Kerala HC on Section 100: Govt Use of Patented Medicine

Kerala HC on Section 100: Govt Use of Patented Medicine in Public Interest

The Kerala High Court recently delivered a significant ruling on the government's power to use patented inventions under Section 100 of the Patents Act, 1970, affirming its role in ensuring access to essential medicines. The case arose in the context of the drug Ribociclib, used in cancer treatment, where the state sought to invoke its authority to allow manufacturing or importation without the patent holder’s consent, citing public health needs.

The court examined the scope of Section 100, which permits the government or authorized entities to use patents for government purposes without a licence. It emphasized that such use must serve public welfare, particularly in healthcare emergencies, and must comply with procedural safeguards including adequate compensation to the patentee.

The state cannot remain a mute spectator when access to life-saving drugs is hindered by monopolistic pricing or supply constraints,

the court observed, aligning with precedents like Bolar Exemption and compulsory licensing jurisprudence.

This decision reinforces the principle that patent rights are not absolute and must yield to public interest in exceptional circumstances. For practitioners, it underscores the need to assess both validity and policy implications when advising clients on patent enforcement or challenges. The ruling may influence future government use and compulsory licensing applications, especially in oncology and rare disease domains.