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Holds Centre Can Invoke Patents Act for Affordable Ribociclib
The has delivered a landmark ruling affirming that the Central Government possesses the legal authority under , to manufacture patented medicines and supply them on a non-commercial basis to needy patients when such drugs are sold at exorbitant prices. The judgment, authored by Justice Harisankar V Menon, arises from a case concerning the high cost of life-saving patented medicines, particularly the breast cancer drug Ribociclib. However, the Court stopped short of ordering immediate government action, instead directing the Centre to collect comprehensive data on affordability before deciding whether to invoke the provision.
The Case: A Patient’s Struggle and a Broader Public Health Issue
The proceedings originated from a petition filed in by Saroja Radhakrishnan, a former bank employee diagnosed with HR+/HER2-metastatic breast cancer. She sought affordable access to Ribociclib (marketed as Kryxana by ), which cost approximately ₹58,140 for a 21-day course at the time of filing. Tragically, she died in while the case was pending. The High Court then took cognisance of the larger issue of of patented life-saving medicines, renaming the matter .
The Court appointed as . Later, another breast cancer patient, Majida AM, joined the proceedings. Majida, a lawyer, reported spending around ₹80,000 per month on Ribociclib and associated treatments, and her insurance claims had faced repeated rejections. The case thus spotlighted the financial burden on patients and the systemic barriers to accessing patented therapies.
Section 100: Government Power to Use Patents for Public Health
The central legal question was the scope of Section 100 of the Patents Act, which allows the Central Government to authorise the use of a patented invention “.” The Court rejected the narrow interpretation advanced by the Centre and pharmaceutical companies that this provision could only be used for internal government operations, such as defence or public works.
Justice Menon held that “the provisions of Section 100 impose no restriction on who the purchaser could be.” The Court ruled that the expression “” must be understood in light of the State’s constitutional duty under to improve public health and under to protect the . Consequently, Section 100 empowers the government to manufacture a patented medicine and sell it on a non-commercial basis to any person, including a needy patient.
The judgment further noted that Section 100(4) specifically includes “medicines or drugs” within its ambit, reinforcing the legislature’s intent to address . The Court emphasised that the provision is “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.”
No Immediate Relief, But a Roadmap for Action
Despite its expansive interpretation, the Court declined to direct the Centre to immediately invoke Section 100 for Ribociclib or other patented breast cancer drugs like Abemaciclib () and Palbociclib (). It reasoned that invoking the provision is ultimately a requiring sufficient data on affordability. The Court observed that the material before it was inadequate to determine whether the medicines were genuinely unaffordable for the majority of patients.
The judgment thus mandates the Union Government to collect specific information from hospitals across India, including: - The number of patients suffering from the relevant cancers, - The number actually using the patented medicines, - Cases where patients forego treatment due to high prices, - The effectiveness of existing government schemes providing subsidised medicines, - Whether such schemes need expansion.
Only after this data is collated and assessed can the government decide whether intervention under Section 100 is warranted. The Court also clarified that Section 100 does not require a prior application for under Sections 84 or 92, and that the government’s power is independent.
Rejecting the
A significant aspect of the ruling was the Court’s finding that Palbociclib – whose patent expired in , leading to cheaper generics – is not a substitute for Ribociclib or Abemaciclib. The Centre had argued that patients could simply switch to the cheaper drug, but expert opinions from the and the , showed that the medicines are not interchangeable. Ribociclib is indicated for early-stage breast cancer, while Palbociclib is primarily used for metastatic (Stage IV) disease. The Court therefore rejected the “alternative drug” argument, underscoring that treatment decisions depend on and cannot be based solely on cost.
Balancing Innovation and Access
The judgment also addressed the tension between patent protection and public health. The Court acknowledged that patents incentivise innovation and that invoking Section 100 without proper justification could be counterproductive. It stated: “If such sanctity is not being extended to a patentee, that would be a factor which would be counterproductive insofar as no one will come forward to register their patent under the statute.”
However, the Court stressed that the benefit of patented inventions must be available at reasonably affordable prices, as required by . It cited the 139th Report of the , which highlighted the high out-of-pocket expenditure on cancer care and the reliance on borrowings and asset sales to finance treatment. In a poignant reference, the Court also invoked the Malayalam film Sukrutham (starring Mammootty), noting that the plight of cancer patients and their families depicted in the film three decades ago remains largely unchanged today.
Implications for the Legal and Healthcare Communities
This ruling is a significant step towards clarifying the government’s powers under patent law to address public health emergencies. It provides a legal foundation for the Centre to intervene when patented life-saving drugs are priced beyond reach, without waiting for voluntary licensing or competition from generics. Legal experts, including K. M. Gopakumar of the , have called the judgment “a potentially powerful legal route to make patented medicines cheaper.”
Nevertheless, the lack of a direct order means that patients may face further delays. The onus is now on the to gather the required data and take a . The Court has not set a timeline, leaving room for bureaucratic inertia. , who continues her own legal battle, has indicated she will approach the Division Bench to raise constitutional questions under .
For the pharmaceutical industry, the ruling serves as a warning that is not absolute when public health considerations are at stake. Companies like and , which argued that Section 100 should not be invoked without prior consideration of , will now have to engage with a more interventionist legal landscape.
Conclusion
The ’s judgment in the of Life Saving Patented Medicines case marks a pivotal moment in Indian patent jurisprudence. By affirming that Section 100 of the Patents Act can be used to make patented drugs affordable to needy patients, the Court has armed the government with a powerful tool to fulfil its constitutional obligations. Whether the Centre will wield that tool effectively depends on the quality of the data it collects and the political will to act. For the thousands of cancer patients awaiting affordable access to life-saving drugs, the wait continues – but the legal door has been opened.
