Patent Office Rejections of Pharma Patents in India: A review. Presented by Feroz Ali, Indian Institute of Technology.

1. Patent Office Rejections of
Pharma Patents in India:
A Review
Feroz Ali
IPR Chair Professor, Indian Institute of Technology Madras, India
Advocate, High Court of Judicature at Madras, India

2. Background: Indian Patent Law
• Importance of the Indian Example
• 1995-2005: Transition Period
• 3 Amendments: 1999, 2002 and 2005
• Compliant Changes: mail-box, EMR, 20 year term, product
patents for pharma
• Reactive Changes: patentability standard, Opposition, CL
• Post 2005, mail-box applications examined
• 4 Patent Offices

3. TRIPS Flexibilities in India
• Substantive Patent Examination
• Tests of Patentability: Novelty, Inventive step and Industrial
application
• Exceptions to Patentability: 15 exceptions
• Grounds of Revocation: 17 grounds
• How the flexibilities in India worked in practice
• First study on How India Rejects Patents

4. www.accessibsa.org

8. Explanation:
1. Early Oppositions alerted the Patent
Office
2. Examination First, Opposition Later
3. Secondary Patents (ever-greening)
4. Focus on Patent Office Reforms

9. Oppositions Alert Patent Office
Application of section 3(d) by the Indian Patent Office

11. Impact of Section 3(d)

12. What this means:
• Section 3(d) works well in combination than in insolation
• Comparative yardstick of section 3(d) similar to than the new
heightened standard of patentability [Amended definition of
inventive step] – “enhanced efficacy” “technical advance”
• Support system:
• Obligation to disclose foreign application and their status
• Heightened Patentability Standard
• Higher disclosure standards for secondary patents
• Co-operation between Patent Offices