FDA Resolves Pre-MMA/Post-MMA 180-Day Exclusivity Ambiguity; Determines that Pre-MMA 180-Day Exclusivity Regime Will Apply in “MMA Straddle” Cases

By Kurt R. Karst –      

FDA’s April 15th decision to approve ANDAs for generic versions of Topiramate Sprinkle Capsules signals a new FDA interpretation of the 180-day generic drug exclusivity provisions of the FDC Act, which were amended in December 2003 under Title XI of the Medicare Modernization Act (“MMA”).  Although Topiramate Sprinkle Capsules is the first drug product approved that is subject to this new interpretation, according to FDA, there are other products that are affected.

Under the pre-MMA version of the statute, 180-day exclusivity was patent-based, such that an ANDA applicant (or different applicants) could be eligible for 180-day exclusivity with respect to different Orange Book-listed patents covering the Reference Listed Drug (“RLD”) if they submitted the first ANDA to FDA containing a Paragraph IV certification to a particular patent.  Pre-MMA 180-day exclusivity is triggered either by first commercial marketing (for all patents), or by a court decision favorable to an ANDA applicant (with respect to a particular patent).  The MMA amended the FDC Act such that the first company to submit an ANDA to FDA containing a Paragraph IV certification to any Orange Book-listed patent covering the RLD – i.e., a “first applicant” – is eligible for 180-day exclusivity.  Post-MMA, 180-day exclusivity is triggered by first commercial marketing of the drug product by any first applicant.  A first applicant can forfeit 180-day exclusivity eligibility under one or more forfeiture provisions created by the MMA. 

The MMA includes – at § 1102(b)(1) – an effective date provision for purposes of deciphering when the pre- or post-MMA 180-day exclusivity regime will apply.  That provision states:

. . . the amendment made by subsection (a) shall be effective only with respect to an [ANDA] filed . . . after [December 8, 2003] for a listed drug for which no [paragraph IV certification] was made before [December 8, 2003].

In explaining this provision, FDA’s October 2004 draft guidance document, titled “Guidance for Industry: Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 – Questions and Answers,” stated only that “[w]ith two exceptions, the [MMA] provisions relating to 180-day exclusivity govern only ANDAs filed after the date of the MMA’s enactment (December 8, 2003) that reference a listed drug for which no paragraph IV certification was made in any ANDA before that date.”  This had led some people to believe that the pre-MMA 180-day exclusivity regime would apply only when there was an ANDA pending pre-MMA containing a Paragraph IV certification.  In a “Dear ANDA Applicant” letter FDA issued on April 15th, however, FDA explains that this is not the case, and that while the MMA’s effective date provision at § 1102(b)(1) is ambiguous, the Agency interprets the law such that pre-MMA patent-by-patent 180-day exclusivity applies.  FDA’s letter states, in relevant part, that:

when one or more applications were submitted before December 8, 2003, but the first paragraph IV certification was submitted after December 8, 2003, the statutory effective date provision is ambiguous. . . .  After consideration of the statutory language and the nature of each approach to exclusivity, we have concluded that it is appropriate to apply the pre-MMA statutory 180-day provisions to these applications.

Applying this interpretation to Topiramate Sprinkle Capsules ANDAs, FDA determined that two applicants – Cobalt and Barr – are eligible for 180-day exclusivity as a result of their Paragraph IV certifications to a single Orange Book-listed patent covering the RLD.  Barr submitted the first ANDA to FDA pre-MMA.  That ANDA contained a Paragraph III certification to a patent that has since expired.  After the MMA’s enactment, Cobalt submitted the first ANDA to FDA containing a Paragraph IV certification to that now-expired patent.  Both Cobalt and Barr later amended their ANDAs to include a Paragraph IV certification to a later-listed Orange Book patent covering the RLD, and both companies, as a result of FDA’s interpretation of MMA § 1102(b)(1), are eligible for 180-day exclusivity.

We understand that FDA’s new interpretation could affect a handful (or two) of products for which an ANDA was first submitted to FDA before the MMA’s enactment – even if such ANDA did not include any patent certification (because, for example, there was no patent listed in the Orange Book pre-MMA).  Because FDA’s Paragraph IV Certification List only identifies the date on which an ANDA (that has been received by FDA) containing a Paragraph IV certification was submitted to FDA, it is unclear what products are affected by FDA’s new interpretation.  Hopefully, FDA will devise a method for identifying what drug products are subject to the Agency’s new interpretation.  Absent such identification, an applicant could be under the false impression that the MMA’s 180-day exclusivity regime applies and that it is a first applicant and that another applicant cannot qualify for 180-day exclusivity based on a later-listed Orange Book patent.