Kerala High Court clarifies government power over costly patented cancer drugs
The Kerala High Court ruled that Section 100 of the Patents Act can be used to supply patented cancer medicines to needy patients on a non-commercial basis, but it left any action to the central government.
A petition concerning the high price of ribociclib and abemaciclib prompted the Kerala High Court to interpret Section 100 of the Patents Act, confirming that the provision extends beyond internal government use to non-commercial manufacturing and supply for patients in need. While the court recognized exorbitant pricing as a trigger for possible intervention, it stopped short of directing the Centre to invoke the power.
It also rejected the notion that the off-patent drug palbociclib could serve as a blanket substitute, citing differing clinical evidence. The court tasked the government with gathering data on affordability and access, but gave no timetable. The ruling highlights a legal avenue for price mitigation, though actual implementation remains a policy decision.
Why it matters
The decision outlines a legal tool that could lower out-of-pocket costs for life-saving cancer drugs in India.
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