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 entitled to a pediatric exclusivity period for its orange book patents. during the exclusivity period of the Paragraph III patent, the non-infringed Paragraph IV patent would expire. So far, so good.
The weird thing is that, apparently, under "longstanding FDA practice" Mylan's paragraph IV certification would be automatically converted into a paragraph II certification (for patents that are already expired). This would in turn trigger the pediatric exclusivity period for that patent and ultimately delay approval by several months, even though there was no allegation that Mylan actually infringed the patent, and Bayer's time to sue and be entitled to a stay had passed.
Thus, we arrive at the case at hand, where Mylan brought a DJ action seeking a declaration that it did not infringe the relevant patent. Bayer provided a covenant not to sue and then moved to dismiss for lack of a subject matter jurisdiction.
Judge Hatcher (YAY!) held that a mere covenant not to sue was not enough to divest the Court of jurisdiction in an ANDA case:
. . . I conclude that Defendants' covenant not to sue does not "extinguish" any case or controversy over the '053 Patent. In arguing otherwise, Defendants principally rely on non-Hatch-Waxman Act authority arising in ordinary infringement actions Although Defendants maintain that, "[n]othing warrants departure from those principles here," courts considering subject matter jurisdiction in the Hatch-Waxman context have consistently rejected the argument that a covenant not to sue renders a declaratory judgment action categorically non-justiciable. . . . Applying those principles, I conclude that, even if Defendants' covenant not to sue extinguished any reasonable apprehension of suit, the '053 Patent remains a barrier to Mylan's market entry and accordingly gives rise to a justiciable case or controversy . . .
Id. at 8, 10 (internal citations omitted).
The Court went on to reject a half-dozen similar standing challenges, including that Mylan's dispute was really with the FDA, and an argument that the bizarre chain of events Mylan worried of was too speculative to be ripe. The whole thing is worth a read, especially for the fed. courts nerds amongst you.
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