Court: Supreme Court of India
Date of Judgment: 1st April 2013
Bench: Justice Aftab Alam and Justice Ranjana Prakash Desai
Citation: (2013) 6 SCC 1
Introduction
The Novartis case is one of the most significant and controversial judgments in Indian patent law. It marked a crucial turning point in how India balanced intellectual property rights with public health obligations. At its heart, the case centered on Novartis’s attempt to patent a modified version of a cancer drug called Glivec (Imatinib Mesylate). The Supreme Court’s decision drew global attention for reinforcing India’s commitment to preventing evergreening and promoting affordable access to medicines.
Background of the Case
Novartis AG, a Swiss pharmaceutical company, had developed the anti-cancer drug Glivec, used primarily to treat Chronic Myeloid Leukemia (CML) and certain gastrointestinal cancers. The active pharmaceutical ingredient was Imatinib Mesylate. Although the base compound was discovered earlier, in 1998 Novartis filed a patent application in India for a specific crystalline form of the salt—known as the beta crystalline form of Imatinib Mesylate.
India’s amended Patents Act (post-TRIPS) allowed pharmaceutical product patents from 2005 onwards. Novartis’s application was among those held in a “mailbox” awaiting examination. When examined, the Indian Patent Office rejected the application in 2006, citing Section 3(d) of the Patents Act, which prohibits patents for new forms of known substances unless they demonstrate enhanced efficacy.
Novartis challenged the decision before the Madras High Court, questioning not just the rejection but also the constitutionality of Section 3(d). The Madras High Court upheld the constitutionality of the provision. The matter then reached the Supreme Court, which delivered its landmark ruling in 2013.
Legal Issues Involved
Whether the beta crystalline form of Imatinib Mesylate qualifies as a patentable invention under the Indian Patents Act.
Whether Section 3(d) of the Indian Patents Act violates the TRIPS Agreement or is unconstitutional under Indian law.
Whether the new form of the known substance results in enhanced therapeutic efficacy, as required by Section 3(d).
Arguments by Novartis
The company claimed that the beta crystalline form of Imatinib Mesylate was not merely a new form of a known substance but a true invention, being more stable, more soluble, and having improved bioavailability.
It argued that improved bioavailability implies enhanced efficacy, and the compound should therefore qualify for patent protection.
Novartis contended that Section 3(d) was vague, arbitrary, and unconstitutional, and did not comply with India’s obligations under the TRIPS Agreement.
The company also claimed that denying such patents would discourage innovation and deter investment in India’s pharmaceutical sector.
Arguments by the Respondents
The beta crystalline form of Imatinib Mesylate was a slightly modified version of a previously known substance and did not offer any significant therapeutic advantage.
They argued that improved properties such as better flow, stability, or bioavailability do not amount to increased therapeutic efficacy.
Section 3(d) was introduced as a public health safeguard to prevent evergreening—a strategy where companies extend patent monopolies through minor modifications.
NGOs like the Cancer Patients Aid Association emphasized that granting the patent would limit access to affordable generics, affecting thousands of cancer patients in India and globally.
Judgment
On April 1, 2013, the Supreme Court of India dismissed Novartis’s appeal and upheld the decision of the Indian Patent Office to reject the patent. The Court interpreted “efficacy” under Section 3(d) as therapeutic efficacy—meaning the drug must demonstrably produce a better therapeutic effect in patients. Improved physical properties like better solubility or stability, even if proven, would not satisfy this requirement unless they resulted in better therapeutic outcomes.
The Court concluded that Novartis had failed to demonstrate any enhancement in therapeutic efficacy of the beta crystalline form over the known substance. It ruled that Section 3(d) does not violate the Constitution of India or the TRIPS Agreement and serves a legitimate public interest by ensuring that patents are granted only for true inventions, not for minor tweaks to existing drugs.
Significance and Impact
This judgment was hailed globally as a landmark in the struggle between intellectual property rights and access to medicines. By denying the patent, the Court allowed Indian generic manufacturers to continue producing affordable versions of Glivec, which would otherwise have cost patients over ₹1,20,000 per month as opposed to the generic price of around ₹8,000.
It reaffirmed India’s commitment to public health safeguards under the Doha Declaration on TRIPS and Public Health (2001), which affirms the rights of WTO members to protect public health and promote access to medicines for all.
The case also set a strong precedent by defining how Section 3(d) should be interpreted in the context of pharmaceutical inventions. It clearly differentiated between genuine innovations deserving of patent protection and incremental changes that do not enhance the substance’s therapeutic efficacy.
Globally, the decision was seen as a bold stance, especially from a developing country, asserting its right to define patentability standards in a way that suits its socio-economic context.
Conclusion
The Supreme Court’s ruling in Novartis AG v. Union of India is a landmark in Indian legal history and global pharmaceutical regulation. It emphasized that patent law in India is not just about promoting innovation but also about protecting public health. The case became a symbol of resistance against the pharmaceutical industry’s practice of evergreening and was instrumental in ensuring continued access to life-saving drugs at affordable prices.
India’s interpretation of patent law—especially the stringent requirements of Section 3(d)—has since influenced other developing countries exploring ways to balance patent rights with access to medicines. The decision continues to be cited in international debates on health, innovation, and intellectual property.