Title: The Analytical Framework for the Specific Intent to Induce Infringement in Hatch-Waxman Disputes
Abstract: “Whoever actively induces infringement of a patent shall be liable as an infringer.” Inducement is a long-established form of infringement under Federal Circuit law, requiring three steps be met: 1) infringing acts occurred; 2) the defendant knew or should have known their acts would induce these acts of infringement; and 3) defendant had “actual intent to cause the acts which constitute the infringement.” In this Essay, I will focus on the third step of this analysis, the “actual intent” prong of induced infringement, especially as it applies to generic drug companies allegedly inducing infringement in Hatch-Waxman suits.
I will begin by summarizing at the Federal Circuit’s indecision on the appropriate standard of intent for induced infringement in a general patent context. The Federal Circuit initially split between two lines of cases, Hewlett-Packard v. Bausch & Lomb–requiring a comparatively low standard, “actual intent to cause the acts that constitute infringement” – and Manville Sales v. Paramount – requiring knowledge of the legal consequences of their acts of inducement. In the mid-2000s the Federal Circuit reconciled certain obvious differences in its induced infringement jurisprudence, but there remained significant tension regarding the requisite level of specific intent. After surveying this tension in the general patent infringement context, I will look to how specific intent plays out in the Hatch-Waxman context. There are certain features of Hatch-Waxman cases that make intent to induce infringement distinctly challenging, including that the infringement is artificial, the fact-finder is the judge, and the evidentiary standard is often based on the generic drug company’s proposed labeling. I will look to how the Federal Circuit and district courts vary in the type of evidence they will consider, and in the legal weight they give to circumstantial evidence. Lastly, I will argue that it is appropriate and proper for courts to look beyond the drug’s labeling to determine intent, still grounding their analyses in the actions of the defendant, but also inferring intent from external sources of information.
Publication Year: 2018
Publication Date: 2018-08-02
Language: en
Type: article
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Cited By Count: 1
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