India: Patentability Of Stem Cell Technology

Stem cell technology is not a new concept having been popular since last decade. Stem cells are auto-generative cells which have the capability of indefinite division. They can easily be maintained in laboratories as cell lines. Since they can divide and differentiate to form different cells of the body, they have vast scope in medical realm with respect to repair and replacement of human tissues and a probable cure for many conventional and non-conventional diseases. There are two kinds of stem cells i.e. embryonic stem cells and adult stem cells.

Embryonic stem cells are obtained from the blastocyst stage of the human embryo, where embryo is a gestational stage in the human birth cycle. Since this extraction unfortunately makes the embryo nonviable1, this technology raises many ethical and moral concerns in the society. However, recent advancements in in-vitro fertilization and ability to derive stem cells from umbilical cord blood and amniotic cell lining2 (a biological waste after delivery of the child) have resolved majority of such issues, thus, accelerating research in the area. Deriving stem cells from umbilical cord blood is deemed more acceptable ethically, and therefore, this process has become very popular in exercising benefits out of stem cell technology. There is high awareness about the preservation of umbilical cord blood among the educated Indians and it has gained popularity with a number of stem cell banks, both public and private, facilitating cryopreservation of stem cells in India.

On the other hand, working with adult stem cells is comparatively easier since the process does not require invasion of the source from which it is taken. Adult stem cells can be obtained mainly through three sources i.e. bone marrow, adipose tissue and blood. Functionality of adult stem cells has been found to be very limited as compared to the functionality of embryonic stem cells. Therefore, majority of the therapeutic researches involve human embryonic cell lines.

Embryonic stem cells are considered to be pluripotent cells i.e. they have the ability to develop into different cell types of the human body. Embryonic cells can even be totipotent if they are obtained from a very young embryo which has undergone only a few cycles of cell division. Such cells, in addition to being pluripotent, have the ability to get differentiated into extraembryonic and placental cells. Adult stem cells have the capability of regenerating only similar or related tissues from which they are derived and therefore, have limited applicability.3 Such cells are known to exhibit multipotent characteristics but have limited scope compared to pluripotent cells.

Application of stem cells lies primarily in utilizing their pluripotent and totipotent characters in repair and replacement of tissues. Technology for making patient specific stem cells, and tissues thereof, has been developed. This ensures the repair and/or replacement offered by such tissues a better probability of getting accepted by the immune system of the body4. This therapeutic aspect of stem cells finds benefit in curing various malignant and non-malignant diseases like diabetes, Parkinson's disease, cancer etc.

Different countries have different countenance about this technology as a breakthrough in medical science. Some countries offer full support to researchers to explore this field to the fullest extent, whereas in some others there are no formal policies resulting in the majority of research being governed by private contributors without the support of the government. The countries' acceptance of this technology shows their clear preference toward therapeutic benefits of stem cells over the concerned ethical issues. Countries supporting this technology include United Kingdom, Belgium, Israel, South Korea, India, Japan, Singapore, China and Australia. Other countries like Germany, Austria and Italy offer stricter policies for stem cell research. Some other countries like United States, Canada, European Union, however have limited opportunities which can be availed only if the research is deemed ethically acceptable.

It is to be noted that the majority of the countries, irrespective of whether they support stem cell research or not, exploit this technology only for therapeutic purposes, while cell cloning is highly restrained being used just for the purpose of research. Most research is carried out ethically by either exploiting the embryos that are deemed to be a waste after in-vitro fertilization, or those embryos that are unwanted or sacrificed; or stem cells derived from umbilical cord blood.

PATENTABILITY OF STEM CELL RESEARCH

Just like policy framework, patentability of this kind of research is also highly varied among different countries. For an invention to be patentable, it should suffice three basic requirements of i) novelty, ii) non-inventiveness and iii) industrial applicability. Invention related to stem cell technology generally qualifies these requirements and becomes a patentable subject matter. The Indian Patents Act (1970) says that an application should also qualify criteria given under section 3, for it to be considered as an invention. Stem cell technology falls under the purview of 3(b) of the Act, according to which 'an invention, the primary or intended use or commercial exploitation of which could be contrary public order or morality or which cause serious prejudice to human, animal or plant life or health or to the environment, are not inventions'.

Whether the stem cell technology should be considered non-ethical or against moral values, vis-à-vis the various benefits it offers to those who do not have any other cure, is a debatable topic, which keeps recurring between the researchers and the policy makers.

As far as India and most of the other countries are concerned, they have voted for technology only in case ethical ways are used to derive embryonic stem cells. These ethical ways, as reported by the researchers, like using human embryos, produced by in-vitro fertilization, aborted fetuses, and asexually produced human embryos for deriving such cells, are not against public order or morality in any way5. India is lucky in a way that the government is supporting researchers in this area for the good of the nation. In addition, nothing has been mentioned in Patents Act (1970) which makes stem cell and related research not patentable. Therefore, stem cell technology is considered patentable, and a good number of patent applications are made every year and several are granted6 to bring in optimistic competition among the researchers.

It will not be wrong to say that stem cell research is a very promising field and can prove to be a boon for biotechnology sector of the country. Research in this field should be encouraged by giving suitable intellectual property rights to such inventions.

Footnotes

1. The Limits of Patentability: Stem Cells. Available at: https://www.researchgate.net/publication/278661138_The_Limits_of_Patentability_Stem_Cells

2. Biological characteristics of stem cells from foetal, cord blood and extraembryonic tissues. Available at: https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC2988276/

3. What is the difference between totipotent, pluripotent, and multipotent? Available at: https://stemcell.ny.gov/faqs/what-difference-between-totipotent-pluripotent-and-multipotent

4. The patentability of stem cells, reforms to patent law. Available at: https://www.lawteacher.net/free-law-essays/medical-law/patent-law-stem-cells.php

5. Patent: Stem Cell Patent Debate Never Dies. Available at: https://www.bananaip.com/ip-news-center/stem-cell-patent-debate-never-dies/

6. ibid

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