicines can revolutionize the world of medical sciences and the way diseases are cured all over the globe. Other important facet to consider is the economic aspect of this breakthrough researches. Pharmaceutical companies are willing to invest billions of dollars to earn profit and increase the market value of the firm. As per the data collected from US National Library of Medicine and National Institutes of Health, CDI (Cellular Dynamics International) raised $40.6 million to revolutionize pharma drug research with stem cells and similar methodologies. Thus the investment and expected returns in millions of dollars is one of the reason the companies want to have a monopoly on the rights to use their innovations and inventions.
Secondly, the application of stem cell research and regenerative medicines can positively transform the current medical situation, and can change cumbersome treatment relating to diseases such as arthritis, Parkinson’s disease, type-1 diabetes, coronary diseases and even Cancer. It is predicted that stem cell therapies and Regenerative medicines may one day be able to replace organ donation and eliminate the issues that accompany it such as rejection and tissue insufficiency.
A Patent is an exclusive right granted to an inventor or an innovator. In other words, a patent provides a patent owner with the right to decide how the invention can be used by others. Acquisition of patents gives pharmaceutical companies (if they are the original inventors) a monopoly right for their intellectual efforts which are capable of industrial application. Patent protection for drugs and/or other researches ensures that they will earn profit, on billions of dollars which they have invested for inventions by making sure that they will have an exclusive right to commercially exploit the same.
For any invention to be patentable it has to suffice these three basic requirements namely:
- Inventive step;
- Industrial applicability.
If Stem cell therapy and regenerative medicines have all the above-mentioned requirements, the inventor qualifies for acquiring a patent. Section 3 of Patents Act, 1970 lists down what are not inventions for the meaning of this Act. Thus to be qualified as an invention, it should not fall under the realm of Section 3 of this Act. But the problem arises when Section 3(b) of this act is considered which is discussed further.
According to Section 3(b), 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 the environment, are not inventions.
To understand how stem cells fall under the ambit of this section, it is important to know about its sources. As discussed above, the stem cells are of two types: Embryonic stem cells and adult stem cells.
The Embryonic stem cells (i.e. the cells that are self-replicating, are derived from human embryos or human fetal tissue) are obtained from the blastocyst stage of pregnancy (this is the stage where the implantation potential is highest) of the human embryo where embryo is at gestational stage in human birth cycle, which is the recent advancement wherein stem cells are derived from umbilical cord blood and amniotic cell lining which is a biological waste after the delivery of a child.
The sources of adult stem cell are majorly bone marrow, adipose tissue and blood.
As the sources of these stem cells are biological, stem cell research therapy and regenerative medicines becomes a debatable issue and fall under the ambit of section 3(b) of Patents Act, 1990. According to the guidelines issued by the Indian Patent Office, in the 2005 draft, the use of human and animal embryos was stated to be against public order and morality and was prohibited from patentability. However, this prohibition was withdrawn from the subsequent drafts of guidelines and was never included since then. Despite of this, the Patent Office still raises objections under Section 3(b) of the Patents Act. The major and most frequent objection being the possibility of destruction of human embryos.
The National Guidelines for Stem Cell Research (published by ICMR and DBT under the Ministry of Science and Technology) lays down certain conditions subject to which research on stem cell should be conducted. The conditions prescribe affirmation that the blastocysts used are spare (supplementary) embryos. The establishment of new human embryonic stem cell lines from stem embryos subject to certain committees are also included in the guidelines. Thus, the Government guidelines permit safe and responsible stem cell research.
In Europe, the embryonic stem cells are not patentable. As per the Biotechnology Directive (98/44/EC), the patentability of certain inventions are ruled out, including the uses of human embryos for industrial and commercial purposes. Article 6(2)(c) of Directive 98/44 must be interpreted to mean that any human ovum after fertilization, any non-fertilized ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilized human ovum whose division and further development have been stimulated to constitute a ‘human embryo’.
The patenting of stem cells is less restrictive than that in Europe. An invention relating to embryonic stem cell (i.e. pluripotent cells which have the capacity to give rise to every cell type in the fully formed body, but not the placenta and umbilical cord), can be patented as per US Patent Law, regardless of whether such inventions involves the destruction of human embryo.
WARF (Wisconsin Alumni Research Foundation), which is an independent non-profit organization serving the University of Wisconsin-Madison and Morgridge Institute for Research, have obtained multiple patents relating to human embryonic stem cells.
“As time and science move forward, the law struggles to keep pace while, at the same time, resisting change in order to maintain stability.” as it is rightly said in the report, Patentability of Human Embryonic Stem Cells: Finding the balance between the Moral Hazard in Europe and the wide scope in the U.S.”, it is a need of the hour that the Indian Patent Law prescribes clear guidelines on the subject of stem cell research therapy and regenerative medicines.
It can be concluded that in India, there is an absence of judicial precedents in relation to the patentability of stem cell research therapy and regenerative medicines. The Indian Patent Law lacks well-defined guidelines relating to this subject. The current approach currently adopted is debatable as the Indian Patent Office has been following an unwritten code. There is still ambiguity in policymakers and the researchers regarding stem cell research and regenerative medicines, as to whether the stem cell technology should be considered non-ethical and comes under the ambit of Section 3(b) of Patents Act, 1990, vis-à-vis considering the various benefits and advancements it offers for diseases with highest morality rate and most cumbersome treatment procedures. Other countries like US, Belgium, Israel, South Korea and Australia.
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