Bringing out the circumstances in 2005 which forced amendment to the section 3(d) in Indian Patent Law,…

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Bringing out the circumstances in 2005 which forced amendment to the section 3(d) in Indian Patent Law, 1970, discuss how it has been utilized by the Supreme Court in its judgement in rejecting Novratis' patent application for 'Glivec'. Discuss briefly the pros and cons of the decision.

Ghissu Editorial · Accepted Answer

Section 3(d) was tightened in 2005, when TRIPS forced product patents on medicines, to stop evergreening, and the Supreme Court used it to reject Novartis's Glivec patent. It held that beta-crystalline imatinib was a new form of a known drug without enhanced therapeutic efficacy.

**Introduction**

When TRIPS required product patents on medicines from 1 January 2005, the affordable generics that made India the pharmacy of the developing world faced a serious threat. Section 3(d) was Parliament's safeguard, and the Glivec case its defining test.

**Circumstances Behind the 2005 Amendment of Section 3(d)**

1. **TRIPS deadline**: The transition ended on 1 January 2005, so the Patents (Amendment) Act, 2005 brought in drug product patents and opened the mailbox applications.
2. **Evergreening and Doha**: To stop monopolies on trivial variants such as salts or crystal forms, and using the Doha Declaration (2001), Parliament denied patents to new forms of known substances unless they enhance "known efficacy".

**How the Supreme Court Used Section 3(d) Against Glivec**

SKETCH: timeline | Glivec Patent Journey
- 1993 :: Imatinib patent filed
- 1998 :: Mailbox application
- 2006 :: Chennai office rejects
- 2009 :: IPAB rejects
- 2013 :: Supreme Court rejects

1. **Known substance**: In Novartis AG v Union of India (2013), the Court held beta-crystalline imatinib mesylate a mere new form of imatinib, disclosed earlier.
2. **Therapeutic efficacy**: For a medicine, efficacy meant therapeutic efficacy, and the claimed 30% higher bioavailability was not shown to improve treatment, so the claim failed.

**Gains and Costs of the Glivec Verdict**

1. **Pros**: Generic imatinib stayed at a fraction of Glivec's reported Rs 1.2 lakh a month, and the ruling showed that TRIPS flexibilities can be used lawfully.
2. **Cons**: Critics, including US Special 301 reviews, said it deters incremental innovation, and the undefined efficacy test breeds uncertainty.

**Conclusion**

The judgment affirmed that patents reward genuine invention, not tweaks to old molecules. Clear efficacy guidelines would protect access to medicines while encouraging real innovation.

Bringing out the circumstances in 2005 which forced amendment to the section 3(d) in Indian Patent Law, 1970, discuss how it has been utilized by the Supreme Court in its judgement in rejecting Novratis' patent application for 'Glivec'. Discuss briefly the pros and cons of the decision.

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