Context: High Court refused to grant interim injunction to Novo Nordisk against Dr. Reddy’s Laboratories (DRL) over alleged infringement of semaglutide-related patents.
About Semaglutide
- Active Pharmaceutical Ingredient (API) used for Type-2 diabetes and obesity treatment.
- Marketed by Novo Nordisk as Ozempic (diabetes) and Wegovy (weight loss).
- API = the component that produces the intended therapeutic effect.
Why the Injunction Was Denied?
- Court observed that Novo Nordisk’s additional patents involved minor variations of semaglutide.
- These variations may constitute evergreening, hence not eligible for strong interim protection.
Evergreening of Patents
- Strategy to extend patent monopoly beyond the 20-year term by:
- New forms, salts, polymorphs
- New dosages or delivery systems
- Minor modifications without improved therapeutic efficacy
Legal Provisions in India
Section 3(d) – Patents Act, 1970
- Bars patents on new forms/derivatives of known substances unless they show enhanced therapeutic efficacy.
- Designed to prevent evergreening.
Patentability Requirements
- Must satisfy:
- Novelty
- Inventive step
- Industrial applicability
- Minor or obvious changes do not qualify.
TRIPS & Doha Declaration
- India remains TRIPS-compliant.
- Uses Doha Declaration flexibilities to safeguard public health and ensure access to affordable generics.
IAS-2026 - OPTIONAL / GEOGRAPHY / PUBLIC ADMINISTRATION / SOCIOLOGY / ANTHROPOLOGY / ORIENTATION ON 03 & 04-10-2025 
