Happy Orange Book New Year! Comments on the FDA’s January 2019 raw data

Welcome to the start of a new Orange Book year! We are now in Volume 39. Early last week, the FDA released their January 2019 (Vol. 39, Supp. 1) Orange Book raw data. So I went right to work updating my Orange Book Companion®. Here are a few observations about Supplement 1:

We had a light month of patent listings. Only 35 new patents were listed. Maybe a New Years hangover? That number has to be considered even lighter when we take into account that over half of those 35 patents were listed for a single product! Acorda’s INBRIJA (levodopa) had 18 patents listed. INBRIJA is an inhalable levodopa for treating Parkinson’s disease. Uncharacteristically for an inhaled drug, none of the 18 patents are directed to the inhaler device.

We have a new process patent in the Orange Book. The claims are all directed to “a method of making a gel.” Unlike last month’s process patent, the claimed process is directed to making a product directly related to the approved drug. That makes 11 process patents in the Orange Book, not counting last month's process patent that was caused by a typo.

Talking about the process patent that was listed last month due to a typo in the patent number; it is still there. I informed the Orange Book Staff about that typo, but they told me I should file a formal dispute under21 CFR 314.53(f)(1), Correction of patent information errors. That has to mean that the typo was not their fault, which was nice to know.

I am going to wait a little longer to see if the NDA holder notices the mistake. If they do not make the correction soon I will change my original email to the Orange Book Staff so that it conforms with the regulation (the “title” of the email must be “314.53(f) Patent Listing Dispute”) and resend it. That should get the job done although I really do not think of this as a “dispute.” I consider a dispute to be when a third party believes that the listing is inappropriate. In my case, I am just trying to be a nice guy by pointing out a typo. Why should this end up on the FDA’s “Patent Listings Disputes” list


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