The Kerala High Court issued a ruling on September 26 in the matter concerning the high price of life-saving patented medicines against the Union of India. According to Scroll, the judgment addressed access to two patented breast cancer drugs, ribociclib and abemaciclib. The court clarified the scope of Section 100 of the Patents Act, which governs governmental use of patented inventions. It established that this provision extends beyond the government’s own institutional use, allowing it to manufacture and supply patented medicines to needy patients on a non-commercial basis. The court also recognized that exorbitant pricing can warrant government intervention, distinguishing this power from compulsory licensing under Sections 84 and 92.
The case originated from a 2022 petition by a retired bank employee with metastatic breast cancer who sought affordable access to ribociclib. Although she passed away during the proceedings, the court kept the matter alive on its own initiative. Scroll reported that the court did not immediately direct the Centre to invoke Section 100 for the two drugs. Instead, it left the decision to the government, requiring an assessment of affordability and access, though no specific timeline was set for this evaluation.
In evaluating substitutes, the court considered palbociclib, a generic version of a drug in the same treatment category. Relying on expert evidence, the court declined to treat the patented medicines as interchangeable with palbociclib. Scroll noted that while a German observational study showed similar survival rates between palbociclib and ribociclib in advanced disease, the evidence for early-stage, high-risk breast cancer showed benefits for ribociclib and abemaciclib that palbociclib did not demonstrate in a major post-surgery trial.
Financial context was central to the ruling. Scroll reported that ribociclib costs Rs 78,400 monthly, not counting other care expenses. Manufacturers Novartis and Eli Lilly argued their products involved high development costs but reportedly offered no specific numbers. A study of 12,148 cancer patients cited in the report estimated average annual out-of-pocket spending at approximately Rs 3.31 lakh, with medicines making up 45% of outpatient and hospitalization costs. While the Ayushman Bharat scheme covers up to Rs 5 lakh for hospitalization, it leaves a gap for expensive outpatient medicines, a limitation the court’s ruling aims to address by clarifying the government’s legal avenues for intervention.