Section 3(d) of the Patent Act, 1970 is a major provision for medicines. It protects public interest while encouraging real innovation. Added in 2005 through the Patents (Amendment) Act, it responds to global rules under the TRIPS Agreement, which pushed India to update its patent laws. However, Section 3(d) of Indian Patent Act is created to stop “evergreening,” where drug companies make small changes to existing medicines to keep their patents longer without major improvements. This rule ensures only inventions with better results get patents. It balances rewards for new ideas with access to affordable drugs. For lawyers, understanding Section 3(d) is vital because it affects patent filings, court cases, and policy debates in India and beyond.
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Historical Background
The Patent Act, 1970, first allowed patents only for how medicines were made, not the medicines themselves. This helped India build a strong generic drug industry. In 1995, India joined the World Trade Organization (WTO) and had to follow the Trade Related Aspect of Intellectual Property Rights(TRIPS) Agreement, which required patents for medicines. The 2005 changes to the Act allowed these patents but added protections like Section 3(d).
Section 3(d) of Indian Patent Act came from worries about big drug companies using small changes to keep control of the market. India’s lawmakers wanted to stop evergreening, especially for life-saving medicines. The rule was shaped by global talks on patent quality and public health. It reflects India’s focus on affordable healthcare. Over time, court rulings have clarified how Section 3(d) works, making it a model for other developing countries fighting weak patents.
What is Section 3(d) of Indian Patent Act
To understand Section 3(d), we need to look at its exact words. The Act says that “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.
Explanation: For this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of a known substance shall be considered the same substance, unless they differ significantly in properties with regard to efficacy.”
This text lists what cannot be patented under Section 3, which covers things that don’t count as inventions. The explanation lists specific changes, like salts or polymorphs, that are treated as the same substance unless they show a big improvement in results.
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Interpretation and Scope of Section 3(d) of Indian Patent Act
Section 3(d) of Indian Patent Act, 1970 sets a high bar for patentability which ensures that only genuine innovations receive protection. It prevents the patenting of trivial modifications to existing substances, especially in pharmaceuticals, while promoting access to affordable solutions. This section explores its interpretation and scope, focusing on key concepts and their application across industries.
Defining 'Known Substance' and 'New Form'
A “known substance” in Section 3(d) is any compound already known to the public, whether patented or not. A “new form” includes changes like polymorphs or salts. Courts say that if a new form is very similar to the original compound, it falls under this rule. The person applying for the patent must prove the new form is an invention with real improvements, not just a discovery.
Enhancement of Efficacy
The main test is “enhancement of the known efficacy.” For medicines, efficacy means better healing effects. Improvements like better stability or easier absorption don’t count unless they lead to better treatment results. The Madras High Court says efficacy doesn’t need exact numbers but should be clear from evidence like clinical tests. This stops patents for small changes and ensures Section 3(d) supports real innovation.
Broader Application Beyond Pharmaceuticals
Section 3(d) is often linked to medicines, but it applies to any chemical substance. For example, in farming or industrial chemicals, efficacy could mean better function. Recent court rulings, like those from the Madras High Court, confirm that Section 3(d) works in many fields, stopping evergreening in areas beyond drugs.
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Landmark Judgements on Section 3(d) of Indian Patent Act
Section 3(d) of Indian Patent Act has been shaped by significant judicial decisions that interpret its application. The following cases shows the role of Section 3(d) in balancing between innovation and public access:
1. Novartis AG v. Union of India (2013)
Facts: Novartis AG, a Swiss drug company, applied for a patent in India for a specific form of Imatinib Mesylate, a medicine for chronic myeloid leukemia, sold as Gleevec. This form, called beta-crystalline, was said to dissolve better and stay stable longer than the original Imatinib, which was patented elsewhere. The Indian Patent Office rejected the application, saying it was just a tweak of an existing substance and didn’t improve treatment enough. Novartis argued that India’s patent law, Section 3(d), was unclear and didn’t follow international trade rules (TRIPS). After lower courts agreed with the rejection, the case went to India’s Supreme Court.
Issues: Does Section 3(d) of the Patents Act, 1970, follow TRIPS and India’s Constitution?
What does “efficacy” mean in Section 3(d)? Does it only mean better treatment results, or can improvements like better absorption count?
Is the beta-crystalline form of Imatinib Mesylate a new invention with better treatment results, or just a new version of an old substance?
Judgment: The Supreme Court upheld the rejection. It ruled that Section 3(d) is legal and follows TRIPS by stopping companies from extending patents with small changes, a practice called “evergreening.” The Court said “efficacy” means better treatment results, not just physical improvements like better absorption. Novartis didn’t prove the beta-crystalline form treated leukemia better than the original hence it could not be patented under Section 3(d) of Indian Patent Act. This judgement strengthened India’s focus on public health by limiting patents on minor drug changes.
2. Novozymes A/S v. Assistant Controller of Patents and Designs (2023)
Facts: Novozymes, a company, applied for a patent for variants of phytase, an enzyme used in animal feed to help digestion. They claimed these variants stayed stable at high temperatures. The Indian Patent Office rejected the application, saying the variants were just new forms of a known substance without better performance (under Section 3(d)) and were simple mixtures (under Section 3(e)). Novozymes appealed to the Madras High Court, showing data like Improvement Factor values to prove better heat stability.
Issues: Does Section 3(d) and its Explanation apply to biochemical substances like enzyme variants? Does the Explanation’s list of derivatives (like salts or polymorphs) include biochemicals?
What does “enhanced efficacy” mean for non-drug substances under Section 3(d)? Are small improvements enough?
Is the data on heat stability enough to meet Section 3(d) requirements?
Judgment: The Madras High Court allowed the appeal. It said Section 3(d)’s main rule applies to biochemicals, but its Explanation doesn’t, as the listed derivatives (like salts) are for man-made chemicals, not biochemicals like phytase variants. The Court said “enhanced efficacy” for biochemicals isn’t just about enzyme activity but includes benefits like heat stability which helps digestion by preventing breakdown. Novozymes’ data showed this improvement and no specific amount of improvement is needed. The invention was patentable, clarifying that biochemicals are treated differently from drugs under Section 3(d).
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Impact of Section 3(d) of Indian Patent Act on the Pharmaceutical Industry
Section 3(d) has had a big impact on India’s drug industry, often called the “pharmacy of the world.” By stopping evergreening, it lets generic drug makers produce affordable medicines, helping people in developing countries. Critics say it discourages small improvements that could still be useful. Big drug companies argue it hurts foreign investment but Indian companies gain from fair competition. Since 2005, patent applications in India have increased but many are rejected under Section 3(d) for lacking real improvements. Globally, this rule shapes debates on TRIPS flexibilities and inspires similar laws in other countries.
Criticisms and Debates
Section 3(d) is praised but also criticized for being unclear. Words like “enhancement” and “efficacy” aren’t clearly defined, leading to uneven use. Big drug companies say it breaks TRIPS rules by adding an extra test beyond newness, creativity and industrial use. Proving efficacy often requires clinical trials, which can ruin novelty if shared too soon. Some suggest clearer guidelines from the patent office or changes to include non-healing benefits like better storage. Debates also focus on economic effects: Section 3(d) protects public health but might slow research in areas like drug delivery, where Indian firms are strong.
Summary
Section 3(d) of Indian Patent Act, 1970 shows the focus on a fair patent system that puts public health first. By requiring clear improvements in results, it stops weak patent claims while rewarding true inventions. Lawyers need to understand both science and court rulings to work with this rule. As global patent rules change, Section 3(d) stands out as a model for fair intellectual property laws. It ensures innovation helps society. Future changes could make it clearer, but its main goal of stopping evergreening keeps essential technologies accessible.
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Section 3d of Indian Patent Act: FAQs
Q1. What is Section 3 of the Indian Patent Act with example?
Section 3 lists what cannot be patented in India, like a new use of a known drug (e.g., using aspirin for heart disease is not patentable).
Q2. What is Form 3 in the Indian Patent Act?
Form 3 is a statement and undertaking filed by patent applicants to disclose foreign patent applications for the same invention.
Q3. What is Section 3(b) of the Indian Patent Act case law?
Section 3(b) bars patents for inventions against public morality; in Dimminaco AG v. Controller (2002), a vaccine process was patentable as it wasn’t immoral.
Q4. Which inventions are not patent eligible subject matter under Section 3 of the Indian Patent Act?
Inventions like discoveries, trivial modifications, immoral or harmful methods, and traditional knowledge are not patentable under Section 3.
Q5. What is Section 3(c) of the Indian Patent Act?
Section 3(c) prevents patenting mere discoveries of scientific principles or natural substances, like isolating a plant extract without modification.
