All of us vividly remember the COVID-19 era, a time when almost everyone was confined to their homes, fearing the spread of the coronavirus. During this period, the world anxiously awaited a breakthrough—a drug or vaccine that could protect and cure those affected by the virus. Giant pharmaceutical companies were in a frantic race to develop this innovation, but the goal wasn’t just to save lives; it was also to fill their pockets. Let us make it simple with an example. Let’s say a single dose of vaccine costs us in rupees, but the pharmaceutical company has invested in crores for the research. How would companies fund their extensive research? The simple answer to this question is Patent.
Originally, patents were designed to reward innovators for their creations and to promote innovation that benefited mankind. It was only after signing the TRIPS (Trade-Related Aspects of Intellectual Property) agreement in 2005 that India started to give patents for drugs. Since the TRIPS agreement is primarily drafted by the western countries, it overlooks accessibility issues of developing countries, forcing them to abide by the law. In this blog, you will see how India has managed to put its people first despite signing the TRIPS agreement.
Table of Contents
What is a Patent?
The definition of patent at the official website of intellectual property India states that a patent is a statutory right for an invention granted for a limited period of time to the patentee by the government in exchange for full disclosure of his invention for excluding others, from making, using, selling, or importing the patented product or process for producing that product for those purposes without his consent.
For better clarity, a patent is like a special “no-sharing” rule granted by the government of a country to innovators. For example, you have created a brand-new, delectable cake recipe. If you decide to sell it, someone may attempt to sell it right away after discovering the ingredients. However, if you are awarded a patent, you will have the only authority to sell it, and anyone wishing to use your recipe must obtain your permission and pay you a fee in order to do so. Therefore, a patent is a reward for the inventor.
Innovation vs Accessibility
The process of discovering new methods, products, services, or solutions that have a positive impact on society is termed innovation. While accessibility can be defined as the practice of making information, activities, and environments sensible, meaningful, and usable for as many people as possible. If we coin the term innovation and accessibility with respect to medicine, then this clearly implies that if innovation is accessible, then only it can have meaning to billions of people on this planet.
Dr. Jonas Salk, the man behind the polio vaccine, proved that innovation and accessibility can coexist. Instead of seeking profit by patenting his innovation, he dedicated his breakthrough to the world by sharing his vaccine freely and helping countless nations, like India, to completely eradicate polio. Salk’s selfless act is a testament to the potential of science to benefit humanity without financial reward.
Innovation is meant to serve mankind, with the aim to alleviate human suffering. If the large pharmaceutical companies had not agreed to waive the patents for COVID-19 vaccines, the world might still be locked inside their houses.
In essence, innovation that is not accessible to those who need it loses its true value and purpose.
The TRIPS Agreement
What is a TRIPS Agreement?
The World Trade Organization (WTO) was established on January 1st, 1995, and one of its key components is the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS is one of the three pillars of the multilateral trading system, alongside agreements on goods (GATT) and services (GATS).
The TRIPS agreement allows its members to protect patents by setting minimum standards for intellectual property rights (IP). One of the main features of this agreement is that the patent holder can protect their rights through civil suits and can take a criminal action in case of patent infringement. This agreement helps in generation of innovation and its exchange globally.
TRIPS and Developing countries
The TRIPS agreement has been heavily criticized for mandating uniform rules across countries with vastly different needs. Developed countries that can invest more in research and invention are also home to a majority of IP rights holders. These developed nations often make up the TRIPS agreement and benefit from it, while developing nations often face disadvantages from it. Twenty billion dollars are transferred annually from developing nations that purchase technology to wealthy nations that sell it, according to a 2001 World Bank analysis.
The TRIPS agreement is heavily criticized for having unsuitable universal standards that apply to a wide variety of nations. Since wealthy nations that are also home to the majority of IP rights holders often make up the TRIPS agreement, these nations stand to gain from it. For developing nations, however, this is not the case.
Many commissions have emphasized that there should be different IP strategies for developing countries depending upon the level of development.
Challenges posed by TRIPS Agreement
Affordability of medicine
TRIPS rules for access to medicine are a nightmare for poorer countries. You see, before the TRIPS agreement, many countries did not patent medicine or provide less than 20-year protection after the introduction of medicine. After the TRIPS agreement was introduced, medicines became less affordable, and cheaper generic options were limited.
Limitations and loopholes
The few allowances that have been given by TRIPS to developing nations is insufficient and holds various limitations. Here are some of the challenges:
As per the TRIPS agreement, the developing countries can issue compulsory licensing.
Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself. Compulsory licensing (CL) is not always beneficial for developing countries. While it allows them to produce generic versions of patented drugs without the patent holder’s consent, it can also lead to serious consequences. These may include trade sanctions, legal challenges, and a reduction in foreign investment, as developed countries often retaliate against the use of CL.
TRIPS agreements have no policy against evergreening.
To put evergreening into simple terms, imagine a time when the wheel hadn’t yet been invented. Someone invents the wheel and patents it, meaning they can charge others for using their technology. Those who can afford it will benefit, possibly even in situations where they don’t need it, while the people who truly need this innovation but can’t afford it miss out. Now if the inventor, driven by greed, decides to make a tiny change to the wheel—like adding a small hole—and then patents it again, this extension doesn’t really benefit society. Instead, it keeps the innovation out of reach for many. This process of extending a patent or making minor alterations just to secure a new patent is what we call evergreening.
A case study: Neem Biopiracy
Neem is a very well-known tree in India. Because of its medicinal properties, it has been an integral part of Indian households. Its leaves, bark, and seeds are used in a wide range of applications, from treating ailment to acting as a natural pesticide. However, in the 1990s, there was a big controversy that highlighted the complex issue of intellectual property rights, traditional knowledge, and biopiracy. This controversy underscores the challenges faced by developing countries when their indigenous knowledge is stolen by foreign citizens without providing them compensation or acknowledgment.
What is Biopiracy?
For a clear understanding of this neem case, let us first understand what biopiracy is. Biopiracy refers to the use of biological material and associated traditional knowledge without the consent of or giving credit or compensation to the communities that have maintained the knowledge for the years. Let us understand Biopiracy with an example of Neem patent case of India.
Controversial case of Neem patent
In the year 1994, an American W.R. Grace filed a patent at the European Patent Office (EPO) for the fungicidal properties of neem oil. It was regarded as a breakthrough in the field of science, but neem has been used in India for its fungicidal property for years. EPO granted the patent to W.R. Grace for this innovation. This grant to patent sparked a widespread protest in India, as this was the traditional knowledge among Indians that has been followed for centuries. The outcry was so strong that EPO revoked the patent, acknowledging that the fungicidal property of neem was not a new invention but a traditional practice that had been in India for generations.
Broader implication of the Neem Biopiracy case
The absence of a law for biopiracy in the TRIPS agreement highlights the critical need for protection of traditional knowledge. This case reflects the importance of incorporating such protection of intellectual property rights. By framing laws against biopiracy, the TRIPS agreement will gain global trust and confidence. As developing countries heavily rely on their traditional knowledge and practice it on a daily basis, their inclusion in intellectual property rights will alleviate their feeling of marginalization and build stronger international partnerships.
India as a Model for Patent Policy
As we all know, Western nations drafted the majority of the TRIPS agreement, which makes it harder for developing nations to comply. The actual conflict emerges when the rights to health and intellectual property (IP) rights collide. When thousands of lives could be at risk, protecting the innovator is always exceedingly tough. Everyone has the right to health care, regardless of caste, nationality, or anything else. With this policy, I will provide a real-world example of how India upheld this principle and showed other nations that, even after signing the TRIPS agreement, a nation can still protect its citizens’ welfare.
The Glivec patent dispute (Evergreening thwarted)
Imagine a situation where IP rights are made stricter. In such a case, the price of essential, life-saving medicines could escalate, making them unaffordable for common people, specifically in developing countries. These nations already struggle with economic challenges, and higher drug prices would fuel issues like productivity loss and economic downturns.
To clarify this point, let us take a look at a case of Novartis Glivec in India highlighting the complexity between IP rights and public health.
Novartis developed a formulation of imatinib mesylate, an established medication used to treat chronic myeloid leukemia, back in 2006. Novartis patented the formulation in 35 countries and renamed it Glivec. Novartis attempted, but was unsuccessful, to patent the formulation in India. Novartis’ application was denied by an Indian patent official who explained that it was just a modification of the existing formulation and not a novel invention in accordance with Section 3(d) of the Indian Patent Act. This case is a classic example of evergreening.
An important thing to note here is that Glivec does not cure cancer, meaning that this medicine needs to be taken for a lifetime. Currently, the price of Imatinib is 350 rupees. If India had granted the patent for Glivec, the cost would have been 10 times higher, which means now it would have cost around 3500 rupees. In a country like India where 95% of people do not have health insurance, this surge in the price of medicine would be a financial burden on them. meaning that now a cancer patient would buy Glivec at 3500 rupees, and this he would require to buy for his lifetime. Novartis was not happy with the officer’s rejection and took the case to lower court to the Supreme Court of India, but faced rejection every single time.
Finally, in 2013, the Supreme Court of India ruled against Novartis, ensuring that this life-saving drug would be available to everyone at a more affordable price. This case is a prime example of how prioritizing the needs of the nation can lead to better outcomes for its people.
Conclusion
Though the TRIPS agreement was created to reward innovators and boost innovation, it is largely drafted by the developed countries, often making it hard for the developing countries to comply. Conflict arises when innovation and accessibility do not go hand in hand. This is not just a hypothetical debate; it has real-life implications, as seen in the Glivec case of India. India’s stand against Novartis serves as a powerful reminder to every developing country that public health must be a prime focus of every nation over corporate interests.
The concept of waiving patents in the public interest gained global interest during the COVID-19 pandemic when India, along with South Africa, pushed for a waiver of COVID-19 vaccine patents. Initially, pharmaceutical companies resisted, fearing how they would generate revenue that they had invested in the research, but once they agreed, it allowed countries around the globe to access life-saving vaccines. And when it comes to waving of patents, how can we forget the great Dr. Salk who did not patent the polio vaccine, which made eradication of patents possible.
When faced with the choice between adhering to international agreement or prioritizing its citizens, India chose the latter, standing firm despite global criticism. India’s stance serves as a powerful example for other developing countries, showing that rewarding innovation should not come at the cost of your people. Developed countries are rich due to centuries of exploitation of the developing countries; the least they can do is share the innovations in an affordable manner with the rest of the world.
