Catholic University Law Review


Michael Marusak


The Hatch-Waxman Act drastically altered the way pioneer and generic pharmaceutical manufacturers litigate patent infringement disputes, allowing generic manufacturers to submit an abbreviated new drug application (ANDA) to the FDA, which states that it intends make a chemical equivalent of a patent owner’s drug. When the ANDA is accompanied by a Paragraph IV certification, representing that the generic intends to market the drug before the patent’s expiration because it believes the patent is invalid or will not be infringed by the generic’s drug, the ANDA submission itself creates an “artificial” act of infringement. With the Supreme Court’s recent tightening of general personal jurisdiction, many pioneers seeking to litigate these “artificial” infringement claims relied on a theory of specific personal jurisdiction to bring suits against defendants in their chosen forums. Consequently, it is important that courts hearing these cases clearly understand how they must apply the prongs of the specific jurisdiction “minimum contacts” analysis. However, in the decades following the Supreme Court’s decision in Helicopteros, which introduced the so-called “nexus” test – the requirement that courts must determine whether the litigation “arises from or relates to” the defendant’s contacts with a forum – the Supreme Court has provided frustrating little guidance for interpreting this requirement, leaving it up to lower courts to decide their preferred approach. This lack of guidance is particularly problematic in Paragraph IV cases, because the litigation is “artificial,” arising almost out of thin air when the generic submits an ANDA. Thus, a defendant’s contacts with a forum in these cases are, by nature, much more tenuous than a typical defendant’s contacts in a typical infringement suit.

This Comment reviews a recent case decided by the Federal Circuit, Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., in which the Federal Circuit considered the “nexus” requirement within the context of a Paragraph IV case, but failed to provide the type of clarity that Paragraph IV cases desperately need. Furthermore, this Comment argues that the public policy considerations behind the Hatch-Waxman Act support a permissive interpretation of the Helicopteros “nexus” requirement in Paragraph IV cases, and urges the Federal Circuit to adopt the “sliding scale” test favored in other circuits for these types of suits in the future.