Notably, the Orange Book Addendum contains patent and exclusivity information. Under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy. To seek this approval, a generic applicant must provide in its application a “certification” that a patent submitted to FDA by the brand-name drug’s sponsor and listed in FDA’s Orange Book is, in the generic applicant’s opinion and to the best of its knowledge, invalid, unenforceable, or will not be infringed by the generic product. This certification is called a “paragraph IV certification.” The first company or companies to submit an application that (1) is determined by the agency to be “substantially complete” upon submission and (2) contains a paragraph IV certification to at least one of the patents listed in the Orange Book is generally eligible for the exclusive right to market the generic drug for 180 days.
In order to challenge a patent in court, the generic applicant that submitted a paragraph IV certification must notify the brand product sponsor and any patent holder of the submission of the ANDA and patent challenge. If the brand product sponsor or patent holder files an infringement suit against the generic applicant within 45 days of the ANDA notification, FDA approval to market the generic drug is generally postponed for 30 months unless the patent expires or is judged to be invalid or not infringed before that time. This 30-month postponement, commonly referred to as the “30-month stay,” gives the brand product sponsor and patent holder a prescribed amount of time to assert patent rights in court before a generic competitor is approved and can market the drug.
Robert P. Mino, PA, offers affordable invalidity searches to support Paragraph IV filings. In such invalidity searches, the office will make a reasonable effort, leveraging knowledge and skill to search available tools for art, however there is no guarantee the office will find any art or that the office will uncover any or all art, even if such art exists.
Note: This page includes general information from the FDA which is provided for educational purposes only. The advice of an attorney should be sought to obtain legal advice relevant to your particular circumstances.