The Controller General of Patents, Designs and Trade Marks has rejected the Mumbai-based BDR Pharmaceuticals' application for compulsory licence for anti-cancer drug dasatinib, patented by pharma major Bristol Myers Squibb (BMS).

“The applicant did not follow the scheme of the law as well as the procedure mandated by the law. I am therefore of the considered opinion that the applicant has failed to make out a prima facie case for the making of an order under Section 87 of the Act. The application for compulsory licence, along with all the petitions for condonation of delay/irregularity, is hereby rejected,” Controller General of Patents, Chaitanya Prasad, in his order dated October 29 said.

Earlier, the Mumbai-based BDR Pharmaceuticals had filed an application, under Section 84 of the Patents Act, 1970, with Patent Controller's office in Mumbai on 4th March 2013, seeking the grant of a compulsory licence for patent number 203937 titled "A compound 2-amino-thiazole-5-carboxamide" granted to the patentee on November 16, 2006 on the patent application number TN/PCT/2001, 01 I38/MUM.

In its application, the BDR Pharmaceuticals had assured that the drug dasatinib will be made available to the public at a proposed price of Rs.135 per tablet working out to Rs.8100 per month for the treatment of a chronic myeloid leukaemia (CML) patient.

Dasatinib is a suitable chemotherapeutic option for the treatment of CML and is prescribed when a patient is resistant or develops resistance to the drug imatinib, in view of the improved tolerance and efficacy of the drug. Dasatinib is administered as 50 mg tablets with a dosage of 100 mg per day. Thus, two tablets are to be consumed per day until disease progression or until the patient can no longer tolerate the medicine. The price of each tablet sold by the patentee (BMS) is Rs.2761 which works out to Rs.1,65,680 for 60 tablets per month per patient. The drug is sold by the patentee under the brand name Sprycel.

It may be noted here that the Union Health Ministry had recommended dasatinib along with two other cancer drugs, namely trastuzumab and lxabepilone, to the Department of Industrial Policy & Promotion (DIPP) to put them under Compulsory Licensing (CL) under the provisions of the Indian Patents Act, 1970.