Patentability Of CRISPR, Gene-Editing Technology - Legal And Ethical Considerations

Author: LawSphereX

Category: Technology, Cyber & Privacy

Published: 2026-08-23T20:43:35.204774+00:00

Updated: 2026-08-26T17:10:12.229+00:00

PATENTABILITY OF CRISPR, GENE-EDITING

TECHNOLOGY: LEGAL AND ETHICAL CONSIDERATIONS

M Prachi, CHRIST (Deemed to be University), Bengaluru, Karnataka, India

ABSTRACT

Gene Editing Technologies (GET) have been on a widespread increase over the recent years, especially with the advent of the CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) editing technology. The CRISPR technology provides for genetic modifications of micro-organisms, animals, plants and humans, thereby resulting in a completely new gene. The absence of effective regulatory framework both legally and ethically, poses a threat to use this technology for the purpose of gene editing. Thus, the present article shall deal specifically with GET pertaining to human genes, and the legal framework regulating its patentability in India.

Moreover, India ratified the Trade Related Aspects of Intellectual Property Rights (TRIPS)(Amendment) Agreement, 2005 in 1995 and hence, India had to formulate domestic legislations for all intellectual property rights matters, including Patents. Thus, in order to understand the patenting position from an international standpoint, an analysis is drawn with other nations to understand the position of GET. Hence, a doctrinal research methodology is undertaken to present the following article on patentability of Gene Editing Technologies in Human Genes.

INTRODUCTION

Gene editing technology, particularly CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), represents a groundbreaking advancement in biotechnology with profound implications for medicine, agriculture, and various other industries. Its ability to precisely alter DNA sequences has garnered global attention, but it also raises significant legal and ethical challenges, particularly concerning its patentability. This research paper seeks to explore the patentability of CRISPR technology in the context of four major jurisdictions: India, the United States, the European Union, and China. Patent laws vary significantly across these regions, creating complexities for innovators and stakeholders seeking to protect their intellectual property.

The United States and Europe have been at the forefront of the CRISPR patent battle, with key legal disputes between institutions like the Broad Institute and the University of California. These cases highlight the differing criteria for patent eligibility, including issues related to novelty, inventiveness, and the utility of the technology. 1 In India, patentability of biotechnological inventions like CRISPR faces additional challenges due to the restrictive nature of the Indian Patent Act, particularly with respect to living organisms and genetic materials2. Similarly, China has evolving patent regimes that offers unique perspectives on biotechnological patents, shaped by its legal framework and national priorities.

3 This paper aims to provide a comparative analysis of CRISPR’s patentability across these four jurisdictions, identifying key legal precedents, regulatory challenges, and potential future trends. By examining both the similarities and divergences in patent laws, the paper will contribute to a deeper understanding of how intellectual property rights in gene editing technologies are shaped globally, and the impact these differences have on innovation, research, and commercialization efforts.

UNDERSTANDING CRISPR AND ITS APPLICATIONS

Genome editing technologies like CRISPR/Cas9 enable precise DNA modifications across all species. They offer vast potential for developing disease-resistant microorganisms, plants, and animals, and humans paving the way for improved agricultural, medical, and industrial

1 Broad Inst., Inc. v. Regents of the Univ. of Cal., 940 F.3d 1342 (Fed. Cir. 2019).

2 Anindya Chatterjee, Patentability of Biotech Inventions in India: Challenges and Prospects, 25 J. Intell. Prop. Rts. 201 (2020). 3 A. Loke & J. Zhao, Patent Protection of CRISPR Technology in China and Japan: A Comparative Study, Asian J. Biotech. (2017).

advancements. 4 CRISPR-Cas9, derived from the bacterial immune system, enables precise genome editing. Bacteria use CRISPR arrays to store viral DNA snippets, allowing them to recognize and disable future attacks via the Cas9 enzyme. Scientists harness this system by designing guide RNA to target specific DNA sequences, directing Cas9 to cut and modify genes. This breakthrough allows precise DNA alterations and has potential applications in treating genetic disorders like cystic fibrosis, haemophilia, and sickle cell anaemia. CRISPR- Cas9 is also being explored for complex diseases such as cancer and HIV. 5 Thus, though gene editing might have a lot of advantages and benefits that come along with it, it also attracts a number of legal and ethical complications and irreversible changes that might be harmful to such edited gene and the future generations following therefrom.

These, legal and ethical implications shall also be dealt with in the present article.

PATENTABILITY UNDER TRIPS AGREEMENT

The Trade Related Aspects of Intellectual Property Rights Agreement, (TRIPS Agreement), 1994, administered by the World Trade Organisation, has been signed by 166 countries and is one of the most prominent treaties regulating intellectual property rights. Thus, its purpose is to provide minimum standards for protecting and enforcing intellectual property rights, including patent rights, in order to maintain uniformity amongst nations. In furtherance of the above Agreement, Article 2 of the TRIPS Agreement states that the member countries shall be governed by provisions of the Paris Convention as well. The Paris Convention, though being an International Convention binding on many nations, it was not very effective for Patents, since it did not provide for minimum standards required for patentable subject matter.

Further, many countries disputed as to what accounted for a patentable subject matter, since biotechnology and pharmaceuticals were not considered patentable by many developing countries. This disagreement by developing countries resulted in a round of negotiations to amend the Paris Convention. Thus, as an effect of these negotiations, minimum standards were set forth in the TRIPS Agreement which prohibited countries from denying Patent Rights in the field of biotechnology and pharmaceuticals. These standards come with certain restrictions 4 M. N. Karagyaur et al. , Ethical and Legal Aspects of Using Genome Editing Technologies in Medicine, 11 STM

118 (2019).

5 Duncan Matthews, Access to CRISPR Genome Editing Technologies: Patents, Human Rights and the Public Interest, in Access to Medicines and Vaccines 112 (C.M. Correa & R.M. Hilty eds., 2022).

placed on medical treatments and inventions which are considered as immoral and against ‘ordre public’, thereby denying them Patent protection. 6 Article 27. 2 of the TRIPS Agreement provides for two conditions as to when member countries may exclude inventions for being patentable. The first condition being ‘ordre public’ and the second, being ‘morality’. It states that, if any member country, for the purpose of preventing commercial exploitation may exclude patentability of inventions on the ground of protecting ‘ordre public’ or ‘morality’. 7 ‘Ordre public’, which is a French word, basically means ‘public order’ in English. Thus, any invention which the member countries believe might affect public order, thereby threatening the social structures of a civil society, the member country may exclude such invention from being patented.

Further, ‘morality’ refers to upholding the moral principles of that country, and thus, different cultures and norms, might have different understanding of what constitutes as an immoral invention. Thus, in order to protect that ‘morality’ of their country, member countries may exclude inventions from being patentable if they are considered to be immoral by that country. 8 The TRIPS Agreement currently has 166 member countries as signatories. To comprehensively assess the patentability of GET across these nations, the author will analyse and evaluate the domestic patent laws of four key jurisdictions: the United States of America, the European Union, China, and India. This comparative approach will provide valuable insights into how different legal frameworks regulate and protect innovations in genome editing.

PATENTABILITY OF CRISPR IN DIFFERENT JURISDICTIONS

I.

United States of America The United States Patent and Trademark Office (USPTO) allows patents on CRISPR-Cas9 under 35 U.S.C. § 101 provided that the invention is novel, non-obvious, and industrially applicable.9 The Broad Institute and the University of California, Berkeley, have engaged in 6 Jessica Wachowicz, The Patentability of Gene Editing Technologies such as CRISPR & the Harmonization of Laws Relating to Germline Editing, 10 Intell. Prop. Brief 37, 38 (2019). 7 Agreement on Trade-Related Aspects of Intellectual Property Rights, art. 27.2, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299. 8 Jessica Wachowicz, The Patentability of Gene Editing Technologies such as CRISPR & the Harmonization of Laws Relating to Germline Editing, 10 Intell. Prop. Brief 41 (2019).

9 35 U.S.C. § 101 (2012).

high-profile patent wars regarding CRISPR, particularly its use in eukaryotic cells. 10 While somatic cell gene editing is patentable and permitted for therapeutic use, germline gene editing, which includes modifications heritable to offspring, is faced with substantial regulatory hurdles. The FDA forbids federal funding of germline genome editing research under the Rider to the Appropriations Act, except for its clinical use. 11 Moreover, ethical concerns are encountered under deliberations in public policy, with critics arguing that human enhancement uses can be sources of socioeconomic inequalities. In spite of these regulatory hurdles, U. S. patent law does not exclude germline modifications in general from patentability, so CRISPRbased human germline editing patents are still a possibility, although with commercialization still restricted.

12 The America Invents Act, 2011 also impacts CRISPR patent wars, as it introduced a first-to-file system, and priority of invention became a main concern in court cases. Thus, while CRISPR patents are a legal possibility in the U. S. , ethical and regulatory hurdles restrict its use in human germline editing. II.

European Union European Patent Convention (EPC) and Directive 98/44/EC on Biotechnological Inventions govern CRISPR patentability in the European Union (EU). While CRISPR is largely patentable in the United States, the EU restricts human gene editing patents, particularly on the germline edits. The EPC Article 53(a) clearly avows that the patents on ‘ordre public’ or morality inventions against them are prohibited and do not allow the patents on methods of altering human genome. 13 In addition, Rule 28(1)(b) EPC restricts patents on processes that give rise to making the human germline change, further expressing the restrictive EU policy. 14 Still, CRISPR patents involving somatic gene editing, modifying non-inherited DNA, are generally allowed.

The European Patent Office (EPO) has granted many patents on CRISPR, though issues of patents in court, particularly involving the Broad Institute and UC Berkeley, have complicated patentability. 15 EPO follows strong ethical assessment while reviewing CRISPR patent cases, being aligned with the precautionary principle on the EU aspect of

10 Broad Inst., Inc. v. Regents of the Univ. of Cal., 940 F.3d 1342 (Fed. Cir. 2019).

11 Consolidated Appropriations Act, Pub. L. No. 117-103, § 733(a), 136 Stat. 49, 453 (2022).

12 Jessica Wachowicz, The Patentability of Gene Editing Technologies such as CRISPR & the Harmonization of Laws Relating to Germline Editing, 10 Intell. Prop. Brief 37, 42 (2019).

13 Convention on the Grant of European Patents, art. 53(a), Oct. 5, 1973, 1065 U.N.T.S. 199.

14 European Patent Convention, Rule 28(1)(b), as amended by Decision of the Administrative Council of 29 June 2017, O.J. EPO 2017, A56.

15 Duncan Matthews, Access to CRISPR Genome Editing Technologies: Patents, Human Rights and the Public Interest, in Access to Medicines and Vaccines 105, 112 (C.M. Correa & R.M. Hilty eds., 2022).

human genetic alteration.16 As a result, CRISPR is patentable for health and agricultural purposes, but germline editing patents face serious roadblocks in the EU due to ethics and prohibition of biotechnology patents. III.

China China's patent policy for CRISPR-Cas9 technology for human gene editing is governed by the Patent Law of the People’s Republic of China (PRC), 2020 Amendment, based on the same principles as the TRIPS Agreement but with more robust ethical protections. Article 5 of the PRC Patent Law explicitly prohibits patents for inventions against public morality or public interest, and these exclude patents for human germline gene editing. 17 Somatic gene-editing patents are approved if new, with an inventive step, and of industrial applicability under Article 22, but germline editing poses ethics and regulations issues. 18 The 2018 He Jiankui’s CRISPRedited babies scandal further highlighted human gene-editing patents ‘scrutiny and pushed China’s National Medical Products Administration (NMPA) towards exercising more control over genetic experiments.

19 But China National Intellectual Property Administration (CNIPA) still grants patents for CRISPR-based therapeutic, agricultural, and industrial technologies subject to their non-germline applications and their not involving human changes inherited in germlines. 20 China is different from the European Union, whose germline editing is formulated to be illegal. China is liberal in policy but on a case-to-case basis and is sensitive to finding a balance between science on one hand, and ethics on the other. Thus, while CRISPR patents for non-germline purposes are easily accepted, germline changes are a victim to ethical as well as legal restrictions. IV.

India India's patentability of CRISPR is governed by the Patents Act, 1970, which places moral and public interest restrictions on biotech inventions. Section 3(b) of the Patents Act bans patents on inventions likely to cause harm to public order, morality, or human life, thus making patents

16 European Group on Ethics in Science and New Technologies, Statement on Gene Editing (2016).

17 Patent Law of the People's Republic of China (promulgated by the Standing Comm. Nat’l People’s Cong., Dec. 27, 2008, amended Oct. 17, 2020, effective June 1, 2021), art. 5.

18 Id. art. 22.

19 Rumiana Yotova, Regulating Genome Editing Under International Human Rights Law, 69 Int’l & Comp. L.Q. 653, 654 (2020). 20 A. Loke & J. Zhao, Patent Protection of CRISPR Technology in China and Japan: A Comparative Study, Asian J. Biotech. (2017).

on germline editing extremely unlikely.21 Section 3(j) also bans patents on plants, animals, and biological processes except microorganisms, further limiting CRISPR uses in employing human genetic material.22 Yet, somatic gene-editing therapies that do not modify inheritable DNA can still be patented if they pass ordinary novelty and inventive step tests. While India has an emerging biotech sector, it does not have a specific regulatory environment for genome editing, causing legal uncertainty. The Indian Council of Medical Research (ICMR) Guidelines (2019) govern genetic research but ban human germline editing on grounds of safety and ethics.23 Unlike the U.S. and EU, where issues of CRISPR patents are the major concern, India has seen fewer filing of CRISPR patents, possibly due to strict patent exclusions and regulatory uncertainty.24 Hence, while

CRISPR

is patentable in non-human applications, its employment in human gene editing, especially germline modifications, remains legally and ethically banned in India. Thus, it is inferred that the patentability of CRISPR for human gene editing is different across jurisdictions. In the United States, patents on CRISPR are permitted under 35 U. S. C. § 101, but germline editing is controlled by the FDA. The EU excludes patents on germline editing under EPC Article 53(a) and Rule 28(1)(b), but somatic editing is patentable China’s Patent Law (Article 5) prohibits patents violating public morality, restricting germline modifications. India's Patents Act, Section 3(b) and 3(j), prohibits germline editing patents on moral grounds.

Hence, although somatic gene-editing patents are a general acceptance across the four jurisdictions, germline modifications are very much restricted globally due to ethical and legal issues.

ETHICAL AND LEGAL CHALLENGES IN PATENTING CRISPR

Ethical Issues with Patenting CRISPR The patenting of CRISPR is morally contentious, particularly its implications on human rights and access to health. Article 27.2 of the TRIPS Agreement allows members to exclude patents

21 The Patents Act, No. 39 of 1970, § 3(b), India Code (1970).

22 Id. § 3(j).

23 Indian Council of Medical Research (ICMR), National Guidelines for Gene Therapy Product Development and Clinical Trials (2019). 24 M.N. Karagyaur et al., Ethical and Legal Aspects of Using Genome Editing Technologies in Medicine, 11 STM 117, 118 (2019).

that go against ‘ordre public’ or morality, and this could apply to germline genome editing. 25 It is feared that granting exclusive rights over CRISPR-based therapeutic uses could restrict access and exacerbate healthcare inequalities, particularly in the developing world. 26 The Indian perspective also raises issues regarding socio-economic disparities in accessing geneedited therapy, emphasizing the need for a balanced patent policy. 27 • Ownership, Control, and Access to Genetic Modifications CRISPR patents are controlled by a few institutions, namely the Broad Institute and UC Berkeley, which leads to licensing conflicts that could hinder scientific collaboration. 28 Exclusive licensing can restrict the application of life-saving gene therapies disproportionately affecting low-income groups.

29 In India, where genetic diseases like sickle-cell anaemia and thalassemia prevail, making them affordable to attain is crucial. 30 Patent pools and compulsory licensing are proposed by some as a solution to enhance access, in an effort to preclude monopolies stifling innovation. 31 • Role of Public Agencies and Public Opinion Regulatory agencies such as the United States' FDA, the European Union's EMA, and India's ICMR are significant in evaluating the ethical and safety effects of CRISPR. 32 There is divided public opinion, with apprehensions of the long-run effects of germline editing and designer babies. 33 India’s National Bioethics Committee places significance on public involvement in regulation of gene-edited guidelines, rendering ethical regulation sensitive to the values of the society.

34 Thus, while CRISPR patents are an incentive for innovation, ethics, 25 Agreement on Trade-Related Aspects of Intellectual Property Rights, art. 27. 2, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U. N. T. S. 299. 26 Duncan Matthews, Access to CRISPR Genome Editing Technologies: Patents, Human Rights and the Public Interest, in Access to Medicines and Vaccines 105, 112 (C. M. Correa & R. M. Hilty eds. , 2022).

27 Prof. (Dr.) Madhumita Dhar Sarkar & Belayet Hussain Mazumder, Human Gene Editing and Its Inherent

Conundrums: Legal Perspectives, 13 Indian J.L. & Just. 46, 49 (2022). 28 Jessica Wachowicz, The Patentability of Gene Editing Technologies such as CRISPR & the Harmonization of Laws Relating to Germline Editing, 10 Intell. Prop. Brief 37, 41 (2019).

29 Supra note 26, at 113.

30 Supra note 27, at 50.

31 Supra note 26, at 114.

32 Jacob S. Sherkow, Controlling CRISPR Through Law: Legal Regimes as Precautionary Principles, 2 CRISPR J. 299, 301 (2019).

33 M.N. Karagyaur et al., Ethical and Legal Aspects of Using Genome Editing Technologies in Medicine, 11 STM 117, 118 (2019).

34 Supra note 27, at 52.

access, and regulatory issues require equilibrium so that there is equitable gain for all.

CONCLUSION

Patentability and regulation of CRISPR technology require a delicate balance based on ethical, legal, and social considerations against safeguarding innovation and access. The U. S. , EU, China, and India, each have different regulatory systems, but a harmonized approach will address patent monopoly, human rights, and public health concerns. While patents encourage research, they must not restrict access to gene therapies that save lives and widen socioeconomic disparities. Besides, providing equal worldwide access to CRISPR technology is crucial in preventing inequalities in healthcare and scientific advancements between industrialised and developing nations. To achieve equal and ethical regulation of CRISPR, a number of reforms need to be undertaken.

First, there needs to be a global system of ethics for patents, so that patents for human germline editing are not in contradiction with fundamental rights or ‘ordre public’ principles. Second, countries need to adopt compulsory licensing and patent pools to prevent monopolies, so that gene-editing therapies can be made accessible. Third, international regulations by bodies like World Health Organization, World Trade Organization and World Intellectual Property Organization needs to harmonize ethics with patent law, particularly for heritable genetic modification. Fourth, regulatory bodies like India's ICMR, the FDA, and the EMA need to ensure public involvement in decision-making, so that policies actually reflect societal values. Also, promoting patent ownership and openness in licensing can enable more access and fair competition.

Finally, instead of prohibition, conditional approvals need to be used for controlled human trials, under rigorous ethical and legal scrutiny. Hence, global collaboration, moral patenting, and accountable innovation must shape the destiny of CRISPR regulation. With open, inclusive, and science-informed policies, the world can actualize the potential of CRISPR while upholding human rights and access to universal healthcare.