Ethical and Legal Considerations of Bio-printing Patents in India

Ethical and Legal Considerations of Bio-printing Patents in India

This piece has been authored by Tirthaj Mishra 2nd year student at MNLU Mumbai


The process of “bio-printing” builds complex biological structures layer by layer by utilizing developments in 3D printing, biomaterials, and cellular biology. With its immense potential for regenerative medicine, this state-of-the-art technology allows for the manufacturing of human organs that function. Using stem cells—adaptable cells with the capacity to differentiate into a wide range of specialized cell types—is one method to do this. Through the manipulation of stem cell development in 3D printed frameworks, scientists hope to bio-print complex tissues that resemble organs such as livers, kidneys, and hearts.
The possibility for on-demand organ bio-printing could contribute to reducing the severe organ scarcity that claims thousands of lives each year. Organs that match the patient could lower the requirement for immunosuppressive drugs and the risk of rejection. However, the seemingly endless possibilities of bio-printing are offset by serious moral and legal issues. There are ethical questions about eliminating potential human life while using embryonic stem cells such as the destruction of embryos for research purposes sets a precedent that could lead to further devaluation of human life, potentially leading to practices that are widely considered unethical, such as human cloning or creating embryos solely for research purposes. Legal complications in bio-printing include patenting bioprinted tissues and organs, which involves concerns about ownership, eligibility, and intellectual property in light of recent technological developments.

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The debate over the patent eligibility of 3D bio-printing products revolves around their nature-based characteristics. Some argue that these products, including bioprinted tissues and organs, are essentially duplications of natural organs, lacking markedly different characteristics. Therefore, they may not pass the eligibility test for patents. However, others contend that bio-printing products still possess essential differences from their natural counterparts, making them patent-eligible. This viewpoint suggests that while bioprinted components are naturally occurring, they may exhibit distinct characteristics, such as being composed of genetically engineered cells, thereby warranting patent protection. Additionally, it’s proposed that certain strategies, like deriving products from non-natural precursors or combining natural and non-natural materials, could enhance their patentability.

Statutory Interpretation:

The Indian Patents Act of 1970 sets strict requirements for patentability, including novelty, non-obviousness, and industrial applicability. However, the Act also contains notable exclusions that limit the patenting of bioprinted products. Sections 2(1)(j) and 3(j) effectively bar the patenting of plants, animals, and their essential biological processes. This is justified by the need to preserve harmony between moral, cultural, and scientific values.

The Act’s definition of “invention” excludes living organisms created through bioprinting, as they are considered products of essentially biological processes. Section 3(j) further reinforces this, prohibiting the patenting of plants, animals, and their propagation. The legislature has prioritized ethical considerations over unfettered patenting of biotechnological advancements.

This statutory landscape poses significant challenges for the bioprinting industry, requiring careful navigation of the Act’s exclusions and their underlying rationale of preserving moral and cultural values. 

Judicial Interpretation: Distinguishing Discoveries and Inventions

The legal and ethical challenges around bioprinting stem from the fundamental question of whether bioprinted products can be considered true “inventions” eligible for patent protection. As the excerpt notes, the use of human tissues and cells, particularly embryonic stem cells, in bioprinting raises deep moral and ethical concerns.

Courts have grappled with this issue of distinguishing between patentable inventions and unpatentable discoveries of natural phenomena. In the landmark U.S. Supreme Court case Association for Molecular Pathology v. Myriad, the court ruled that isolated human genes are not patentable, even if they have been extracted and purified, because they represent a discovery of a natural substance rather than a human-made invention.

This precedent suggests that bioprinted tissues and organs composed of natural human cells and materials may face similar challenges in meeting the patent eligibility criteria. The extraction and manipulation of these fundamental building blocks of life, despite their potential medical applications, may be viewed as mere discoveries rather than inventions deserving of patent protection. Navigating this fine line between discovery and invention remains a central judicial consideration in the bioprinting space.

Moral and Ethical Considerations

Concerns regarding fair access, exploitation, and the possible development of an unregulated organ trade market have been introduced by the possibility of commercializing bioprinted organs and tissues. Even though the potential to reduce urgent organ shortages through the on-demand bio-printing of organs is exciting, there is a justifiable concern that this technology may deepen already-existing disparities and inequalities in healthcare access, especially for underprivileged people.

Lastly, the ethical consequences of bioprinting go beyond the realm of organ transplantation. The availability of bioprinted tissues and organs could facilitate unethical practices such as organ trafficking, reproductive cloning, or the creation of chimeric organisms, blurring the line between humans and non-humans. Patents on inventions that violate public morality or order are also prohibited by Section 3(b), a clause that may limit patents on bioprinted organs designed for transplantation. While the legislation aims to keep in mind moral and public policy grounds into patentability assessments, there is a shortage of jurisprudence on how to apply and understand them. This lack of clarity aggravates uncertainty for bio-printing inventions.

Patentability Exceptions and Limitations

A significant exemption is given by the second portion of Section 3(j), which permits the patenting of processes that are not essentially biological in nature. This exclusion might apply to bio-printing methods which creates organ replacements by combining 3D bio-printing technology with bio-inks or other non-biological materials. It appears that the legislative intent supports the patentability of bioprinted products made using these kinds of non-biological techniques.

Moreover, Section 47(3) of the Indian Patents Act provides an exception for research and experimentation, which encourages bio-printing innovation by permitting researchers to conduct studies on patented technologies. But there are concerns that it would be interpreted too broadly, which would lessen the benefits associated with patents for innovation. Lack of clarity regarding permissible research boundaries can result in unapproved commercial exploitation of research under false pretences, which discourages investment and impedes advancement. Without a guarantee of intellectual property protection, businesses could be reluctant to invest in bio-printing research and development, which would impede innovation and commercialization. This uncertainty may give rise to legal conflicts, which would take funds away from research and hinder cooperation making it essential to strike a balance between the patent rights’ protection and the exemption’s ability to boost innovation.

Comparative Perspective: The U.S. Approach

The U.S. Patent Act takes a broad approach to defining patentable subject matter. According to the Act, this includes “any new and useful process, machine, manufacture, or composition of matter.” This expansive language reflects Congress’ intent to preserve and encourage a wide range of technological advances.

However, the courts have placed certain restrictions on patentability, particularly when it comes to products derived from nature. The “product of nature” doctrine holds that patents cannot be granted for naturally occurring phenomena. This principle was established in cases like American Wood Paper Co. v. Fiber Disintegrating Co., where the court ruled that patent protection could only cover the extraction process, not the end product itself.

Over time, the courts have grappled with how to apply the product of nature doctrine, particularly in the context of biological inventions. In Parke-Davis & Co. v. H.K. Mulford Co., the court suggested that purified natural substances could be patentable if they demonstrated medical utility not found in their natural state. This laid the groundwork for patents on purified chemicals and other isolated natural products with therapeutic value.

The landmark Diamond v. Chakrabarty decision further expanded patentability to include living microorganisms, as long as they were created through human intervention and differed from their natural counterparts. This signalled a shift towards granting patents on inventions involving the manipulation of living materials.

However, the U.S. Supreme Court later drew a distinction in Association for Molecular Pathology v. Myriad. The court ruled that isolated genomic DNA, despite its potential medical applications, was not patentable because it lacked sufficient human-made modifications to distinguish it from its natural form. This emphasized the need to differentiate between mere discoveries of natural substances and true inventions involving human creativity and intellect.


Bioprinting is a point of convergence where moral and ethical considerations meet scientific progress. Navigating the legal landscape becomes crucial as this technology advances the field of regenerative medicine. While encouraging an atmosphere that is favorable to innovation, the Indian Patents Act imposes a number of major exclusions and limits that are based on upholding moral and cultural values that are deeply ingrained in society.

Bioprinting breakthroughs that include the manipulation of human cells and tissues face significant problems due to the statutory bans on patenting living forms, biological processes, and inventions that are contrary to public order. However, the Act provides a means of obtaining intellectual property protection for organ constructs and bioprinting methods that result from the combined use of biocompatible materials and 3D printing techniques, even though these processes cannot be limited to just biological phenomena.

Going forward, patentability evaluations may become even more challenging due to the growing application of artificial intelligence (AI) in biotechnology and bioprinting. The use of AI systems to create new bio-inks, improve printing settings, and even create bioprinted tissues on their own may raise concerns regarding the patentability of these innovations and the degree to which they can be classified as non-biological processes. Ultimately, in order to create an atmosphere that supports ethical values and promotes responsible innovation, legislators and the judiciary will need to address these new issues.


Tran, J. L. (2015). To bioprint or not to bioprint? North Carolina Journal of Law and Technology, 17(1), 123-153.

Kirillova, A., Bushev, S., Abubakirov, A., & Sukikh, G. (2020). Bioethical and legal issues in 3D bioprinting. International Journal of Bioprinting, 6(3), 272. doi:10.18063/ijb.v6i3.272

Vijayavenkataraman, S. (2016). 3D bioprinting – An Ethical, Legal and Social Aspects (ELSA) framework. Bioprinting, 2(3), 152-163. doi:10.1016/j.bprint.2016.08.001

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