Novartis A.G. v. Union of India
Supreme Court on Section 3(d), therapeutic efficacy, and India’s stand against evergreening.
novartis-ag-v-union-of-india
Quick Summary
Novartis sought a patent for the beta-crystalline form of imatinib mesylate (Gleevec). The Patent Office and IPAB said it failed Section 3(d). The Supreme Court agreed. The Court read “efficacy” in Section 3(d) as therapeutic efficacy. Better properties like stability or flow do not, by themselves, prove better treatment. The claim was rejected to prevent evergreening.
Issues
- Does the invention meet Section 3(d) of the Patents Act, 1970?
- What does “efficacy” mean under Section 3(d) for medicines?
Rules
- Section 3(d): For known substances, only a new form that shows enhanced therapeutic efficacy is patentable.
- Traditional tests still apply: Novelty, inventive step, and industrial application remain necessary but not sufficient for such claims.
- Anti-evergreening aim: The provision is designed to stop minor tweaks that extend monopoly without real treatment benefit.
Facts (Timeline)
Patent filing: Novartis applied in India for the beta-crystalline form of imatinib mesylate (Gleevec) used for GIST and CML.
Rejection by IPO: Patent Office refused the application. Reason: no proof of significantly enhanced therapeutic efficacy under Section 3(d).
IPAB (2007): Found novelty and non-obviousness, yet held the claim hit by Section 3(d).
SLP: Novartis challenged IPAB before the Supreme Court.
Outcome: Supreme Court dismissed the claim for failing the Section 3(d) test.
Arguments
Appellant (Novartis)
- The beta-crystalline form is improved: better stability, flow, and bioavailability.
- These features, they argued, justify a patent.
- They claimed practical benefits in dosage and patient use.
Respondent (Union of India)
- The substance is a new form of a known medicine.
- No data proves enhanced therapeutic efficacy in patients.
- Granting a patent here would enable evergreening.
Judgment (Supreme Court of India)
- “Efficacy” in Section 3(d) for drugs means therapeutic efficacy.
- Improved bioavailability by itself does not prove improved therapeutic effect.
- Incremental pharma inventions must show enhanced therapeutic outcome.
- Patent claim rejected: Section 3(d) not satisfied.
Citation: AIR 2013 SC 1311.
Ratio (Core Principle)
For medicines, only improvements that lead to better therapeutic results can cross the Section 3(d) bar. Cosmetic or physico-chemical gains are not enough.
Why It Matters
- Protects access to medicines by curbing evergreening.
- Gives a clear standard to examiners and courts.
- Signals India’s public-interest approach in pharma patents.
Key Takeaways
- Section 3(d) demands enhanced therapeutic efficacy for new forms of known drugs.
- Bioavailability ≠ therapeutic efficacy (not automatically).
- Anti-evergreening policy is central to Indian patent law.
Mnemonic + 3-Step Hook
Mnemonic: “HEAL > FEEL” — law cares about how the drug heals, not how it feels.
- Health outcome must improve (therapeutic).
- Evidence must show better treatment, not just better form.
- Anti-evergreening: minor tweaks don’t pass.
IRAC Outline
| Issue | Does the beta-crystalline form of imatinib mesylate satisfy Section 3(d)? What does “efficacy” mean here? |
|---|---|
| Rule | Section 3(d): only new forms with enhanced therapeutic efficacy are patentable; regular tests also apply. |
| Application | Data showed improved properties (e.g., bioavailability), but not a proven increase in therapeutic outcome for patients. |
| Conclusion | Section 3(d) not met; patent refused to prevent evergreening. |
Glossary
- Therapeutic Efficacy
- Actual improvement in treatment outcome for the patient.
- Evergreening
- Extending monopoly by patenting minor changes to a known drug.
- Bioavailability
- How much and how fast a drug enters the bloodstream; not always equal to better therapy.
- IPAB
- Intellectual Property Appellate Board (now abolished), earlier heard patent appeals.
FAQs
What did Section 3(d) require in Novartis?
A higher bar for patentability: show enhanced therapeutic efficacy, not just better properties.
Did improved bioavailability prove efficacy?
No. The Court said bioavailability alone does not prove better treatment results.
Why is it important for access to medicines?
It curbs evergreening, keeping prices in check and promoting generic entry.
What was finally decided?
The patent claim was rejected for failing the Section 3(d) test.
What is the exam-friendly punchline?
Incremental pharma patents in India need proof of better therapy—not just better chemistry.
Popular & Recent Post
Comment
Nothing for now