Addressing derivation and obviousness issues, the US Court of
Appeals for the Federal Circuit affirmed the district court’s
denial of a generic drug manufacturer’s attempt to invalidate
a patent based on the theory that the claimed invention was the
result of an exchange with the US Food and Drug Administration
(FDA) during the drug’s approval process, rather than the
named inventor’s idea. Cumberland Pharms. Inc. v. Mylan
Institutional LLC, Case No. 16-1155 (Fed. Cir., Jan. 26, 2017)
(Taranto, J.).
The case relates to a formulation for the medication
acetylcysteine, sold by Cumberland under the brand name
Acetadote® as an intravenous antidote for
acetaminophen poisoning. The relevant claims cover a stable
formulation of acetylcysteine that is “free of chelating
agents.” Chelating agents are preservative chemicals that
bind to heavy metal ions that would otherwise cause the degradation
of the acetylcysteine, interfering with its stability and shelf
life.
