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The USPTO recently issued a study concerning AIA trial proceedings challenging Orange Book-Listed patents. The study was presented by the PTAB in a webinar entitled “New PTAB Studies in AIA Proceedings:  Expanded Panels and Trial Outcomes for Orange Book Listed Patents” held on March 13, 2018.

Orange Book-Listed patents cover FDA-approved drug products. The patents are listed in the publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. Orange Book-Listed patents are often the subject of litigation under the Hatch-Waxman Act, which provides for an abbreviated regulatory approval pathway for generic drug products. In its study, the PTAB specifically considered how Orange Book-Listed patents have fared in three key areas of AIA trial proceedings: (1) institution, (2) final written decisions, and (3) situations involving multiple petitions and multiple petitioners.

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