Kerala HC Ruling on Section 100 Raises Access vs. Patent Debate

Kerala High Court Interprets Section 100 in Ribociclib Access Case

A recent Kerala High Court ruling concerning the drug Ribociclib has brought renewed attention to Section 100 of the Patents Act, 1970, which permits government use of patented inventions. The judgment, which allows state governments to manufacture or procure generic versions of patented drugs under certain conditions, is seen as a critical intervention in the access-to-medicine discourse.

The Court emphasized that public health interests can override patent exclusivity when justified by urgent need, particularly in life-saving treatments. While the decision did not revoke the patent, it affirmed the state’s authority to invoke compulsory licensing mechanisms under appropriate circumstances. The ruling also touched upon pricing policy and regulatory transparency, noting that

patent rights must be balanced against the fundamental right to health under Article 21

of the Constitution.

With multiple litigations pending over Ribociclib’s patent status and pricing, this order sets a precedent for how courts may interpret state intervention in pharmaceutical markets. For practitioners, it underscores the importance of addressing public interest clauses in patent strategy and regulatory compliance.