Written By: Apoorv Agarwal, Vaibhav Manu Srivastava, Anushka Koushika, Abhishek Jaiswal
INTRODUCTION:
Technological advancement is reshaping society at an extraordinary pace, opening new avenues for economic growth and innovation, but also giving rise to serious social, legal, and environmental concerns. Technology, while immensely beneficial, functions as a double-edged sword, making it essential for legal frameworks to both promote innovation and safeguard society from unforeseen harms. The uncertainty surrounding emerging areas such as artificial intelligence, biotechnology, and cybersecurity exposes the limits of traditional regulatory models and underscores the need for flexible, adaptive, and globally coordinated legal responses.[1]
Law and technology are closely intertwined, each influencing the development of the other. While technology drives progress and efficiency, law provides the structure, accountability, and order necessary for its responsible use. Legal systems can either facilitate or constrain innovation and play a crucial role in addressing the unintended consequences of technological growth. As reflected in the ideas of jurists like H.L.A. Hart[2], Herbert Spencer, and Aristotle, maintaining a careful balance between technological progress and legal order is vital to ensure that advancement serves the broader goals of justice, stability, and good governance.
This article examines how biotechnology patent regimes attempt to balance innovation incentives with public interest considerations across major jurisdictions. By analysing the legal frameworks of the United States, India, and China, the author argues that contemporary biotechnology patent law reflects competing visions of property, public health, and technological development. The article contends that while the United States adopts a market-driven and innovation-centric approach, India emphasises access and public welfare, and China pursues a state-guided model of technological advancement. The author ultimately suggests that biotechnology patent regimes must evolve towards a calibrated framework that protects innovation while ensuring equitable access to life-saving technologies.
THEORETICAL AND JURISPRUDENTIAL FOUNDATIONS OF LAW AND TECHNOLOGY:
The relationship between law and technology, particularly in the context of medical biotechnology patents, is complex and constantly evolving, shaped by diverse legal philosophies and the ideas of influential legal thinkers.
- Natural Rights Theory:The thinkers like John Locke of the Natural Rights Theory considers patents an expression of the natural rights of inventors over their creations[3].
- UtilitarianismTheory: The concept of Utilitarianism championed by Jeremy Bentham and Jhon Stuart Mill holds that patents are necessary to encourage innovation, but must be balanced against public access to beneficial technology[HP1] . Theory aims to achieve the “greatest good for the greatest number”. [4].
- Legal Positivism: On the other hand legal positivists like HL.A. Hart, focuses on the validity and flexibility of the law itself, suggesting that patenting systems must keep pace with technological advancements to be effective.[5]
- Legal Realism:Legal Realists emphasize the role of social, political, and practical factors in shaping the operation of patenting laws in practice. [6]
- Rights Based theory: Ronald Dworkin’s theory centres on protecting individual rights. In patent law, it requires balancing inventors’ rights with the public’s access to life-saving treatments, with judges playing a key role in ensuring fair and rights-respecting interpretations.[7]
- Justice theory:John Rawls’ theory stresses fairness, requiring medical biotechnology patents to allow equitable access to healthcare, particularly for the disadvantaged.[8]
- Law and Economics: The theory assesses patenting law from the perspective of efficiency and innovation incentives, and emphasises on the ability to stimulate the economic growth.[9]
- Lessig’s Approach:Lawrence Lessig illustrates how technology is governed not only by law, but also by social norms, markets, and technology design, which together determines the development, regulation, and use of medical biotechnology.[10]
These theoretical perspectives provide a framework for understanding how different jurisdictions regulate biotechnology patents. Patent systems, stricto sensu do not operate in a vacuum; rather, they reflect underlying philosophical commitments regarding property, innovation, and public welfare. The comparative analysis that follows in the article clearly demonstrates how the United States, India, and China embody distinct theoretical orientations, ranging from utilitarian and market-based models to welfare-oriented and state-guided approaches.
LEGAL FRAMEWROK WITH RESPECT TO BIOTECHNOLOGY PATENTS:
Biotechnology has revolutionized numerous fields, from medicine to agriculture. At the heart of this progress lies a complex dance between innovation and regulation. Patents, which grant exclusive rights to inventions, play a crucial role in this dance. This chapter will delve into the legal framework of three countries namely i.e. United States of America, China and India surrounding the grants of Patent in the field of Biotechnology.[HP2]
- UNITED STATES:
In the United States, the patenting system is based on Article I, Section 8 of the United States Constitution, which gives Congress the power to encourage scientific innovation by granting innovators temporary exclusive rights.[11] The United States patenting system generally pertains to “any new and useful process, machine, manufacture, or composition of matter,” including biotech inventions such as genetically modified organisms, DNA, proteins, and pharmaceuticals, as established in the landmark cases of Diamond v. Chakrabarty (1980).[12]
However, the USPTO and courts are very strict about the requirements of novelty, utility, non-obviousness, and sufficient disclosure to avoid mere speculation. Cases such as Amgen v. ChugaiPharmaceutical[13]and Brenner v. Manson[14] illustrate the need for specific utility and sufficient technical disclosure, especially in a technically complex area such as genetics.
Overall, the U.S. approach reflects a predominantly utilitarian and market-driven model that prioritises innovation incentives and private investment, while relying on judicial interpretation to impose limits.
- CHINA:
China’s patent system has progressively adapted to biotechnology advancements through amendments to its Patent Law. While early laws excluded medicines and plant varieties, later reforms expanded protection to biotechnological inventions such as microorganisms, genes, cells, and related processes, supported by international commitments like the Budapest Treaty[HP3] , 1977. Plant and animal varieties themselves remain excluded, though methods for producing them may be patented.
At the same time, China maintains clear exclusions and strict patentability standards, limiting protection to technical solutions and excluding discoveries and medical treatment methods. Enforcement remains challenging, but recent amendments [HP4] effective in 2024 strengthen disclosure rules and procedural clarity, reflecting China’s ongoing effort to balance innovation with regulatory control.[15]
China’s biotechnology patent regime reflects a strategic effort to promote domestic innovation while maintaining strong regulatory oversight. The state plays a central role in shaping patent policy to align with broader industrial and technological objectives, including self-reliance in pharmaceuticals and genetic technologies. While enforcement challenges remain, recent reforms demonstrate China’s intention to strengthen intellectual property protection as part of its transition toward a knowledge-based economy.
Key Highlights of the 4th Amendment to China’s Patent Law:
- Deadlines for electronically filed applications now depend on the actual filing date, not the mailing date.
- Restoration requests are allowed within 14 months for convention applications and 2 months for national phase PCT applications.
- Priority claim errors can be corrected within 16 months of the priority date or 4 months of filing.
- Existing documents may be used to correct missing or incorrect application parts under specified conditions.
- Applications may include colour drawings and more descriptive titles, subject must be within the 60words limit.
- Examination can be deferredup to 3 years for inventions and designs, and 1 year for utility modelswith early cancellation permitted.
- Accidental public disclosure within the past 6 months at approved academic or technical events may still allow patent protection.
- New rules for drug patent challenges require clearer documentation from generics and greater disclosure by patent holders, with challenges examined in filing order.
- INDIAN SCENARIO
The biotech patent regime in India has emerged mainly as a reaction to the TRIPS requirements and advances in biotechnology. Although the Patents Act, 1970 did not provide for biotech patents, the Patents Act was amended in 2002 and 2005 to provide product and process patents for pharmaceuticals and biotechnology, including microorganisms and genetically modified inventions.[16] Judicial pronouncements in such decisions as Dimminaco AG v. Controller of Patents[HP5] [17] have further widened the scope of patents, resulting in a significant increase in biotech and pharmaceutical patents.
In 2019, Monsanto Technology LLC v. Nuziveedu Seeds Ltd.[18] a landmark 2019 Supreme Court dealt with intellectual property rights over Bt cotton technology. The dispute arose when Nuziveedu stopped paying Monsanto’s trait fees, citing government price controls, leading Monsanto to terminate the licence and allege patent infringement. The Supreme Court set aside the High Court’s summary invalidation of Monsanto’s patent, holding that patent validity required detailed evidence and could not be decided at an interim stage. It reinstated the licence agreement temporarily, directing payment of royalties at government-fixed rates, while leaving the broader question of patentabilityparticularly the interface between patent law and the Protection of Plant Varieties and Farmers’ Rights Act, 2001 open for further examination.
However, the Indian patent regime also provides stringent conditions. Sections 3 and 4 of the Patents Act, 1970provide that discovery of new forms of natural substances, methods of medical treatment, plants and animals (except microorganisms), and inventions contrary to public interest are not patentable. Biotech inventions are also required to satisfy the criteria of novelty, utility, inventive step, and non-obviousness.[19]
India’s biotechnology patent regime thus reflects a careful balancing of innovation incentives with constitutional commitments to public health, access to medicines, and socio-economic justice, making it one of the most public-interest-oriented patent systems globally.
CONCLUSION:
A comparison of the biotechnology patent systems in the United States, India, and China shows a shared struggle to strike the right balance between encouraging innovation and protecting the public interest. While the U.S. leans toward strong patent protection with rigorous legal standards, India places greater emphasis on access, affordability, and social welfare, whereas China continues to refine a carefully controlled yet innovation-friendly framework. The U.S. patent regime prioritises robust enforcement mechanisms, high damages awards, and a well-developed litigation ecosystem, encouraging technological innovation and private investment but often attracting debate over patent monopolies and litigation costs. In contrast, India adopts a more balanced approach that integrates public interest considerations, reflected in provisions such as strict patentability standards, safeguards against evergreening, compulsory licensing mechanisms, and judicial sensitivity to access to essential medicines and affordable technologies. China, meanwhile, has significantly strengthened its intellectual property regime through specialised IP courts, increased statutory damages, and streamlined examination procedures, aiming to foster domestic innovation while maintaining regulatory oversight aligned with broader industrial policy objectives. Together, these differing approaches illustrate how patent systems evolve in response to national economic priorities, public policy goals, and developmental strategies.Taken together, these approaches underline an important reality: patent laws must remain flexible and responsive, supporting scientific progress without losing sight of the human need for fair and timely access to life-saving medical technologies.
[1] Maria Weimer and Luisa Marin, “The Role of Law in Managing the Tension between Risk and Innovation”, EJRR 469 (2016)
[2]H.L.A. Hart, “The Concept of Law”, 89–96 (Clarendon Press, United States, 2nd edn., 1994)
[3]Locke’s Political Philosophy, available at: https://plato.stanford.edu/entries/locke-political/ (Last Visited March 15, 2024)
[4]The History of Utilitarianism, available at https://plato.stanford.edu/entries/utilitarianism-history/
(Last Visited March 15, 2024)
[5]Legal Positivism, available at: https://iep.utm.edu/legalpos/ (Last Visited March 15, 2024)
[6]Legal Realism, available at: https://www.law.cornell.edu/wex/legal_realism (Last Visited March 15, 2024)
[7]Samra Ibric, “Ronald Dworkin: Seeking Truth and Justice through Responsibility”, 3 LAWS 12 (2023)
[8]John Rawls, available at: https://plato.stanford.edu/entries/rawls/ (Last Visited March 15, 2024)
[9]Law and Economics, available at: https://iep.utm.edu/law-and-economics/ (Last Visited March 15, 2024)
[10]Lessig, Lawrence. Code and Other Laws of Cyberspace. New York: Basic Books, 1999., available at: https://pne.people.si.umich.edu/kellogg/045.html (Last Visited March 15, 2024)
[11]The U.S. Constitution, Article I, Section 8.
[12]447 U.S. 303 (1980)
[13]927 F.2d 1200 (Fed. Cir. 1991)
[14]383 U.S. 519, 86 S. Ct. 1033 (1965)
[15]Ming Hu and Jiao Feng, “Legal Protection of China’s Biotechnology Patents”, 103 BLR 33 (2014)
[16]Jahnavi Deshpande, “An Analysis on Patentability of Biotechnological Invention in India”, 102 IJIL 2 (2021)
[17]AID No. 1 of 2002
[18](2019) 3 SCC 381
[19]The Patents Act, 1970 (Act 39 of 1970), Sec. 3 & 4
[HP1]Expand the schools of thought. Deal with both the schools separately in two different paras
[HP2]We can discuss the framework across different countries separately then followed by the framework in India under a specific head ‘Indian Scenario’
[HP3]Year of the treaty
[HP4]Mention the notable amendments to support the argument
[HP5]Discuss Monsanto vs. Nuziveedu Seeds as well if we are discussing Dimminaco
