Many of us wondered as to why there was no compulsory licensing (CL) application after Natco’s momentous victory in procuring India’s first CL more than a year ago. This licence was upheld only a week or so ago by the IPAB (the written order is expected anytime next week).
It appears that the jinx has finally broken! We’re given to believe (from very authentic sources) that a second CL application was just filed at the Indian Patent Office (IPO) by BDR Pharmaceuticals International Pvt Ltd, a generic company headquartered in Mumbai. BDR made patent news a month or so ago when it announced its intention to launch a generic version of Sunitib, whose patent had just been revoked after a hotly contested post grant opposition.
BDR’s recent CL application covers Dasatinib, an anti cancer drug patented by BMS and mired in several legal controversies in India, including patent fights, DCGI controversies, as well as a defamation suit against me.
Dasatinib has another interesting India connection, in that it is named after an Indian chemist, Jagabandhu Das, who co-discovered it while working at Bristol Myers Squibb.
These are the only facts that I have at the moment and I will update when I receive more information:
1. BDR approached BMS for a license in early 2012. BMS responded asking for a rather extensive and elaborate set of documentation/facts. BDR sent a note to the patent office stating that it was clear that BMS was not interested in granting the license and that the information called for by BMS was irrelevant and nothing more than a delay tactic. Therefore, it considered BMS’ letter as a refusal. Given that more than six months elapsed since then, it filed a CL application with the Indian Patent Office.
2. BMS sells Dasatinib at Rs 1,68,000 (USD 3000 approximately) per month. In its application, BDR has offered to sell at Rs 8100 (USD 150). It has also offered to hand it out free to any patient that cannot afford the drug.
The Controller General of Patents (CG) is yet to issue a notice to BMS on the said application. One will recollect that this was an issue in the earlier CL case, where Bayer claimed that the Controller could not issue a notice, without first hearing the patentee and satisfying itself that a prima facie case had been made out. The IPAB recently disagreed stating that the CG need not hear the patentee and that a prima facie determination can be made on the basis of the CL application and the accompanying documents in support.
It bears noting that Dasatinib was one of the three drugs considered for compulsory licensing by the government under the section 92 route. Unfortunately, after the initial announcement, the enthusiasm appears to have ebbed and one wonders if this was all sound and fury, signifying nothing? With this new CL application under section 84, will the government step back even more from the controversial section 92 route? Only time will tell.
The last two weeks have witnessed significant IP developments in India and we’ve been struggling to stay abreast with this “breaking” spree. The IPAB order upholding the compulsory licence was the first; we then had an Indian court endorsing a new tort of unfair competition to prevent alleged misappropriation of cricket scores. Followed by a controversial Madras High Court decision that permits lawyers to file and prosecute patents without a science/technical degree and a qualifying exam. And now, we have this new compulsory licensing application by a small spunky Indian company. We certainly need a break from this breaking spree!