Patent evergreening refers to a strategy employed by pharmaceutical companies to prolong the exclusivity of a drug by implementing minor changes in its formulation or dosage. This tactic effectively prevents generic or biosimilar alternatives from entering the market, allowing companies to sustain their market dominance and keep drug prices elevated for extended periods.
Evergreening poses significant concerns within the pharmaceutical sector, as it limits access to affordable medications. This restriction can adversely affect public health by delaying the availability of lower-cost generics and biosimilars, which is especially critical in countries like India where exorbitant drug prices can strain healthcare systems.
India’s Patents Act of 1970 addresses the issue of evergreening through Section 3(d), which disallows patents for incremental innovations that do not demonstrate substantial therapeutic benefits. The landmark 2013 Supreme Court ruling against Novartis’s Glivec patent application reinforced the nation’s position against the practice of evergreening.
Globally, there are varying approaches to regulating evergreening. In the European Union, stringent regulations are in place to prevent unnecessary patent extensions, thereby promoting access to biosimilars. Conversely, in the United States, the practice remains prevalent, leading to higher drug prices due to frequent patent renewals on existing medications.
Combating evergreening is crucial for public health as it fosters competition in the pharmaceutical market. By allowing affordable generics to enter the marketplace more swiftly, access to essential medications is broadened, and genuine innovation is encouraged.
These instances exemplify India's dedication to thwarting evergreening, ensuring a balance between fostering innovation and providing public access to affordable medicines through the implementation of Section 3(d).
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