Gilead is reported to be in talks to issue voluntary licenses to Indian generic manufacturers for the production of sofosbuvir, an important new drug to fight hepatitis C.
If the intended territorial scope of licenses is only 60 countries, it will be far less than what Gilead first offered through it voluntary licenses for ARVs and much more limited than the licensed territory negotiated with the Medicines Patent Pool. Moreover, if the territories are limited to sub-Saharan Africa, India, and low-income countries, it will miss key countries with with very high HEP C burdens, e.g., Egypt.
In addition, there is a certain cynicism in Gilead seeking voluntary licenses with a select number of preferred supplier in India, especially since the underlying patent is facing a fierce opposition by I-MAK. In its initial ARV voluntary licenses, Gilead tried to restrict licensee challenges to its IP – a clause that was per se anti-competitive under several the law of multiple nations. Although it seems doubtful that Gilead would try to impose such a clause again, it is possible that it’s preferential voluntary licenses will undermine generic oppositions.
However, even if the opposition in India is successful, it will not directly address sofosbuvir’s patent status in other countries.
In addition, the initial price of $2000, though welcome compared to extortionate pricing in the U.S., is still far too high. Reports on projected costs of production indicate that a much lower selling price is possible and it will only be robust generic competition that produces such a result. Accordingly, Gilead should issue licenses to all qualified generic producers who can manufacturer bioequalivalent sofosbuvir to global Good Manufacturing Practices standards.
Gilead should also describe its efforts to help ensure registration of generic equivalents, preferably by first registering the product itself and then allowing reference/reliance on such registration by its generic licensees.
