Rs 78,468 A Month For A Cancer Drug: Kerala HC Asks Centre To Explore Patent Law

The Kerala High Court on Monday asked the Centre to assess whether it could use its powers under Section 100 of the Patents Act to expand access to expensive patented medicines.

Justice Harisankar V Menon said the government must make the decision as a matter of policy. He added that the Centre could intervene when life-saving medicines cost more than patients can afford.

Section 100 permits the Central government to authorise the use of a patented invention for public purposes without obtaining the patent holder’s consent.

The court stopped short of directing the Centre to exercise this power in the current case. It instead asked the government to gather affordability data and consider intervention if the findings warranted it, both in this matter and other cases involving essential medicines.

The petition concerned Ribociclib, a patented breast cancer medicine produced by Novartis, and Palbociclib, another treatment whose patent has expired and which costs less.

Expert assessments from cancer care institutions and the Drugs Controller General of India stated that the two medicines could not be treated as substitutes.

The court stressed that officials should use relevant evidence to assess whether patients could afford the treatment.

A cancer patient brought the petition in 2022, seeking access to Ribociclib at an affordable price. The medicine then cost approximately Rs 78,468.75 a month.

The petitioner died in September 2022, but the High Court chose to pursue the issue because of its broader implications for access to costly treatment.

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