The Kerala High Court interpreted Section 100 of the Patents Act, allowing government use of a patented cancer drug, Ribociclib, in public health emergencies. The ruling balances patent rights with access to medicine, citing compulsory licensing and public interest.
Kerala High Court Interprets Government Use of Patented Drugs
In a significant ruling, the Kerala High Court examined the scope of Section 100 of the Patents Act, 1970, concerning government use of patented inventions for public health purposes. The case centered on Ribociclib, a patented cancer drug, where the state sought to procure generic versions despite active patent protection. The Court held that Section 100 permits such use in emergencies, especially where life-saving drugs are unaffordable or inaccessible.
The judgment emphasized the constitutional right to health under Article 21 and referenced Article 73 of the TRIPS Agreement, which allows governments to use patented inventions without the consent of the patent holder under certain conditions. The Court noted that while compensation must be paid to the patentee, the government may proceed with procurement through authorized manufacturers. The order referenced ongoing litigations and parallel patents on Ribociclib, underscoring the complexity of layered intellectual property claims.
The right to life includes access to life-saving medication, and patent rights, while important, are not absolute in the face of public health emergencies.
This decision is likely to influence future pricing policies and compulsory licensing decisions, particularly in cases involving high-cost oncology drugs. With the EU-India FTA negotiations ongoing, the ruling may also inform debates on data exclusivity and patent linkage. Practitioners should assess how emerging public health doctrines may override patent enforcement in critical sectors.
Citations
- Section 100, Patents Act, 1970
- TRIPS Agreement, Article 73
