Dasatinib (Sprycel) Compulsory License Application Rejected by Indian Patent Office

In recent development in compulsory license domain, as reported by Economic Times, The Indian Patent Office (IPO) has rejected Mumbai-based BDR Pharmaceutical's application for Compulsory Licence (CL) on cancer drug Dasatinib, according to an affidavit filed by Bristol Myers Squibb (BMS), the patent holder for the drug.

As we already aware that BDR had filed CL application in March 2013 with IPO under section 84 of Indian patent Act.  Dasatinib was one of the three drugs considered for compulsory licensing by the government under the section 92 route. Dasatinib, which Bristol-Myers Squibb sells as Sprycel, is used in the treatment of chronic myeloid leukaemia. In India, a month's dose of this drug costs about Rs 1 lakh while BDR Pharmaceutical said its version will cost Rs 8,100/month.

But on May 04, 2013, BDR received notice from IPO that prima facie case has not been made for the making of an order under section 84 of Patents Act. BDR then requested hearing in accordance with rule 97 (1) of the Patent Rule 2003 and hearing scheduled on May 23, 2013. Then petition under Rule 137 on same day was filed to condone the delay in complying with procedural irregularities to make compulsory license application to meet the requirement of prima facie case and further proceed with the application. BDR subsequently submitted written submissions on June 24, 2013 pursuant to the oral gearing held on May 23, 2013. On July 10, 2013, BDR filed correspondence in relation to Voluntary License, sought form BMS and requested patent office to take it on record.

In its affidavit filed in the Delhi High Court last month, the US-based drug maker has accused BDR Pharmaceutical of suppressing information regarding the status of its application and patent.

"It is respectfully submitted that, as per the knowledge of the plaintiffs, the Controller of Patents has not found a prima facie case as regards the defendant's application under Section 84 of the Patents Act, 1970 and the same stands rejected," Bristol Myers has said in its affidavit.

"It is further submitted that the defendants are guilty of suppression as they have not informed this hon'ble court about the aforementioned order of Controller of Patents, nor have they supplied a copy of the application to the court," the affidavit added.