Just When You Thought All the Questions on 180-Day Exclusivity Were Answered!

Late Tuesday evening, the FDA placed a “Dear Applicant Letter” on Regulations.gov (here) relative to a request for comments from interested and affected parties on two very interesting issues relative to 180-day exclusivity.   The facts are rather complex so read the letter first to better understand the questions upon which the Agency is seeking comments.  The drug product in question is Cyclosporine Ophthalmic Emulsion and the two issues before the Agency based on the facts described in the letter are:

(1) the one or more applicants that submitted ANDAs or patent amendments with paragraph IV certifications to the ‘979 patent after the ‘342 patent expired, but before January 14, 2014, and that did not receive Acknowledgement Letters until after the ‘979 patent had expired, are “first applicants” under FD&C Act section 505(j)(5)(B)(iv)(II)(bb); and

(2) whether 180-day generic drug exclusivity for this product was forfeited on May 17, 2014, when the ‘979 patent expired, such that no ANDA applicant for Cyclosporine Ophthalmic Emulsion, 0.05%, is eligible for 180-day generic drug exclusivity.

As part of its consideration, FDA is considering whether the fact that FDA did not issue an Acknowledgement Letter for this drug product until after the patent expired impacts this analysis. FDA also seeks comment on whether there are any other factors that are material to this question. With this docket, we are soliciting any interested parties’ position on this matter. It is FDA’s general policy to make exclusivity decisions at the time an application becomes eligible for approval, and not before. However, due to the unusual facts of this case, the Agency has determined that it is in the best interest of all concerned to alert affected parties to the facts of this case, and to allow the submission of comments.

While “[T]his letter is addressed to applicants of ANDAs that reference Restasis, but any interested party may submit comments. We ask that interested parties submit comments to http://www.regulations.gov by August 28, 2015. Please include the proper docket number, FDA-2015-N-2713 in your correspondence.”

Historically, once a patent has expired, the claim for 180-day exclusivity dies with the patent.  But there are additional patents at play in this case.  In addition, the issue of whether a patent expires prior to the FDA acknowledging an ANDA as substantially complete is a fact that I believe the Agency has not had to deal with to date.

180-day exclusivity is complicated enough, but mix it in with the forfeiture provisions of the Medicare Modernization Act and you have yourself a nice kettle of fish.  To steal a line from Mark Twain “The difference between the right word and almost the right word is the difference between lightning and a lightning bug.”   In this case, the right word (or decision) appears to be currently eluding the Agency and they want to hear your opinions.  Also I suggest that you follow the comments submitted to the docket – we will!