A fresh public-interest litigation invoking Section 100 of the Patents Act against another high-cost patented drug will surface in a different Indian High Court within six months, with Merck & Co, Novartis, Pfizer and Roche all facing renewed scrutiny of their India oncology and rare-disease portfolios.

The Kerala High Court ruled this week that the Centre can invoke Section 100 to manufacture and sell a patented medicine to needy patients on a non-commercial basis whenever it is priced exorbitantly, arising from a case over Novartis's breast cancer drug Ribociclib, priced around ₹75,000 ($780) a month. Litigants elsewhere will seize on this route, since it skips the tougher preconditions of full compulsory licensing under Sections 84 and 92. Drugmakers holding a patent on high-priced drugs will be pressured to respond with expanded patient-assistance programmes or licensing deals with generics majors like Cipla and Dr Reddy's to satisfy patient needs while avoiding government issuance of compulsory licences.