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|