1. Introduction
Intellectual Property Rights are the rights provided for the protection of holders of Intangible property. They guarantee the security and protection of the intellectual property’s creators or inventors. It aims to strike a balance between security and fair competition. IPRs promote innovation and foster a competitive environment. Copyrights, Patents, Trademarks, and Trade secrets are all methods for providing intellectual property protection.
The pharmaceutical industry stands at a crossroads when innovation meets life-saving responsibility. On one hand, research and development (R&D) in the pharmaceutical sector is time-consuming, extremely expensive, and high-risk, while on the other hand, millions around the world depend on access to essential medicines, many of which have extremely high prices and become unaffordable due to patent protection. This has become an issue, especially for developing countries like India where the majority of the population falls into the lower-middle class category. They serve as a crucial incentive for innovation but also raise serious concerns about affordability and public health. The patent laws answer the question of whether a company’s right to profit from its invention outweighs a person’s right to access life-saving treatment.
2. The Role of Patents in Pharmaceutical Innovation
In the case of pharmaceuticals, IPR protection is especially crucial. Patents are legal protections granted to inventors, giving them exclusive rights to produce and sell their inventions for a fixed period, which is typically 20 years from the date of filing of Patent application. In the pharmaceutical world, patents allow companies to recover their research and development costs and other investment costs, to promote further innovation because, if the innovators are not incentivized then it will hamper their willingness and ability to make further research and invention. In the pharmaceutical industry, patents can be granted for both medicine and medical devices used for doing surgeries and treatment procedures. The average cost of developing a new drug can exceed $2 billion and take over a decade (including numerous clinical trials and regulatory hurdles) before it comes to market for sale and public use.
Patents give inventors and innovators a short-term monopoly that allows them to benefit from their creations and recover their investment without facing instant competition or worrying about genetic manufacturers copying and selling the same drug. Protection of drugs has led to life-saving breakthroughs in areas like HIV, cancer, and rare genetic disorders. Without the lure of patent protection, many pharmaceutical companies argue, such breakthroughs would be economically unviable. While patents reward innovation, they can also lead to monopolies that keep drug prices high and out of reach for large sections of the population, especially in low- and middle-income countries. This affordability crisis raises pressing ethical questions and the challenge lies in ensuring that the patent system does not become a barrier to access to essential and life-saving medications.
3. IPR and Drug Pricing: A Double-Edged Sword
The same patent system that promotes innovation can also restrict access. Patents prevent generic medicine producers from producing patented medications. With no generic competition during the patent term, companies often set high prices to maximize profits and recoup their investments. While this is legally justified by IPR laws, it makes life-saving drugs inaccessible to large parts of the population in low- and middle-income countries. The high prices become a barrier to public health, limiting government efforts to roll out widespread treatment programs efficiently. It affects the efficacy of the nation as a whole as the government has to spend a huge sum of money on public health which could have been allocated for some other public purpose if the drug prices were lower. This is even more problematic when patented drugs are not just for some treatments but rather are essential medicines.
For example: sofosbuvir, a breakthrough hepatitis C drug patented by Gilead. In the US, the initial cost of a 12-week course was more than $80,000. Although Gilead allowed generic versions in India allowing them to produce and sell sofosbuvir at lower prices, these agreements included restrictions on exporting the drug to certain countries.
Thus, IPR and Drug pricing is a double-edged sword, as while it protects and incentivizes the inventors at the same time the high drug pricing poses difficulties to the public in accessing the essential and life-saving drugs.
4. Public Health vs. Patent Protection
The tension between patent protection and public health has been the subject of global debate on intellectual property in the pharmaceutical industry. International law, specifically the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights), mandates patent protection but Article 31 of the TRIPS Agreement also provides certain flexibilities to protect public health. Compulsory licensing gives the government the power to produce a patented invention without the patent holder’s approval, usually in situations of public interest or national emergency. Later, the Doha Declaration on TRIPS and Public Health (2001) reaffirmed the Trips Agreement and allowed the member states to determine the grounds for granting compulsory licensing. The argument behind empowering compulsory licensing is does the innovation holds any value if it does not serve its purpose and reach the people who need it most. It also advocates that public health should not be seen as a threat to innovation but rather as an equally important goal that the intellectual property system must serve.
A landmark example is the Bayer v. Natco case (2012) in India. Bayer, a German Pharmaceutical Company invented and owned the patent for the cancer drug named Nexavar, priced at ₹2.8 lakhs per month. Indian pharmaceutical company approached Bayer for the grant of a voluntary license to manufacture the drug. After their request was denied they approached the controller of Patents to seek the grant of compulsory license. Natco was granted a compulsory license to sell a generic version for ₹8,800—a 97% reduction—making it far more accessible reason being Bayer’s failure to make the drug available at affordable prices. However, Natco Pharma was also asked to pay 6% royalties every quarter.
5. The Indian Patent Landscape
In the Indian system of patent protection, the protection is granted under the Indian Patents Act, of 1970. India’s approach to pharmaceutical patents is unique and often viewed as pro-public health that balances global obligations with domestic healthcare needs. Previously, India did not allow product patents on medicines, only process patents were permitted in the pharmaceutical sector. This enabled Indian drug manufacturers to legally reverse-engineer patented medicines by using alternative processes, leading to the rise of the Indian generic drug industry. As a result, India became the biggest supplier of low-cost, high-quality generics to other countries globally.
However, when India became a member of the World Trade Organization in 1995, it was required to make amendments to its patent laws to comply with TRIPS, including the provision for product patents. In response, India introduced significant amendments to its Patents Act and completed its transition from process patent to product patent in 2005. Now no process could be used to manufacture the patented drug. The generic drug manufacturers had to wait till the patent term was over to manufacture the low-priced drug. While the updated law allowed product patents, it also included key safeguards to prevent the abuse of patent rights and ensure continued access to affordable medicine. It includes the ban on patent evergreening in addition to the requirement for forced licensing.
One of its most significant legal tools that has been adopted by India is Section 3(d) which prevents the practice of evergreening of Patents. Evergreening of Patents means making minor modifications to existing drugs to extend their patent life. By introducing slight formulation changes, altering drug delivery mechanisms, or patenting secondary aspects of the drug (such as new dosages or combinations with other compounds), companies can effectively delay the expiration of their primary patents. This extended exclusivity period provides additional leverage for negotiating pay-for-delay agreements with potential generic competitors. The inventors argue that it acts as an incentive to continue innovation and come up with a more efficient drug than the already existing one but the opponents claim that the reason behind getting a patent over the same product is more economic rather than for the public good.
In the Novartis v. Union of India (2013) case. Novartis applied for a patent on the cancer medication Glivec, which is based on a new crystalline version of the well-known imatinib mesylate.
The Indian Supreme Court rejected the patent, citing Section 3(d), stating that the new version did not demonstrate enhanced therapeutic efficacy and is a tweaked form of an already existing substance. This case set a precedent for giving importance to access to medicines over incremental innovation with no actual increase in the efficacy of the drug.
India’s patent framework, especially the use of Section 3(d), compulsory licensing, and opposition procedures have helped maintain a balance between protecting innovation and promoting access and reflect India’s commitment towards an approach to intellectual property rights in the pharmaceutical industry that is more humane and equitable.
6. Global vs. Local Perspectives on IPR in Pharma
The global debate on IPR in pharmaceuticals often reflects economic and ethical issues. While the global IPR framework, particularly the TRIPS Agreement, sets a minimum standard for the protection of intellectual property, the interpretation and enforcement of these rights vary across nations depending on their healthcare systems, industrial capabilities, and public health needs. Developed countries and multinational pharma companies advocate for stricter IPR enforcement, arguing it fuels global R&D and promotes stricter TRIPS-plus measures. TRIPS-plus includes longer patent terms, data exclusivity, and tighter controls on generic competition, which go beyond the original TRIPS requirements. Meanwhile, countries like India, Brazil, and South Africa emphasize access and affordability. They oppose the TRIPS-plus Agreement and are reluctant to sign it. They also push for greater freedom to use legal tools like Sec. 3(d), compulsory licensing, parallel importation, and pre-grant opposition to manage the social and economic costs of IPR compliance.
7. Conclusion
The relationship between intellectual property rights and access to medicines represents one of the most complex and consequential dilemmas in global health and innovation. On one hand, patents are essential for incentivizing the long and costly process of innovation in the pharmaceutical industry, as without the promise of market exclusivity, many life-saving breakthroughs would have never reached the development stage. On the other hand, the same patent system can undermine public health by restricting access to essential drugs through high prices and monopolistic practices. This issue becomes even more problematic in low- and middle-income countries, where healthcare resources are limited and people have low economic ability. The goal should not be to abandon patents or undermine innovation, but to ensure it is responsive, flexible, and equitable. This includes promoting transparency in drug pricing, strengthening public-private partnerships, encouraging innovation for neglected diseases, and allowing for TRIPS flexibilities without fear of trade retaliation. Ultimately, a just and sustainable pharmaceutical ecosystem must balance the profit to inventors and innovators with the duty to care towards the public because access to life-saving medicines must not be like a luxury for the few but a fundamental right for all. Only by embracing this balance can we ensure a future where innovation and inclusion go hand in hand. Patents play a vital role in driving pharmaceutical innovation, but they must not become barriers to life-saving treatments.
