A COMPARATIVE ANALYSIS ON THE LEGAL FRAMEWORK GOVERNING THE PROPRIETARY STATUS OF LAB-GROWN ORGANS

Author: Tarika from St.Joseph’s College of Law

ABSTRACT

The rapid progress of regenerative medicine and tissue engineering has led to the development of laboratory-grown organs created through stem cell technology, cellular scaffolds, and three-dimensional bioprinting. While these innovations offer transformative solutions to the growing demand for organ transplantation, they also raise complex legal and ethical issues concerning ownership, proprietary interests, and the commercialisation of human biological materials. This paper examines the fundamental question of whether lab-grown organs should be recognised as a form of property and, if so, what legal framework should govern their ownership, transfer, and commercialisation.

This paper undertakes a comparative doctrinal analysis of the legal frameworks governing the proprietary status of lab-grown organs in India and across international jurisdictions. It examines how countries such as the United States, the United Kingdom, and the European Union regulate issues relating to human body parts, biotechnology, intellectual property rights, and organ transplantation in the context of rapidly advancing bioengineering organs. The study also traces the evolution of the common law “no-property” principle, its gradual judicial modifications, and its continuing relevance in relation to engineered biological tissues. 

The paper further analyses pivotal judicial decisions, including Moore v. Regents of the University of California, the Myriad Genetics case, Yearworth v. North Bristol NHS Trust, along with Indian constitutional jurisprudence on bodily autonomy, to assess how courts have interpreted property rights over biological material. The analysis reveals critical lacunae in Indian domestic law, inadequacies in the Transplantation of Human Organs and Tissues Act, 1994, and the absence of a coherent international legal framework governing ownership of bioengineered organs. It also examines ethical tensions between the commodification of the human body, the protection of patient rights, and the advancement of scientific research and medical innovation. 

Keywords: Lab-grown organs, bioengineering, property rights, transplantation law, bioethics, comparative analysis, tissue engineering, regenerative medicine, intellectual property, bodily autonomy.

INTRODUCTION

The idea of growing functional human organs in laboratories was once regarded as science fiction, but it has now become a significant development in the field of translational medicine. Bioengineered tracheas, bladders, skin grafts, and experimental cardiac patches have been clinically implanted; three-dimensional bioprinted kidneys and liver tissue are progressing toward viability.

These innovations challenge the traditional legal distinction between naturally occurring human organs which are considered inalienable, unowned, and outside the scope of commercial exchange and manufactured products that may be subject to proprietary claims. Simultaneously, a lab-grown organ represents human innovation, biological material, and a personal bodily extension.

The legal vacuum surrounding these objects is stark. Traditional property law was constructed around tangible objects of clear human origin or manufacture. The human body, and organs derived therefrom, were excluded from that framework by deep moral, religious, and philosophical intuitions codified in the common law principle res nullius corporis humani  the body is no one’s property. Yet when a kidney is constructed ex vivo using a patient’s own stem cells on a synthetic scaffold, this maxim becomes epistemologically strained.

This paper proceeds in the following manner. Part II traces the historical background of the law governing body parts and biological materials. Part III surveys the legal frameworks operative in India and internationally. Part IV analyses seminal judicial decisions. Part V examines the implications of existing frameworks. Part VI offers concrete suggestions for legislative and regulatory reform.

II. HISTORICAL BACKGROUND AND DEVELOPMENT OF THE LAW

1. The Common Law ‘No-Property’ Rule

The foundational common law position, traceable to Sir Edward Coke’s Institutes and affirmed in Williams v. Williams (1882), held that there could be no property in a corpse. This principle was extended over time to cover separated bodily substances and organs. The philosophical underpinning was derived partly from Roman law’s res extra commercium doctrine and partly from Kantian ethics rejecting the instrumentalisation of the human person.

The no-property rule served an intelligible purpose in preventing the commodification of human remains and protecting dignitary interests. However, it operated as a blunt instrument, failing to distinguish between a cadaverous corpse, a living donor’s organ, a separated tissue sample, and a bioengineered construct cultivated over weeks in a laboratory environment.

2. The Work-and-Skill Exception

Courts gradually recognised what is termed the ‘work-and-skill exception’: where human labour and expertise had been applied to biological material, a proprietary interest could arise in the resulting product. This was affirmed in Doodeward v. Spence (1908) in Australia, where the High Court held that a preserved foetal specimen over which work and skill had been exercised constituted property. The exception established the conceptual bridge between biological origin and proprietary transformation.

3. Biotechnology and the Patentability of Life

The landmark decision of the United States Supreme Court in Diamond v. Chakrabarty (1980) fundamentally altered the intellectual property landscape, holding that genetically modified micro-organisms were patentable subject matter. This inaugurated an era of biotechnology patents extending to isolated genes, cell lines, and modified organisms generating enormous commercial value and triggering vigorous ethical debate about the ownership of life-forms.

In Europe, the Biotechnology Directive 98/44/EC of the European Parliament sought to balance patentability with ordre public restrictions, prohibiting patents on the human body at various stages of formation but permitting patents on isolated biological material. The tension between these two imperatives scientific progress and human dignity has remained unresolved, and its articulation with lab-grown organs has not been addressed by any legislature.

4. Transplantation Law and Its Limitations

The legal regulation of organ transplantation emerged primarily as a public health and anti-commodification exercise. The United States enacted the National Organ Transplant Act, 1984, which prohibited the transfer of human organs for valuable consideration. The United Kingdom’s Human Tissue Act, 2004 similarly imposed strict controls on the storage and use of human tissue. India enacted the Transplantation of Human Organs Act in 1994, amended significantly in 2011. All these instruments were premised on the paradigm of cadaveric or living donor transplantation and do not contemplate bioengineered organs as a distinct category.

III. LEGAL FRAMEWORK

1.  Indian Legal Framework

India’s primary legislation on organ transplantation is the Transplantation of Human Organs and Tissues Act, 1994 (THOTA), as amended by the Transplantation of Human Organs and Tissues (Amendment) Act, 2011. THOTA prohibits commercial transactions in human organs, defines ‘human organ’ as any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body a definition plainly designed for natural organs and inapplicable to lab-grown constructs.

The Drugs and Cosmetics Act, 1940 and Rules thereunder, as amended, regulate biological products and new drugs. The Central Drugs Standard Control Organisation (CDSCO) has begun developing frameworks for advanced therapy medicinal products (ATMPs), including somatic cell therapy and tissue-engineered products, through the New Drugs and Clinical Trials Rules, 2019. However, lab-grown organs as proprietary objects with attendant questions of ownership, transfer, and commercialisation remain entirely outside any statutory scheme.

The Patents Act, 1970, as amended by the Patents (Amendment) Act, 2005, excludes from patentability under Section 3(c) the mere discovery of any living thing or non-living substance occurring in nature. However, bioengineered organs involve significant human intervention and are arguably not ‘occurring in nature.’ Section 3(b) prohibits patents for inventions contrary to public order or morality. Whether ownership of a lab-grown organ offends public order is a question of profound importance that has not been judicially determined.

The Constitution of India provides a broader normative framework. Article 21, interpreted expansively by the Supreme Court in cases such as K.S. Puttaswamy v. Union of India (2017) and Common Cause v. Union of India (2018), encompasses the right to bodily integrity, the right to health, and the right to make autonomous decisions about one’s own body. These rights have implications for determining whether a patient retains proprietary interests in organs grown from their own biological material.

2.  International Legal Framework

The Council of Europe’s Convention on Human Rights and Biomedicine (Oviedo Convention, 1997) provides the most comprehensive international instrument in this domain. Article 21 prohibits financial gain from the human body and its parts, while Article 22 requires appropriate information and consent before any retained biological material may be used. The Convention, however, was adopted before tissue engineering matured as a medical discipline and does not address lab-grown constructs.

The World Health Organization’s Guiding Principles on Human Cell, Tissue and Organ Transplantation (2010) extend their scope to ‘reconstructed organs’ and ‘organs produced from human cells.’ Principle 5 prohibits remuneration for organs while permitting recovery of reasonable expenses. These principles lack binding force and leave substantial ambiguity regarding the proprietary status of bioengineered organs used for purposes other than clinical transplantation, such as pharmaceutical testing or research.

The United States regulatory framework, administered by the Food and Drug Administration (FDA), classifies most tissue-engineered products as combination products under 21 C.F.R. Part 3, subject to regulation as biological products, medical devices, or drugs depending on their primary mode of action. The FDA’s Center for Biologics Evaluation and Research (CBER) oversees these products. Property rights, however, are a matter of state common law and remain governed by unsettled judicial precedents rather than any federal statutory framework.

The European Union regulates tissue-engineered products under Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products (ATMP Regulation), which imposes a centralised authorisation requirement for tissue-engineered products intended for commercial use. The regulation addresses manufacturing standards, clinical safety, and traceability but deliberately leaves questions of intellectual property and ownership to national law, creating significant fragmentation across member states.

The United Kingdom, post-Brexit, has retained the ATMP framework through the Medicines and Healthcare products Regulatory Agency (MHRA). The Human Tissue Act, 2004, administered by the Human Tissue Authority, governs the storage and use of human tissue. Under Section 32, commercial dealings in controlled material defined as material that consists of or includes human cells are prohibited where the purpose is transplantation. The definition of ‘controlled material’ is, however, expansive enough to encompass certain lab-grown products.

IV. JUDICIAL DECISIONS

1.  International Judicial Decisions

Moore v. Regents of the University of California, remains the foundational judicial statement on property rights in biological material. The California Supreme Court held that a patient whose spleen cells were commercialised without his knowledge had no property right in the excised cells, reasoning that California law did not recognise such an interest and that conversion liability could impede socially beneficial medical research. The court’s majority, however, affirmed that informed consent obligations were breached, signalling a partial vindication of dignitary interests through an alternative legal route.

Justice Mosk’s influential dissent in Moore argued that property rights in biological material are not inherently incompatible with public policy and that denial of such rights merely transferred economic value from the patient to the researcher, without any principled justification. This dissent has been cited extensively in subsequent academic literature and has partially shaped the trajectory of bioethics discourse.

Yearworth and Others v. North Bristol NHS Trust [2009] represented a significant departure from the common law no-property rule in England and Wales. The Court of Appeal held that men who had deposited sperm for storage prior to cancer treatment had a property interest in that sperm sufficient to found a claim in negligence when it was destroyed through the hospital’s fault. The court grounded this conclusion in the men’s exclusive ability to direct the use of the sperm, effectively recognising a functional property right anchored in autonomy rather than the work-and-skill exception.

Greenberg v. Miami Children’s Hospital Research Institute, held that plaintiffs who donated tissue samples for research into Canavan disease had no property interest in those samples or in the resulting patent obtained by the research institute. The court found that property conversion claims were inconsistent with public policy encouraging tissue donation and research. The case illustrates the systematic way in which courts have structured incentives to favour institutional commercialisation over donor rights.

In Washington University v. Catalona, the Eighth Circuit Court of Appeals affirmed that tissue samples donated to a biobank became the property of the university, not the physician who collected them, and not the donors who provided them. The donors’s attempt to redirect their samples to a researcher of their choice was unsuccessful.

Association for Molecular Pathology v. Myriad Genetics, Inc., is a landmark decision of the United States Supreme Court with profound implications for the proprietary status of biological material, including lab-grown organs. The Court unanimously held that naturally occurring DNA segments are products of nature and therefore not patentable merely because they have been isolated from the human body. Justice Thomas, writing for the Court, drew a definitive distinction between the discovery of natural phenomena which lie beyond the domain of patent protection and human-made inventions, which may be the legitimate subject of proprietary rights. Critically, the Court upheld the patentability of complementary DNA (cDNA), synthetically created from messenger RNA and not occurring naturally, on the ground that it represents a genuinely new creation of the inventor.

The significance of Myriad Genetics for lab-grown organ jurisprudence is considerable. A lab-grown organ, constructed through bioengineering processes involving synthetic scaffolds, gene-edited cell lines, and bioreactor cultivation, may well constitute a sufficiently non-natural creation to satisfy the patentability threshold established by the Court. At the same time, the decision reinforces the principle that the underlying cellular and genetic material if derived from the patient’s own body retains a nature-derived character that resists full proprietary appropriation by the research institution or manufacturer. The tension between these two conclusions maps directly onto the central question of this paper: who owns an organ that is simultaneously natural in its cellular origin and artificial in its assembly.

The Myriad Genetics ruling has also been interpreted as setting an outer limit on the intellectual property claims of biotechnology corporations over human genetic material a principle of particular relevance in the Indian context given the country’s genomic diversity and the risk of bio-prospecting by foreign entities. India’s Patents Act, Section 3(c), which excludes from patentability the mere discovery of any living thing occurring in nature, resonates with the Myriad majority’s reasoning, though the Indian provision has not yet been authoritatively interpreted with reference to bioengineered organ constructs.

2.  Indian Judicial Decisions

The Supreme Court of India has not directly adjudicated the proprietary status of biological material or lab-grown organs. However, a series of constitutional decisions establish a robust normative foundation. In K.S. Puttaswamy v. Union of India, a nine-judge bench unanimously recognised the right to privacy as a fundamental right under Article 21, encompassing bodily integrity and informational self-determination. Justice D.Y. Chandrachud’s concurring opinion expressly acknowledged that the body is not a vessel for state control and that individuals retain sovereignty over their physical persons.

In Common Cause v. Union of India, the Supreme Court recognised the right to die with dignity as a dimension of Article 21, validating advance medical directives. While the case concerned end-of-life decisions rather than proprietary rights, its reasoning that the State cannot compel individuals to submit to unwanted medical interventions implies a broad conception of bodily autonomy with implications for organ ownership.

Devika Biswas v. Union of India, concerned coercive sterilisation and affirmed that reproductive autonomy is protected under Article 21. The Court held that the State’s power to regulate medical procedures must be exercised consistently with dignity and free informed consent. These principles, extended by analogy, would support recognition of a patient’s autonomy over biological material derived from their body.

The Madras High Court in Arun Sharma v. Union of India considered, albeit peripherally, the regulatory vacuum surrounding stem cell banking and therapies, directing the Union Government to frame comprehensive guidelines. Though the case did not address proprietary rights per se, the court’s recognition of regulatory gaps in the biotechnology sector is germane to the present analysis.

V. ANALYSIS: IMPLICATIONS AND IMPACT OF THE EXISTING LEGAL FRAMEWORK

1. Implications for Patient Rights and Bodily Autonomy

The cumulative effect of the judicial decisions surveyed above is the systematic subordination of patient rights to institutional and commercial interests in biological material. The no-property rule originally conceived as a shield against the commodification of the human body has paradoxically operated as a sword against patients who seek to assert control over biological material derived from their own bodies. When research institutions and corporations are permitted to patent and commercialise cell lines and tissues while donors are denied any share of the resulting value, the law perpetuates an asymmetry that is difficult to justify on principled grounds.

In the context of lab-grown organs, this asymmetry is accentuated. Where an organ is grown from a patient’s own stem cells, the biological material itself originates with the patient. The intellectual contribution lies in the engineering process, and legitimate intellectual property protection might be warranted for that process. However, denying the patient any continuing proprietary interest in the organ which may be their only viable treatment option raises profound concerns regarding access, affordability, and the reduction of patients to passive recipients of commercial largesse.

2. Implications for Research and Development

Conversely, the recognition of broad proprietary rights in lab-grown organs by patients or donors could create significant impediments to research. If every tissue donor could exercise property rights over cell lines derived from donated material, the complex web of consents and transactions required to conduct multi-institutional research would become administratively prohibitive. The Moore court’s concern about impeding medical progress was not without foundation.

The resolution of this tension requires a nuanced legal architecture that distinguishes between the patient’s interest in organs grown for their own therapeutic use, the researcher’s intellectual property interest in bioengineering processes, the manufacturer’s commercial interest in products developed for clinical sale, and the public interest in broad access to life-saving technologies. No existing legal framework provides this architecture.

3. Regulatory Fragmentation and International Implications

The absence of a harmonised international framework creates conditions for regulatory arbitrage. Entities seeking to develop and commercialise lab-grown organs may choose to incorporate in jurisdictions with permissive intellectual property and transplantation laws, manufacturing in countries with lower regulatory standards and distributing products globally. This fragmentation disadvantages patients in jurisdictions with stringent protections and creates race-to-the-bottom pressures on regulatory standards.

For India specifically, which has a large biotechnology sector and significant regulatory capacity, the absence of domestic legislation governing the proprietary status of lab-grown organs creates both vulnerability and opportunity. Vulnerability arises from the risk that foreign entities will patent bioengineering processes derived from Indian biological material without commensurate benefit to Indian patients. Opportunity lies in India’s ability to establish a progressive, rights-based framework that could serve as a model for other developing countries.

4. Ethical Tensions: Commodification and Human Dignity

The commodification of the human body is a deeply contested terrain in bioethics. Kantian ethics, rooted in the categorical imperative, militates strongly against treating persons or parts of persons as means to commercial ends. The prohibition on organ markets, embedded in virtually every national and international legal instrument, reflects this intuition. However, the ethical analysis is complicated when the organ in question is an ex vivo construct, assembled from cells that may have been voluntarily donated or purchased.

Religious and cultural traditions bear significantly on this question. Hindu legal tradition, rooted in the concept of deha-dharma, treats the body as a sacred trust rather than a commodity. Islamic jurisprudence, through the principle of maqasid al-Shariah, permits the use of the body to preserve life while rejecting its commercialisation.These diverse normative frameworks must be accommodated by any legal regime aspiring to international validity.

VI. SUGGESTIONS

1. Legislative Reforms in India

The Transplantation of Human Organs and Tissues Act, 1994 should be comprehensively amended to incorporate a dedicated chapter on bioengineered and laboratory-grown organs. The definition of ‘human organ’ should be revised to distinguish between naturally derived transplantable organs and bioengineered constructs, with tailored legal regimes for each category. The amended statute should expressly recognise that a patient retains a qualified proprietary interest in any organ grown from their own biological material for therapeutic use, subject to reasonable licensing conditions where commercial development is involved.

The Patents Act, 1970 should be amended to provide explicit guidance on the patentability of bioengineered organ constructs. A sui generis protection regime, analogous to plant variety protection, could be considered to balance innovation incentives with access obligations. Any patent on a bioengineered organ or process should be subject to a compulsory licensing provision upon a finding of national health emergency, consistent with TRIPS Article 31 flexibilities already incorporated in the Patents Act.

A dedicated National Bioengineered Organ Regulatory Authority should be established, comprising experts in medicine, law, ethics, biotechnology, and patient rights. This authority should be empowered to license manufacturing and clinical use, set standards for traceability and informed consent, adjudicate disputes over proprietary rights, and liaise with international counterparts.

2. International Law Reform

The Council of Europe’s Oviedo Convention should be updated through an Additional Protocol specifically addressing tissue-engineered and bioengineered biological products. The Protocol should define the permissible scope of intellectual property rights over bioengineered constructs, establish minimum standards for informed consent and donor rights, and prohibit the exercise of proprietary rights in a manner that impedes access to life-saving treatments in low- and middle-income countries.

The WHO Guiding Principles should be accorded binding force through incorporation into a multilateral treaty on advanced biological therapies. The treaty should establish a global registry of bioengineered organ manufacturers, require disclosure of originating biological material, and create a benefit-sharing mechanism ensuring that a portion of commercial revenues from lab-grown organs is directed to public health funds in countries from which originating biological material was sourced.

3. Judicial Guidance

In India, the Supreme Court should be invited through appropriate public interest litigation to articulate the constitutional dimensions of proprietary rights over biological material derived from one’s own body. A definitive ruling grounded in the right to privacy, bodily integrity, and health under Article 21 would provide the legislative impetus currently lacking and set appropriate limits on institutional appropriation of patient-derived biological material.

Internationally, the International Court of Justice’s advisory jurisdiction could be invoked by a requesting state or UN organ to render an advisory opinion on the compatibility of existing national frameworks governing bioengineered organ ownership with jus cogens norms of human dignity and the right to health under international human rights law.

CITATIONS AND REFERENCES

Cases

1. Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990).
2. Yearworth and Others v. North Bristol NHS Trust [2009] EWCA Civ 37.
3. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
4. Doodeward v. Spence (1908) 6 CLR 406 (High Court of Australia).
5. Greenberg v. Miami Children’s Hospital Research Institute, 264 F. Supp. 2d 1064 (S.D. Fla. 2003).
6. Washington University v. Catalona, 490 F.3d 667 (8th Cir. 2007).
7. K.S. Puttaswamy v. Union of India, (2017) 10 SCC 1 (Supreme Court of India).
8. Common Cause v. Union of India, (2018) 5 SCC 1 (Supreme Court of India).
9. Devika Biswas v. Union of India, (2016) 10 SCC 726 (Supreme Court of India).
10. Arun Sharma v. Union of India, W.P. No. 22120 of 2019 (Madras High Court).
11. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (United States Supreme Court).
12. Williams v. Williams (1882) 20 Ch D 659.

Statutes and Regulations

13. Transplantation of Human Organs and Tissues Act, 1994 (India), as amended by the Transplantation of Human Organs and Tissues (Amendment) Act, 2011.
14. Patents Act, 1970 (India), as amended by the Patents (Amendment) Act, 2005.
15. Drugs and Cosmetics Act, 1940 (India).
16. New Drugs and Clinical Trials Rules, 2019 (India).
17. National Organ Transplant Act, 42 U.S.C. § 274e (United States, 1984).
18. Human Tissue Act, 2004 (United Kingdom).
19. Regulation (EC) No. 1394/2007 of the European Parliament and of the Council on Advanced Therapy Medicinal Products.
20. Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions.
21. 21 C.F.R. Part 3 (United States FDA Combination Product Regulations).

International Instruments

22. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention), Council of Europe, 1997.
23. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, World Health Organization, 2010.
24. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), Annex 1C to the Agreement Establishing the World Trade Organization, 1994.
25. Universal Declaration on the Human Genome and Human Rights, UNESCO, 1997.
26. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, 2013 (Fortaleza revision).

Books and Journal Articles

27. Nwabueze, R.N., Biotechnology and the Challenge of Property: Property Rights in Dead Bodies, Body Parts, and Genetic Information (Ashgate, 2007).
28. Harmon, S.H.E., Ethical Rhetoric: Genomics and the Moral Content of UNESCO Universal Declarations (2005) 31 Journal of Medical Ethics 11.
29. Liddell, K. and Hall, A., ‘Beyond Bristol and Alder Hey: The Future Regulation of Human Tissue’ (2005) 13 Medical Law Review 170.
30. Bagchi, A.K., ‘Property Rights in the Human Body: The Indian Legal Framework and Emerging Challenges in Biotechnology’ (2019) 61 Journal of the Indian Law Institute 45.
31. Streiffer, R., ‘At the Edge of Humanity: Human Stem Cells, Chimeras, and Moral Status’ (2005) 15 Kennedy Institute of Ethics Journal 347.
32. Atala, A., et al., ‘Tissue-Engineered Autologous Bladders for Patients Needing Cystoplasty’ (2006) 367 The Lancet 1241.
33. Murphy, S.V. and Atala, A., ‘3D Bioprinting of Tissues and Organs’ (2014) 32 Nature Biotechnology 773.
34. Dickenson, D., Body Shopping: Converting Body Parts to Profit (Oneworld Publications, 2008).
35. Radin, M.J., ‘Property and Personhood’ (1982) 34 Stanford Law Review 957.
36. Gold, E.R., Body Parts: Property Rights and the Ownership of Human Biological Materials (Georgetown University Press, 1996).