In a stunning reversal of opinion on the issue of FDA’s failure to award new chemical entity (NCE) exclusivity to the drug Prepopik, the world of NCE awards and ANDA acceptance for receipt for fixed dose combination (FDC) products that contain a first-time approved active ingredient may be turned on its head.  This was discussed in Kurt Karst’s excellent post on the FDA Law Blog (here) that details the legal issues of the case, and reviews the history of the court decisions and FDA’s actions.  Therefore, I will refer the reader to that post as background.   However, there is one issue that crops up that that deserves additional attention, in my opinion.

In his blog post, Kurt mentioned a number of FDC products that the FDA refused to retrospectively grant 5-year NCE exclusivity, even though they changed their minds, and after October 10, 2014 prospectively agreed to grant 5-year NCE protection to FDC products that contained an NCE.   For those products for which FDA did not initially grant NCE exclusivity, ANDA applicants could submit applications for those products and have them received by FDA.  (Remember that FDA is barred from receiving an ANDA subject to 5-year exclusivity until the period of exclusivity expires or until the passage of 4 years post-approval, if the ANDA contained a paragraph IV certification claiming the still active and listed patent is invalid, unenforceable, or would not be infringed by the ANDA product.)

However, for products without NCE exclusivity, an ANDA can be submitted and received by FDA at any time, as long as the applicant certified to the patents listed on the reference product and addressed its intention towards the marketing of the product in relation to any other period of non-NCE exclusivity associated with the reference product.   In certain cases, (including Prepopik’s case) at least one ANDA (according to FDA paragraph IV database) was received by FDA on May 21, 2014.  Fast forward to today and the Judge’s ruling that NCE should have been retrospectively applied, and now FDA has a big mess on its hands.  What does it do with the first-to-file ANDA submitted back in May 2014?  How will the Agency handle this issue? This administrative nightmare is one reason FDA decided not to make its change in policy retrospective, but now they may be faced with having to deal with the issue head-on.  As Kurt noted, there may be additional appeals and or suits by the impacted parties (FDA or the first filer[s]) in this case.  But how many other cases are there out there?  How will the Agency sort out first-to-file issues and what will they do with the applications that may have already had their first substantive reviews completed, when now, the FDA should not have accepted the application for review in the first place? Keep your eye on this story as it unfolds.  For us Hatch-Waxman geeks, this is fascinating stuff, but for the Agency, it is going to be one massive migraine.