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PATENT CERTIFICATIONS ARE NECESSARY FOR NEW-USE NDA SUPPLEMENTS

Executive Summary

PATENT CERTIFICATIONS ARE NECESSARY FOR NEW-USE NDA SUPPLEMENTS or filings for other conditions of use, such as route of administration, formulation changes, and strength changes. FDA informed NDA and ANDA holders of the policy in an Oct. 31 letter. Center for Drugs & Biologics Deputy Director Paul Parkman said "most supplements should be treated like full and abbreviated applications" with respect to patent certifications. However, he noted that supplements for such things as changes in manufacturing site or packaging would not require a patent certification. Parkman said all NDA holders and applicants should certify the indications or other conditions of use covered by any use patent. He added that it would also be helpful if NDA applicants would state the indications of use covered by a patent that are approved for inclusion on labeling in the U.S. Parkman said FDA will publish information on indications covered by each use patent in the (ITALICS)Orange Book.(END ITALICS) For patents that claim a drug substance, Parkman said NDA applicants should only file information on patents that refer to an approved drug product. The agency's letter was the fourth in a series of letters concerning FDA policy and interpretation of the Waxman/Hatch Act. Parkman requested comments on FDA's policies and said they would be taken into account, if possible, when the agency prepares proposed regulations to implement the law. FDA urged companies to bring questions on patent dates to the agency's attention. "If anyone disputes the accuracy or relevance of patent information submitted by an NDA applicant and published by FDA, or believes that an NDA applicant has failed to submit required patent information, that person should first notify the agency informally, stating the grounds for the disagreement," Parkman said. The agency "will write to the NDA holder requesting that the correctness of the filing or omission be confirmed. Unless the NDA holder withdraws or changes the patent filing, the agency will not change the patent information in the list." Parkman explained that "if the NDA holder does not change the information filed, a section 505(b)(2) or 505(j) application submitted for the drug should, despite any disagreement, contain a certification for each listed patent and any patent challenge can then be pursued through private legal action under the patent laws." Discussing the requirements for obtaining marketing exclusivity, FDA reiterated that an application for exclusivity must contain clinical trials conducted by the sponsor that are essential for approval. FDA said it interprets the phrase "essential to approval" to "mean that the application could not be approved by the FDA without that investigation." The agency said an applicant must "submit a list of all published studies or publicly available reports of clinical investigations known to the applicant that are relevant to the conditions of approval sought in the application or the change sought in the supplement." Further, the agency stated that an applicant must submit a certification that the applicant sponsored (provided 50% or more of the cost) or conducted the study.
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