Patents – Making available fungicide for use in high-temperature regions is ‘enhancement in efficacy’ under Section 3(d)

The Delhi High Court has held that the fact that the fungicide is made available to be used and sprayed at regions where the temperature would ordinarily go beyond 40°C, without crystallization, would clearly be an enhancement in the efficacy of the compound.

Rejecting the Controller’s objection under Section 3(d) of the Patents Act, 1970, that in pharmaceutical preparations or agrochemicals, the efficacy has to be measured in terms of enhancement in the therapeutic efficacy of the compound alone, the Court observed that in the context of the agrochemical in the dispute, enhancement of efficacy of a known substance would also include the thermodynamic stability at high temperatures.

The subject patent invention of an agrochemical had claimed primarily thermodynamic stability of a polymorph at temperatures ranging upto 50°C-60°C. The Court noted that there was no dispute that the thermodynamic stability in the invention prevented the formation of crystals in the compound which earlier caused the formation of lumps and in turn clogged the spray gun preventing spraying of the agrochemical on the plants.

Distinguishing the Supreme Court decision in the case of Novartis AG v. Union of India [(2013) 6 SCC], the High Court here in Syngenta Participations Ag v. Controller of Patents Designs noted that the Apex Court had held that ‘efficacy’ would be ‘therapeutic efficacy’ in case of the medicine. The High Court was thus of the view that it can be stated that in other cases, the test of efficacy would be determined as per the function, utility or the purpose of the product under consideration. Madras High Court decision in the case of Novozymes v. Assistant Controller of Patent [(T) CMA (PT) No.33 of 2023] was relied upon.