Can an examiner require information submitted to other government agencies?
Yes, an examiner can require information submitted to other government agencies under certain circumstances. The MPEP states:
“This requirement could include statements made or information submitted to other Government agencies such as the FDA.”
For example, when examining a claim related to a drug manufacturing process filed more than a year after FDA approval, an examiner might require the applicant to submit information provided to the FDA about the manufacturing process. This could include information from:
- New Drug Applications (NDAs)
- Biologics License Applications (BLAs)
Such requirements are based on the examiner’s authority under 37 CFR 1.105 to request information reasonably necessary for examination.
To learn more:
Topics:
MPEP 2000 - Duty Of Disclosure,
MPEP 2005 - Comparison To Requirements For Information,
Patent Law,
Patent Procedure