[20190517]IF11214_药品定价与法律：药品专利纠纷.pdf

https:/crsreports.congress.gov May 17, 2019Drug Pricing and the Law: Pharmaceutical Patent DisputesPatent rights play an important role in the development and pricing of pharmaceutical products. Patent law seeks to encourage innovation by granting the holder of a valid patent a temporary monopoly on an invention, potentially enabling him to charge higher-than-competitive prices. Patent disputes relating to the entry of follow-on pharmaceuticals are subject to specialized procedures. Because patent rights may deter or delay competition from generic drug and biosimilar manufacturers, these procedures can affect whether and when follow-on products can enter the market, influencing the prices of patented pharmaceuticals. This In Focus provides an overview of the complex procedures governing pharmaceutical patent disputes. FDA Regulation of Drugs and Biologics Drugs and biological products (biologics) are both articles used in the diagnosis, cure, mitigation, treatment, or prevention of human disease. Nonbiological drugs do not derive from living organisms, and are generally artificially synthesized, small-molecule chemicals. In contrast, biologics are generally large, complex molecule