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Presentation Materials in English [pdf] - United States Patent and ...

Presentation Materials in English [pdf] - United States Patent and ...

U.S. Practice• How FDA

U.S. Practice• How FDA becomes aware of patents– Requirement to list patents that cover thedrug as part of NDA filing– Must submit signed declaration– FDA relies on innovator drug company’sassertion– Patent information published in OrangeBook

U.S. Practice• Generic companies are aware of patentsthrough the Orange Book:– Lists a wide variety of approved drug patents, asincluded in a New Drug Application– Opportunity for generic drug companies to informFDA that a particular listed patent does not cover theFDA-approved drug product– FDA request evaluation of complaint by innovatorcompany– Innovator company can request de-listing or respondwith good-faith belief that listing is proper

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