A preliminary injunction (PI) is an important remedy in patent infringement actions. For the patentee, it provides an opportunity to protect the market share a patented product has earned. For the accused infringer, it is a threat to a significant investment of time and resources into the development and launch of a new product. Consequently, this remedy is a frequent consideration in the drug, chemical and medical device (DCM) industry where the accused product (such as a generic drug) has the potential to cause tens of millions of dollars in lost revenue for the patentee. With such high stakes, it is beneficial for a patentee and accused infringer in the DCM industry, as a part of their due diligence, to assess the likelihood that a district court would impose a PI. Similarly, a company looking to develop and introduce a new product in the market should analyze the possibility of a PI as a part of its freedom to operate analysis.

This article will discuss how the PI win-rate has changed over the last 15 years, whether there is a difference in the success rate for DCM patents, and how district courts apply the famous four-factor test in DCM patent cases.

Preliminary Injunctions