PHARMACEUTICAL PATENTING IN INDIA - BREAKING MYTHS
IND SWIFT LABORATORIES LTD. VS. CADILA HEALTHCARE LTD.
Ind Swift Laboratories Ltd. [hereinafter referred to as Ind] also filed an opposition against the grant of the patent application filed by Cadila, titled “crystalline clopidogrel besylate and process for preparation thereof”. Said opposition was disposed of in September 2009 and all the grounds taken up by Glochem i.e. anticipation by prior publication, anticipation by prior claiming, anticipation by prior use, lack of inventive step, non-patentable subject matter, insufficiency of disclosure were rejected by the Controller. Since Ind did not cite any new documents, the Controller reiterated the contents of the decision in the Glochem opposition with respect to Section 3(d) of the Act taken up by the Opponent and accordingly, granted the patent.
Thereafter, Ind filed a petition for review of the order granting a patent to Cadila and submitted four new annexures to substantiate the challenge to the patentability of the subject matter claimed in the invention.
However, the Controller reiterated its decision of granting a patent to Cadila and held that “in view of the advantageous effects of Crystalline Clopidogrel besylate of instant invention over the known clopidogrel bisulphate and also over the solvated forms of Clopidogrel besylate in different characterization aspects, it can be held that the Crystalline Clopidogrel besylate of present invention compound is patentable and cannot be rejected under Section 3(d) of the Patents Act, 1970”.
Thus, the Controller refused the ground taken up by the Opponent in light of the enhancement of therapeutic efficacy established by the Applicant.