Amarin Corp Plc (AMRN)

[HDGabor]

N-

A hypothetical example illustrates how FDA determines whether forfeiture has occurred under the “failure to market” provision. For the purposes of evaluating item (aa), presume that on June 1, 2009, the applicant for ANDA A submitted its substantially complete application containing a paragraph IV certification, which it lawfully maintained. FDA approved the ANDA on December 20, 2012, and the 75-day period identified in subitem (AA) of this forfeiture provision ended on March 4, 2013. Thirty months after the date the ANDA is submitted was December 1, 2011 (the date identified in subitem (BB)).
The relevant date for item (aa) of the forfeiture analysis is December 1, 2011, the earlier of these two dates.

For the second part of the analysis under item (bb), presume that on January 1, 2013, a court entered a final decision (from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken) that the relevant patent is invalid and not infringed in an infringement action against a subsequent applicant for this RLD whose ANDA received tentative approval at some point before FDA makes the forfeiture determination. The relevant forfeiture date for ANDA A pursuant to subitem (AA) is March 17, 2013, 75 days after the date on which the court issued its decision. Notably, this date applies even though ANDA A in this example was not the subject of the litigation.

In this scenario, the failure to market forfeiture provision requires the first applicant to market by March 17, 2013, the later of the dates applicable under item (aa) (December 1, 2011) and item (bb) (March 17, 2013). In this example, if ANDA A applicant did not begin commercial marketing until after March 17, 2013, it would forfeit its exclusivity.

Hikma has to market (to get 180-day excluvity) on or before the 75th day after CAFC decision.

+ Q15 and Q16

Guidance for Industry, 180-Day Exclusivity: Questions and Answers

Best,
G