Federal Circuit notes safety and effectiveness of patented medicines are the domain of the FDA not the USPTO

Anti-cancer, anti-viral patent invalidated despite contention its expert was ignored

Decision flipped after replacement for a retired judge sides with original dissenter

Federal Circuit states there is no heightened written description standard for negative limitations

The patent specification did not support a claim to a specific dose of 480 mg/day of DMF, sold under the brand name Tecfidera for the treatment of MS

Held: Written description cases are intensively fact-oriented and a disclosure with isolated examples does not support claimed ranges with lower and upper bounds