ABSTRACT
OBJECTIVE: To figure out the balance mechanism between brand-name drugs and generic drugs in American drug review. METHODS: This paper reviewed FDA laws and regulations, domestic and foreign literature to retrospect the basis of generic development and explore the brand-name drug companies' action to prevent generic competition. RESULTS AND CONCLUSION: The abbreviate new drug application, patent challenge and market exclusivity in the Hatch-Waxman Act were the basis of generic development. Brand-name drug companies prevented competition by occupying the market, refusing to provide samples, submitting citizen petitions to extend generic drug review time and extending the patent term and market exclusivity of brand-name drugs. The United States legislated and amended relevant laws and regulations, adjusted the generic drug user fee to maintain the stability of the balance, which is worthy of further research.
ABSTRACT
OBJECTIVE: To compare lipitor patent protection and challenges of both China and America, such as defense and invalidity strategies in patent litigations, patent linkage in generic drug industry. METHODS: The literatures which related to lipitor patents and court decisions were researched. And the case law of patent, the policy of drug were analyzed. RESULTS AND CON CLUSION: Domestic legal environment should be improved with the development of Chinese generic drug industry, which requests non-infringement actions in drug application.