Federal Circuit:
We agree with Amerigen that it has standing to appeal from the Board’s decision because the launch of its tentatively approved drug is blocked by the ’650 patent, and invalidation of the patent would advance its drug’s launch. The ’650 patent is listed in the FDA’s “Orange Book”12 entry for Toviaz®. Amerigen has a Paragraph III certification for the ’650 patent,13 which means that the FDA will only approve Amerigen’s ANDA after the ’650 patent has expired. 21 U.S.C. § 355(j)(5)(B)(ii). However, if the ’650 patent is held unpatentable through reversal of the Board’s decision, then the New Drug Application (“NDA”) holder14 must “promptly notify” the FDA that the patent “no longer meet[s] the statutory requirements for listing.” 21 C.F.R. § 314.53(f)(2)(i). And § 314.53 expressly states that a patent does not meet the requirements for listing “if there has been a judicial finding of invalidity for a listed patent, from which no appeal has been or can be taken.” Id. After a notification from the NDA holder that a patent may no longer be listed, the FDA “will remove a patent . . . from the list if there is no first applicant eligible for 180–day exclusivity based on a paragraph IV certification to that patent or after the 180–day exclusivity period of a first applicant based on that patent has expired or has been extinguished.” Id.
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2596.Opinion.1-11-2019.pdf
We agree with Amerigen that it has standing to appeal from the Board’s decision because the launch of its tentatively approved drug is blocked by the ’650 patent, and invalidation of the patent would advance its drug’s launch. The ’650 patent is listed in the FDA’s “Orange Book”12 entry for Toviaz®. Amerigen has a Paragraph III certification for the ’650 patent,13 which means that the FDA will only approve Amerigen’s ANDA after the ’650 patent has expired. 21 U.S.C. § 355(j)(5)(B)(ii). However, if the ’650 patent is held unpatentable through reversal of the Board’s decision, then the New Drug Application (“NDA”) holder14 must “promptly notify” the FDA that the patent “no longer meet[s] the statutory requirements for listing.” 21 C.F.R. § 314.53(f)(2)(i). And § 314.53 expressly states that a patent does not meet the requirements for listing “if there has been a judicial finding of invalidity for a listed patent, from which no appeal has been or can be taken.” Id. After a notification from the NDA holder that a patent may no longer be listed, the FDA “will remove a patent . . . from the list if there is no first applicant eligible for 180–day exclusivity based on a paragraph IV certification to that patent or after the 180–day exclusivity period of a first applicant based on that patent has expired or has been extinguished.” Id.
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2596.Opinion.1-11-2019.pdf
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