How is the approval date determined for drug products in patent term extension applications?
For drug products, the approval date used in patent term extension applications is determined based on the Food and Drug Administration’s (FDA) communication. According to MPEP 2754.01: “For drug products the approval date is the date of a letter by the Food and Drug Administration indicating that the application has been approved, even if the…
Read MoreHow is the approval date determined for food or color additives in patent term extension applications?
For food or color additives, the approval date used in patent term extension applications is determined differently from drug products. According to MPEP 2754.01: “For food or color additives, the relevant date is the effective date of the regulation or order, which is set forth in the regulation or order, and generally is the date…
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