Icosapent ethyl – USA

Icosapent ethyl – USA

On Jan. 04, 2022, Delaware court granted Hikma’s motion to dismiss the complaint filed by Amarin.

 

Amarin sued Hikma when later filed ANDA with USFDA to market generic version of Vascepa®. Another defendant,  Health Net is an insurer that provides coverage for Vascepa and Hikma’s generic version. Amarin sells Vascepa for the treatment of severe hypertriglyceridemia (the “SH indication”) and cardiovascular risk reduction (the “CV indication”). Only the CV indication is covered by Plaintiffs’ patents. Hikma received FDA approval to sell a generic version for the SH indication under “section viii carve-out” regime. Plaintiffs alleged that Defendant Hikma’s label is “not-skinny-enough” and that the label, along with Hikma’s public statements, induce infringement of Plaintiffs’ patents for the CV indication. Defendants moved to dismiss the complaint.

 

Arnarin contended that Hikma’ s label teaches CV risk reduction for two reasons. First, Hikma’s label contains a notice regarding side effects for patients with CV disease. Second, Hikma’s label does not “state that Hikma’s ‘generic version’ of VASCEPA should not be used for the CV Indication. Hikma responded that (1) the notice regarding side effects is a warning and thus not an instruction to use icosapent ethyl to reduce cardiovascular risk, and (2) the removal of the CV risk reduction limitation is mere silence and that Hikma has no duty to discourage infringing use. Court agreed with Hikma and said that the statements in the label are just warnings. This is hardly instruction or encouragement. The generic labels must not contain a “clear statement” discouraging use of the patented indication. Plaintiffs must plead that “Hikma took affirmative steps to induce, not affirmative steps to make sure others avoid infringement.” Even if Plaintiffs are right that Hikma’ s label’s silence regarding CV risk reduction communicates to the public that icosapent ethyl can be used to reduce CV risk, “merely describing an infringing mode is not the same as recommending, encouraging, or promoting an infringing use.”

 

The next question is whether Hikma’ s public statements, including press releases and Hikma’ s website, induce infringement. Hikma’s press releases state that its product is the “generic equivalent to Vascepa®” and that “Vascepa is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (~500 mg/dL) hypertriglyceridemia. Court said that Hikma’ s press releases might be relevant to intent but they do not support actual inducement. Hikma’ s advertising of icosapent ethyl as the “generic equivalent” of Vascepa does not expose Hikma to liability. The citation of Vascepa’ s sales figures go to Hikma’s intent to induce. Intent alone is not enough; Amarin must plead an inducing act. Accepting the facts in the light most favorable to Amarin, Amarin has pled that the category “hypertriglyceridemia” includes infringing uses. The question is whether this is enough, without a label or other public statements instructing as to infringing use, to induce infringement. The Court found that it was not.

 

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