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ANDA Submission
Which type of patent certification must state during ANDA submission?
The applicant’s patent certification must state one of the following:
- That such patent has expired (a paragraph II certification)
- The date on which such patent will expire (a paragraph III certification)
- That such patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted (a paragraph IV certification)
What happens when an ANDA applicant submits a paragraph IV certification?
On or after the date on which FDA has received an ANDA for review, an applicant that has submitted a paragraph IV certification to a listed patent must provide the NDA holder and each patent owner notice of its paragraph IV certification, including a description of the legal and factual basis for the ANDA applicant’s assertion that the patent is invalid, unenforceable, or will not be infringed.
If a patent is listed at the time an original ANDA is submitted and, in response to a notice of a paragraph IV certification, the NDA holder or patent owner initiates a patent infringement action against the ANDA applicant within 45 days of receiving the required notice, approval of the ANDA generally will be stayed for 30 months from the latter of the date of receipt of the notice by any patent owner or the NDA holder, or such shorter or longer time as the court might order.
The statute provides an incentive and a reward to certain ANDA applicants that expose themselves to the risk of patent litigation; the statute does so by granting a 180-day period of exclusivity vis-à-vis certain other ANDA applicants to the applicant that is first to file a substantially complete ANDA that contains, and for which the applicant lawfully maintains, a paragraph IV certification to a listed patent for the RLD (First Applicant).