Pediatric Exclusivity 101

Shortly before Alex Azar’s confirmation hearing (to be Secretary of HHS), a reporter called me with questions.  She had an angle she wanted to pursue: that Lilly had “gamed” a patent, using pediatric exclusivity, under Azar’s watch.  I explained pediatric exclusivity – what it was designed for, how it works, and how Lilly seemed to have used it precisely as designed. I mentioned the constraints that apply to company requests for pediatric exclusivity and told her that they were meaningful, mentioning Amgen’s ongoing litigation against FDA regarding exclusivity for Sensipar.

My explanation had little impact; the story ran as initially conceived.  Judge Moss ruled in the Sensipar dispute in late January, however, and Amgen has confirmed that it plans to appeal the ruling.  This is therefore the first of two posts on the issue of pediatric exclusivity.  Below I explain how pediatric exclusivity works; in the next post I will explain the Sensipar dispute.

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