Stories
Kerala HC: Exorbitant Drug Prices Can Trigger Section 100, Centre to Decide
- •The Kerala High Court ruled that the Central government can invoke Section 100 of the Patents Act if exorbitant pricing makes life-saving drugs inaccessible, broadening its interpretation.
- •The court did not immediately direct the government to invoke the provision for patented breast cancer drugs but asked it to study affordability and make a policy decision.
- •The judgment stemmed from a petition by a patient unable to afford ribociclib, which became a suo motu public interest case after her death.
- •Justice Harisankar V. Menon rejected the Centre's argument that palbociclib was an interchangeable alternative, stating they are not due to different uses.
- •Section 100, which allows the government to use patented inventions for public purposes, was linked to constitutional obligations under Articles 21 and 47 concerning the right to life and public health.
Key Questions Answered
The Kerala High Court held that the Central government can invoke Section 100 of the Patents Act when exorbitant drug pricing makes life-saving medicines inaccessible. The court rejected the narrow interpretation that the provision applies only for governmental purposes, ruling instead that it allows the government to manufacture or authorize the non-commercial sale of patented medicines to needy patients.
The initial petition was filed in 2022 by a retired bank employee who suffered from breast cancer and could not afford the patented therapy ribociclib. After the petitioner passed away while the case was pending, the High Court converted the matter into a suo motu public interest case addressing broader access to life-saving patented medicines.
No, the court stopped short of directing the government to immediately invoke Section 100 for patented breast cancer drugs, leaving the final decision as a matter of government policy. Instead, it directed the Centre to study affordability, gather data on affected patients, and evaluate existing subsidy schemes before deciding on intervention.
