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FDA Updates Patent Listing Disputes

When an NDA holder lists a patent in the Orange Book (OB), it sometimes appears that the patent listing use claim, or other information is challenged by prospective ANDA applicants.  FDA has updated its Listing of Patent Disputes (here) through July 13, 2018.  This is the first time that we have seen this list (maybe we were asleep at the switch), but given that all the due dates for the NDA holder’s response to the challenge are on or after 5/28/2017, that is unlikely.

Some interesting statistics on the data reported include:

  • There are total of 18 patent disputes included in the listings
  • Three (3) of the 18 disputes are still pending
  • Nine (9) resulted in no change to the OB patent listing description, or resulted in removal of the patent from the OB
  • Six (6) resulted in a change in the OB patent listing description

That appears to be a good success rate, and if the three (3) pending disputes result in change, then that would mean that 50% of the challenges resulted in some type of change.  If the three do not result in a change in the OB, then it would result in a 33% success rate.  Not bad!  Patent challenges that result in a use code description change may, or may not, play into whether the Generic product may get to market faster, but it shows that Generic applicants are doing everything in their power to impact first potential market-entry for their products.