The theme of Wednesday October 26, 2016 at the GPhA Fall Technical Conference was Patent and Exclusivity day (at least for part of the day) and in the category of “you learn something new every day!”, it was Pediatric Exclusivity that took the stage for me.  Turns out that, if you are an ANDA applicant and you file with a paragraph IV certification and you are not sued or if your suit is dismissed, and if there is a period of pediatric exclusivity that extends beyond the original patent expiration date your ANDA cannot be approved unless:

  • You obtain a waiver from the innovator stating that they have no objection to approval prior to expiration of the pediatric exclusivity or:
  • You obtain ruling that the patent subject to the pediatric exclusivity is invalid, will not be infringed or is unenforceable.

How about that!  I am wondering what case the trigger for that decision was pulled for.  Imagine asking the innovator for a waiver!  Unless there is a prior settlement agreement with the innovator, you can imagine what the response might be.

Anyway, the presentation by Martin Shimer, Deputy Director, Division of Legal Regulatory Support, Office of Generic Drug Policy, OGD, went on to tell sponsors what they are doing well and what things need improvement in term of patent and exclusivity, as depicted in the slides below.





There were a couple of additional interesting tips, like while it is not required, OGD asks for applicants to send in a complete copy of any patent settlement agreement.  This is especially important if the settlement agreement states the applicant can market on a certain date prior to expiration of a patent. Watch out for pre-MMA exclusivity as there are still some cases lingering on. Applicants cannot maintain a PIV certification to an expired patent, so change it to a PII certification as the FDA will consider it a PII anyway.

Patent and exclusivity issues seem to pop out of nowhere as the issues are so diverse.  New Chemical Entity (NCE) exclusivity for combination products is another issue that is squarely on the radar screen with petitions and suits against FDA abounding.  It is some 32 years since Hatch-Waxman was enacted and yet this area of the regulations and statute continue to provide a fertile field for interpretation and litigation.