A Threat to NJ and Del.'s Primacy as Top Venues for Hatch-Waxman Matters?

The Districts of New Jersey and Delaware are recognized as the primary venues for Hatch-Waxman or ANDA (Abbreviated New Drug Application) litigation. As of 2015, more than three-quarters of all pending ANDA cases were filed in these two districts. But these preferred venues could be in jeopardy in light of the U.S. Supreme Court’s review of the Federal Circuit’s decision in Acorda Therapeutics v. Mylan Pharmaceuticals, 817 F.3d 755 (2016), which affirmed two lower court cases holding that generic companies are subject to specific personal jurisdiction on the basis of their future intended sales of ANDA product in the jurisdiction.

Traditionally, district courts exercised personal jurisdiction in ANDA cases based on theories of general jurisdiction because there was no “real” act of infringement in any district (infringement under 35 U.S.C. §271(e)(2) being “imaginary” or “artificial”) that would subject an ANDA applicant to specific personal jurisdiction. Tending to find that such “acts” of infringement did not really “occur” anywhere, courts instead relied on general jurisdiction to exercise power over a party. See, e.g. Eli Lilly v. Sicor Pharmaceuticals, No. 06-cv-238, (S.D. Ind. Apr. 27, 2007).