Apotex Sues FDA Over Decision on Generic Zofran, Challenging FDA's Interpretation of "Court Decision" Trigger Again

Apotex filed a complaint and motion for preliminary injunction against the FDA in the U.S. District Court for the District of Columbia last week, alleging that the FDA unlawfully refused to acknowledge that the dismissal of its patent infringement suit against GlaxoSmithKline over generic Zofran was a "court decision" triggering the first ANDA filer's 180 day period of exclusivity.  The dismissal order was entered May 25, 2005, and therefore Apotex claims that the 180 day exclusivity period expired in November, 2005.  Apotex would like to launch its generic Zofran next month, when the last of GSK's patents expire.  Unless the FDA changes its position, however, Apotex will have to wait until at least 180 days later.

Apotex had previously challenged the FDA's interpretation of a "court decision" sufficient to trigger a 180 day exclusivity period, in a declaratory judgment action involving generic Pravachol.  In that case, FDA decided that the dismissal of a patent suit was not such a court decision; instead, a court must issue a holding on the merits of the suit.  FDA explained in a November 3rd letter to counsel for Apotex that its "holding-on-the-merits" standard "is equally applicable to affirmative patent suits," such as the Zofran case.  Apotex filed its lawsuit against the FDA shortly after receiving the letter.

The impact of this case will be relatively limited because the Medicare Modernization Act of 2003 got rid of the "court decision" trigger entirely.  For ANDAs filed after December 8, 2003, if no other ANDAs containing a paragraph IV certification for the listed drug were filed prior to December 8, 2003, a court decision no longer triggers the 180-day exclusivity period.  Instead, the exclusivity period does not begin until the first commercial marketing of the generic drug.

NOTE:  Thanks to Kurt Karst for bringing this case to my attention.

Comments

[Wally]

Under the new and improved rules, what happens if the first ANDA filer refuses to enter market because of an agreement with the originator? I think I heard that there is some sort of time limit imposed for entering the market.