Indian Pharmacy IP Act
#IndianPharmacyIPAct
India’s pharmacy-related Intellectual Property (IP) laws, particularly as they apply to pharmaceuticals, are primarily governed by the Indian Patent Act, 1970, which has undergone major amendments to comply with the World Trade Organization (WTO)’s TRIPS Agreement.
Here’s a structured overview:
India Pharmacy – Intellectual Property & Patent Act Overview
1. Governing Law
• The Patents Act, 1970
• Key amendments: 1999, 2002, 2005
• Administered by the Controller General of Patents, Designs & Trade Marks (CGPDTM)
2. Key Features of Indian IP Law (as applied to Pharma)
Provision Description
Section 3(d) Prevents evergreening of patents by rejecting new forms of known substances unless they show enhanced efficacy. Crucial for pharma.
Product Patents Allowed for pharmaceuticals since 2005 (TRIPS-compliant). Prior to that, only process patents were allowed.
Compulsory Licensing (CL) India allows compulsory licenses under Section 84 in cases of public need, affordability, or non-working of a patent.
Patent Term 20 years from filing date (TRIPS standard)
Pre- & Post-Grant Opposition Third parties can oppose patent applications before and after grant.
3. Section 3(d): The Most Controversial Clause
This clause has made India a model for access to affordable medicines:
What it says:
“The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is not patentable.”
Impact:
• Prevents “evergreening” — i.e., extending patent life by minor tweaks (e.g., salts, isomers)
• Used to reject Novartis’ patent on Gleevec (imatinib mesylate) in 2013
• Ensures generic competition and affordable drugs, especially in HIV, cancer, and TB
4. Compulsory Licensing in India
First and most famous case:
• Natco vs. Bayer (2012)
• Bayer’s patented cancer drug Nexavar (sorafenib) cost ₹2.8 lakh/month
• Natco given a compulsory license to sell it at ₹8,800/month
• Natco had to pay 6% royalty to Bayer
Grounds for CL:
1. Drug not made available at reasonable price
2. Drug not available in adequate quantity
3. Patent not “worked” (i.e., manufactured) in India
5. TRIPS & Indian Compliance
India complied with the TRIPS Agreement in stages:
Year Change
1995 Became WTO member (TRIPS applies)
1999 “Mailbox” provision introduced for pharma product patents
2005 Full product patent protection granted for pharmaceuticals and agrochemicals
India still uses TRIPS flexibilities to protect public health, in line with the Doha Declaration on TRIPS and Public Health (2001).
6. Criticisms & Praise
Group Perspective
Multinational pharma (Pfizer, Novartis, Bayer) Critical of India’s strict patent regime (especially Section 3(d) & CL)
Global health organizations (MSF, WHO, UNITAID) Praise India as “Pharmacy of the Global South” for affordable generics
US Trade Representative (USTR) Puts India on “Priority Watch List” annually for IP issues
7. Related Laws & Regulations
Law/Act Relevance
Drugs and Cosmetics Act, 1940 Regulates manufacture, sale, and distribution of drugs
Trade Marks Act, 1999 Brand protection for drugs
Biological Diversity Act, 2002 Affects patents involving Indian genetic material
Pharmacy Act, 1948 Regulates pharmacists, not IP directly
Summary
Feature India’s Approach
Patent Type Product & Process
Pharma Patents Allowed since 2005
Compulsory Licensing Yes (Natco-Bayer case is precedent)
Evergreening Prevention Strong (Section 3(d))
Public Health Focus Very high
TRIPS Compliance Yes (with use of flexibilities)
Would you like:
• Case studies (e.g., Gleevec, Nexavar, HIV drugs)?
• Comparative view with China or Brazil?
• Summary of Indian pharma generic patent strategies?
Let me know how deep you’d like to go!
