FAQs Patent Questions

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.

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.

Question:How many weeks of the Electronic Official Gazette - Patents will be available on the USPTO web site?

Answer:
Current plans are to maintain one year on the web site. To locate patents announced in earlier OGs, search the USPTO Patent Full Text Database by patentee name, keyword, current classification, or patent number.

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