Stem Cells- A brief
Science has been revolutionizing the field of medicine and transcending the boundaries of disease prevention and cure through some unique and advanced methods and technology. One such promising technology is Stem cell Technology.
Cells are the basic building block of life. The cells differentiate into tissues, tissues into organs, organs into the organ system and further constitute an entire organism. As distinct as these cells are, they have the same origin, i.e. the totipotent cells of a human embryo. The totipotent cells are capable of differentiating into any cell of the body and can form a fully functional embryo.
The embryonic stem cell (ESC) that forms the most imperative component of the stem cell technology is extracted from these totipotent cells from the blastocyst stage (5 days post-fertilization) of the embryo development, before implantation into the uterus, making the embryo non-viable. The Embryonic stem cells are pluripotent, unlike their originator totipotent cells. This implies the ESC can give rise to three primary germ layers. The different specialized cells that make up the human body arise from these three primary germ layers via differentiation. Further, embryonic stem cells have the capability of dividing indefinitely and remain undifferentiated, i.e. they do not specialize into different cells rather remain as stem cells, under certain conditions in-vitro.1
This feature of the ESC can be exploited in maintaining an indefinite cell line. Stem cells find application in curing various diseases such as Parkinson's disease, heart-related diseases, congenital diseases such as autism and also find huge potential in regenerative medicine2.
Despite its immense prospect in the field of curative medicine, stem cell technology has been the pivot of discussion revolving around the beginning of life and the end of science. Therefore, protecting any invention using stem cell technology in India seems to be challenging.
The below passages intend to examine the challenges in the patentability of human stem cells from the Indian Perspective:
Patentability of Human Stem Cells:
In India, in order for an invention to be patentable, it has to satisfy the conditions of Novelty, Inventive step, and Industrial Applicability, as in any other jurisdiction. However, the Indian Patent Law provides additional bar to the patentability of inventions that fall under the imposition of Section 3 of the Patents Act. Therefore, in order to be a patentable invention in India, the inventions should not only be novel, inventive, and industrially applicable but also should not attract any of the provisions laid down in Section of the Patents Act. Having said that, some of the major hurdles faced by an invention pertaining to stem cell technology are Section 3(b), Section 3(c) and Section 3(j) of the Patents Act.
Section 3(b) of the Indian Patent Act
Section 3(b) of the Patents Act bars, "an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment," from patentability.
The invention pertaining to the stem cells may fall under the imposition of Section 3(b) of the Patents Act. It has been observed in various patent applications that the Indian Controllers impose Section 3(b) objections, as soon as it comes to notice that the invention uses embryonic stem cells. An example of such case is given below:
In the Indian Patent granted for Patent application No: 1965/CHENP/2013, the Examiner had raised the objection under Section 3(b), which was traversed by disclaiming that the human stem cell was sourced from foetal lever, embryonic yolk sac. The claims disclosing the source of human stem cell was from bone marrow, thymus and peripheral blood was allowed. One has to also note that stem cells derived from adults do not fall under the imposition of Section 3(b), however, the functionality of the adult stem cell is very less compared to embryonic stem cell3.
The Guidelines for examination of Biotechnology Applications for Patent specify the use of human embryos for commercial exploitation as an example of subject matter barred under Section 3(b).
However, it is to be noted that there are ethical ways of obtaining embryonic stem cells from human embryos such as spare embryos from in-vitro fertilization, aborted foetus termination of pregnancy, from umbellical cord blood4. This has also been substantiated by the National guidelines on Stem Cell Research5, 2017 issued by the ICMR and DBT, Government of India. This also reveals that the Government of India is not against research on embryonic stem cells, in the instance if such cells are derived ethically.
Therefore, while assessing if the subject matter falls under Section 3(b), Indian Controllers may assess if stem cells have been extracted through ethical ways. It would be highly appreciated if the Indian Patent Office issues a guideline or could offer clarity in this regard, consistent with the National guidelines on Stem Cell Research.
Section 3(j) of the Indian Patent Act
Inventions pertaining to stem cell technology (method and product) are usually faced with objection under Section 3(j) citing either the stem cell product is a part of an animal or the method is essentially a biological process.
Section 3(j) of the Patent Act recites the following:
What are not inventions -The following are not inventions within the meaning of this Act, - "Plants and animals in whole or any parts thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production and propagation of plants and animals."
The term "any part thereof" is not defined in the Patents Act, however, the Indian Controllers assume cells or tissues as part of plants and animals and out rightly object them under Section 3(j).
Therefore, claims directed explicitly towards stem cells are deemed to be not patentable as they form the part of animals.
This is also evident from granted Indian Patents bearing the patent application number: 3332/DELNP/2008, 1005/MUMNP/2013, 1777/KOLNP/2014, wherein claims directed towards stems cells were not allowed and only method claims were granted. The Applicants in these cases either deleted the claims directed explicitly to stem cells or amended it to method claims.
However, there are certain exceptional cases. For instance, in the granted Patent bearing the Application Number 1965/CHENP/2013, the Controller of Patents allowed a therapeutic composition comprising of Human Hematopoietic stem cells, human facilitating cells and human T cells though all of them were a part of an animal.
In another granted Patent Application with the Application No: 437/CHENP/2007, the Applicant traversed the objection related to cells derived from primate pluripotent stem cells, by stating that the cells are maintained in pluripotent stage throughout, in vitro conditions, without differentiating, contrary to what is seen in animals. The Applicant asserted that such cells do not exist in animals, and if so existed they differentiate into specialized cells. The cell lines of the aforementioned invention, contrary to this, maintain pluripotent stage indefinitely under suitable conditions and hence not found in animals.
However, in most cases, the Indian Controllers do not allow claims directed towards cells and cellular composition.
In some instances, the Indian Controllers do raise an objection that the method of producing stem cells is essentially a biological process. However, demonstrating that the method is in-vitro should suffice to overcome the objection.
Patentability of induced pluripotent stem cells and Human parthenogenetic stem cells
Section 3(c) of the Indian Patent Act prohibits patenting of any living substance that occurs in nature.
Therefore, apart from the imposition of Section 3(j), stem cells may prima facie fall under Section 3(c) as well.
Stem cells like induced pluripotent stem cells and human parthenogenetic stem cells are produced by human intervention. Induced pluripotent stem cells are derived from adult somatic cells that have their genes reprogrammed to be pluripotent6. They resemble embryonic stem cells. Human parthenogenetic stem cells are derived from unfertilized oozyte7.
There is neither any judicial precedent nor any statutes/ guidelines to determine the patentability of such cells.
However, even if the subject matter overcomes Section 3(c), as they are made by human intervention, they may be still subjected to Section 3(j), much like a transgenic cell.
Way forward:
Having said the above, it is observed that the Indian Patents Act does not provide any strict guidelines for examining inventions particularly pertaining to stem cells technology. However, the Indian Patent Office does allow application for methods of producing/activating/culturing stem cells in -vitro, compositions for modulating stem cells and the likes by examining their individual merits.
Although there is no explicit bar in the Patents Act towards the patentability of stem cells, it is assumed that filing the large number of patent applications directed particularly towards stem cells might put a compulsion on the Indian Patent Office and Government of India to take a restrictive stance, specifically on Section 3(j) of the Patents Act that may lead to further revisions in the Patents Act.
Footnotes
1. National Research Council (US) and Institute of Medicine (US) Committee on the Biological and Biomedical Applications of Stem Cell Research. Stem Cells and the Future of Regenerative Medicine. Washington (DC): National Academies Press (US); 2002. CHAPTER THREE, Embryonic Stem Cells. Available from: https://www.ncbi.nlm.nih.gov/books/NBK223690/
2. Mahla R. S. (2016). Stem Cells Applications in Regenerative Medicine and Disease Therapeutics. International journal of cell biology, 2016, 6940283. https://doi.org/10.1155/2016/6940283
3. Zakrzewski, W., Dobrzynski, M., Szymonowicz, M., & Rybak, Z. (2019). Stem cells: past, present, and future. Stem cell research & therapy, 10(1), 68. https://doi.org/10.1186/s13287-019-1165-5
4. Abdulrazzak, H., Moschidou, D., Jones, G., & Guillot, P. V. (2010). Biological characteristics of stem cells from foetal, cord blood and extraembryonic tissues. Journal of the Royal Society, Interface, 7 Suppl 6(Suppl 6), S689-S706. https://doi.org/10.1098/rsif.2010.0347.focus
5. https://dbtindia.gov.in/sites/default/files/National_Guidelines_StemCellResearch-2017.pdf
6. Ye, L., Swingen, C., & Zhang, J. (2013). Induced pluripotent stem cells and their potential for basic and clinical sciences. Current cardiology reviews, 9(1), 63-72. https://doi.org/10.2174/157340313805076278
7. Semechkin R., Isaev D., Abramihina T., Turovets N., West R., Zogovic-Kapsalis T., Semechkin (2011).Human neural stem cells of parthenogenetic origin , Molecular therapy https://doi.org/10.1016/S1525-0016(16)36672-2
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