Patent Office continue refusing pharmaceutical formulations under S.3 (d) and (e)

The Delhi Patent Office lately refused the Application Number 4015/DELNP/2006 filed by Warner Lambert claiming topical formulation of Pfizer’s potential potassium channel opener UK-157147 for the treatment of alopecia, which got discontinued in phase II trials. The Application got refused on the grounds of lack of inventive step and not patentable under S.3 (d) and (e). During the prosecution, Warner tried to substantiate the inventive step in terms of selection of UK-157147 from thousands of potassium channel openers disclosed in the closest prior art document. Warner also argued that the closest prior art document generically suggested that potassium channel openers can be delivered orally, by inhalation, rectally, or topically, and also list twenty different diseases that may be treated which included male pattern baldness. The Controller found Warner’s argument unconvincing and held that the prior art document disclose all elements of the claims at issue and hence lack inventive step under S.2 (1) (j). It is bit harsh that a broad, presumptive generic disclosure will make the claims obvious. 

Over S.3 (d) and (e) objections, Warner argued that the claims relate to pharmaceutical formulation and is neither a mere new form of a known substance under S.3 (d) nor a mere admixture under S.3 (e). The independent claim at issue, as amended during the prosecution, recites topical formulation containing UK-157147 with inactive ingredients propylene glycol and ethanol. In his order, the Controller held that formulation is merely a new form of the known substance which is not patentable under S.3 (d). He further equated using inactive excipients with active agent with mere combination that needs efficacy data under S.3 (d). It is unfair to equate use of excipients in formulations and compositions with mere combination. 

The Controller further held that the claims fail to prove the enhanced efficacy against the combined efficacy of the individual component of the formulation and hence claimed formulation is a mere admixture of UK-157147 and excipients which fall under S.3 (e). Firstly, this is absolute ridiculous that enhanced efficacy is quoted under S.3 (e) when there is no such requirement mandated by S.3 (e). Secondly, the pharmaceutical formulation is not a mere admixture where components used have additive effect, it is always the synergistic effect of components (active and inactive ingredients) which results in proper delivery and therapeutic effect of active agent. There is no doubt that in absence of proper guidelines, S.3 (d) and (e) are often and erroneously applied against pharmaceutical formulations, drug delivery systems and compositions.