Source: http://www.fdalawblog.net/2010/06/a-new-180day-exclusivity-punt-but-dont-read-too-much-into-it/
Timestamp: 2019-04-20 14:16:55+00:00

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FDA's recent approval of an ANDA submitted by Perrigo R&D Company ("Perrigo") for a generic version of the over-the-counter drug MONISTAT 1 Combination Pack (1200 mg miconazole nitrate vaginal insert and 2% miconazole nitrate cream) contains some interesting language concerning 180-day exclusivity eligibility. It it the latest type of post-Medicare Modernization Act ("MMA") 180-day exclusivity "punt" language adopted by FDA.
As we previously reported, FDA has, on several occasions punted on the issue of post-MMA 180-day exclusivity eligibility. Those punts have come up in the context of 180-day exclusivity forfeiture under FDC Act § 505(j)(5)(D)(i)(IV), where a company failed to obtain tentative ANDA approval within 30-months of application submission. In each of those cases, FDA did not make a formal forfeiture determination at the time of ANDA approval and stated it would do so only if another applicant becomes eligible for approval within 180 days after exclusivity is triggered.
The latest punt comes under the failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I), which provide that 180-day exclusivity is forfeited based on the "later of" two dates: (1) the earlier of 75 days after ANDA approval or 30 months after ANDA submission; and (2) 75 days after which "[t]he patent information submitted under [FDC Act § 505(b) or (c)] is withdrawn by the holder of the" NDA holder (FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC)), among two other litigation-related events (FDC Act § 505(j)(5)(D)(i)(I)(bb)(AA) & (BB)). In March 2010, the U.S. Court of Appeals for the District of Columbia Circuit ruled in Teva Pharms USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), that Teva did no forfeit 180-day exclusivity eligibility under the failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I), and FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) in particular. In doing so, the Court reasoned that the patent delisting counterclaim provision at FDC Act § 505(j)(5)(C)(ii)(I) added by the MMA must be read together with the patent delisting forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC), and that FDA's broad reading of FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC), in which the Agency interpreted the provision such that the mere request to withdraw patent information from the Orange Book is a forfeiture event under FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC), was not sustainable. FDA has been reluctant to adopt a narrow interpretation of FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC), but has done so nevertheless.
Now, someone could read the emphasized language above and conclude that FDA has not fully embraced the Teva decision. After all, there has not, to our knowledge, been a counterclaim brought under FDC Act § 505(j)(5)(C)(ii)(I) that would call Perrigo's 180-day exclusivity into question. So why even include the "punt" language in the approval letter at all? We think that FDA included the language in the letter to cover all of the bases. That is, as a placeholder just in case a counterclaim is brought by another applicant under FDC Act § 505(j)(5)(C)(ii)(I).

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