FAQs Patent Questions

Question:Applicants must submit amendments to drawings as replacement or new drawings together with explanations of the changes

Answer:
Applicant must submit any amendments to drawings as replacement or new drawings accompanied by explanations of the changes in either the drawing amendment section or remarks section of the amendment paper. Any replacement sheets of drawings must be labeled as "Replacement Sheet" and any new sheets of drawings must be labeled as "New Sheet" in the header.

Question:How long is exclusivity granted for?

Answer:
It depends on what type of exclusivity is granted. Orphan Drug (ODE) - 7 years New Chemical (NCE)- 5 years "Other" Exclusivity - 3 years for a "change" if criteria are met Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)

Question:Why does a particular drug product only have patents?

Answer:
Some drugs have both patent and exclusivity protection while others have just one or none.

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