Mass Forfeiture of 180-Day Exclusivity!

By Kurt R. Karst –   

FDA’s recently posted approval letter for Orchid Healthcare’s (“Orchid’s”) ANDA No. 78-357 for a generic version of Schering-Plough Corp.’s (“Schering’s”) blockbuster drug CLARINEX (desloratadine) Tablets, 5 mg, reads like any run-of-the-mill ANDA approval letter; however, it’s what is not said in the letter that is important and that represents a new 180-day exclusivity forfeiture precedent.

Orchid, and a large cohort of other applicants (based on a review of documents in In Re Desloratadine Patent Litigation (MDL No. 1851 Civil Action No. 07-3930) and other related litigation), submitted ANDAs to FDA on June 21, 2006 for Desloratadine Tablets, 5 mg.  According to FDA’s Paragraph IV Certification List, June 21 , 2006 is the first date on which an ANDA was submitted to FDA containing a Paragraph IV certification – in this case to U.S. Patent No. 6,100,274 (“the ‘274 patent”), the only patent listed in the Orange Book at that time.  Thus, Orchid and other applicants that submitted ANDAs to FDA on June 21, 2006 containing a Paragraph IV certification to the ‘274 patent were first applicants eligible for 180-day exclusivity.  Yet, FDA’s approval letter for ANDA No. 78-357 does not even mention 180-day exclusivity.  That’s because there was a mass forfeiture event.

FDA tentatively approved Orchid’s ANDA on August 25, 2009.  That is more than 30 months after the ANDA was submitted to FDA (i.e., June 21, 2006).  FDC Act § 505(j)(5)(D)(i)(IV) – “Failure to obtain tentative approval” – is one of the six 180-day exclusivity provisions added to the FDC Act by Title XI of the 2003 Medicare Modernization Act (“MMA”), and provides that 180-day exclusivity eligibility is forfeited if:

The first 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.

The 2007 FDA Amendments Act clarrified FDC Act § 505(j)(5)(D)(i)(IV), such that if “approval of the [ANDA] was delayed because of a [citizen] petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates) . . . .” (FDC Act § 505(q)(1)(G)).)  In the case of Desloratadine Tablets, 5 mg (and other desloratadine product as well), there was no citizen petition submitted to FDA.  Thus, unless FDA determined that there was “a change in or a review of the requirements for approval,” 180-day exclusivity was forfeited (not only for Desloratadine Tablets, but other desloratadine drug products as well noted in FDA’s Paragraph IV Certification List).

The absence of any mention in FDA’s approval letter for Orchid’s ANDA No. 78-357 of 180-day exclusivity is the Agency’s way of communicating that there was a mass forfeiture of 180-day exclusivity.  That is, that every first applicant forfeited 180-day exclusivity eligibility.  Had FDA determined that there was “a change in or a review of the requirements for approval,” then the Agency would have stated as much, as it did in a recent case concerning a generic version of ALDARA (imiquimod) Cream, 5% (see our previous post here). 

Although most first applicants presumably forfeited 180-day exclusivity eligibility based on FDC Act § 505(j)(5)(D)(i)(IV) (failure to obtain tentative approval), at least one ANDA sponsor likely forfeited based on FDC Act § 505(j)(5)(D)(i)(III).  That provision states that 180-day exclusivity eligibility is forfeited if  “[t]he first applicant amends or withdraws the certification for all of the patents with respect to which that applicant submitted a certification qualifying the applicant for the 180-day exclusivity period.”  FDA tentatively approved Glenmark Pharmaceuticals, Inc.’s (“Glenmark’s”) ANDA No. 78-362 (an ANDA number very close to Orchid’s) on August 24, 2009.  Although that date is more than 30 months after ANDA submission, in March 2008 (less than 30 months after ANDA submission), Glenmark reportedly (see page 57) reached a consent agreement with Schering whereby Glenmark converted its Paragraph IV certification on the ‘274 to a Paragraph III certification.  Thus, Glenmark likely forfeited 180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i)(III).