Administrative law is famously labyrinthine. And not the fun kind of labyrinth with awesome bull-headed dudes.
Today's case deals with an FDA practice -- not even a regulation! -- that had an outsized effect on an ANDA.
Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GMBH, C.A. No. 23-556-RGA (D. Del. Jan. 31, 2024) (R&R) was a declaratory judgment action spawned from an earlier ANDA dispute. In that earlier case, Mylan had filed given a Paragraph IV certification as to several of Bayer's orange book patents for Xarelto, and a Paragraph III certification as to another.
(Eds. Note - if you're wondering what a paragraph IV certification is, you should probably just stop here, this one gets pretty weedsy and the jokes are mostly over).
When all was said and done in that earlier case, one of the patents was invalid, and another Bayer never sued on at all, apparently conceding the product did not infringe. Mylan thus should have been able to launch as soon as the paragraph III patent expired.
But there was a twist. Bayer was ...