On December 3, 2014, the Federal Circuit issued a decision in Par Pharmaceutical, Inc. and Alkermes Pharma Ireland Limited v. TWI Pharmaceuticals, Inc., agreeing with the district court’s analysis and conclusions on motivation to combine, reasonable expectation of success, and objective indicia of nonobviousness but vacating and remanding for further analysis on the issue of inherency.

Patent at Issue -

Par obtained U.S. Patent No. 7,101,576 to a method of using megestrol nanoparticles to increase body mass in a human patient suffering from anorexia, cachexia, or loss of body mass, wherein after a single administration in a human subject, there is no substantial difference in the Cmax of megestrol when the formulation is administered in a fed versus a fasted state (“the food effect limitation”). The FDA approved Par’s New Drug Application for its megestrol nanoparticle formulation, Megace ES, and Par listed the ‘576 patent in the Orange Book. TWI filed an Abbreviated New Drug Application, asserting among other things that the claims of the ‘576 patent are invalid as obvious under 35 U.S.C. §103. Specifically, TWI argued that the food effect limitation was disclosed in the prior art under the principle of inherency. The district court agreed and held the ‘576 patent invalid as obvious...