Application 924/DELNP/2006 refused under S.15

In an order dated January 12, 2011, the Delhi Patent Office refused the Application Number 924/DELNP/2006 filed by Boehringer Ingelheim claiming polymorphic form II of anticoagulant drug Dabigatran etexilate mesylate. The Assistant Controller, Dr. Rajesh Dixit, refused the Application after Boehringer failed to overcome the substantive objections raised in the First and Subsequent Examination Reports concerning lack of inventive step under S.2 (1) (j) and not patentable under S.3 (d).

While replying to the examination reports, the Applicant tried to substantiate the inventive step in terms of better solubility and argued that the cited prior art documents provide no hint that mesylate salt have better solubility and exists in different polymorphic modifications. The Applicant further argued that better the solubility of the compound the higher is its bioavailability, which, as direct consequence, translates to a higher efficacy as required by S.3 (d). However, the Applicant failed to submit to validate its bioavailability presumption. Moreover, in its post hearing reply the Applicant argued that to prove enhanced efficacy a clinical trial in human beings would be required and for which regulatory approval is needed. The Applicant further argued that such a regulatory permission would hardly be granted just to prove efficacy under S.3 (d). The Controller was nowhere persuaded by the Applicant’s arguments and concluded that the claims lack inventive step and fail to meet efficacy requirement under S.3 (d).