Update on the “Raising Arizona” Metaphor Missing Patent for OSENI

Back in October I blogged about an Orange Book listed patent, 6,329,404, that disappeared from the Orange Book for one of six strengths of Takeda’s OSENI® (alogliptin benzoate/pioglitazone HCl). The FDA had apparently not updated the expiration date for the 12.5/45mg strength (Prod. No. 006) when Takeda filed their 3542 form to inform the agency that their patent had received a Patent Term Extension (“PTE”). The patent’s expiration date had been updated for the five other OSENI strengths. So when the 2017 Orange Book was prepared, the FDA deleted the ‘404 patent from Prod. No. 006 due to its original, unextended expiration date in 2016 still being shown.

In addition to my blog posting, I made a phone call and sent an email to the Takeda contact person listed on their 3542 form. However, I never received a response. So I decided to take the bull by the horns and let the Orange Book Staff know about the missing patent. Unfortunately, this was about the same time as my wife and I were going through all of the work needed to sell our house in NJ and get ready to move back to Bucks County, PA which we had left twenty-eight years earlier. By the time I came up for air after our move it was already New Year’s Day.

So I sent an email to the Orange Book Staff while waiting for some bowl game or other to start. I described the situation and attached the two Takeda 3542 forms that I had received from the FDA as a result of a FOIA request (the second of the two was apparently only submitted to correct the contact person’s email address). And then I waited to see what would happen.

On January 9 I decided to check the OSENI Prod. No. 006 patent listings to see if anything had happened. Lo and behold, the ‘404 patent was listed with its extended expiration date! Yay! And today (January 10) I received an email from the Orange Book Staff confirming that they had updated the Orange Book and  thanking me for letting them know about this matter.

So now I can saddle up my trusty steed and ride off into the sunset knowing that my work here is done.


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