Introduction

Novartis is a pharmaceutical company that produces a wide range of medicines and health products. It developed a cancer treatment drug called Gleevec, also known as Imatinib. When Novartis applied for a patent in India, the Novartis patent bid raised critical legal and ethical questions. This case sparked a global debate on balancing intellectual property rights with the need for affordable medicines. India ultimately denied the patent rights, stating that minor changes to existing drugs should not justify exclusive protection especially when it affects public access and pricing.

Facts and Procedural History

In the year 1998, Novartis filed a patent application for the beta crystalline form of Imatinib mesylate, one of the active ingredients in Gleevec. According to them, this new form gets absorbed by the body easily. 

But the Madras Patent Office rejected this application, stating section 3(d) of India’s Patent Act, that is:

“Sec 3 (d) What are not inventions:  The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

According to the patent office, the Beta-crystalline form does not have a huge improvement over the original Imatinib Mesylate. After this, Novartis challenged the constitutionality of section 3(d), saying it does not align with an international trade agreement, which was further challenged in the Supreme Court. The court upheld the validity of section 3(d), ensuring access to affordable medicines.

Legal Issues Raised

The main issue was whether imatinib mesylate met the criteria of “enhanced efficacy” under Section 3(d) of the Indian Patents Act. This means that Novartis’ claim that the new variant was different from the original form was difficult to prove and incorrect. 

Novartis claimed that Section 3(d) of the Indian Patents Act was going against the international trade agreement TRIPS, as it was stricter than what the international agreement has stated. It was mentioned that this section puts pharmaceutical companies at a disadvantage.

In this scenario, developing countries focus on a balancing act. They strive to incentivise pharmaceutical innovation and access to affordable medicines. In this process, developing countries end up having stricter patent laws in comparison to developed countries. 

Judgment and Reasoning

The Supreme Court agreed with the lower court that the beta-crystalline form of Gleevec does not meet the enhanced efficacy requirement of section 3(d). The Supreme Court also specified that this section is perfectly designed for Indian law and aims at preventing Evergreening. That is, companies modify the original version when it is about to expire. The main purpose is to keep their monopoly on the drug and charge a high price for a long time.

The Supreme Court emphasised that just because the drug is easy to work with chemically, this does not mean it is the best for the patients.

Impact and Precedent

Though the pharmaceutical companies were opposing this judgment, it was a big win for public health advocates. This concept of a life-saving drug at an affordable price was largely appreciated. This set a precedent, showing India will never compromise easy access to essential medicines. This influenced other developing countries to implement similar policies, and with this, India’s role as a supplier of affordable drugs came into the picture. It also sets a precedent that limiting patent protection for minor modifications ensures that essential medicines remain accessible.

Critical Analysis

Novartis AG v. Union of India (2013) is a perfect balance of protection of intellectual property rights under TRIPS and ensuring easy access to affordable medicine for the public, as stated in the DOHA Declaration. That says that the state can prioritise public health over patents when it comes to medicines. This was essential for developing countries, as it ensures that citizens get access to life-saving treatments. 

One think tank also believes that such strict patent rules will discourage pharmaceutical companies from inventing in research and development. Many also worry that this patent restriction will make companies focus on countries with lenient regulations, which will slow down the development of improved drugs for diseases that affect people in developing countries like India. 

Conclusion

Novartis AG v. Union of India played a role as a landmark judgment in Patent law. This is a perfect blend of commitment towards public health and international obligations. This ruling focuses on the pharmaceutical company. India, being a developing country, made it clear that companies should also solve social issues and not just be able to make corporate profits. To add to this, the Supreme Court made it clear that India will protect innovation but will not do so at the cost of public access to essential goods and services, especially in the case of life-saving medications. 

Reference

1. Novartis AG v. Union of India, (2013) 6 S.C.C. 1 (India).
2. The Patents Act, No. 39 of 1970, § 3(d), India.
3. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, 1869 U.N.T.S. 299.
4. Ellen’t Hoen, The Global Politics of Pharmaceutical Monopoly Power (2013).
5. Novartis Ag v. Union of India & Ors, (2013) 6 SCC 1, available at, https://indiankanoon.org/doc/165776436/