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:

• 37 CFR 1.105
• requirements for information
• FDA
• government agencies
• drug patents