FAQs Patent Questions

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:Is it necessary to go to the USPTO to transact business concerning patent matters?

Answer:
No. Most business with the Office is conducted by written correspondence. Interviews regarding pending applications can be arranged with examiners if necessary and are often helpful.

Question:When is a patent extension application submitted and where is it submitted?

Answer:
Application for patent extension must be filed within 60 days of FDA approval of the drug product even if the product cannot be commercially marketed at that time.

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