Kerala High Court expands Section 100 to address drug affordability
In a landmark judgment, the Kerala High Court held that Section 100 of the Patents Act can be invoked when patented medicines become inaccessible because of exorbitant pricing. The ruling was delivered in a case concerning the breast‑cancer drugs Ribociclib and Abemaciclib, which are priced at several lakh rupees per year.
The court stopped short of ordering the Centre to act immediately. Instead, it instructed the government to assess patient access, affordability and treatment gaps before deciding whether to use the provision. Section 100 allows a government or its authorised entities to use a patented invention without the patent holder’s consent, provided compensation is paid. Unlike compulsory licensing under Section 84, it does not invalidate the patent.
Implications for drug access and public health
The judgment is seen as a “milestone” by patient advocacy groups and legal scholars. It provides a clear legal pathway for the government to intervene when drug prices threaten public health. A senior executive from a global pharmaceutical company, speaking anonymously, noted that predictable IP enforcement can help bring life‑saving drugs to patients while encouraging investment in research and development.
Advocate Maitri Hegde, who served as amicus curiae, described the ruling as a “milestone judgment” that interprets Section 100 in the context of public health. She emphasised that the court recognised exorbitant pricing as a ground for invoking the provision, though the final decision remains with the government after a thorough assessment.
Trade‑policy tensions
India is currently negotiating trade agreements with the EU and the US, where intellectual‑property protection is a sensitive topic. Multinational pharmaceutical companies and western governments often criticize developing countries for using patent flexibilities that could affect returns on innovative medicines.
While Section 100 complies with the WTO’s TRIPS agreement, aggressive use of government‑use provisions could become contentious in trade discussions. The EU has repeatedly pushed for stronger IP protections in bilateral negotiations, and US industry groups routinely raise concerns about patent enforcement and market access in India.
The Kerala High Court ruling could therefore place the Centre in a difficult position: it must improve access to high‑cost treatments while reassuring trade partners and global innovators that patent rights will be respected.
What the government must do next
The court’s decision leaves the Centre with a mandate to evaluate affordability and access but does not impose a deadline. Critics worry that the assessment could drag on, delaying potential relief for patients. The government will need to balance the legal opportunity to use Section 100 against the diplomatic and commercial implications of its use.
Bottom line
The Kerala High Court’s ruling expands the toolkit for ensuring affordable access to patented medicines in India. While it offers hope for patients, it also signals a potential friction point in India’s trade negotiations with major partners. The coming months will reveal how the Centre navigates this new legal landscape and whether it will exercise the provision in practice.