![JMA – Ninja & Deep Jandu [Official MV] Kaptaan](https://i.ytimg.com/vi/-dsfIh319s0/maxresdefault.jpg "JMA – Ninja & Deep Jandu [Official MV] Kaptaan")
The observations came in a case concerning the affordability of abemaciclib and ribociclib, two patented medicines used in the treatment of HR-positive, HER2-negative breast cancer, which accounts for around 55-60% of breast cancer cases in India. US drug maker Eli Lilly holds the parent for abemaciclib, while Swiss company Novartis supplies ribociclib.
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The court held that protection of public health was an important function of the government and rejected a narrow interpretation that would restrict the term “government use” to matters such as the government’s own institutional or departmental requirements or national security.
According to advocate Maitreyi Sachidananda Hegde, the judgment established that when access to a patented medicine was compromised because of its exorbitant price and government intervention is required, Section 100 of the Patents Act could be invoked.
The section allows the government to manufacture a patented drug for governmental use without the explicit consent of the patent holder and supply it on a non-commercial basis.
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The court recognised exorbitant cost as a ground for government use of a patented medicine, she said, calling the clarification important for affordable access to patented medicines in India.The court rejected arguments advanced by pharmaceutical companies and the government that the need for abemaciclib and ribociclib could be addressed through a generic version of palbociclib, according to Chetali Rao, an IP law expert with the non-profit research and advocacy group Third World Network.
Generic variants of palbociclib are available in the Indian market, while abemaciclib and ribociclib are under active patent protection.
The judgment leaves the immediate decision on invoking Section 100 to the government. The court said the government would first need to collate the required data and arrive at a decision on whether a particular medicine is affordable and, on that basis, proceed in accordance with Section 100.
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The court also did not prescribe any specific timeline for the Centre to complete the collection of data and determine whether abemaciclib and ribociclib are affordable.
Arathi PM, a women’s rights activist and legal scholar, said the absence of a timeline could prolong the wait for patients requiring the two medicines.
“The denial of access to abemaciclib and ribociclib has resulted in a large number of avoidable deaths in the country,” she said, urging the Ministry of Health to immediately undertake the affordability assessment for the two medicines.
KM Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatments, said while the court had recognised the issue of exorbitant prices and rejected palbociclib as a substitute for the two medicines, leaving the decision on Section 100 to government policy discretion would continue to leave patients dependent on executive action.
The ruling could have wider implications beyond the two medicines, particularly on how the government assesses affordability and access to patented medicines and determines when public-health considerations warrant intervention under the government-use provision of the Patents Act.
