FAQs Patent Questions

Question:After the second consideration, the rejection or other action may be made final.

Answer:
On the second or later consideration, the rejection or other action may be made final. The applicant’s reply is then limited to appeal in the case of rejection of any claim and further amendment is restricted. Petition may be taken to the Director in the case of objections or requirements not involved in the rejection of any claim.

Question:Applicants can reinstate a cancelled claim by presenting the text of the canceled claim with the changes in a new claim

Answer:
Applicant can reinstate a canceled claim by presenting the text of the canceled claim with any desired changes in a new claim with a new claim number and use the status identifier, (new).

Question:What is the difference between patents and exclusivity?

Answer:
Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

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