INTELLECTUAL PROPERTY RIGHTS AND GENE SEQUENCING: PATENTABILITY AND ACCESS TO DATA IN INDIA

INTELLECTUAL PROPERTY AND GENETIC SEQUENCING

Intellectual property rights are the legal privileges bestowed on people or organisations concerning their intellectual property, which include inventions, designs, trademarks, copyrights and trade secrets. Creators and inventors can obtain a competitive edge in the market thanks to these rights, which guarantee exclusive ownership and protection against unauthorised use. Genetic sequencing, which entails the study and decoding of genetic information, is a sector in which IPRs are of utmost importance.[1]

Decoding and analysing DNA, which includes important knowledge about a person’s genetic composition, is the process of genetic sequencing. It has important effects on development, research, and healthcare. Scientists are now better able to comprehend hereditary illnesses and provide specialised treatments because of advances in DNA sequencing technology. It is crucial to safeguard the intellectual property rights connected to this technology since it is a complicated process that necessitates a sizable investment in research and development.[2] However, the confluence of genetic sequencing and intellectual property rights presents significant legal as well as ethical issues.

THE PATENTABILITY OF GENES

The term ‘Patentability’ describes whether or not an innovation qualifies for a patent, which is an exclusive right to prevent others from making, marketing or using an invention for a prescribed period. The capacity to secure a patent for particular gene sequences or associated technology is referred to as patentability in the context of genetic sequencing.[3] The Patents Act, 1970[4] governs the patentability of any innovation in India. However, Section 3 of the provisions of the Act, which includes several matters and innovations that are not considered patentable, including discoveries, scientific ideas, and medical procedures, applies to genetic sequencing as well.[5] Pharmaceuticals are expressly addressed in Section 3(d)[6], which stipulates that the mere discovery of a novel version of a chemical that is already recognised does not qualify for patent protection unless it shows greater effectiveness. Applying this provision to genetic sequencing, it becomes important to determine whether a genetic sequence alone qualifies as patentable subject matter.

India is one of the many members of the World Trade Organisation (WHO) that has ratified the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)[7], which provides a basic foundation for each member nation’s domestic IPR regulations. [8]Article 27[9] of the TRIPS Agreement states that, with some limitations, patents shall be granted without prejudice for inventions in any field of technology.[10] This implies that patents are available for biotechnological inventions. Patenting genes and/or DNA sequences is a prevalent procedure in the US, EU, and Japan. India did not, however, permit the patenting of genes or DNA sequences in general before January 2005.[11] It was, however, patentable subject matter to create proteins utilising recombinant DNA technology and a gene or DNA sequence. Following the third amendment, product patents for DNA, RNA, or genetic innovations became patentable subject matter in January 2005. [12]Additionally, gene/DNA sequence functions that are unknown and have no practical use cannot be considered patentable. Indian Patent No. 243373 (279/MUM/2004), which is awarded to Sichuan Biotechnology Research Centre, is one such instance of a gene patent in India. It provides an artificial gene sequence for generating recombinant super compound interferon with improved action.[13] Further, the Indian Patent Office published the Indian Biotechnology Guidelines[14] in 2013 and the Manual of Patent Office Practise and Procedure in 2005[15] to address the worldwide advancements in biotechnology and their concomitant expansion in the Indian economy.

JUDICIAL PRECEDENT ON PATENTABILITY

Living things or procedures about the creation of a product including them were not patentable in India up until 2002. In the historic case Dimminaco v. Controller of Patents Designs & Others[16], which marked a turning point in the development of the Indian patent system, the Calcutta High Court declared that it was acceptable to patent a method for creating a product that contains live creatures. The judiciary has since occupied a stance that isolated genetic sequences, without any specific utility or application, may not meet the requirements of patentability. The Supreme Court of India interpreted Section 3(c)[17] of the Patent Act and decided about the patentability of the cancer treatment Glivec in the historic case of Novartis AG v. Union of India.[18] The Court ruled that Section 3(d)[19] of the Patent Act’s exclusion of inventions from patentability for lack of an inventive step applied to the simple discovery of a novel form of a known chemical without any improvement in therapeutic effectiveness. This ruling made it clear that additional patentability requirements, such as novelty and inventive steps, must be taken into consideration when interpreting Section 3(c).[20] A court in India has not yet taken into account the patentability of human genes in general. However, due to its overall stance on gene-related IP concerns, the Delhi High Court’s views in Emergent Genetics India v. Shailendra Shivam and Others[21] may be taken into consideration to be informative. The court rejected the plaintiff’s claim of copyright infringement and stated that the genetic sequence was “not an ‘original’ expression of ideas but merely a reproduction of something found in nature” although the decision dealt with, among other things, the copyright about a genetic sequence of hybrid seeds.[22]

ACCESS TO GENETIC DATA FOR RESEARCH AND PUBLIC HEALTH

Access to genetic data for scientific study and public health needs is a building problem, even if intellectual property rights encourage innovation and research. Genetic research in public health offers the potential to prevent, diagnose, and cure a variety of diseases. For this, access to substantial genetic datasets is required. The knowledge of genetic abnormalities, the development of targeted medicines, and the advancement of medical research all depend on genetic information. While genetic information is infrequently used to support a clinical diagnosis, it is increasingly used to assess the risk or susceptibility of developing a certain illness. [23]Strict patent regulations and exclusive ownership of genetic sequences, however, can impede research and restrict access to vital data.

In India, the principles of access to healthcare and public welfare are enshrined in the Constitution and various laws. The National Health Policy, 2017[24] emphasizes the need to promote affordable access to healthcare services, including genetic testing and therapies. In this context, concerns arise about the potential impact of gene patents on the availability, accessibility, and affordability of genetic testing and treatments.

BALANCING PATENT RIGHTS AND PUBLIC INTEREST

The Indian patent law includes several requirements to guarantee access to patented innovations to harmonize intellectual property rights and the public interest. One such clause enables the government to give licences to third parties so they can produce and market patented goods or utilise patented technologies.[25] This clause may be used if the patented innovation is not reasonably priced for the general public if it is not functioning adequately in India, or if the patented genetic sequence is necessary for conducting research, creating diagnoses, or offering treatment. This can make it easier for researchers and the general public to obtain genetic data while still upholding the rights of patent holders.

Apart from legal considerations, ethical aspects surrounding genetic sequencing and data sharing also come into play. While patent holders have rights over their inventions, the sharing of genetic data can lead to collective scientific progress and public health benefits. Encouraging collaborative efforts and open access initiatives can enhance research capabilities, improve understanding of genetic disorders, and foster innovation. It is also found that offering genomics research participants more direct control over who accesses their data can help to reduce concerns with data security and discriminatory practices.[26] When it comes to intellectual property rights, genetic sequencing, and access to genetic data, there are many issues at work in India. Striking a balance between promoting innovation and ensuring access to genetic data is crucial for advancements in science, advances in healthcare, and the welfare of the general population. Even while patentability rules give the legal justification for genetic sequence preservation, it is essential to adopt measures to make it simpler for scientists and the general public to access genetic data. Encouraging ethical data-sharing behaviours and the application of obligatory licencing requirements can help create an environment that benefits both innovators and the general public.

Author(s) Name: Gowri Bipin (Symbiosis Law School, Hyderabad)

References:

[1] David Adams, ‘DNA Sequencing’ (National Human Genome Research Institute, 14 August 2023)

<https://www.genome.gov/genetics-glossary/DNA-Sequencing> accessed 15 July 2023

[2] Ibid

[3] Vijay Pal Dalmia, ‘Patent Law In India – Everything You Must Know’ (Mondaq, 11 June 2015) <https://www.mondaq.com/india/patent/403564/patent-law-in-india—everything-you-must-know> accessed 15 July 2023

[4] Patent Act 1970

[5] Patent Act 1970, s 3

[6] Patent Act 1970, s 3(d)

[7] TRIPS Agreement 1994

[8] Tojo Jose, ‘TRIPs and India’s Intellectual Property Rights Regime’ (IndianEconomy, 19 September 2016) <https://www.indianeconomy.net/splclassroom/trips-and-indias-intellectual-property-rights-regime/> accessed 20 August 2023

[9] TRIPS Agreement 1994, art 27

[10] Ibid

[11] Archana Raghavendra, ‘Gene Patenting: An India Perspective’ (Mondaq, 29 June 2021) InvnTree Intellectual Property Services Pvt. Ltd .<https://www.mondaq.com/india/patent/1085392/gene-patenting-an-india-perspective> accessed 15 July 2023

[12] Malathi Lakshmikumaran, ‘Patenting of Genetic Inventions’ (Manupatra, January 2007) 12 Journal of Intellectual Property Rights 45 <https://docs.manupatra.in/newsline/articles/Upload/28657BF6-ADAE-43AD-A87F-0DBB440B8D75.pdf> accessed 15 July 2023

[13] ‘Patent Laws on Gene & Gene Sequencing’ (IIPRD, 29 August 2020) <https://www.iiprd.com/patent-laws-on-genes-gene-sequencing/> accessed 15 July 2023

[14] Indian Biotechnology Guidelines 2013

[15] Manual of Patent Office Practise and Procedure 2005

[16]Dimminaco A.G. v Controller of Patents and Designs & Others (2001) 1 AID

[17] Patent Act 1970, s 3(c)

[18] Novartis A.G. v Union of India and Others (2013) SC 1311

[19] Patent Act 1970, s 3(d)

[20] Patent Act 1970, s 3(c)

[21]Emergent Genetics India Pvt. Ltd. v Shailendra Shivam and Others (2011) 47 PTC 494 (DEL)

[22] Swarup Kumar, ‘Patenting Genes: How Do India and the US Compare?’ (ISIPR, 17 November 2016)

<http://www.lifesciencesipreview.com/article/patenting-genes-how-do-india-and-the-us-compare> accessed 15 July 2023

[23] Jon F. Merza and Mildred K. Chob, ‘What Are Gene Patents and Why Are People Worried About Them?’ (2005) 8(4) Community Genet <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2220018/> accessed 15 July 2023

[24] National Health Policy 2017

[25] Patent Act 1970

[26] Mariana Amorim and others, ‘Benefits and Risks of Sharing Genomic Data for Research: Comparing the Views of Rare Disease Patients, Informal Carers and Healthcare Professionals’ (National Library of Medicine, 19 July 2022) 19 International Journal of Environmental Research and Public Health <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9319916/> accessed 15 July 2023