BYDUREON BCISE patent delisting requests: Now you see them, now you don’t

I am finally coming up for air after our move back to Pennsylvania after twenty-eight years in New Jersey. So I will be focusing my next few posts on some interesting things that occurred in Orange Book Land over the last several months.  However, I never let our move delay me from making the monthly updates of my Orange Book Companion® subscription service!

Orange Book Volume 39, Supplement 8 for 2019 showed that AstraZeneca’s BYDUREON® BCISE (exenatide) had six new patents listed. Ho hum! What was more interesting was the addition of fifteen new Use Codes (U-2588 to U-2602) to the new and already-listed BYDUREON BCISE patents. Fifteen? Where did those come from? A look at the Drugs@FDA database showed that BYDUREON BCISE received approval for seven supplements on July 25. Quite a load! So those approvals might have been the source of the new Use Codes.

But that is not the end of the story. The very next month, the FDA’s Supplement 9 data showed that ten of the BYDUREON BCISE patents were the subject of a delisting request from AZ. The FDA will not delist those patents if their continued listing is needed to make a first ANDA filer eligible for 180-day generic exclusivity based on a paragraph IV certification. They simply tag them. However, the FDA’s “Paragraph IV Patent Certifications” list dated January 28, 2020 does not show that BYDUREON BCISE has been the subject of an ANDA with a Paragraph IV certification, and my search through GOOGLE for BYDUREON BCISE patent litigation was fruitless. So why did the FDA not simply delist the ten patents?

An interesting subplot is that fourteen of those fifteen new Use Codes I mentioned above were attached solely to the patents whose delisting was requested. So AZ was apparently adding fourteen new Use Codes in August (Supplement 8), and then delisting the patents that those Use Codes were attached to in September (Supplement 9). Having drafted many Use Codes over my career, I felt sorry for the attorney or attorneys who were assigned to draft those fourteen new Use Codes since their work would disappear with the delisted patents.

The FDA’s Supplement 10 raw data continued to show that the same ten patents were the subject of delisting requests.

Then, in the FDA’s Supplement 11 data, a strange thing happened. Instead of the ten patents being delisted because the FDA realized that no pending P.IV existed, the delisting request tags themselves disappeared from the ten patents! Poof! The Supplement 12 data was similarly devoid of the delisting request tags for the BYDUREON BCISE patents.

So what happened? It seems unlikely that a computer hiccup or typo at the FDA, or at AZ, would effect ten different patents in the same way. Or did AZ simply request the delistings and then change their mind a couple of months later? That still does not explain the FDA’s addition of the delisting request tags to the Orange Book instead of simply delisting the ten patents outright. Anyone have any thoughts? I would love to hear from you.


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