Indian Patent Office Rejects BDR Pharmaceutical’s Application for Compulsory License to Manufacture Anti-Cancer Drug Dasatinib

The Controller of Patents (Controller) vide order dated 29th October 2013, rejected BDR Pharmaceutical’s (BDR) compulsory license application against Bristol Meyer Squibb’s (BMS) anti-cancer drug Dasatinib. This was the second compulsory license application after Natco’s application for Nexavar.

Brief facts of the case: BDR filed an application on 4th March 2013 seeking grant of compulsory license for patent no: 203937 titled ‘A Compound 2-amino-thiazole-5-carboxamide’ granted to BMS and covering the active pharmaceutical ingredient of the drug Dasatinib. Prior to making an application for compulsory license, BDR initially sent a request to BMS for a voluntary license vide letter dated 2nd February 2012. In response to BDR’s request, BMS raised certain queries on BDR’s ability to manufacture and market the drug. BDR chose not to respond to the queries and filed an application for compulsory license before the Patent Office.

BDR claimed that patentee was employing delaying tactics by raising queries, which according to BDR could also be used against BDR in various legal forums. A suit for patent infringement filed by BMS against BDR is pending before the Delhi High Court. The Controller however observed that no query was specifically highlighted by the BDR that could adversely affect BDR’s position before this or any other legal forum. In the absence of reasoning / justification, Controller did not accept the arguments put forth by BDR.

When considering an application for grant of compulsory license under Section 84 of the Patent Act, the Controller is required to take into account whether credible efforts were made by the Applicant in obtaining a license from the patentee on reasonable terms and conditions and whether such efforts have not been successful, within a reasonable period as the Controller may deem fit. The ‘reasonable period’ has further been defined to mean a period not ordinarily exceeding a period of 6 months.

Controller further observed that the term ‘efforts’, under Section 84 of the Patent Act is not accompanied by the qualifying term ‘reasonable’ and the applicant ought to have appreciated that the duty cast upon the applicant to make ‘efforts’ is absolute and inflexible and without exceptions. In view of the above, the Controller held that BDR did not make enough efforts to obtain license from the patentee on reasonable terms and conditions and a prima facie case for grant of compulsory license has not been made out by the applicant. Accordingly the application was rejected.

It is open for BDR to either challenge this order of rejection before the Intellectual Property Appellate Board or re-negotiate a voluntary license with BMS and file a fresh application for compulsory license after six months.

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One thought on “Indian Patent Office Rejects BDR Pharmaceutical’s Application for Compulsory License to Manufacture Anti-Cancer Drug Dasatinib

  1. The complete details of this case is detailed in the Indian patent online site.I really appreciate the controller’s verdict. This verdict will be a trend setter for the other Indian generic companies seeking for compulsory license to have a thorough knowledge on this and be proactive before venturing into it.Let us not take things for granted.

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