Alza defeats Mylan in fentanyl case

Part of the case involved inequitable conduct. Mylan asserted that Alza was guilty of inequitable conduct, specifically with respect to seven statements in a declaration (by Gale) in the second re-exam.

The key issue was with one statement wherein it was asserted that data generated in studies supported the conclusion that skin permeability of fentanyl citrate was too low to produce effective transdermal administration.

The potential to mislead was in the fact that it was technically possible to use the Keith patent to generate a fentanyl transdermal system. That is, the data supported the idea that a large amount of fentanyl citrate could produce effective transdermal administration. However, no data were omitted and nothing was affirmatively misstated.