Stem cells are cells that can differentiate or develop into many different types of cells. This unique characteristic grants them great medical significance as they can unravel many secrets about living organisms, diseases, and mortality, and may even be able to treat them.
The two main types of stem cells are: Somatic Stem Cells (SSCs) also known as adult stem cells, and Embryonic Stem Cells (ESCs). SSCs are undifferentiated cells found throughout our bodies. They replace dying cells and regenerate or repair damaged tissues. SSCs are multipotent, i.e., they can differentiate into specialized cells in a particular lineage. For example, hematopoietic stem cells can differentiate into types of blood cells. ESCs are derived from embryos. They are typically isolated from the embryo 3-5 days after fertilization. ESCs are pluripotent, i.e., they can differentiate into most types of cells. There are other sources or types of stem cells as well. For example, stem cells can be obtained from the umbilical cord, or through artificially activating an unfertilised egg to behave like an embryo (parthenogenesis), etc.
Stem cell research in India operates within the contours of the government-issued Guidelines for Stem Cell Research and Therapy of 2017 (Guidelines). Permissible areas of research include establishing new human ESC lines from spare embryos with prior approval from the Institutional Committee for Stem Cell Research and Institutional Ethics Committee and subject to other conditions in the Guidelines. At present, only Hematopoietic Stem Cell Transplantation is approved in India.
Patenting stem cell based inventions in India
Stem cells per se are not patentable in India as per the Patents Act, 1970 (the Act), due to exclusions under Section 3(c) (discovery of any living thing or non-living substances occurring in nature) and Section 3(j) (plants and animals in whole or any part thereof other than micro-organisms).
Stem cell based therapies are also not patentable in India, under Section 3(i), which excludes processes for the medical or related treatment of human beings or animals.
Some inventions relating to stem cells, such as novel and inventive synergistic compositions, and methods of preparing, processing, obtaining, differentiating stem cells may be patentable provided they do not fall under Section 3(b). This provision excludes from patentability inventions whose use or commercial exploitation could be contrary to public order or morality or cause prejudice to the health of living organisms or the environment. Section 3(b) is derived from Article 27(2) of the Agreement on Trade-Related aspects of Intellectual Property (TRIPS). TRIPS adds a caveat that such exclusion from patentability must not be merely because the exploitation of the invention is prohibited by law.
The source of stem cells are of primary concern in stem cell based inventions. Moral and ethical issues emerge due to ESCs being obtained from the destruction of embryos. The issues become more complex when commercial exploitation is added into the mix. The Indian Patent Office (IPO) has had various run-ins with patent applications for stem cell based inventions. How they fare during prosecution has depended upon applicants demonstrating that the applications do not fall within the various restrictions contained in Section 3 of the Act.
When Indian patent application (IPA) 1492/DELNP/2007 was objected to under Section 3(b), the Applicant argued that the stem cells were collected from the umbilical cord, otherwise usually discarded after birth, which was collected with the consent of the mother. The specification also discussed the collection of the cord, and the application was allowed.
IPA 4551/CHENP/2008 originally claimed a method for selecting cardiomyocytes from a cell mixture containing cardiomyocytes and non-cardiomyocytes derived from embryonic stem cells or cells having similar characteristics. To overcome the objection under Section 3(b), a disclaimer was added to the claim that no cells derived from human embryonic stem cells were involved. A similar disclaimer was added to the claims of IPA 6526/CHENP/2008. The specifications in both these cases taught that the disclosed inventions could work with stem cells obtained without the destruction of human embryos.
The IPO sought a clarification about IPA 3649/DELNP/2008, whose claim was directed to an in vitro method for producing pluripotent human stem cells, which involved parthenogenetically activating an unfertilized human egg. The applicant submitted that a parthenote was different from an embryo as it was incapable of developing into a viable fetus, and the application was allowed. Here, the decision of the European Court of Justice (CJEU) in C‑364/13 on parthenotes was relied upon, where it was held that in order to be classified as a 'human embryo', a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being. The CJEU said that unfertilised human ova whose division and further development have been stimulted by parthenogenesis are not included in the term 'human embryos' as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity.
A different fate lay in store for 3853/KOLNP/2008, which claimed compositions comprising human ESCs, methods for expanding human ESCs, and methods for preparing a ready to use preparation of human ESCs. The applicant argued that the invention provided safe and effective human ESC compositions, and that Section 3(b) was not attracted. The applicant also submitted that the invention could be practiced without destroying a human embryo, and that the stem cells could be obtained from a cell line repository or parthenotes. The Controller, however, cited parts of the specification that suggested the use of ESCs obtained from the destruction of human embryos (the examples in the specification worked against the applicant in this case) The Controller further stated that the established or commercially available cell lines used were also necessarily produced by a destruction of human embryos, and the application was eventually refused.
Applying for stem cell based inventions in India
The law is clear that stem cells per se, and stem cell based therapies are not patentable. For the other types of stem cell based inventions, prosecution and practice suggest that inventions involving the use of human ESCs obtained by the destruction of human embryos are not patentable in India. The point in time at which such destruction takes place is irrelevant. Thus, even if an inventor has used established cell lines derived from human embryos, the claims are likely to be rejected.
If an application is filed for a human ESC-related invention, the patent specification should contain at least some embodiments or examples showing that, at the date of filing of the application, the invention could be worked without destroying human embryos. Documented scientific results accompanied by an affidavit would help demonstrate this. If required to do so, it is advisable to amend claims to add a disclaimer that human ESCs obtained from human embryos were not used. The IPO may also insist on requiring the deletion of paragraphs relating to human ESCs obtained by destroying human embryos from the specification.
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