FAQs Patent Questions

Question:How long does an applicant holder have to submit patent information?

Answer:
Patent information is required to be submitted with all new drug applications at the time of submission of the NDA. If appropriate, the patent information is published at the time of approval of the NDA. For patents issued after approval of the NDA, the applicant holder has 30 days in which to file the patent to have it considered as a timely filed patent. Patents may still be submitted beyond the 30 day timeframe but the patent is not considered a timely filed patent.

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 long does it take for a patent application to be processed?

Answer:
The average patent application pendency is 24.6 months. Applications received in the U.S. Patent and Trademark Office are numbered in sequential order and the applicant will be informed within eight weeks of the application number and official filing date if filed in paper. If filed electronically, the application number is available within minutes.

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