Gilead (GILD) - Get Report said Friday that it received notice Teva Pharmaceuticals (TEVA) - Get Report is challenging two of its patents in an effort to manufacture a generic version of the HIV drug Truvada, but the threat seems to be far off.
Israeli generic drug maker Teva submitted an abbreviated new drug application to the Food and Drug Administration requesting permission to make and market a generic version of Truvada. The filing challenges two patents associated with Emtriva, a component of Truvada. Those patents are owned by Emory University and licensed exclusively to Gilead.
Gilead now has 45 days to commence a patent infringement suit against Teva, which would prevent approval of the ANDA for up to 30 months or until a district court ruled in favor of Teva. However, Gilead said in a press release that Truvada is protected by 10 patents that would have to expire or be proved invalid before a generic version could be marketed.
The specific patents being challenged expire in 2020 and 2021, and Teva doesn't appear to be going after the other patents. This was widely expected, according to JP Morgan analyst Geoffrey Meacham, who called Teva's chances of invalidating all the patents "very unlikely."
In all likelihood, Teva is ultimately trying to position itself to be the first in line to get the rights to produce a generic, should the opportunity eventually arise.