A New 180-Day Exclusivity Punt – But Don’t Read Too Much Into It

By Kurt R. Karst –   

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ANDA submission; and (2) 75 days after which "[t]he patent information submitted under [FDC Act § 505(b) or (c)] is withdrawn by the holder of the" NDA holder (FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC)), among two other litigation-related events (FDC Act § 505(j)(5)(D)(i)(I)(bb)(AA) &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. 
 
MONISTAT 1 Combination Pack is listed in the Orange Book with two patents – U.S. Patent Nos. 5,514,698 ("the '698 patent) and 6,153,635 ("the '635 patent").  Both patents are identified with a "Delist Requested" flag, which first appeared in the May 2009 Orange Book Cumulative Supplement.  According to FDA's Paragraph IV Certification List, FDA received Perrigo's ANDA containing a Paragraph IV certification to the '698 and '635 patents on December 5, 2007.  This set up a potential 180-day exclusivity forfeiture under FDC Act § 505(j)(5)(D)(i)(I) for late last week, as the "later of" date was 30 months after ANDA submission.  FDA timely approved Perrigo's ANDA, however, and stated in the approval letter that:

With respect to 180-day generic drug exclusivity for Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%), Perrigo was the first ANDA applicant to submit a substantially complete ANDA for Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%), with a paragraph IV certification to the patents listed above.  Therefore, with this approval, Perrigo may be eligible for 180 days of generic drug exclusivity for Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%). . . .   The agency notes that a delisting request has been submitted for the '698 and '635 patents.  The agency is not making a formal determination at this time of Perrigo's eligibility for 180-day generic drug exclusivity.  It will do so only if another applicant becomes eligible for approval within 180 days after Perrigo begins commercial marketing of Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%). [(emphasis added)]

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).