This article is written by Harinibai R. during her internship with Le Droit India.
Abstract:
Biotechnological inventions—spanning genetic engineering, pharmaceuticals, diagnostics, and agricultural innovations—face complex patentability challenges across jurisdictions. The U.S. and India, despite shared commitments under the TRIPS Agreement, diverge significantly in legal frameworks, eligibility criteria, and judicial interpretation. This comparative analysis examines these differences through statutory provisions, landmark rulings, and emerging challenges, highlighting how each jurisdiction balances innovation incentives with ethical and public-interest considerations.
Keywords: Patentability, Biotechnology, TRIPS Agreement, Chakrabarty, Myriad Genetics, Section 3, CRISPR
Introduction
Biotechnology represents a dynamic intersection of life sciences and innovation, with profound implications for medicine, agriculture, and industry. As this field grows exponentially, so does the need for a robust legal framework to protect biotechnological inventions. Intellectual property law, particularly patents, serves as a key tool for incentivizing investment in biotechnology. However, patenting life and its components poses unique ethical, legal, and practical challenges. From genetically modified crops to personalized gene therapies, the question of what qualifies as a patentable biotechnological invention remains contested.
This issue is particularly significant in jurisdictions such as the United States and India. While both countries are WTO members and are bound by the TRIPS Agreement, their approaches to patenting biotechnology diverge sharply. The U.S. historically supports broad patentability, emphasizing innovation and commercial incentives. In contrast, India adopts a more restrictive stance, guided by public health, access to medicine, and ethical considerations. This paper explores the legal frameworks, judicial interpretations, policy rationales, and emerging challenges related to the patentability of biotechnological inventions in both nations.
Legal Frameworks
- United States
The foundation of U.S. patent law lies in 35 U.S.C. § 101, which allows patents for “any new and useful process, machine, manufacture, or composition of matter.” To qualify for patent protection, biotechnological inventions must meet four key requirements: novelty, non-obviousness, utility, and adequate disclosure. These criteria are interpreted through both statutory law and case law, allowing for broad protection, particularly for synthetic biological inventions.
U.S. patent law distinguishes three categories of patents relevant to biotechnology:
- Utility patents: Applicable to genetically engineered organisms, pharmaceutical compositions, and processes such as DNA amplification.
- Plant patents: Cover new and distinct asexually reproduced plant varieties.
- Design patents: Though less relevant in biotech, may cover ornamental aspects of biotech products.
Despite this breadth, § 101 contains critical exclusions: laws of nature, natural phenomena, and abstract ideas. Courts have often applied these exclusions to restrict claims involving biological materials that lack sufficient human intervention.
- India
India’s approach to biotechnology patents is governed by the Patents Act, 1970, substantially amended in 2002 and 2005 to align with the TRIPS Agreement. The law is more restrictive than that of the U.S., with express limitations on what constitutes a patentable subject matter.
Key statutory provisions include:
- Section 2(1)(j): An invention must be novel, involve an inventive step, and be capable of industrial application.
- Section 2(1)(ja): Defines “inventive step” as involving a technical advance or having economic significance.
- Section 3: Lists specific exclusions from patentability, many of which apply directly to biotechnological inventions. These include natural substances (3(c)), methods of treatment (3(i)), and biological processes involving plants, animals, or human beings (3(j)).
Microorganisms are patentable in India if they are not naturally occurring and are capable of industrial application. The Indian Patent Office has also issued examination guidelines to assess biotechnological inventions, emphasizing full disclosure and compliance with the exclusions.
Comparative Patentability Criteria
| Criterion | U.S. Approach | Indian Approach |
| Novelty | Evaluated globally through prior art. | Similar global standard. |
| Inventive Step | Requires a non-obvious technical leap. | Requires technical advancement or economic significance. |
| Utility | Broad and flexible interpretation. | Must be industrially applicable. |
| Disclosure | Detailed and reproducible description. | Same standard with emphasis on sufficiency. |
| Exclusions | Natural laws, phenomena, abstract ideas. | Includes plants, animals, diagnostics, and traditional knowledge. |
While both countries assess novelty and inventiveness similarly, India imposes far stricter exclusions based on ethical and socio-economic grounds.
Judicial Interpretation and Landmark Rulings
United States:
- Diamond v. Chakrabarty (1980): A breakthrough case where the Supreme Court held that a genetically modified bacterium capable of degrading oil was patentable. The Court famously stated that “anything under the sun made by man” is patentable, setting a liberal tone for biotech.
- Association for Molecular Pathology v. Myriad Genetics (2013): The Court ruled that naturally occurring DNA sequences are not patentable, although cDNA (synthetic DNA) is, reinforcing the distinction between discovery and invention.
- Mayo Collaborative Services v. Prometheus Labs (2012): The Court invalidated a patent on a method of measuring drug metabolites, deeming it a law of nature. This decision raised the bar for diagnostic method claims.
India:
- Dimminaco AG v. Controller of Patents (2002): The Calcutta High Court upheld a patent on a live vaccine, affirming that living organisms could be patented if produced through a process.
- Novartis AG v. Union of India (2013): The Supreme Court denied patent protection to Glivec, a cancer drug, under Section 3(d), ruling that mere discovery of a new form of a known substance without enhanced efficacy is not patentable. This landmark case emphasized access to essential medicines over monopoly rights.
Ethical, Policy, and TRIPS Considerations
Biotech patents carry significant ethical and policy implications. The U.S. system generally defers ethical considerations to regulatory bodies (like the FDA), allowing the USPTO to focus strictly on legal criteria. However, the scope of patent protection has sometimes raised ethical concerns, especially in areas like gene editing and synthetic biology.
In contrast, India integrates ethical scrutiny directly into its patent system. Section 3(b) allows the rejection of patents deemed contrary to morality or public order. This reflects India’s broader emphasis on public health and accessibility.
Both countries are TRIPS-compliant, but India exercises greater flexibility under Article 27.3(b), which permits exclusions for plants, animals, and essentially biological processes. The U.S., while formally compliant, often pushes for broader protections in international trade negotiations.
Patentable Subject Matter: Key Debates
Gene Patenting: While the U.S. permits synthetic gene patenting (cDNA), it disallows claims on naturally occurring genes. India, similarly, bars patents on naturally occurring genes and sequences but permits synthetic constructs that demonstrate technical innovation.
Human Embryonic Stem Cells and Life Forms: India explicitly excludes human embryos and genetically modified animals from patentability. The U.S. does not categorically exclude these but faces ethical challenges in granting such patents.
Diagnostic Methods: Following Mayo, the U.S. imposes stringent limitations on diagnostic method claims. India, meanwhile, excludes such methods under Section 3(i), precluding any patent on medical treatment procedures.
AI and Synthetic Biology: Emerging debates in both jurisdictions now include AI-generated biotech inventions and complex synthetic organisms. These pose novel challenges to traditional patent law, particularly around authorship, inventiveness, and reproducibility.
Challenges and Future Outlook
Legal Uncertainty: In the U.S., decisions like Mayo and Myriad have created uncertainty, particularly for diagnostics and personalized medicine. This deters investment and complicates patent strategies.
Restrictive Policies: India’s restrictive framework, while promoting access, may discourage biotech R&D and foreign investment. Startups in the Indian biotech sector often face hurdles in protecting their innovations.
Global Harmonization Issues: Diverging standards between jurisdictions complicate multinational patent filing and enforcement. For example, what is patentable in the U.S. may be rejected in India due to Section 3 exclusions.
Data Exclusivity and Patent Pools: India does not currently grant data exclusivity, unlike the U.S., which offers protection for clinical trial data. Meanwhile, global discussions on patent pools and open-access platforms for biotech innovations are gaining momentum.
Public Health Crises: The COVID-19 pandemic reignited debates around access to essential medicines and the role of IP in emergencies. India advocated for a TRIPS waiver, while the U.S. balanced voluntary licensing with IP protections. Future reforms must account for pandemic preparedness.
Conclusion and Recommendations
Patent law must balance the rights of inventors with the broader public interest. In biotechnology, where inventions impact fundamental aspects of life and health, this balance becomes even more delicate. The U.S. model favors incentivizing innovation through broad patent eligibility, yet faces criticism for enabling monopolies on life-saving technologies. India, conversely, prioritizes accessibility and ethical safeguards, but may undercut innovation and global competitiveness.
To navigate these tensions, both nations must refine their legal frameworks. The U.S. could benefit from clearer legislative guidance to restore confidence in patent eligibility, especially for diagnostic and bioinformatics tools. India should consider conditional patentability models that protect genuine biotech innovation while upholding public health imperatives.
Internationally, harmonizing standards for biotech patents, promoting technology-sharing platforms, and ensuring equitable licensing mechanisms will be essential. As biotechnology continues to evolve—through CRISPR, mRNA vaccines, AI-driven diagnostics, and beyond—legal systems must remain adaptive, inclusive, and fair.
A comprehensive approach that marries innovation with responsibility is not just a legal necessity—it is a moral imperative in the age of biotechnology.
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