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Personal Jurisdiction In Hatch-Waxman Cases, Michael Marusak

Catholic University Law Review

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 …