PHARMACEUTICAL PATENTING IN INDIA - BREAKING MYTHS
M/S FDC LIMITED, INDIA VS. VENUS REMEDIES LIMITED, INDIA
In 2009, in a matter of a pre-grant opposition filed by M/S FDC Limited, India [hereinafter referred to as FDC] against the grant of a patent to M/s Venus Remedies Limited [hereinafter referred to as Venus] for "ANTIBIOTIC COMBINATIONS FOR PROVIDING TOTAL SOLUTION TO THE TREATMENT OF INFECTIONS", the IPO discussed the extent of the onus on the Applicant of establishing enhancement of therapeutic efficacy and synergistic effect of the claimed invention. In the present matter, the Controller relied on the opinion of the EPO in the matter of SUMITOMO/Yellowdyes wherein the Board of Appeal held that “An invention which relates on substantial and surprising improvement of a particular property need not also show advantages over the prior art with regard to other properties relevant to its, use, provided, the latter are maintained at a reasonable level so that the improvement is not completely offset by disadvantage in other respect.....”
The Controller agreed with the above decision of the EPO and accordingly granted a patent to Venus. Relevant excerpt from the order of the Controller is reproduced hereinbelow:
“Aminoglycoside cause oxidative stress when administered individually separately either alone or in combination with other antibiotic & causes toxicity, which has been reduced in the fixed dose combination of cefepime & amikacin along with the stabilizing agent L-arginine. Therefore, the combination the individual component & its feature mentionally influence each other to achieve a technical advancement by way of efficacy. Therefore I feel that the combination of cefepime & amikacin enhances the synergism and qualifies the requirement of section 3(d)”.
 O.J. EPO 1989, 115, (1989)
Available at: https://www.epo.org/law-practice/case-law-appeals/pdf/t860254ep1.pdf