While the IP law world is being rocked by new developments in biosimilars, patent-eligible subject matter and IPR’s, it is almost refreshing to see a decision upholding the validity of claims to a “small molecule” drug based on application of the principles of obviousness–particularly the no-no of hindsight reconstruction. Shire LLC v. Amneal Pharmaceuticals, LLC, Appeal no. 2014-1736 et al. (Fed. Cir., September 24, 2015). (A copy of this decision can be found at the end of this post.)
This was a straightforward Hatch-Waxman infringement suit, during which Shire had to defend the validity of four patents covering a derivative of “speed,” L-lysine-d-amphetamine (“LDX”) dimesylate, marketed as Vyvanse® to treat autism. Defendants needed to convince the court that it would be obvious to both make the L-lysine derivative of d-amphetamine and then to make the dimesylate salt.