FAQs Patent Questions

Question:What is FDA’s role in the Patent Term Restoration Program?

Answer:
FDA’s primary responsibility is to assist the Patent Trademark Office (PTO) in determining a product’s eligibility for patent term restoration and to provide information to PTO regarding a product’s regulatory review period.

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:The title of the design must identify the article in which the design is embodied.

Answer:
The Title of the design must identify the article in which the design is embodied by the name generally known and used by the public. Marketing designations are improper as titles and should not be used. A title descriptive of the actual article aids the examiner in developing a complete field of search of the prior art.

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