Biotech Values

[DewDiligence]

Re: IDX899 partnership and Truvada patent status

Could there be other [than GILD] partners looking at the possibility of Truvada becoming generic by the time IDX899 actually can get to market? If this is the case, then IDX899 could be a franchise saver for Gild and perhaps a franchise breaker for somebody else seriously interested in the space.

The answer, IMO, is no. After looking into Teva’s patent challenge against Truvada in some detail, I’m convinced that Truvada will not go generic in the US until Jan 2018, when the 5914331 patent expires (including allowance for a six-month pediatric extension).

Truvada consists of Viread + Emtriva. Teva is attacking Truvada by challenging two Emtriva patents (6642245 and 6703396) that expire in 2021. I think Teva will succeed in knocking out these patents by arguing that they are redundant with three Emtriva patents that expire between 2010 and 2016. If Teva’s challenge succeeds, the 5914331 patent will be the last Truvada-related patent standing. (The various US patents on Viread expire in 2017.) Thus, what Teva is aiming to accomplish in this patent challenge is to own the 180-day H-W exclusivity on generic Truvada starting in Jan 2018.