QUESTION 14
GS3
10 marks
Bringing out circumstances in 2005 which forced amendment to Section 3(d) in Indian Patent Law, 1970, discuss how it was used by the Supreme Court in rejecting Novartis’ patent application for ‘Glivec’. Discuss briefly pros and cons of the decision.
WRITE IN
7 min
200 words
What the examiner wants
Explain why Section 3(d) was amended in 2005, how the Supreme Court used it against Novartis' Glivec patent, and the decision's pros and cons.
Bring out; DiscussAnswer exactly what the question asks.
Demand-wise check
- 1Circumstances: TRIPS deadline (1 January 2005) forced product patents for drugs; Patents (Amendment) Act 2005 added the 'enhanced efficacy' test to 3(d) to block evergreening≈35 words
- 23(d) rule: new forms of a known substance (salts, polymorphs, esters) are the same substance unless they differ significantly in efficacy≈35 words
- 3Supreme Court use: beta-crystalline imatinib mesylate was a new form of a known drug; 'efficacy' means therapeutic efficacy; better bioavailability alone is not enough≈35 words
- 4Pros: affordable generics for India and Africa, upholds TRIPS flexibilities. Cons: US Special 301 pressure, claimed chill on R&D and drug launches≈35 words
Open in about 30 words and close in about 30.
Answer plan
TRIPS and 2005 amendmentMeaning of 3(d)Novartis facts and holdingProsConsConclusion
Where marks usually go
- Not explaining that 'efficacy' was read as therapeutic efficacy
- Skipping why the amendment was needed in 2005
Draw this
- Timeline: 1995 TRIPS → 2005 amendment → 2006 rejection by Patent Office → 2007 Madras HC → 2013 Supreme Court
Value addition
- CaseNovartis AG v Union of India (1 April 2013): Glivec patent rejected under Section 3(d).Supreme Court, 2013
- CaseMadras High Court (2007) upheld Section 3(d) as constitutional and TRIPS-compatible in Novartis' challenge.Madras High Court, 2007
Next: plan for one minute, write it in 7 minutes, then get it checked.