180-Day Exclusivity Forfeiture – A Zen Moment

As the backlog of pre-Medicare Modernization Act (“MMA”) ANDAs is cleared and disputes over 180-day exclusivity under the old statutory regime become a vestige of the past, new post-MMA disputes over 180-day exclusivity will certainly take their place, particularly as they concern forfeiture.  Indeed, within 24 hours of the enactment of the MMA, Senator Orrin Hatch (R-UT) was already expressing concern about the “failure to market” forfeiture provision in FDC Act § 505(j)(5)(D)(i)(I). 

In a somewhat recent case involving the “failure to obtain tentative approval” 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(IV), FDA took a stance that is reminiscent of the old “if a tree falls in the woods and nobody is there” enigma. 

The “failure to obtain tentative approval” forfeiture provision provides that:

The first applicant [forfeits 180-day exclusivity eligibility if the applicant] fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.

Sandoz submitted ANDA #76-969 for Metoprolol Succinate Extended-Release Tablets USP, 25mg, 50mg, 100mg, and 200mg, to FDA in December 2003.  The ANDA contained paragraph IV certifications to four Orange Book-listed patents for the Reference Listed Drug, TOPROL-XL.  In July 2006, subsequent to a lawsuit involving two of the patents and a decision by the U.S. District Court for the District of Delaware that the challenged patents are invalid and unenforceable, FDA approved ANDA #76-969.  Specifically, FDA tentatively approved Sandoz’s 50mg, 100mg, and 200mg drug products because Sandoz was not a “first applicant” for these strengths, and granted full approval for the 25mg drug product for which Sandoz was the “first applicant.”

FDA’s approval letter states that with respect to 180-day exclusivity for the 25mg drug product:

Sandoz was the first ANDA applicant to submit a substantially complete ANDA for Metoprolol Succinate Extended-Release Tablets USP, 25 mg, with a paragraph IV certification to the four [OrangeBook-listed patents].  Therefore, with this approval, Sandoz may be eligible for 180 days of generic drug exclusivity for Metoprolol Succinate Extended-Release Tablets USP, 25 mg. . . .  The agency notes that Sandoz failed to obtain tentative approval of this ANDA within 30 months after the date on which the ANDA was filed. [citation omitted]  However, the agency is not making a formal determination at this time of Sandoz’s eligibility for 180-day generic drug exclusivity.  It will do so only if another applicant becomes eligible for approval within 180 days after Sandoz begins commercial marketing Metoprolol Succinate Extended-Release Tablets USP, 25 mg.

FDA’s decision (or non-decision as the case might be) begs the question: does a “first applicant” forfeit exclusivity if a forfeiture event is triggered?  FDA has not, to our knowledge, had to deal with another case where a “first applicant” failed to obtain tentative approval within 30 months; but it is likely that this issue will arise in future cases.  FDA is presumably in the process of drafting regulations to implement the MMA forfeiture provisions that will attempt to answer this and many other unresolved forfeiture issues.