Replies to post #68577 on Biotech Values

[DewDiligence]

>Teva still would have to bust the tenofovir patents to be able to sell generic Truvada.<

By filing a Paragraph-IV certification against Truvada based on only the Orange Book patents for Emtriva, Teva would seem to be implying that the Viread patents will be without force. Alternatively, GILD may not be divulging the full extent of Teva’s Paragraph-IV certifications. In any event, I’ll be interested in seeing the court pleadings when they come out. Regards, Dew

p.s. The quiz question in #msg-33586560 hinges on a different issue than the one above.

[DewDiligence]

GILD sues Teva on P-IV challenge against Truvada:

http://finance.yahoo.com/news/Gilead-Sciences-Files-Patent-bw-13821920.html

This starts the clock on the 30-month stay of FDA approval of generic Truvada.

Technically, Teva’s P-IV challenge is against GILD’s US patents on Emtriva, one of the two constituent drugs in Truvada; however, Emtriva is hardly ever used other than as a component in Truvada and hence it makes much more sense for Teva to submit an ANDA for Truvada (as it has done) rather than an ANDA for Emtriva.

How Teva expects to get around GILD’s patent on Viread, the other constituent of Truvada, is unclear.

[DewDiligence]

Teva still would have to bust the tenofovir patents to be able to sell generic Truvada.

I no longer think Teva intends to challenge the Viread (tenofovir) patents—please see #msg-34894135. Regards, Dew