Government policies affecting intellectual property rights and the review of food and health care products dramatically influence investments in research leading to the development and sale of products that serve unmet medical needs or provide consumers with safe sources of food and drug products at a low cost. When statutes that affect several regulatory agencies are revised within a short time period, institutions that rely on exclusive rights offered by those agencies in exchange for obligations of disclosure and compliance must alter their business plans to adjust to new rules leading to the benefit conferred by the government. In 2011, the Leahy-Smith America Invents Act (AIA) was passed, changing many aspects of the federal statutes relating to the United States Patent and Trademark Office (PTO), and in 2010, the Patient Protection and Affordable Care Act (PPACA) was passed, which included the Biologics Price Competition and Innovation Act (BPCIA), requiring the United States Food and Drug Administration (FDA) to establish an abbreviated regulatory approval pathway for complex macromolecules produced in living cells or organisms. This series of articles briefly reviews key aspects of the AIA and the BPCIA, plus recent court cases relating to complementary periods of exclusivity offered by the FDA and the PTO, which should be of great interest to academic and corporate institutions having an interest in the life sciences. Important aspects of the AIA will be discussed in the first article in this series…