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Kerala High Court invokes Mammootty film, rules government can invoke Section 100 for cancer drugs
The has ruled that the government can invoke to ensure affordable access to patented life-saving medicines, in a case that began with a breast cancer patient's plea and ended with a poignant reference to Mammootty's film Sukrutham .
A Case Born from Tragedy
The writ petition was originally filed by a retired bank employee suffering from HR+/HER2- metastatic breast cancer. She was prescribed Ribociclib, a CDK 4/6 inhibitor costing around ₹58,140 for a 21-day course. Before the court could hear the matter, the petitioner succumbed to her illness. However, the court, on , converted the petition into a proceeding titled , appointing as .
The Core Legal Question
The central issue was whether the could be directed to exercise its power under Section 100 of the Patents Act to authorize the use of the patent for Ribociclib to make the drug available at an affordable price. The petitioner and intervenors argued that the violated the under and the state's duty to improve under . They contended that Section 100, read with , empowers the government to use patented inventions for public purposes, especially when medicines are unaffordable.
Government and Patentees’ Objections
The
, through
, argued that Section 100 applies only when the invention is used
"for the
"
as defined in
, i.e., for the direct use of the government or its departments, not for supplying to the public at large. The patentee companies,
(manufacturer of Ribociclib) and
(manufacturer of Abemaciclib), emphasized that patents are conditional and that pricing alone cannot justify invoking Section 100. They pointed to existing price controls and patient assistance programs.
Court’s Interpretation: Section 100 Covers
Justice Harisankar V. Menon, after an extensive analysis, rejected the narrow interpretation of " ." He noted that explicitly includes the right to vend medicines and drugs, and allows sale on a to any person, including needy patients. The court relied on the 's observations in In Re Distribution of Essential Supplies and Services During Pandemic ( ) and the 's flexibility for .
The judgment further emphasized
(d), (e), and (g) of the Patents Act, which state that patents should not impede
and must be made available at reasonably affordable prices. Citing
and the
under
, the court held that
"the term '
' also includes the duty of the Government to improve
as mandated under
."
Data Deficit and
While affirming the legal scope of Section 100, the court declined to issue a positive direction to the government, holding that it is a that requires comprehensive data on affordability, patient numbers, and existing schemes. The court directed the government to collate such data and consider invoking Section 100 if necessary.
An Epilogue that Echoes a Classic
In a notable epilogue, Justice Menon referenced the Malayalam film
Sukrutham
(
), written by Jnanpith laureate M.T. Vasudevan Nair and starring Mammootty. The film's protagonist, a journalist diagnosed with blood cancer, chooses not to undergo treatment due to the crushing financial burden. The judge observed,
"It is highly distressing that despite the passage of more than three decades since this story was adapted into the movie vocabulary... the plight of patients and their families remains the same."
Key Observations
-
"The provisions of Section 100 of the Act are required to be invoked in circumstances where the Government is required to intervene, such as when the medicine is unaffordable on account of its exorbitant price."
-
"The term '
' also includes the duty of the Government/State to improve
as mandated under
of the
."
-
"Section 100 of the Act would include the entitlement of the Government to use the patent or invention for manufacturing the medicine covered by the patent and sell the same on a
to the needy patient."
The Decision
The court disposed of the writ petition with findings that Section 100 can be invoked for purposes, and directed the government to collect data and decide on its invocation. The court also placed on record its appreciation for the 's assistance.
