Big Brand Name develops and files a patent for a drug that kills bacteria in an innovative way. The drug is groundbreaking and potentially marketable, so Big Brand Name incurs the enormous cost (estimated at $868 million) and time of drug discovery research and safety determinations of clinical trials to bring the drug to market. Small Generic Company wants to sell the same drug but must wait until Big Brand Name’s patent expires or, in the alternative, Small Generic Company can file an Abbreviated New Drug Application (“ANDA”) with the FDA and allege Big Brand Name’s patent is invalid or the patent does not cover Small Generic Company’s Drug. Filing an ANDA application is an attractive option for Small Generic Company because it can market and sell the same drug for a fraction of Big Brand Name’s development and clinical trial cost. Thus, Small Generic Company files an ANDA application, stating the relevant patent (Big Brand Name’s patent) is invalid or their drug does not infringe the relevant patent. The ANDA application allows Small Generic Company to bypass the expensive clinical trials.
A Vaccine Approach to the Reverse Payment Illness,
Rich. J.L. & Tech
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