This Article is written by SANJANA RAKHI KUJUR, AMITY UNIVERSITY, KOLKATA, BA.LLB(H), 3RD YEAR, during her internship with LeDroit India
LIST OF TOPICS COVERED :
1.Introduction
2.Background of the Case (Or: How a Swiss Company Learned Not to Mess with Indian Courts)
2.1 Timelines of the event
2.2 Legal journey through Indian Court
3. Understanding Section 3(d) and Patent Evergreening (India’s Anti-BS Filter)
3.1 What is Section 3(d)?
3.2 What is Patent Evergreening?
3.3 Why sec 3(d) exists ?
3.4 Why evergreening is a problem?
4. The Supreme Court’s Decision
5. Similar Case Laws
6. What Law Students Need to Learn
7. Conclusion
KEYWORDS: Novartis, Section 3(d), Patent Evergreening, Glivec, TRIPS Agreement, Pharmaceutical Patents
ABSTRACT
In 2013, the Indian Supreme Court delivered a landmark judgment in the Novartis AG v. Union of India case, rejecting the pharmaceutical company’s patent application for a modified version of the cancer drug called ‘Glivec’. The Court held that under Section 3(d) of the Patents Act, 1970, minor modifications to existing drugs do not qualify for patent protection unless they demonstrate significantly increased therapeutic value. This decision focused on the practice of patent evergreening, where pharmaceutical companies make small changes to existing medicines to extend their patent monopolies, similar to resubmitting old work with minor edits.
This article explains the Novartis case in simple, accessible language, covering the background of the dispute, the meaning and purpose of Section 3(d), what patent evergreening is and why it matters, the Supreme Court’s reasoning and final decision, and similar cases that followed the same principles. The paper also examines the judgment and its relevance for law students studying intellectual property and pharmaceutical law. The outcome ensured that cancer patients in India could continue accessing affordable generic versions of life-saving medicines, while establishing clear legal standards that pharmaceutical companies must meet when seeking patents in India.
INTRODUCTION
Picture this: You’re a massive pharmaceutical company. You’ve got billions of dollars. You’ve got lawyers on speed dial. You’re basically the Thanos of Big Pharma. Now imagine getting absolutely wrecked by a developing country’s courts. That’s basically what happened to Novartis in 2013.
The Novartis case is like if Apple tried to sell you the iPhone 12 as the “revolutionary iPhone 12S” because they changed the charging cable from white to black, and the Supreme Court of India said “we’re not buying it, literally.”
Here’s the situation: Novartis had a cancer drug called Glivec that cost ₹1.2 LAKHS per month (that’s “selling your kidney” expensive). Meanwhile, generic companies in India were making the exact same drug for ₹8,000-10,000. Novartis was obviously not happy about this competition and tried to patent a “new version” that was basically the same drug just arranged in a different crystal form. India’s Supreme Court looked at this attempt and said “nice try, but no” and rejected it.
For law students, this case is absolutely essential. It has drama, international pressure, life-or-death stakes for patients, and most importantly, it shows how law can actually protect ordinary people instead of just helping rich companies get richer. Whether you’re interested in intellectual property law, want to work in public health, or just enjoy seeing powerful corporations learn important lessons, this case is worth studying carefully.
The best part? This wasn’t just one company getting rejected. This case set a precedent that affected the entire pharmaceutical industry’s approach to patents in India. It’s like when your teacher catches one student cheating and then announces new rules for the entire class.
2. Background of the Case (Or: How a Swiss Company Learned Not to Mess with Indian Courts)
Glivec, called Gleevec in the United States, is a cancer drug for chronic myeloid leukemia. Basically, it’s the difference between life and death for cancer patients. The main ingredient is “imatinib mesylate” remember this name, it’s important.
Now here’s where it gets interesting. Novartis originally discovered imatinib in its “free base form,” think of it as the original version. Then they created a “beta crystalline form” which is like the same song but remastered. And they claimed this remastered version deserved a whole new patent.
The price difference tells the whole story:
- Novartis’s Glivec: ₹1,20,000 per month
- Generic versions: ₹8,000-10,000 per month, still expensive but not “sell your house” expensive
This is like if someone charged you ₹120 for chai and someone else sold the same chai for ₹8. You’d obviously pick the ₹8 chai, right? That’s what Indian patients wanted to do, but Novartis had other plans.
2.1 Timeline of Events
1998: Novartis files patent application in India
2005: India changes patent laws to allow drug patents because WTO said so
2006: Indian Patent Office rejects Novartis’s patent, first major setback
2006-2007: Novartis appeals to Madras High Court, even tried to say Section 3(d) was unconstitutional
2007: Madras High Court says Section 3(d) is totally constitutional, another setback for Novartis
2009: IPAB also rejects their appeal, third consecutive loss
2013: Supreme Court delivers the final rejection
2.2 Legal Journey Through Indian Courts
Imagine playing a video game where you keep losing but instead of learning, you just keep trying the same strategy. That’s basically what happened here.
Stage 1 – Patent Office: Novartis gets rejected under Section 3(d). They decide to appeal.
Stage 2 – Madras High Court: Novartis tries a new strategy which is attack, Section 3(d) itself! Says it’s unconstitutional and violates international law. Court says “nice try” and sends them back to Patent Office.
Stage 3 – IPAB: Novartis argues their version has “enhanced efficacy.” IPAB checks the evidence, finds no proof, rejects again.
Stage 4 – Supreme Court: Novartis pulls out all the stops. After 4 years of fighting, Supreme Court drops the hammer on April 1, 2013. Yes, April Fool’s Day—the universe has a sense of humour.
3. Understanding Section 3(d) and Patent Evergreening
3.1 What is Section 3(d)?
Section 3(d) is basically India’s filter for fake innovations. It says:
“You can’t patent something that’s just a new form of something we already know UNLESS it actually works significantly better.”
In simple terms: if you’re just repackaging the same thing, we’re not giving you a patent.
The law blocks these common tricks:
- Salts, esters, ethers – different chemical forms of the same molecule
- Polymorphs – same molecule, different crystal structure
- Combinations – mixing old stuff together
- Pure forms – cleaning up the original
It’s like saying “you can’t trademark Coca-Cola, Coca-Cola Zero, and Coca-Cola Diet as separate drinks unless they taste significantly different.”
3.2 What is Patent Evergreening?
Patent evergreening is when drug companies try to extend their patent monopoly by making tiny changes to existing drugs.
Imagine you write a hit song. You get 20 years of copyright. Right before it expires, you re-release it with a different beat and claim it deserves another 20 years. That’s evergreening.
The Connection: Section 3(d) exists specifically to stop this practice.
3.3 Why Section 3(d) Exists
India added Section 3(d) in 2005 for important reasons:
- Stop Fake Innovation: Companies were trying to extend patents by changing anything, the shape, colour, packaging. India said “this needs to stop.”
- Public Health Over Profits: India has 1.4 billion people, many living in poverty. Life-saving medicines need to be affordable.
- Promote Real Innovation: If you want a patent monopoly, invent something actually NEW.
- Use TRIPS Flexibility: International law allows countries some flexibility. India used it.
3.4 Why Evergreening is a Problem?
For Patients: People need drugs to stay alive but they cost ₹1.2 lakhs per month because companies keep extending patents. People die when they can’t afford medicine.
For Healthcare: Governments waste money on drugs that should be cheap by now.
For Generic Companies: They can make affordable versions but are blocked by patent games.
For Innovation: Instead of discovering new drugs, companies waste time repackaging old ones.
The Numbers:
- Original patent: 20 years of high prices
- With evergreening: Could extend to 30-40 years
- Price difference: Often 10-20 times more expensive than generics
- Impact: Millions unable to get treatment
4. The Supreme Court’s Decision (The Final Boss Battle)
Novartis came in HOT with these arguments:
“Our version has better properties!” Yeah, it’s more stable, doesn’t absorb moisture, easier to manufacture. The Court said “That’s great for YOUR factories, but does it cure cancer better? No? Then bye.”
It’s like claiming your new phone deserves a patent because it has a prettier box. The box isn’t the innovation though.
“We have 30% better bioavailability!” (Bioavailability = how much gets absorbed into the body)
Novartis said their version gets absorbed 30% better than the alpha form. Court said “But you didn’t compare it to the FREE BASE form, which is what patients were actually using. Try again.”
Big “I did better than my friend” energy when you were supposed to beat your own high score.
“Section 3(d) violates TRIPS!” Novartis claimed India was breaking international law. India said “Actually, TRIPS gives us flexibility, read the fine print.” Court agreed with India.
“‘Efficacy’ is too vague!”
Novartis: “What even IS efficacy? It’s unclear! Unconstitutional!”
Court: “For drugs, it means therapeutic efficacy and how well it treats disease”
“You’re discriminating against pharma!”
Novartis: “Section 3(d) only applies to drugs! That’s discrimination!”
Court: “Different industries can have different rules. Next.”
4.2 India’s Comeback (The Clapback Heard Round the World)
India came PREPARED with the receipts:
“Show us the therapeutic efficacy or take the L” India: “Your drug doesn’t treat cancer better. Better manufacturing? Cool story bro, not relevant. Show clinical trial data proving better treatment outcomes.”
Novartis: crickets
“We’re allowed to set our own standards” India: “TRIPS says minimum standards. We can be stricter if we want. Cope.”
This is like your school having stricter rules than the education board requires. Totally allowed.
“Efficacy is crystal clear” For drugs, efficacy = therapeutic efficacy. It’s not deep. It’s not vague. It’s straightforward.
The legal equivalent of “it’s not that complicated, you’re just overthinking it.”
“Public health matters” While not the main argument, India reminded everyone: cancer patients need affordable medicine. Patents shouldn’t be death sentences.
The moral high ground? Claimed.
“We’re fighting evergreening, not innovation” India: “If you make a genuinely better drug, we’ll patent it. If you’re just repackaging, we won’t. Simple.”
4.3 The Court’s Reasoning (When Logic Enters the Chat)
The Supreme Court, channelled through Justice Aftab Alam, delivered some ICONIC reasoning:
On Efficacy: “For medicines, efficacy means therapeutic efficacy. Better stability, better bioavailability.These are nice-to-haves. But do they make patients healthier? That’s the question.”
The Court wasn’t having any of Novartis’s “but it’s technically better” arguments. They wanted proof it cured cancer better. Spoiler: there was none.
On Section 3(d)’s Validity: “Section 3(d) is constitutional. It’s TRIPS-compliant. Countries can set higher standards. India chose to prevent evergreening. Valid.”
Court said “we’re protecting public health, not violating international law” and dropped the mic.
On Clarity: “‘Efficacy’ isn’t vague. In the pharmaceutical context, everyone knows it means therapeutic efficacy. Stop playing.”
Imagine trying to argue “hello” is too vague of a greeting.
On the Known Substance: “The original imatinib free base is the known substance. Your beta crystalline form is just a new form of that known substance. Section 3(d) applies. Case closed.”
On Public Interest: While the decision was based on law, not just policy, the Court acknowledged: millions of cancer patients depend on affordable Glivec. That context matters.
4.4 The Final Verdict (Novartis Left the Chat)
Supreme Court said:
- Section 3(d) is valid and constitutional
- For drugs, efficacy = therapeutic efficacy
- Novartis didn’t prove enhanced therapeutic efficacy
- Patent rejected
- Generic companies can keep making affordable Glivec
Novartis: 0 India:
Cancer patients: Can still afford medicine Generic companies: Can keep operating Indian courts: Established they don’t play Section 3(d): Validated and protected
- SIMILAR CASE LAWS
- F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2008)
Case Details: Roche sought to patent erlotinib hydrochloride, a lung cancer drug, and attempted to prevent Cipla from manufacturing generic versions.
Court Decision: The Delhi High Court rejected Roche’s patent application, holding that erlotinib hydrochloride was merely a salt form of the known substance erlotinib and did not demonstrate enhanced therapeutic efficacy under Section 3(d).
Legal Significance: This decision predated the Supreme Court’s Novartis judgment but applied similar reasoning, establishing that Section 3(d) applies not only to polymorphs but also to salt forms of known pharmaceutical compounds.
2. Bayer Corporation v. Union of India (2014)
Case Details: This case concerned compulsory licensing for Sorafenib (Nexavar), a kidney cancer drug priced at ₹2.8 lakhs per month. India granted a compulsory license to Natco Pharma to manufacture the drug at ₹8,800 per month.
Court Decision: The Bombay High Court upheld the compulsory license, affirming that even validly granted patents may be subject to compulsory licensing when medicines are priced beyond the reach of patients who need them.
Legal Significance: The judgment demonstrates that patent rights must be balanced against public health imperatives. When pharmaceutical companies exercise their monopoly rights in a manner detrimental to public health, national authorities may intervene through compulsory licensing mechanisms.
- Implications for Law Students and Legal Practice
For law students studying intellectual property law, the Novartis case provides essential lessons in pharmaceutical patent law and Section 3(d) analysis. Students must understand the fundamental patentability requirements which is novelty, inventive step, and industrial application along with Section 3(d)’s requirement that derivatives of known pharmaceutical substances demonstrate enhanced therapeutic efficacy.
The case teaches critical skills including analysing patent applications for evergreening strategies such as polymorph claims and salt forms, understanding evidentiary standards requiring clinical trial data, and recognizing when litigation becomes counterproductive.
Students must appreciate that pharmaceutical patent law involves balancing innovation incentives versus access to medicines, pharmaceutical profits versus public health, and international obligations versus domestic policy priorities. Legal practitioners may represent diverse stakeholders; pharmaceutical companies, generic manufacturers, public interest organizations, or government entities.
Understanding the Novartis precedent prepares students for careers in patent prosecution, litigation, corporate practice, public interest law, government service, academia, and international organizations. Students should reflect on ethical dimensions of pharmaceutical patent practice, particularly where client interests’ conflict with public health concerns, as these considerations inform career choices and professional identity development.
Conclusion
The Novartis AG v. Union of India judgment represents a landmark decision in Indian patent law, establishing clear standards for pharmaceutical patents under Section 3(d). The Supreme Court’s rejection of Novartis’s patent application for the beta crystalline form of imatinib mesylate affirmed that minor modifications to known pharmaceutical substances do not merit patent protection absent demonstrated enhanced therapeutic efficacy. This decision balanced innovation incentives with public health imperatives, ensuring continued access to affordable life-saving medicines for millions of patients.
The judgment’s principles have been consistently applied in subsequent cases, validating India’s approach to preventing patent evergreening while remaining compliant with international obligations under TRIPS. For law students and practitioners, this case exemplifies how judicial interpretation can harmonize intellectual property rights with fundamental public health needs.
