Posted On: April 13, 2007 by YCST

The Intersection of Subject-Matter Jurisdiction and the Hatch-Waxman Act

On Tuesday, Delaware district judge Gregory M. Sleet issued a one-page order granting a voluntary dismissal in the Merck-Apotex ANDA litigation. After Apotex filed an ANDA application, Merck brought an infringement action. Apotex responded with a declaratory-judgment counterclaim. Merck then decided it no longer wanted to pursue the action and granted Apotex a covenant not to sue.

Thereafter, Merck filed a motion to voluntarily dismiss, claiming that the covenant removed the Court's subject matter jurisdiction concerning both the infringement claim and counterclaim. As reported by IPLaw360 (subscription), Defendant Apotex opposed Merck's motion, contending that dismissal of the case would remove a "triggering event" under the Hatch-Waxman Act and therefore would delay Apotex's entry into the market. The Court, which said it would issue a full decision at a later date, apparently rejected this argument and sided with Merck on jurisdictional grounds.

It will be interesting to see how the Court analyzes the jurisdictional argument in the upcoming opinion, especially in light of Apotex's contention that Merck is allegedly manipulating the Hatch-Waxman process. Stay tuned.

<%media(20070413-Merck.pdf|Merck & Co. v. Apotex Inc., C.A. No. 06-230-GMS (D. Del. April 10, 2007) (Sleet, J.).)%>