While rejecting the application, the Assistant Controller had invoked Section 3 (d) of the Act, which says mere discovery of a new form of a known substance cannot be considered a patentable invention, unless it has resulted in “enhancement of its known efficacy or that the derivatives differ significantly in properties with regard to efficacy.”

Novartis went to court challenging the rejection of its application. Its contention was that the section was “vague, arbitrary and ambiguous.” It also did not provide “guidance” to the patent controller as to what constituted “enhanced efficacy” or what was meant by “differing significantly in properties with regard to efficacy,” the firm argued.

But the Bench said Novartis was “no novice” in pharmacological field and could not take the stand that it did not know what the order meant.