Innovation or Inhibition: The Legal Maze Where Patent Law Collides with Healthcare Affordability and Constrains Biomedical Research

“The true purpose of law in healthcare should not be about what law seeks to protect but it is rather about preservation of life & this must be enforceable as a justiciable right upholding principle of humanity.”

Abstract

The biomedical sector represents one of the most dynamic and consequential realms of scientific progress, directly affecting the survival, health, and dignity of individuals across the globe. The legal protection of biomedical innovations through patent law is often justified as a necessary mechanism to incentivize research and development. Yet, when applied without ethical balance, patent exclusivity can restrict access to essential medical treatments and impede collaborative scientific growth. This paper critically examines the contradictions embedded within the Indian and global patent regimes, particularly focusing on how patent law intersects with public health needs and biomedical research. Through an analysis of legislative frameworks, judicial decisions, ethical considerations, and international trade obligations, this paper highlights the tension between promoting innovation and ensuring healthcare affordability. Ultimately, the paper calls for a nuanced recalibration of patent law that balances public welfare with scientific advancement.

Keywords

Biomedical Patenting, Compulsory Licensing, TRIPS Agreement, Right to Health, Healthcare affordability, Beneficence, Non-maleficence, Evergreening, Therapeutic efficacy.

Introduction

Biomedical innovation has the potential to revolutionize public health by producing life-saving drugs, vaccines, diagnostic tools, and therapeutic methods. However, such innovation frequently demands significant investment and scientific risk. Patent law is therefore designed to reward inventors through temporary monopolies that prevent unauthorized replication of their inventions. This model arguably fosters innovation by promising economic returns.

Yet, biomedical inventions differ fundamentally from other forms of intellectual property. They directly concern human life and health—domains where access cannot be governed purely by market logic. When patents drive up drug prices or hinder research collaboration, they do not merely restrict commercial freedom; they may delay treatment, exacerbate health inequalities, and cost lives.

India’s position is particularly complex: it is both the “pharmacy of the Global South” and an emerging biomedical research hub. The challenge lies in maintaining affordable access to medicines while also encouraging domestic innovation. However, India’s patent regime—especially after adopting product patents under TRIPS compliance—reveals deep tensions between innovation and public interest, making biomedical patenting a legal and ethical maze.

Patent Law in the Biomedical Context

Patent grants an inventor of a novel market invention with exclusive rights to manufacture, use and commercialise his invention for a confined period of typically 20 years. In case of patentability of any bio-medical research in order to qualify as a patent protection in India, the invention must meet the core standards as laid down under the Patents Act, 1970. The Act ascertains following criteria in the respective provisions:

• The invention requires to be novel meaning it has not been previously published, used, or disclosed anywhere in the world.
• The creation must involve an inventive step under Section 2(1) (ja), demonstrating a technical advancement over existing knowledge or possessing economic significance that renders it non-obvious to a person skilled in the relevant scientific field.
• The innovation must possess industrial applicability, ensuring that the invention is capable of being made or used in a practical and reproducible manner.

However, biomedical patents often raise distinct challenges.

Complexities in Biomedical Patent Protection

Biomedical patents often raise distinct challenges because of the unique nature of medical innovations and their direct connection to human life. Unlike ordinary commercial products, medicines, vaccines, and diagnostic tools are fundamental necessities, and restricting their availability through patent exclusivity risks limiting lifesaving treatment to only those who can afford it. Furthermore., the ethical principles that govern medical practice, such as beneficence and non-maleficence,¹ conflict with situations in which treatment is withheld or delayed due to prohibitive pricing.

• Beneficence Requires that healthcare decisions prioritize patient well-being, meaning access to essential medicines should not be restricted solely for commercial benefit.
• Non-maleficence Requires avoiding harm, which is compromised when patent-driven pricing makes life-saving treatments inaccessible.

Beneficence and non-maleficence do not reject the legitimacy of biomedical patenting, but they place ethical boundaries on how far commercial rights may extend when the preservation of human life is at stake. These principles call into question the patent practices that result in harm by limiting affordability or delaying access to essential medicines. Therefore, these principles call for a balance where innovation is rewarded without compromising the fundamental right to healthcare.

Key Patent-Relevant Provisions

The Patents Act, 1970 incorporates specific provisions that directly shape the regulation of biomedical inventions in India and several safeguards to ensure that pharmaceutical patents serve public welfare rather than merely commercial advantage.

• Section 2(1)(j): Defines an invention.
• Section 2(1) (ja): Defines inventive step.
• Section 3(d): Restricts patenting of new forms of known substances unless enhanced therapeutic efficacy is proven.
• Section 84: Provides for compulsory licensing in public interest.

Section 3(d): Public Health Safeguard or Scientific Roadblock?

Section 3(d) holds a central place in the Indian patent framework as a measure designed to prevent evergreening² which is a practice where pharmaceutical companies attempt to extend monopoly protection by making only minor modifications to existing drugs. Under this provision, new forms or derivatives of known pharmaceutical substances are patentable only when they demonstrate a genuine enhancement in therapeutic efficacy. From a public health perspective, this safeguard is vital because it curbs artificial monopolies, facilitates the entry of affordable generic medicines into the market, and supports broader access to essential drugs. However, from the scientific research standpoint, biomedical innovation does not always emerge through dramatic breakthroughs; it often advances gradually through improvements in solubility, stability, shelf life, dosage efficiency, and mode of administration—all of which can meaningfully improve patient outcomes. The challenge lies in the fact that the term “therapeutic efficacy” remains scientifically contested and administratively difficult to interpret uniformly. As a result, while Section 3(d) reflects a strong ethical commitment to public health, its strict and sometimes rigid application may inadvertently discourage incremental, yet valuable, biomedical advancements.

Case: Novartis AG v. Union of India, (2013) 6 SCC 1³

Novartis sought a patent for the beta-crystalline form of Imatinib Mesylate (Glivec), a drug used in the treatment of chronic myeloid leukemia. The company argued that the improved form had better bioavailability and therefore should be considered a new invention. However, the Supreme Court held that improved bioavailability alone does not satisfy the requirement of “enhanced therapeutic efficacy” under Section 3(d).

The Court emphasized that Section 3(d) was intentionally included to prevent evergreening and to ensure that patents are granted only for true medical advancements, not for minor modifications of existing drugs.

Section 84 as Commercial intrusion while ensuring social welfare

Section 84 of the Patents Act, 1970 ⁴allows the government to grant a compulsory license to another manufacturer to produce a patented drug when the patent holder fails to make the medicine reasonably affordable, sufficiently available, or accessible to the public. This provision is designed to ensure that commercial monopoly does not override public health needs, particularly in cases where life-saving treatments are priced beyond the reach of most patients. Through compulsory licensing, the law seeks to strike a balance between protecting the patent holder’s investment and upholding the broader social obligation to ensure access to essential medicines.

While Section 84 serves an important public welfare function, it also has implications for the inventor or patent holder. Setbacks for the Inventor can be:

• Reduced monopoly period limiting exclusive market control.
• Lower profit margins due to competition from licensed manufacturers.
• Decreased return on research investment, especially for high-cost drug development.
• Potential disincentive for future innovation in biomedical research.
• Risk of market value decline for patented products.

Case: Bayer Corporation v. Natco Pharma Ltd., (2015) 2 SCC 732⁵

This case is landmark first compulsory licensing case in India wherein the Bayer Corporation owned the patent for the cancer drug Nexavar (Sorafenib Tosylate) and sold it at a price which can’t be accessible to most Indian patients. The Nacto Pharma applied for the compulsory licensing under section 84 to sell the same drug in at a lower price. 

The Controller General of Patents granted the license, and the decision was later upheld by the Intellectual Property Appellate Board (IPAB) and the Supreme Court. The apex court was of the view that affordability and public access as legitimate grounds for compulsory licensing, reinforcing that patent rights cannot override the right to health.

International Context: TRIPS & Doha Declaration

The TRIPS Agreement ⁶introduced globally binding standards for pharmaceutical patents, reshaping how nations regulate access to medicines within international trade frameworks. While this harmonization was justified on the ground that strong patent rights stimulate innovation, it simultaneously raised concerns regarding equity and public health, particularly in countries with limited healthcare resources. The Doha Declaration (2001)⁷ sought to address this tension by affirming that TRIPS should be interpreted in a manner that supports public health, explicitly recognizing the right of states to issue compulsory licenses and adopt other measures to ensure affordable access to essential medicines. However, the practical use of these flexibilities has often been constrained by political and economic pressures exerted by multinational pharmaceutical corporations and high-income nations, revealing a structural imbalance in how global patent norms operate. Thus, while the international framework formally acknowledges public health priorities, its real-world implementation often reflects power asymmetries that reinforce restricted access, especially for low-income populations—making the debate on patent protection not only legal, but deeply ethical and developmental in character.

International intellectual property frameworks such as the TRIPS Agreement are often presented as neutral trade standards, yet their implementation tends to disproportionately benefit countries with advanced pharmaceutical industries. The global south states frequently face diplomatic pressure, trade threats, investment sanctions, or withdrawal of market benefits from economically powerful states and multinational corporations.

Ethical and Medico-Legal Conflicts

Biomedical patenting generates deep ethical dilemmas:

Right to Health vs. Right to Profit

The right to health prioritizes unrestricted access to essential medicines, while the right to profit supports patent exclusivity and high pricing to recover research investment. The conflict emerges when commercial pricing decisions prevent patients from receiving timely and affordable treatment.

Medical Ethics vs. Commercial Secrecy 

Medical ethics requires beneficence and non-maleficence, meaning treatment should promote well-being and avoid harm. However, commercial secrecy protects proprietary drug data and formulas, which can restrict research collaboration and delay access to life-saving innovations. This creates a tension between ethical transparency and corporate confidentiality. Excessive patent exclusivity can force doctors to choose between treating patients and respecting market price barriers, placing medical professionals in moral jeopardy.

Life as a Human Right vs Right to Intellectual Property⁸

The conflict arises between right to life and right to intellectual property when patent-based pricing prevents access to life-saving treatment, placing commercial rights in direct tension with the fundamental human right to health and life.

Positive Impacts of Patents on Biomedical Research

• Stimulate Research and Development: Patents offer exclusive rights that help companies recover high R&D costs associated with drug discovery and clinical trials.
• Encourage Innovation: Guaranteed time-limited market control incentivizes researchers and pharmaceutical companies to pursue new therapeutic breakthroughs.
• Promote Scientific Disclosure: Patent applications require full disclosure of the invention, adding to the global pool of scientific knowledge and enabling further advancements.
• Facilitate Investment: The promise of future returns encourages public and private investors to fund high-risk biomedical research.

Negative Impacts of Patents on Healthcare Affordability and Access

• Increase Drug Prices: Exclusive monopoly rights often lead to high pricing, making essential medicines unaffordable for large populations.
• Restrict Generic Production: Patents delay the entry of lower-cost generic alternatives, prolonging periods of limited access.
• Limit Research Collaboration: Strict IP protection can discourage knowledge sharing and restrict cumulative innovation, which is vital in biomedical science.
• Create Inequitable Health Outcomes: Monopoly control over life-saving treatments reinforces disparities between wealthy and low-income patients and countries.
  

The Way Forward: Suggestions

Clarification 

There should be a clear and simple scientific definition of what counts as a real improvement in a medicine. This will stop companies from getting new patents for small, useless changes while still allowing patents for improvements that genuinely help patients. This can be done by clarifying statutory terms like what “Therapeutic Efficacy” means under (Section 3(d)).

Accessibility 

Compulsory licensing should be seen as a normal way to protect public health, not something used only in emergencies. If the process is made easier, and if fair pricing rules are clearly defined, life-saving medicines can become more affordable and available without stopping companies from doing research.

Collaboration 

The government and universities should fund more medicine and vaccine research so that we are not fully dependent on large private companies. This can be enabled by Supporting Public and Open-Source Medical Research. When research findings are shared openly, it encourages teamwork, lowers the cost of new treatments, and ensures that medical progress benefits the public, not just the market.

Conclusion

Patent law in the biomedical field must strive to encourage innovation without compromising access to essential healthcare. While patents are necessary to support and reward scientific progress, they cannot be allowed to create barriers that prevent patients from receiving life-saving treatment. India’s legal safeguards, such as Section 3(d) and compulsory licensing, show an effort to protect public interest, but these measures must continue to be strengthened and applied thoughtfully. Moving forward, the patent system should be guided by the principle that innovation has value only when it serves human well-being. A balanced approach—protecting research while ensuring affordability—offers the most sustainable and ethical path ahead.

References

1. Novartis AG v. Union of India, (2013) 6 SCC 1.
2. Bayer Corp. v. Natco Pharma Ltd., (2015) 2 SCC 732.
3. The Patents Act, 1970, § 3(d) (India).
4. The Patents Act, 1970, § 84 (India).
5. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, 1869 U.N.T.S. 299.
6. World Trade Organization, Doha Declaration on the TRIPS Agreement and Public Health, ¶ 4, Nov. 14, 2001.
7. Beauchamp & Childress, Principles of Biomedical Ethics (Oxford Univ. Press, 2019).
8. Universal Declaration of Human Rights, art. 25, G.A. Res. 217A (III), U.N. Doc. A/810 (1948).
9. International Covenant on Economic, Social and Cultural Rights, art. 12, Dec. 16, 1966, 993 U.N.T.S. 3.

FOOTNOTES

1. Beauchamp & Childress, Principles of Biomedical Ethics (Oxford Univ. Press, 2019). ↩︎
2.  Patents Act, 1970, § 3(d) (India). ↩︎
3. Novartis AG v. Union of India, (2013) 6 SCC 1. ↩︎
4. Patents Act, 1970, § 84 (India). ↩︎
5. Bayer Corp. v. Natco Pharma Ltd., (2015) 2 SCC 732 ↩︎
6. Agreement on TRIPS, Apr. 15, 1994. ↩︎
7. Doha Declaration, WTO Ministerial Conf., Nov. 14, 2001. ↩︎
8. Universal Declaration of Human Rights, art. 25, G.A. Res. 217A (III), U.N. Doc. A/810 (1948). ↩︎