In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the U.S. Supreme Court heralded more promise in obviousness challenges to patent validity. The Court rejected the U.S. Court of Appeals for the Federal Circuit’s “teaching, suggestion and motivation” (TSM) test for patent obviousness as a “rigid preventative rule” and instructed lower courts to take a more “expansive and flexible approach,” one applying “common sense” and recognizing that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”

The Court also held that when there existed a “design need or market pressure to solve a problem,” the pursuit of known options, anticipated to be successful, was likely the product of “ordinary skill and common sense,” making the claimed invention invalid because it would have been “obvious to try.” This pronouncement was significant, since the Federal Circuit had long chastised obvious-to-try invalidity arguments. Recent Federal Circuit decisions applying KSR to cases involving the pharmaceutical arts reveal that obviousness remains an important invalidity defense, particularly for generic drug manufacturers.