Intellectual property (IP) law often raises the question of how to incentivize pharmaceutical innovation while ensuring that patients have access to life-saving treatments. India, commonly known as the “pharmacy of the developing world” embodies this irony. India has been providing millions of people in Africa, Asia and Latin America cheap generic drugs for years. However, it also needs to balance promoting innovation against meeting its international obligations under the World Trade Organization TRIPS Agreement. Drug patent law necessarily involves a trade-off between two competing goals: protecting the investment of innovators and promoting public health. This challenge continues even 20 years after India reintroduced product patents. India’s patent process, modelled by specific laws and daring court rulings, has become a global model for negotiating the competing interests of innovation and access. Its decisions have had a critical influence on debates in countries like South Africa and Brazil. This post sets out some like-minded views, puts India’s pharmaceutical patent law history under scrutiny once again and reflects on what obstacles lay in a fast-changing “patent puzzle”.

Introduction:

India has always taken a unique stance on pharmaceutical patent laws driven by the idea that the price of change should not be human life. For decades, the country has turned to a balancing act that seeks to promote research while keeping life-saving medications affordable, both at home and in developing countries around the globe. The equilibrium of this balance is evident from significant developments such as the Supreme Court’s ruling in the Novartis case denying its claim to exclusive rights over the cancer drug Glivec; the issuing of a compulsory license to sell Bayer’s Nexavar at a much lower price and India’s proactive role in the COVID-19 global response, advocating for a TRIPS waiver to ensure greater accessibility to vaccines worldwide. These rulings are significant because they reach far. It’s a model that depicts how other countries are facing their own externalities in health care such as Brazil and South Africa, have borrowed from India’s approach. At the core, this is not just about patents; it is about fairness, dignity, and justice in global health.

India's Pharma Patent System: Priority Access

A key departure from the past was observed in the Patents Act, 1970. Product patents in pharmaceuticals were proscribed, while process protection was narrowed. This reform led to the establishment of a generic pharmaceutical industry with the Indian companies inventing alternate processes for manufacturing patented medicines. India had become, by the 1990s, a key source of inexpensive drugs for maladies ranging from malaria to tuberculosis to HIV/AIDS. However, India was also under an obligation under the WTO to comply with the

TRIPS Agreement. India not only permitted product patents but incorporated public health safeguards into the Patents Act in 2005. The strongest shield was offered by Section 3(d) which bars patent of new forms of known drugs, unless it shows enhanced efficacy. This clause seeks to halt ‘evergreening,’ a practice often used, by drug companies to extend patent monopolies by making small changes. India has also created pre and post-grant opposition processes which allow competitors, patients, and civil society members to challenge weak or wrongful patent applications. As a consequence, the system was more sensitive to the public interest and more open to view.

Novartis and the Meaning of Efficacy:

Novartis AG v Union of India (2013), was the most authoritative reading down of Section 3(d) of the Indian Patents Act,1970 by the Supreme Court. Novartis argued that a crystalline form of the anticancer drug Glivec increased bioavailability and obtained a patent. This contention was refuted by the Court, which said that therapeutic activity had not been demonstrated based on bioavailability alone. As a result, the ruling slashed the expense of leukaemia treatment for patients by guaranteeing that generic forms of Glivec would remain accessible. It also established a significant precedent: patents should be granted only for genuine inventions, not for small adjustments. The ruling was opposed by multinational corporations, who claimed that it deterred investment. In contrast patient advocacy organizations celebrated it as a victory for the right to health. Policymakers outside India, such as those in Argentina and the Philippines, viewed Section 3(d) as a model for thwarting ever-greening, demonstrating how India's strategy influenced international intellectual property standards.

Compulsory Licensing: Natco v. Bayer:

When India issued its first obligatory license in Natco v. Bayer (2012), it once again made headlines throughout the world. Most Indian patients cannot afford Bayer's cancer medication Nexavar, which costs more than ₹2.8 lakhs a month. Natco was able to produce a generic version with a 97% price reduction because of the mandatory license. This case demonstrates that public health must take precedence over intellectual property rights in India. The precedent is still strong, even though India has hardly ever granted obligatory licenses since. Later, using India as an example, Brazil and Thailand implemented mandatory licensing.

COVID-19 and the TRIPS Waiver Debate:

Global access to medications has been received renewed attention since the COVID-19 pandemic. In 2020, India and South Africa together requested a temporary suspension of TRIPS commitments for vaccinations, treatments, and diagnostics. Their logic was straightforward: IP regulations should not prevent access in the event of a worldwide health emergency. Developed nations resisted the waiver, claiming that rapid innovation requires IP safeguards. In 2022, the WTO granted limited exemptions for vaccinations following protracted discussions. By 2023, efforts to apply the waiver to diagnostics and treatments had ceased and even as it did so, the Indian government reiterated the importance of equitable access. Valuable lessons about the pros and cons of aligning intellectual property laws and public health needs can be drawn from the experiences of South Africa and Brazil.

Comparative Insights: Brazil and South Africa:

During the HIV/AIDS crisis of the early 2000s, Brazil was in the vanguard of attempting to negotiate a compulsory license. Brazil could do little more than threaten and, in a few cases, actually grant compulsory licenses in the face of exorbitant prices on the part of the global pharmaceutical corporations for life-saving antiretroviral medicines. These were good negotiating points as well as legal steps as they opened the way for Brazil to haggle down prices with large drug companies. Many lives were saved and Brazil’s national AIDS program was expanded as a result of this tactic. Brazil’s approach was consistent with that of India, whose policy is to prioritize public health over strict patent enforcement. But Brazil’s bold experiment came with downsides. The threats of trade reprisal were constant, and the United States and the European Union condemned Brazil for what they believed was an aggressive contravention of intellectual property rights. In demonstrating that a developing country could challenge the pharmaceutical giants, Brazil also revealed the limits of the strategy under the unique conditions of international trade.

The tale of South Africa’s trajectory, on the other hand, is a very different one although no less significant. For much of the 1990s and the early part of the 2000s, South Africa had one of the most permissive patent regimes in the world, granting patents with little oversight. The conclusion was predictable that few had the privilege to access HIV/AIDS and other disease treatment, and drugs were not accessible. Public health campaigners and a backlash from some organisations have forced a rethink in government. The South African Intellectual Property Policy (2018–2038) was approved after years of policymaking and appeals. This made it considerably more difficult to obtain a patent, and created mechanisms for opposition before and after grant respectively.

Thanks to these modifications, the South Africa's system now more closely resembles India's public health-friendly model. Additionally, forming a coalition among Global South nations on IP law and public health was aided by South Africa and India's co-sponsorship of the COVID19 TRIPS waiver request.

When taken as a whole, Brazil, South Africa, and India's experiences show how the Global South is beginning to resist the broad adoption of Euro-American patent rules and trade retaliation has occasionally resulted from Brazil's audacious use of coercive licensing. Bureaucratic delays and institutional capacity are problematic in South Africa. India is frequently criticized for its inadequate investment in pharmaceutical R&D. These incidents demonstrate that although the Global South is redefining intellectual property law standards, the way forward is convoluted, contentious, and full compromises.

Challenges Ahead - 2025 and Beyond:

As it seeks to enhance its position as a champion of pharmaceutical innovation and guardian of access, India faces several interrelated obstacles in the future. The first significant obstacle is increasing innovation. Despite its success in generating generics, India still lags behind world powers such as the United States and China in pharmaceutical research and development. This disparity is both structural and financial. In addition to the lack of adequate research infrastructure, Indian biotech businesses have difficulty obtaining sufficient venture financing. In order to transform from the "pharmacy of the developing world" to a pharmaceutical hub,

India needs to maintain a climate conducive to clinical research and innovative drug discovery, in addition to ensuring that it fulfils its mandate for the delivery of health care to all those who need it.

The second challenge comes from trade and diplomacy. India has often been in conflict with rich nations like the United States over its patent regulations. Acknowledging that several of its IP protection measures have been proven to be inefficient in protecting foreign innovators, India has been named as a "Priority Watch List" country in the USTR's Special 301 Report for many years now. Public interest safeguards in favour of health, however, are consistently under attack in India. It’s a delicate dance between domestic and international priorities capitulating would limit access, while holding out would invite trade offensives.

The last impediment is remaining the leader in global health governance. But while COVID19 has confirmed that India is the source of relatively low-cost drugs and vaccines, it has also revealed numerous cracks in its processes and supply chains. In the future, India should prove its capabilities as an innovative powerhouse and assert itself as a reliable generic source. Continuation of leadership will require deft diplomacy, continued legal innovation and significant investment in health infrastructure.

Conclusion:

A powerful example of how the law can be used to find a balance between innovation and fairness is India's patent system for pharmaceuticals. In its intellectual property framework, India gives priority to public health. From the Novartis case to the Nexavar compulsory licensing and the negotiation of a TRIPS waiver during the COVID-19 pandemic, India has consistently prioritized public health. This dedication has helped not only India's people but also millions of others living in the Global South who are reliant on inexpensive drugs. More fully narrating the background here supplies a far more complex picture as demonstrated by South Africa's recent changes and Brazil's heavy use of compulsory licensing. The Global South is setting international IP norms rather than just accepting them passively. All three of these countries, each in its own way, are contributing to shaping global conversation toward making the intellectual property regime responsive to social justice and public health demands this century. But the way ahead is difficult. South Africa's administrative problems, Brazil's friction with trade forces, and India's new shortage of innovation all show clearly how tenuous this alternative paradigm is. Nevertheless, a more vital reality is revealed by the steadfastness with which these countries support frameworks aimed at increasing access that intellectual property law has always been a contest, and it is a responsive realm. In order to prosper in the new century, India needs to maintain both of these identities, which is remaining the world's largest exporter of affordable generics and simultaneously become a centre for pharmaceutical innovation. In the twenty-first century, this should be India's living example as it strives to harmonize its intellectual property rights legislation with human welfare while retaining its role as "the pharmacy of the developing world."

Author :- Akshata Singh, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.

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