Impact of America Invents Act on Biotech Intellectual Property

This review introduces the America Invents Act (AIA), a comprehensive reform of U.S. law on patentability and patent enforceability that Congress enacted in 2011. The AIA’s most publicized change transforms the United States from a “first-to-invent” system to a “first-inventor-to-file” regime, bringing U.S. patent law more in line with the patent systems of nearly every other industrialized country in the world. This new system requires small companies and independent inventors to toe the line against larger competitors in what many have called a “race to the patent office.” But a closer look at the AIA reveals several opportunities for smaller entities that may even the playing field, particularly for innovators in the biotech sector. This article addresses changes that the AIA brings to U.S. patent law, keeping an eye toward issues relevant to biotech companies.