An Oldie, But a Goodie: Revisiting a Not-Quite-Yet Vestigial Remnant of a Pre-MMA Era

February 15, 2016

By Kurt R. Karst –      

Question: When was the first time FDA approved an ANDA containing a Paragraph IV certification to a patent listed in the Orange Book for DIPRIVAN (propofol) Injection, 10 mg/mL, approved under NDA 019627, and granted a period of 180-day exclusivity?

Buehler, Buehler?

If your guess is when Gary Buehler, R.Ph., was Director of FDA’s Office of Generic Drugs (“OGD”), you’re wrong. It was actually before Mr. Buehler was appointed Director of OGD in July 2001 (and perhaps while he was serving as OGD‘s Deputy Director in 1999).  When FDA first (and, to our knowledge, the last time, until recently) approved and ANDA for generic DIPRIVAN and granted a period of 180-day exclusivity, Roger L. Williams, M.D., then-Deputy Center Director for Pharmaceutical Science in CDER at FDA, signed the letter approving GensiaSicor ANDA 075102 (approved on January 4, 1999).  That exclusivity seems to have been triggered by commercial marketing, and expired on October 17, 1999.  That was a long time ago.  Bill Clinton was still President. 

Why all the history about the world of ANDA 180-day exclusivity as it existed prior to the December 2003 enactment of the Medicare Modernzation Act (“MMA”), when exclusivity was patent-by-patent and was triggered by the earlier of first commercial marketing or a final court decision of patent invalidity or non-infringement? After all, we now live in a post-MMA Hatch-Waxman world – and we have for some time now – where 180-day exclusivity is largely product-based, and where exclusivity, if eligibility for it is not forfeited, is triggered only through commercial marketing of the drug product. 

That’s all true . . . mostly.

As we noted in our “Bad Penny” post back in February 2014, pre-MMA 180-day exclusivity was not deleted from the law in 2003. Rather, it was put into hibernation for a set number of drugs (a list of which we provide in our previous post).  These days, pre-MMA 180-day exclusivity only comes out of hibernation every once in a while.  One day, it will make an appearance about as frequently as Brood X cicadas, a type of 17- year cicada.  And after that, it will be see about as often as a critically endangered animal.  Finally, pre-MMA 180-day exclusivity may one day become a mythological Hatch-Waxman creature, along the likes of Bigfoot or the Loch Ness Monster.

But we’re not quite there yet . . . .

Last week, after the January 2016 Orange Book Cumulative Supplement was published on FDA’s Orange Book website, we took a look at some of the new entries in the “Patent and Exclusivity Drug Product List.” One addition in particular stuck out like a sore thumb: a period of “PC” exclusivity (i.e., “Patent Challenge,” or 180-day exclusivity) for ANDA 205307 for Propofol Injection, 10 mg/mL, expiring on February 24, 2016. That period of 180-day exclusivity was not triggered by commercial marketing (ANDA 205307 was not even approved until December 22, 2015), but rather by an earlier final court decision with a holding on the merits on the exclusivity-bearing patent: U.S. Patent No. 8,476,010 (“the ‘010 patent”). That’s right!  We have a sighting of a relatively rare pre-MMA period of 180-day exclusivity.  And with a gap of about 17 years since the first period of 180-day exclusivity was granted for generic DIPRIVAN, it’s at least noteworthy. 

The exclusivity was triggered after Dr. Reddy’s Laboratories, Inc., a subsequent Paragraph IV filer to the ‘010 patent (ANDA 205067), filed a Complaint for Declaratory Judgment (after some previous patent infringement court proceeding) and obtained a Final Judgment on August 28, 2015 that the company’s proposed Propofol Injection drug product does not infringe the ‘010 patent. Add 180 days to that August 28, 2015 date and you come up with February 24, 2016.  That’s the date listed in the January 2016 Orange Book Cumulative Supplement for the expiration of 180-day exclusivity associated with ANDA 205307 (and the ‘010 patent).

So keep your eyes peeled folks. Pre-MMA exclusivity is still – or could be –lurking out there in the shadows of a number of old drug products.  When it does come up in the form of a newly listed patent, you have to be quick on the draw to get your certification in to FDA first.