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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 IRequired patent information has not been filedFDA may approve 505(b)(2) immediately;
Paragraph IIPatent has expiredFDA may approve 505(b)(2) immediately;
Paragraph IIIPatent has not expired but will expire on a certain dateFDA may approve 505(b)(2) effective on patent expiry date;
Paragraph IVPatent is invalid or non-infringed by applicantApplicant provides notice to NDA holder; approval  may or may not occur