Another legal development (adverse) on Natco’s aspiration for gNexavar (Sorafenib Tosylate):
Backgound: Back in 2012, Natco was able to secure first and only Compulsory licence so far in India pharma sector from Bayer. The medicine was for the kidney cancer treatment drug Nexavar (Sorafenib Tosylate). Natcos challenging stance was on the fact that Bayer was artificial keeping the medicine beyond reach by way of unreasonable pricing. This compulsory licencing enabled Natco to launch generic Nexavar in Indian market at ~3% of the price offered by Bayer.
On a side note, what I also gather is that this revolutionary Compulsory Licencing concept met with a defiant nip in the bud approach by way of heavy handed lobbying and decline to launch second generation (improvised) drugs (in some cases) in India market by powerful Pharma group.
Current Development: The battle is far from over between Bayer and Natco. Natco intends to have its ground work (clinical study, data dossier etc.) ready for generic launch of gNexavar outside India as well, upon expiry of exclusivity (Nov/2020). For the filling purpose they need to carry out global experiments. Natco was exporting the API Ingredient/doses of sorafenib tosylate to China to run bioequivalence and bioavailability studies (to prove their product is similar to the innovator product) for regulatory approval in China. However, since 2014 Natco and Bayer are in legal tangle to establish if Natco has right to export APIs/finished doses outside or carry out clinical trials outside India under the purview of compulsory licence…
Delhi High court issued a verdict in March 2017 in favor of Natco under section 107A establishing that export of API for the purpose of clinical study/experiment is non infringement.
However, yesterday another Delhi HC bench revisited this matter again upon appeal by Bayer and have put the API/formulation export by Natco on hold till September. Bayers objection is based on the argument that Natco is exporting finished doses not the APIs.
Two key statements from the media coverage:
The bench said there was “a world of difference” between exporting for licence approvals, as claimed by Natco, and exporting for commercial purposes.
“What you cannot do directly, you cannot do indirectly,” the bench said.
Silver line here is that within yesterdays verdict, Delhi HC has indicated that company need to file separate applications for experimentation purpose and for licence application purpose. And approval can be considered for a specified quantity and for specified purpose only.
Dont see much of an immediate material impact for Natco. Appears to be more of technical/regulatory issues towards future launch prospects.
Invested and forms approx 10% of PF now.