Patent submission date in Orange Book and its impact
As
part of transparency initiation, The United States Food and Drug Administration
(USFDA) started addition of patent submission date in Orange Book. In
accordance with FDA’s October 2016 final rule implementing portions of the 2003
Medicare Modernization Act (Also known as MMA 2003, Amendment 2016), FDA has
decided to publish this information in the Orange Book prospectively.
Earlier
Scenario:
- Patent submission date only available by contacting Orange Book Staff.
- Difficult for generic companies to determine if a patent was late-listed, relisted, or properly listed.
- Difficult to know whether an ANDA applicant needed to include a patent certification or needed to update an application with an amended certification.
Usefulness
of patent submission date to generic industry:
- Applicants will have a much clear picture on timely listed patents and listed patents indeed require certification.
- Knowing the submission date clarifies whether listen patent will trigger 30 months stay period in litigation.
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