PHARMACEUTICAL PATENTING IN INDIA - BREAKING MYTHS
INDIAN PHARMACEUTICAL ALLIANCE VS. CHIESI FARMACEUTICI S.P.A. OF VIA PALERMO
In 2018, the IPO granted a patent to Chiesi Farmaceutici [hereinafter referred to as the Applicant] for “PRESSURIZED METERED DOSE INHALER COMPRISING FORMOTEROL AND BECLOMETASONE DIPROPIONATE” thereby rejecting the pre-grant opposition filed in the matter by Indian Pharmaceutical Alliance [hereinafter referred to as the Opponent]. The opposition comprised of objections under several grounds, including but not limited to the claimed invention being non-patentable subject matter under Sections 3(d) and 3(e) of the Act. It is pertinent to note that said grounds had also been taken up by the Controller in the First Examination Report [office action]. However, in light of the examples provided in the specification of the application and the submissions made by the Applicant, the Controller held all the objections to be met by the Applicant and granted the patent in the matter. Relevant excerpt from the order of the Controller is reproduced hereinbelow:
“Regarding 3(e ) of the Patents Act, it is observed that the claimed inhaler comprising the formulation according to the present invention undeniably exhibits unforeseen synergistic effect as explained under Example 2, Comparative Example 3 and Comparative Example 4 of the complete specification starting from page 14, which is summarized below for your ease of reference. In the Example 2 and Comparative Examples 3 & 4 of the complete specification, the solubility of formoterol fumarate dihydrate in the presence and in the absence of each of the ingredients of the claimed composition was estimated. It is further observed that, the presence of BDP in the mixture of HFA134a : ethanol at 2.7 % w/w significantly decreases the solubility of formoterol fumarate dihydrate suspended in the formulation, thereby hindering the occurrence of unwanted Ostwald ripening process, thus improves stability over longer period of time. In addition, Example 5 of the complete specification shows that the excellent aerosol performance of the claimed inhaler, which is capable of providing upon actuation of the inhaler, a fine particle fraction (FPF) much higher than 50% for both the active ingredients that lead to improved therapeutic efficacy. This evidences that every ingredient of the inhaler has not been arbitrarily chosen, but is the useful range for having formoterol fumarate dihydrate in suspension and beclometasone dipropionate (BDP) in solution and exhibiting technical advancement/synergistic effect. Therefore, the Opponent fails to establish such a ground of opposition yet again; whereas the objection raised under Non-Patentability u/s 3 of the hearing notice is also met”.