Impermissibly Redefining ‘Long-Felt Need' Using Hindsight

Establishing long-felt need requires objective evidence that an art-recognized problem existed for a long period of time without solution.¹ In the past, courts identified the long-felt but unmet need as an art-recognized problem that was not necessarily defined in terms of the solution set forth in the claimed invention. For example, in AstraZeneca Pharmaceuticals LP v. Anchen Pharmaceuticals Inc.², the claims of the patent-in-suit were directed to sustained release formulations of the antipsychotic compound quetiapine and a method for treating psychotic states or hyperactivity by administering an effective amount of the claimed formulations. The court defined the long-felt but unmet need more broadly than merely a method for treating psychotic states or hyperactivity by administering an effective amount of the claimed formulation, noting "a recognized but unmet medical need for an effective drug therapy for the treatment of bipolar depression" arose prior to the