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505(b)(2) RLD Patent Certification

In our webinar last week on Patent & Marketing Exclusivity we received an interesting question that I would like to pass along to readers of this blog.

Q: If there are two RLDs, one with IP and one without IP, does a Sponsor have to certify against both RLDs?

A: If you reference a RLD, you always certify. In the case you cite, for the RLD without outstanding IP, you use a paragraph 1 certification.  For the RLD with IP you certify using paragraph 3 (you’ll wait for approval before launching) or 4 (you challenge the patent validity).

To expand, there are 4 potential categories of certifications, as listed in the following table.  As you can see, there is always at least one classification that fits your RLD.

Paragraph I Required patent information has not been filed FDA may approve 505(b)(2) immediately;
Paragraph II Patent has expired FDA may approve 505(b)(2) immediately;
Paragraph III Patent has not expired but will expire on a certain date FDA may approve 505(b)(2) effective on patent expiry date;
Paragraph IV Patent is invalid or non-infringed by applicant Applicant provides notice to NDA holder; approval  may or may not occur