indian-patent-law-section-3d
indian-patent-law-section-3d

Indian Patent Law Section 3d: Preventing Evergreening & True Innovation

Section 3(d) of the Patents Act, 1970, is a key part of India’s intellectual property system especially for the pharmaceutical industry. It aims to ensure that only truly innovative inventions receive patent protection by preventing minor tweaks to existing products from being patented a practice called "evergreening." This section is particularly important because it helps make affordable generic medicines available in India, a country where access to healthcare is critical. This article explains Indian Patent Law Section 3d, covering its text, purpose, important terms, court rulings, criticisms, and its impact on pharmaceuticals and other industries.

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What Does Indian Patent Law Section 3(d) Say?

Section 3(d) of the Patents Act, 1970, is a rule that stops people from patenting minor changes to existing substances, like drugs, unless those changes significantly improve how well the substance works (its "efficacy"). For example, new forms of a known substance—such as different salts, crystal structures (polymorphs), or other variations like esters, isomers, or combinations are treated as the same as the original unless they show a clear improvement in effectiveness. It also prevents patenting new uses or properties of known substances or using known processes, machines, or tools unless the process creates something new or uses a new ingredient. This rule helps ensure that only truly innovative changes get patent protection, preventing companies from extending patents with small tweaks to keep prices high.

Why Does Indian Patent Law Section 3(d) Exist?

The main goal of Indian Patent Law Section 3(d) is to stop the evergreening of patents. Evergreening happens when companies try to extend their patents by making small changes to existing products, like creating a new form of a drug (e.g., a different salt or crystal structure) without improving its actual benefits. This can delay the production of affordable generic drugs, which are vital for people in India and other developing countries. By requiring new forms of known substances to show "enhanced efficacy," Section 3(d) ensures that only meaningful innovations get patent protection, balancing innovation with public access to medicines.

Also, Get to Know About Rights under Patent Law.

Key Terms Explained

To understand Indian Patent Law Section 3(d) let’s break down its most important terms in a simple way. These terms make it clear that Section 3(d) sets a high standard for patenting new versions of known substances especially in the drug industry

1. New Form of a Known Substance: This refers to modified versions of an existing substance. Examples include:

  • Salts: Changing a drug's chemical form, like turning an acid into a sodium salt.

  • Esters: A chemical change where a hydroxyl group is replaced with an alkoxy group.

  • Polymorphs: Different crystal structures of the same substance.

  • Metabolites: Substances created when the body processes a drug.

  • Isomers: Molecules with the same formula but different structures.

  • Other forms like pure forms, particle sizes, or combinations are also included. These are treated as the same as the original substance unless they show a big improvement in efficacy.

2. Enhanced Efficacy: For a new form to be patentable, it must work significantly better than the original. In pharmaceuticals, this usually means it must have a better therapeutic effect, like treating a disease more effectively, reducing side effects, or acting faster.

3. Efficacy: The law doesn’t define this term exactly, but a major court case (explained below) clarified that for drugs, efficacy means therapeutic efficacy—how well the drug produces the desired health outcome.

Read about Revocation of Patent.

The Novartis Case: A Landmark Ruling

The most important court case about Section 3(d) is Novartis AG v. Union of India (2013). This case involved Novartis, a pharmaceutical company, trying to patent a new form of a cancer drug called Imatinib Mesylate (used in Gleevec). They claimed this beta-crystalline form was better because it had improved bioavailability (how well the body absorbs it) and stability.

The Indian Patent Office rejected the patent, saying the new form didn’t show enhanced therapeutic efficacy as required by Section 3(d). Novartis challenged this decision, arguing that Section 3(d) was unclear and violated international trade rules (the TRIPS agreement). The case went all the way to the Supreme Court of India which made a historic ruling in 2013

  1. Section 3(d) is valid and aligns with TRIPS: The court said India’s laws take precedence over international agreements, and TRIPS allows countries to set their own patent rules.

  2. Efficacy means therapeutic efficacy for drugs: Improvements like better absorption (bioavailability) don’t count unless they lead to better health outcomes.

  3. No patent for Novartis: The beta-crystalline form didn’t meet the enhanced efficacy standard because there was no proof it worked better therapeutically.

This ruling set a strong precedent making it harder to patent minor drug changes in India and reinforcing focus on public health.

Other Important Cases

Other court cases have helped clarify how Section 3(d) works:

  • Chugai Seiyaku Kabushiki Kaisha vs Controller of Patents (2022): The Delhi High Court rejected a patent for a method to make a Tofogliflozin tablet (a diabetes drug) using direct compression. The court said this method didn’t improve therapeutic efficacy, suggesting it was an attempt to evergreen the patent.

  • Nippon Steel v The Controller General of Patents (2024): This case wasn’t about pharmaceuticals but about a method and device for repairing gas flues. The Delhi High Court overturned the Patent Office’s rejection under Section 3(d) because the decision lacked clear reasoning and didn’t follow proper procedures. This shows that Section 3(d) applies to other industries and that patent rejections must be fair and well-explained.

These cases show that Section 3(d) is used consistently but also highlight importance of clear and fair decision-making by patent authorities.

Impact on the Pharmaceutical Industry

Indian Patent Law Section 3(d) has had a big impact on pharmaceuticals in India:

  • It makes it harder to patent new forms of existing drugs unless they offer clear therapeutic benefits. This pushes companies to focus on developing entirely new drugs rather than tweaking old ones.

  • Companies may avoid filing patents in India for minor changes due to the strict rules, or they may need to provide strong evidence of therapeutic improvements.

  • By limiting evergreening, Section 3(d) helps India produce affordable generic medicines, benefiting people in India and worldwide.

Beyond Pharmaceuticals: Other Industries

While Section 3(d) is best known for its role in pharmaceuticals, it applies to all technologies. The Nippon Steel case shows it can affect industrial processes, like methods for repairing equipment. The principle preventing patents for minor changes without significant improvements can influence patent decisions in many fields.

Summing Up

Indian Patent Law Section 3d is a powerful part of India’s patent system. It ensures that only genuine innovations get patent protection preventing companies from extending patents through minor changes. The Novartis case clarified that for drugs, "efficacy" means therapeutic benefits setting a high standard for patentability. While some criticize Section 3(d) for being vague or limiting innovation it strikes an important balance between rewarding inventors and ensuring public access to affordable medicines. As India grows as a hub for innovation, Section 3(d) will continue to shape its patent landscape promoting real progress while keeping essential goods accessible.

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Indian Patent Law Section 3(d): FAQs

Q1. What is Indian Patent Law Section 3(d)?

Section 3(d) of Patents Act prevents patenting new forms of known substances unless they significantly improve efficacy, aiming to stop evergreening, especially in pharmaceuticals.

Q2. What is Section 107A of the Patent Act?

It allows activities like research, experimentation, or exporting patented products for regulatory approvals without infringing the patent, supporting generic drug development.

Q3. What is Section 121 of the Patent Act?

It allows the Controller to issue certificates confirming a patent’s validity if it’s upheld in court, making the patent stronger.

Q4. What is Section 47 of the Patent Act?

It allows the government to use patented inventions for public purposes or grant licenses under certain conditions to ensure public access.

Q5. What is Section 48 of the Patent Act?

It gives patent holders exclusive rights to stop others from making, using, selling, or importing their invention without permission.



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