High court refused to grant Danish pharmaceutical company Novo Nordisk an interim injunction against DRL over semaglutide.
- Semaglutide, patented by Novo Nordisk in India, is an active pharmaceutical ingredient (API) used in treating Type 2 diabetes and obesity.
- API is the chemical in a medicine that produces the intended therapeutic effect.
- Novo Nordisk markets its anti-diabetic and weight-loss drugs as Ozempic and Wegovy.
- Court highlighted that Novo Nordisk’s two patents on minor variations of the semaglutide could amount to evergreening.
About Evergreening of Patents
- Generally, patents have a maximum life of 20 years, and evergreening is a strategy used to prolong patent monopolies by making minor changes to existing patented compounds.
- Nature of Modifications: Includes new forms, salts, isomers, polymorphs, dosages, or delivery systems in drugs that do not improve therapeutic value.
- Legal provisions:
- Patents Act, 1970 (Section 3(d)): Expressly prohibits patents on new forms or derivatives of known substances unless they demonstrate significantly enhanced therapeutic efficacy, thereby limiting evergreening practices.
- Patentability Standards: Mandate strict tests of novelty and inventive step, under which trivial modifications or obvious variants of existing drugs are not eligible for patent protection.
- TRIPS and Doha Declaration Flexibilities: India’s framework remains TRIPS-compliant while using public-health flexibilities under the Doha Declaration to curb unjustified secondary patents and ensure access to affordable generics.
