Home Moral guidelines The Ties That Bind: Patenting Embryonic Stem Cell Inventions in India

The Ties That Bind: Patenting Embryonic Stem Cell Inventions in India

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introduction

Stem cells are cells that can differentiate or develop into many different cell types. This unique characteristic makes them of great medical importance as they can unlock 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 (SSC), also called adult stem cells, and embryonic stem cells (ESC). SSCs are undifferentiated cells found throughout our body. They replace dying cells and regenerate or repair damaged tissue. SSCs are multipotent, that is, they can differentiate into specialized cells in a particular lineage. For example, hematopoietic stem cells can differentiate into blood cell types. ESCs are derived from embryos. They are usually isolated from the embryo 3 to 5 days after fertilization. ESCs are pluripotent, that is, they can differentiate into most cell types. There are also other sources or types of stem cells. For example, stem cells can be obtained from the umbilical cord, or by artificially activating an unfertilized egg to behave like an embryo (parthenogenesis), etc.

Stem cell research in India falls within the contours of the government issued Guidelines for Stem Cell Research and Therapy 2017 (Guidelines). Permitted areas of research include establishment of new human ESC lines from supernumerary embryos with prior approval of the Institutional Stem Cell Research Committee and Institutional Ethics Committee and subject to other conditions in the Guidelines. Currently, only hematopoietic stem cell transplantation is approved in India.

Patenting of Stem Cell Based Inventions in India

Stem cells in itself are not patentable in India under the Patents Act 1970 (the Act), due to the exclusions in Section 3(c) (finding of any living being or non-living substances occurring in nature) and the section 3(j) (plants and animals in whole or in part other than micro-organisms).

Stem cell therapies are also not patentable in India, under Article 3(i), which excludes methods of medical or related treatment of humans or animals.

Some Inventions about stem cells, such as new and inventive synergistic compositions, and methods for the preparation, treatment, procurement and differentiation of stem cells may be patentable provided they do not fall under Article 3(b). This provision excludes from patentability inventions the use or commercial exploitation of which could be contrary to public order or morality or harm the health of living organisms or the environment. Article 3(b) derives from Article 27(2) of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). The TRIPS Agreement adds a caveat that such an exclusion from patentability must not be simply because the working of the invention is prohibited by law.

The source of stem cells is a major concern in stem cell-based inventions. Moral and ethical issues arise due to obtaining ESCs from the destruction of embryos. The issues become more complex when commercial logging is added to the mix. The Indian Patent Office (IPO) has had several run-ins with patent applications for stem cell-based inventions. How they fared during the prosecution depended on the plaintiffs demonstrating that the claims did not fall within the various restrictions contained in section 3 of the Act.

When the Indian Patent Application (IPA) 1492/DELNP/2007 was objected to under Section 3(b), the claimant argued that the stem cells were taken from the umbilical cord, usually discarded after birth, which was taken with consent from the mother. The spec also discussed cord collection, and the application was allowed.

APIs 4551/CHENP/2008 originally claimed a method of selecting cardiomyocytes from a cell mixture containing cardiomyocytes and non-cardiomyocytes derived from embryonic stem cells or cells with similar characteristics. To overcome the objection under Article 3(b), a disclaimer was added to the claim that no cells derived from human embryonic stem cells were involved. A similar disclaimer has been added to IPA claims 6526/CHENP/2008. The specifications in both cases taught that the disclosed inventions could work with stem cells obtained without destroying human embryos.

The IPO asked for clarification on the IPA 3649/DELNP/2008whose request was for a in vitro process for producing pluripotent human stem cells, which involved the parthenogenetic activation of an unfertilized human egg. The plaintiff argued that a parthenote was different from an embryo because it was incapable of developing into a viable fetus, and the claim was granted. Here, the decision of the Court of Justice of the European Communities (CJEU) in case C-364/13 on parthenotes was invoked, in which it was held that, in order to qualify as a “human embryo”, a Unfertilized human egg must necessarily have the inherent ability to develop into a human being. The CJEU stated that unfertilized human eggs whose division and further development have been stimulated 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 an ability.

A different fate awaited 3853/KOLNP/2008, which claimed compositions comprising human ESCs, methods of expanding human ESCs, and methods of preparing a ready-to-use preparation of human ESCs. Applicant argued that the invention provides safe and effective human ESC compositions, and Section 3(b) is not appealed. Applicant also argued that the invention could be practiced without destroying a human embryo and that stem cells could be obtained from a cell line or parthenote bank. The controller, however, cited parts of the specifications which suggested the use of ESCs obtained from the destruction of human embryos (the examples of the specifications weighed against the applicant in this case). The Controller further stated that the established or commercially available cell lines used were also necessarily produced by destruction of human embryos, and the application was ultimately denied.

Apply for Stem Cell Inventions in India

The law clearly states that stem cells as such and stem cell therapies are not patentable. For other types of stem cell-based inventions, lawsuits and practice suggest that inventions involving the use of human ESCs obtained by the destruction of human embryos are not patentable in India. The moment at which this 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 an invention related to human CSE, the patent specification must contain at least some embodiments or examples showing that, at the date of filing of the application, the invention can be exploited without destroying human embryos. Documented scientific results accompanied by an affidavit would help demonstrate this. If necessary, it is advisable to amend the claims to add a disclaimer stating that human ESCs obtained from human embryos were not used. The IPO can also insist on requiring the deletion of the paragraphs relating to human ESCs obtained by destruction of human embryos from the specifications.