The Leahy-Smith America Invents Act I (AIA), signed into law on September 16, 2011, represents the first major legislative overhaul to the United States patent laws in 60 years'. The implementation of the AIA is already under way, but it will not be com¬pleted until March 16, 2013, when the final provisions come into effect. Although the AIA brings many significant changes to US patent law, perhaps the most significant will be the conversion from a first-to-invent system to a first-to-file system, which will harmonize the US patent system in this regard with that of nearly every other country in the world.

The immediate implication of a first-to-file system is that it places each inventor in a race to be the first to file a patent application claim¬ing the invention. This will be true across all industries, but the shift comes at a challenging time for the biotechnology industry, as recent court decisions have elucidated the inherent risk in biotech innovation of filing too early and realizing it too late. In an industry in which innovation is just as likely to develop overnight as it is over a decade, the tension between a first-to-file system and the necessity to fully develop an invention to ensure that all other legal patent requirements are met may make it even harder for the inventor who wins the race to take home the patent.

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