Wednesday, January 19, 2011

Application 4015/DELNP/2006 refused under S.15

In an order dated January 10, 2011, the Delhi Patent Office refused the Application No. 4015/DELNP/2006 filed by Warner-Lambert claiming topical formulation of Pfizer’s potential potassium channel opener UK-157147 for the treatment of alopecia but got discontinued in phase II trials. The Assistant Controller, Dr. Rajesh Dixit, refused the Application after Warner failed to overcome the substantive objections raised in the First and Subsequent examination reports concerning lack of inventive step and not patentable subject-matter under S.3 (d) and (e).

While replying to the examination reports, the Applicant 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, and selection of alopecia treatment from the list of twenty different diseases (reach through clause) mentioned in the closest prior document. Over S.3 (d) and (e) objections, the Applicant 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 Controller was nowhere satisfied with the Applicant’s arguments and concluded that the claims lack inventive step over the closed prior art document and the formulation are merely a new form of the known substance and lack synergy.

It is quite unforunate that the pharmaceutical formulations are often refused under S.3 (d) and (e), considering use of pharmaceutically acceptable ingredients as combination and admixture with active ingredients. Formulations facilitate delivery of therapeutic agents and are responsible for achieving proper therapeutic effects that cannot be obtained from its component when used individually. Equating formulations with new form of known substance (putting in category of polymorph, salt, complex etc.) seems to be improper and unfair.

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