A Punt Return, Not a Fumble Return, in the Second FDA Resolution of a 180-Day Exclusivity Punt Case

July 15, 2013

By Kurt R. Karst

Touchdown!  It was just last month that we posted on the first instance in which FDA resolved what has become known as a “180-day exclusivity punt.”  As we explained then, “180-day exclusivity punts” are instances in which a first applicant eligible for 180-day exclusivity gets ANDA approval, but FDA decides not to decide on whether or not to grant exclusivity.  FDA has issued such decisions for years now, beginning in 2006 (see our previous post here). 

Usually FDA’s punt decisions have been in the context of the failure-to-obtain-timely-tentative approval 180-day exclusivity forfeiture provision added by the 2003 Medicare Modernization Act (“MMA”) (FDC Act § 505(j)(5)(D)(i)(IV)), but there’s at least one instance where FDA used the mechanism under the failure-to-market forfeiture provision (FDC Act § 505(j)(5)(D)(i)(I)) added by the MMA (see here).  There was also one curious instance late last year in which FDA used the punt mechanism in a pre-MMA 180-day exclusivity case: the December 28, 2012 approval of Mallinckrodt Inc.’s ANDA No. 202608 for a generic version of Janssen Pharmaceuticals, Inc.’s CONCERTA (methylphenidate HCl) Extended-Release Tablets, 27 mg, 36 mg, and 54 mg.  That’s the topic of our post today. 

As we explained in a January posting, although the first ANDA containing a Paragraph IV certification for all four approved strengths of CONCERTA (18 mg, 27 mg, 36 mg, and 54 mg) was submitted to FDA post-MMA on July 19, 2005, the first ANDA containing a certification to an Orange Book-listed patent for CONCERTA was made pre-MMA.  As such, generic CONCERTA is a pre-MMA/post-MMA straddle drug governed by the pre-MMA rules on 180-day exclusivity (see here).  Under the pre-MMA version of the statute, 180-day exclusivity is patent-based, such that an ANDA applicant (or different applicants) may be eligible for 180-day exclusivity with respect to different Orange Book-listed patents covering the Reference Listed Drug (“RLD”) if the applicant submitted the first ANDA to FDA containing a Paragraph IV certification to a particular patent.  Pre-MMA 180-day exclusivity is triggered by either first commercial marketing (for all relevant patents), or by a court decision favorable to an ANDA applicant (with respect to a particular patent), whichever is earlier. 

The Orange Book lists three patents for CONCERTA: U.S. Patent Nos. 6,919,373 (“the ‘373 patent”), 6,930,129 (“the ‘129 patent”), and 8,163,798 (“the ‘798 patent”).  180-Day exclusivity with respect to the ‘373 and ‘129 patents was likely triggered and ran several years ago.  The ‘798 patent, however, is a new patent that was not listed in the Orange Book until May 18, 2012.  Mallinckrodt was the first company to certify to the patent – as an amendment to ANDA No. 202608 – making it eligible for 180-day exclusivity with respect to the patent.  Despite Mallinckrodt’s eligibility for exclusivity, FDA punted on exclusivity, saying:

Mallinckrodt may be eligible for 180 days of generic drug exclusivity . . .  The agency is not, however, making a formal determination at this time of Mallinckrodt’s eligibility for 180-day generic drug exclusivity.  It will do so only if another paragraph IV applicant becomes eligible for full approval (a) within 180 days of the earlier of the commercial marketing or court decision dates identified in section 505(j)(5)(B)(iv), or (b) at any time prior to the expiration of the ‘798 patent if neither the commercial marketing nor court decision events identified in section 505(j)(5)(B)(iv) has occurred.

It did not take us long to put two and two together and surmise the reason for FDA’s punt: The U.S. District Court for the District of Columbia’s decision in Watson Laboratories, Inc. v. Sebelius, et al., Case No. 12-1344 (ABJ) (D.D.C. Oct. 22, 2012).  In that case, which concerned pre-MMA 180-day exclusivity for generic ACTOS (pioglitazone), the district court overruled FDA’s determination that Watson was not eligible to share in 180-day exclusivity because the company was not the first (or among the first) to amend its pending ANDA to convert a patent certification to Paragraph IV.  Instead, the district court ruled that Watson was entitled to share in another applicant’s 180-day exclusivity period, because FDA’s long-standing interpretation of the FDC Act was contrary to the terms of the statute, and ordered the Agency to approve Watson’s ANDA.  FDA appealed the decision to the U.S. Court of Appeals for the District of Columbia Circuit (Docket Nos. 12-5332 & 12-5342).  Ultimately, a motion for vacatur was filed (because the expiration of 180-day exclusivity mooted the case), and the appeal was ordered dismissed in June.

The ACTOS decision could potentially be interpreted to say that what is in an amendment to an ANDA does not count for 180-day exclusivity purposes.  Rather, it is the original ANDA submission that counts.  In the case of generic CONCERTA, Mallinckrodt became eligible for 180-day exclusivity as the result of an ANDA amendment.  So, at the time FDA approved Mallinckrodt’s ANDA No. 202608, when the ACTOS case was on appeal to the D.C. Circuit, it probably seemed logical to FDA to punt on 180-day exclusivity.  But once the appeal was dismissed and the D.C. District Court was ordered to vacate its October 22, 2012 Order and Memorandum Opinion, FDA probably decided that it was safe to take make a firm decision on exclusivity. 

And that’s clearly what happened when FDA, on July 9, 2013, approved Kudco Ireland’s ANDA No. 091695 for Methylphenidate HCl Extended-Release Tablets, 18 mg, 27 mg, 36 mg, and 54 mg.  FDA granted final approval for the 18 mg and 27 mg strengths, but only tentative approval for the 36 mg, and 54 mg strengths (see here).  Mallinckrodt launched its 27 mg strength shortly after approval in December 2012 (see here), thereby triggering 180-day exclusivity that had expired by July 9th.  But Mallinckrodt delayed launch of the 36 mg and 54 mg strengths until late March 2013 (see here).  Thus, Mallinckrodt’s 180-day exclusivity for these two strengths did not expire by July 9th, meaning that FDA could only tentatively approve Kudco’s ANDAs for these strengths.  Implicit in the Kudco tentative approvals is that FDA resolved the previous punt on 180-day exclusivity in favor of Mallinckrodt (i.e., a punt return for a touchdown).