Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

By Kevin E. Noonan — ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to market a generic version of a branded, innovator drug. Particularly under circumstances where there are several ANDA litigants, and where most of them are not the sole “first filer” entitled to 180-day market exclusivity should they prevail in invalidating the innovator’s patent(s) or (less often) showing that their generic product will not infringe, there is an incentive for the branded drug…