It may be an “important lesson” for Hyderabad-based drug company Natco in terms of legal strategy, but a possible setback for public health, say experts dealing with intellectual property issues.
In an on-going case between Natco and multinational Bristol-Myers Squibb in the Delhi High Court, Natco has admitted that it is selling dasatinib, a generic version of BMS’s cancer drug, though it did not infringe the latter’s patent.
The problem, however, is that Natco had in 2009 told the court that it was challenging the validity of BMS’s patent on this drug, and did not plan to launch the drug in the local market. But in June this year, Natco did in fact launch a generic version of the drug.
Since the case is in court, Natco did not want to comment on the development.
Intellectual property experts say the unfortunate development on Natco’s part could lead to see an interim set-back, both for the company and for public health. Natco sells the generic version of the drug for about Rs 9,000 per month, while the patented drug sells at about Rs 2 lakh.
POster-boy
Natco was issued the country’s first-ever compulsory licence for public health in the country. The compulsory licence allows Natco to make a similar version of Bayer's Nexavar, an advanced kidney cancer medicine, on payment of a six per cent royalty to Bayer.
In intellectual property circles, Natco is increasingly being seen as the poster boy of the domestic pharmaceutical industry for taking on patent challenges against multinational companies.
No one knows why Natco did what it did, says IP expert Shamnad Basheer, referring to Natco’s earlier stand that it was not interested in selling the drug locally.
The company should have said its seeking regulatory approval to sell the drug had no connection with its challenge on the validity of the patent. Specially so, since Indian law does not link issuance of a patent by the Patent office with marketing approvals, given by the Drug Controller’s office.
More clarity will dawn on the development as the case comes up in court later this month.