The Indian Patent Office has rejected the compulsory license (CL) application made by Mumbai-based BDR Pharmaceuticals in March 2013 to make a generic version of Dasatinib, an anti-cancer drug, patented by US drug maker Bristol-Myers Squibb; saying it would sell the drug for `8,100 a month. In India, a month's dose of the Dasatinib costs about `1 lakh.
Just last year India granted its first compulsory license to Natco Pharma for Bayer's anti-cancer drug Nexavar. India's move was criticised by the global pharmaceutical majors. The move of Indian Patent Office was accused to be wrong said to be having a negative impact on drug companies to provide access to the innovative and novel drugs they release in other countries. The Indian public is said to endure suffering as they will not get access to these new drugs.
India, however, has held that the move was very much in compliance with the TRIPS norms which permitted granting such a license in larger public interest, if the price of a drug is not affordable or other criteria are not fulfilled as per Indian Patent Act.
The preliminary criteria to be fulfilled prior to filing an application for CL includes that there should have been made an application for voluntary license to the patentee, rejection of which shall be considered as disinterest to grant a license on behalf of the patentee.
The application of CL can be made with proof that such attempts to get a voluntary license have been made by the applicant on later stage, which has been turned down by the patentee without any satisfactory reasons. Other conditions which are to be fulfilled are:
• The patentee has not fulfill reasonable requirement of public;
• The patented invention is not available to the public at a reasonably affordable price, or
• The patented invention is not worked in the territory of India
BDR had sought a CL on Dasatinib as Bristol-Myers was importing the drug even though it was issued a patent since six years. BDR also contested that they had applied for a voluntary license to patentee and that they had not received any satisfactory answers. Further BDR alleged that Bristol Meyers has filed infringement suit against them and it was violation of the Competition Act, 2002 as they were "delaying tactics".
To this Bristol Meyers said that they had a right to file infringement suit upon violation of their patent right. Further they had sent certain queries regarding the financial capacity of BDR to produce the generic form of Dasatinib to which BDR had not replied.
The Controller of Patents in the order pointed out that BDR deliberately refrained from entering into any dialogue with the patentee (Bristol-Myers) for getting a voluntary license and selected only the CL option without taking the steps outlined in the law.
The Patent Controller also did not entertain submissions by BDR that Bristol-Myers was being "anti-competitive" by filing patent-infringement cases against it on the same drug at the Delhi High Court.
The Dasatinib order would bring some happiness to multinational drug companies, which have in the recent past seen several judicial orders lean in favour of public health.
While the rejection of license to BDR comes as a major disappointment to patients, it also shows that India is not blindly granting rights to produce generic version of patented drugs to every other Pharma companies and is not biased to generic companies. The development should help India hold its ground in its fight for cheaper healthcare.