Check those Orange Book patent submissions before and after listing!

I would like to once again emphasize the need to confirm the correctness of any new patent listings in the Orange Book once they have appeared. In the Supplement 8 data a new patent was listed for an injectable drug packaged as a freeze dried powder in a vial. What drew my attention was the title of the patent: "Method and device for plasma-treating hollow bodies.” Whiskey Tango Foxtrot???

When I looked at the patent it turned out that the “plasma” was not blood plasma, but was instead an electrically generated plasma. The patent covered a device for sterilizing vials and syringes!  Not really eligible subject matter for listing the patent in the Orange Book since it did not claim a drug or a method of using a drug. It just claimed the sterilization device.

Fast forward to Supplement 9. As usual, I read through the “What’s New” page of the Orange Book Companion® to see the changes from Supplement 8. That is when I noticed that the sterilization device patent was described as “no longer listed for this product,” and a different patent was described as “new patent for this product.” The new patent claimed an eminently eligible formulation of the approved active ingredient. 

The difference between the two patents? The last three digits of the sterilization device patent number were 355, while the last three digits of the formulation patent number were 335. It was a “double-number” typo! That is the most common type of typo that I have seen over the years. In this case the NDA holder did their job and caught the error immediately and the correction showed up in the next supplement. But if your patent number contains a double number anywhere within it, not just at the end, you should pay extra careful attention when preparing your 3542 form and when later checking the Orange Book listing. Inadvertent errors can show up in either place.

Normally, my subscribers and I can easily notice patent number typos from the patent titles that I added to the Orange Book Companion (formerly known as in mid-2001. For example, a typo once led to a patent with the title “Windshield wiper bracket” being listed in the Orange Book. But in the current case both patents were related to the pharmaceutical industry, so it was not so obvious. Although it thankfully did not turn out to be, it could have been a case of an overly aggressive patent listing rather than a typo.

The best practice is to docket an Orange Book review for the attorney who is responsible for the patent listing. It is important to remember that each strength of a drug has its own portfolio of patents and exclusivities. So when a new patent is listed, the Orange Book listing for each strength of the drug must be checked separately. A typo could potentially appear in the listing for one strength but not in any others. Of course, at this time the responsible attorney should also assure that there are no errors in the patent expiration dates, drug substance/drug product/delisting request flags, use codes and patent submission dates. 


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