How does the paragraph IV certification process relate to USPTO disclosures?
The paragraph IV certification process, typically associated with generic drug applications to the FDA, can generate information material to patentability that should be disclosed to the USPTO. According to MPEP 2015:
“Consequently, to assist USPTO staff in evaluating patentability effectively and efficiently, the party receiving a paragraph IV certification should review such documents to determine whether they are material to the patentability of any pending matters before the USPTO, such as pending patent applications, reexamination proceedings, or issues in proceedings pending before the PTAB.”
If the detailed statement in a paragraph IV certification or other information from the ANDA process is deemed material to patentability, it must be submitted to the USPTO to meet the duties of candor and good faith under various USPTO regulations.
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