28 September: The Kerala High Court on Monday advised the Central government to invoke its powers under Section 100 of the Patents Act, 1970 (Act).
Justice Harisankar V Menon, in a 65-page judgment, said that the centre can exercise its right to sell on a non-commercial basis the drugs which have been made in exercise of that right.
The justice referred to the sub-section (6) of the Patents Act, 1970, that states, the government can exercise its right to make, use, exercise and vend a patented invention for the purposes of Government under sub-section (1).
Such a decision was made to improve access to heavily priced patented breast cancer medicines.
The petition was filed by a retired Bank employee in June 2022. She was diagnosed with HR+/HER2-metastatic breast cancer and was being treated with targeted therapy, CDK 4/6 inhibitors, through the medicine 'Ribociclib'.
She had moved to the court seeking reduction in the price of the medicine or making it available at an affordable price, as it cost about Rs 58,140 for 21 days.
In September 2022, the petitioner succumbed to her illness.
On September 16, 2022, the Court decided to continue with the case, considering the matter as a suo motu case under the title 'In Re Exorbitant Pricing of Life Saving Patented Medicines.'
Pharmaceutical companies opposed the petition, stating that the Centre had already considered the matter of using Ribociclib’s patent but did not find it necessary, since a cheaper alternative, Palbociclib, was already available in the market.
Novartis and Eli Lilly, which manufacture Ribociclib and Abemaciclib respectively, opposed such intervention by the government, stressing the importance of patent protection.
The Court sought expert opinions from cancer institutions and the Drugs Controller General of India (DCGI) to find out whether Palbociclib could be used as an alternative drug to Ribociclib.
Based on the expert opinions, the Court concluded that the two could not be interchangeable. While both drugs are intended for advanced breast cancer, palbociclib is not a universal substitute for ribociclib.
The Kerala HC’s judgement came out as a suggestion to the central government. The HC stated that, "It is for the Central Government to consider whether Section 100 of the (Patents) Act requires to be invoked since ultimately the same is a policy decision."
"Section 100 is required to be invoked in circumstances where the Government is required to intervene, such as an instance where the medicine manufactured on the basis of a patent is being sold at an exorbitant price," the Court further added.
Besides that, the court also referred to a movie, Sukrutham, which was released three decades ago and won many national and state level awards.
The movie depicted the plight of cancer patients and those attending to them, and said that it was "highly distressing" that there is no change in the situation.
"Yet, despite such heavy social cavalry, society and the situation have been stuck at a standstill in such cases. The government, the people, and stakeholders should, as a joint venture, ensure that no man is refused or refuses treatment exclusively due to financial constraints.
Reference:
1. Income Tax Department, Ministry of Finance, Government of India, “Section 100: Power of Central Government to Use Inventions for Purposes of Government,” Patents Act, 1970, accessed September 29, 2026. https://www.incometaxindia.gov.in/w/section-100-51
(Rh/MF)
