Introduction

Over the past few decades, medical science has advanced in leaps and bounds. Today not only can we diagnose genetic disorders in a fetus but we can also treat them inside the womb . However, parallelly lies the reality of designer babies-where the parents ensure that a given embryo has predetermined genes. In fact, in Nov. 25, 2018He Jiankui had used gene editing technologies to create embryos—two of which led to living babies.

Patent have already been granted over techniques that facilitate the process of creating designer babies. A company, 23andMe, a company was granted a patent for a computerized method of matching the genotypic data of the gamete donor with that of the future parent, in order to increase the chance that the future child will have the desired traits .Designer babies are embryos that carry the desired set of genes achieved by gene editing. Gene editing facilitates genetic material to be added, removed or altered in particular locations in the genome.It can be helpful in preventingthe incidence of genetic diseases. Such techniques can modify the cells of the body which can not onlypotentially cure the patients of chronic, lifelong illnesses but also modify the germline identity of human beings, eliminate hereditary diseases in new-born babies and creating resistance to life-threatening conditions for future generations .At the same time, unrestricted gene editing could end up reinforcing already existing beauty standards and marginalising the marginalised. The issue has triggered ethical and legal problems. The scholars have also pointed out that it is “baby shopping” .

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This article attempts to locate the concept of Designer Babies in the patents law and human rights while remaining geographically limited to India. It is divided into three parts. The first part analyses patentability under the Patents Act, 1970. The second part delves into the scope of gene patenting in India. The last part assesses the issue in the light of fundamental rights guaranteed under the Indian Constitution.

Patent Eligibility In The Context Of Designer Babies

The early 1980s witnessed the advent of oncomouse-a cancer-causing gene was introduced in a mouse.

Article 27.2 of the TRIPS Agreement, which provides that Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality.Section 3(b) of the Patents Act, 1970 lays down inventions that are contrary to public order or morality cannot be patented. Public morality is not defined in the Act.InNovartis AG v. Union of India&Ors. the IPAB had denied granting patent to Novartisbecause the high prices of the drug Gleevec made it unaffordable for the common man. The IPAB noted that it would wreak havoc to the lives of poor cancer patients and their families. Thus, proving to be disastrous for the society. The court not only set aside the patent application under Section 3(d) but also acknowledged that owing to the aforesaid detrimental effects under section 3(b) of the Act. In the light of the said case, not everyone can afford designer babies; this creates a barrier between parents who can afford them and who cannot. A barrier that manifests not just in the physical attributes- both looks and health but also creates a race of “perfect” babies. A luxury not everyone will be able to afford.

Furthermore, Article 53(a) of the European Patent Convention, 2000 prohibits patentability of inventions that run against public morality. In furtherance of the provision, rule 28 lays down that processes that modify the germ line genetic identity of human beings or uses of human embryos for industrial/commercial purposes cannot be patented .

Scope Of Gene Editing In Embryos: An Indian Perspective

In India, the only legal framework concerning the genetic editing of embryos isIndian Council for Medical Research’s National Ethical Guidelines for Biomedical and Health Research on Human Participants which prohibits “eugenic genetic engineering for changing/selecting/altering genetic characteristics and creating so called designer babies…” Further, the National Guidelines for Stem Cell Research 2017 (“Guidelines”) published by the ICMR and the Department of Biotechnology, Ministry of Science & Technology lays down guidelines for gene editing or modification, human germ-line engineering and reproductive cloning.

These Guidelines prohibit research related to human germ line gene therapy in the current state of scientific knowledge and understanding. Research involving implantation of human embryos (generated by any means) after in vitro (i.e., outside the body) manipulation, at any stage of development, into uterus in humans or primates is also strictly prohibited. Even the permitted genome modification can only be done through in vitro studiesand requires thorough review by the Institutional Committee for Stem Cell Research, the Institutional Ethics Committee, the Institutional Biosafety Committee, and the Review Committee on Genetic Manipulation. In-vitro studies can only be carried out on spare embryos, germ-line cells or gametes. Further, the genome modified human embryos should not be cultured beyond 14 days of fertilization or formation of the primitive streak, whichever is earlier to ensure that these embryos should not have a possibility of being inserted into the womb. Therefore, any research that would result in creation of designer babies is prohibited by non-mandatory guidelines in India .

From The Lens Of Human Rights

International Instruments such as Universal Declaration on Human Rights (UDHR) of 1948, guarantees freedom and equality in dignity and rights to all human beings . The UNESCO Declaration on Science and the Use of Scientific Knowledge provides that scientific research should respect the dignity of all human beings.The Oviedo Conventionis a framework convention aiming at protecting the dignity and identity of all human beings with regard to the application of biology and medicine.

The Oviedo Convention Article 13 of the Oviedo Convention prohibits any intervention which aims to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.It therefore establishes two key principles. As such, the wording of Article 13 can be interpreted as giving sufficient room for basic research into preventive, diagnostic or therapeutic purposes. Nevertheless, it should also be borne in mind that the explanatory report to the Convention refers explicitly to the need to “protect the dignity and identity of all human beings”, underpinned by the guiding principle of the primacy of the human being.81 Although the Oviedo Convention is the only international legal instrument that explicitly addresses heritable genetic modification.

The Oviedo Convention is relevant here because countries such as UK and Germany, have considered it in framing their nationallaws pertaining to biomedicine such as its application in genetics.The language of the Oviedo Conventionprioritises human rights and human dignity over the interests of scientific endeavour and technological needs.This emphasis on human rights and human dignity is consistent with Article 3 of the EU Charter of Fundamental Rights, which protects the right to respect for a person’s physical and mental integrity.

The Charter provides that there must be free and informed consent of the person concerned, according to the procedures laid down by law. It prohibits eugenic practices aimed at selecting persons or making the human body and parts thereof a source of financial gain; andthe reproductive cloning of human beings. In the case of designer babies, genetic modifications are made in a future child who cannot consent to it.

Conclusion

With the advent of designer babies, we are aiming to create pre-programmed “perfect” people. If not delimited, it can have catastrophic consequences. Patenting of technologies that facilitate creating designer babies would only incentivize potential inventors. Thus, resulting in human embryos being treated as commodities. This would lead to a world where the ones who cannot afford this technology, they would be left behind in almost all walks of life.

Stereotypes would be reinforced. The cultural barrier would widen- discrimination would exacerbate. We would set up an Orwellian world.The grant of patent aims at giving exclusive rights to the patentee as a reward for fruits of one’s labour. It comes with a time period of 20 years and is always granted in lieu of disclosure. So that others can improve upon it and technology continues to progress.Thus, granting of patent to the genetic modifications in the context of designer babies would not only run contrary to public order and morality under Section 3(b) of the Patents Act, 1970 but also defeat the very purpose of granting intellectual property rights. Using this technology at its full potential will be detrimental to the society at large. With great power comes great responsibility.

Author : Tanvi Tanu, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.

Footnotes

https://www.ucsf.edu/news/2022/11/424166/fetal-therapy-offers-hope-patients-rare-genetic-disorders

2.https://www.cambridge.org/core/journals/cambridge-quarterly-of-healthcare-ethics/article/abs/in-vitro-gametogenesis-and-the-creation-of-designer-babies/234B66F8065CCCF626863A8B36120D7F

3https://library.oapen.org/bitstream/handle/20.500.12657/51469/9783030831141.pdf?sequence=1#page=113

4.https://www.cambridge.org/core/journals/cambridge-quarterly-of-healthcare-ethics/article/abs/in-vitro-gametogenesis-and-the-creation-of-designer-babies/234B66F8065CCCF626863A8B36120D7F

5.https://s3.amazonaws.com/documents.lexology.com/9a2ad351-7f85-4b3a-a3b7-4ffdbbc17840.pdf?AWSAccessKeyId=AKIAVYILUYJ754JTDY6T&Expires=1691147465&Signature=1L2Aq9zQXT%2FimAtxJymHqHK6RJo%3D.

6. The Patents Act, 1970.

7. Ibid.

8. M.P. No. 1 to 5 /2007 in TA/1 to 5 /2007/PT/CH. (IPAB).

9. http://www.nishithdesai.com/fileadmin/user_upload/pdfs/Research_Papers/Designer_Babies.pdf.

10. Article 1 of Universal Declaration on Human Rights, 1948