At the very outset, it is a crucial imperative to substantially decipher/elucidate the purpose of Human Embryonic Stem Cells (hESC) from a holistic point of view. They are also known as Blastocyst and are taken from human embryos (3-5 days) originating from eggs fertilized at in-vitro clinics/laboratories through pharmaceutical/medicinal intervention. They are induced pluripotent and the most flabbergasting fact is that these cells serve as a glaring therapeutic elixir to generate/develop specialized cells with prophylactic and self-renewal affinity which supersedes/supplants the damaged tissues or organs suffering from degenerative impediments/diseases which the body which has failed to do so by itself. The proliferation of stem cell research and regenerative medicines can indubitably transform the current medical situation and provide effective/speedy remedies for the otherwise conventional cumbersome treatment of incurable coronary diseases like arthritis, Parkinson’s disease, type-1 diabetes, Splenomegaly, Autism, dementia and cancer conducted traditionally. Scientists can convert normal abstract cells into stem cells via genetic reprogramming. They can be found/extricated from (i) the amniotic fluid and umbilical cord blood of the female (perinatal) and also from the heart/brain/muscle/skin/blood/bone marrow cells. Contrary to the erstwhile/prior-existing/conventional clinical treatments that focus 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. Many intricate cellular phenotypes of “hESC” are still under investigation and much more is left to be discovered which can be scientific boons for the benevolence of the human race. The economic/industrial profitability that many pharmaceutical companies want to have is another facet crucial enough to be pondered upon while critically discerning why they bleed/invest billions in R&D and also want to acquire monopoly patent rights over hESC innovations/inventions.
Human Embryonic Stem Cell research operates under the supervisory discretion of National Guidelines for Stem Cell Research and Therapy Guidelines, 2017 brought forward by the Indian Council of Medical Research and Department of Biotechnology and also under the contours laid down by the Institutional Ethics Committee.
The Indian Patents Act, of 1970 governs the patentability criterion of intellectual properties and scientific innovations in India. “hESC” per se doesn’t fall/fit well in light of the contours of qualifications, restrictive provisions, and overall legislative framework of the Act. The same has been iterated for reference as follows:
Section 3(b) of the Act lays down that 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 is excluded from patentability.
Section 3(c) of the Act says that the mere discovery of a scientific principle the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature is precluded from patentability.
Section 3(i) of the Act deters the patentability of any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic, or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.
Section 3(j) of the Act states that plants and animals in whole or any parts thereof other than micro-organisms are to be denied patentability.
Therefore, Section 3 counterpoises the efficacy of emerging medical breakthroughs, and innovations and also fosters benignity towards public interest and far-spread benevolence. It ensures that medical practitioners can continue to traverse treatment endeavors without legal constraints. Inventions and discoveries relating to novel and inventive synergistic compositions and methods of preparing, processing, obtaining, and differentiating stem cells may be patentable provided they’re not deterred by the aforementioned provisions.
The prohibited research areas include human germline gene therapy and reproductive cloning (in-vitro culture of intact human embryos beyond 14 days of fertilization), clinical trials involving transfer of xenogeneic cells into a human host, clinical research on Xenogeneic human hybrids, research involving implantation of human embryos (generated by any means) into uterus after in vitro manipulation, at any stage of development, in humans or primates; breeding of animals in which any type of human stem cells have been introduced at any stage of development, and are likely to contribute to gonadal cells have been listed.
Diamond v. Anand Chakrabarty is the first instance where a patent was granted for a living matter. However, a naturally occurring microorganism cannot be patented. It has to be genetically modified or manipulated. Human intervention is the distinctive factor. In the Re Bergy Case, “biologically pure culture” was considered to be a product of nature and hence patent was granted. Following these two landmark decisions, many patents for stem cell technology have been granted. In many instances such as in, the Association for Molecular Pathology v. Myriad Genetics Inc., the US Supreme Court has held that separating a gene from its surrounding material does not amount to inventive steps hence patent can’t be granted. In Brustle Oliver v. GreenPeace, ESC was declared to be non-patentable on the ground that it violates “Human dignity”. The European Union prohibits patents involving embryo destruction but allows those using parthenogenesis, a process not considered embryo creation.
Murky and contentious moral-ethical implications are strongly wedded/intertwined with hESC research due to the destruction of embryos during hESC derivation. The international jurisdictions are unequivocally on the same page about this matter and sensitize it just as India does. Beholding the future and addressing the mettle, and caliber of hESC liberalization in effectuating expanding human life expectancy/welfare should be in proclivity with Article 21 of the Indian Constitution. The research should not bereft anyone of human dignity and desecrate life standards. Quantum leaping towards a new era of scientific/medical advancement and utilizing its flairs is only possible when all international jurisdictions warmly welcome hESC with open hands and shift their mentality and outlook toward its existence. The nature of the legislative framework concerned should be remodeled and should strive to incentivize patenting hESC innovations. All the nations have to concurrently establish a nexus about the same. To conclude, it is vividly evident that not only is hESC the 21st Century elixir scientifically but also economically, as it has immense potential latent intrinsically in itself that can boost a nation's GDP and contribute to commercial prosperity.
https://docs.manupatra.in/newsline/articles/Upload/9D711203-8218-44EA-AB4D-DEB5F64DE485.pdf
https://www.lexology.com/library/detail.aspx?g=2c392001-c830-49d4-9e1b-9c43ed249926
Research Papers from Mendeley, Google Scholar, Scopus and Springer have been additionally referred for persuasive influence in understanding the subject matter.
