Clinical Trials Showing that a “Sufficient Percentage” of Prescriptions Will Practice Claimed Method Held to Prove Induced Infringement

Judge Du of the District of Nevada recently issued findings of facts and conclusions of law in a patent trial related to the drug Vascepa®.  Amarin Pharma, Inc. v. Hikma Pharma. USA Inc.  The court ultimately held that the asserted claims were all invalid as obvious.  But first it held that defendants proposed labels would induce infringement despite satisfying the claims in only some patients.  This ruling effectively provides for a broader scope of patent protection than that provided by the claims.

Vascepa® is a highly purified preparation of eicosapentaenoic acid (“EPA”) that is used along with diet to reduce triglyceride levels in patients with severe hypertriglyceridemia.  The claims of the patents-in-suit all include limitations that require administering the drug for at least 12 weeks. The defendants argued that their proposed ANDA product labels would not induce infringement because they did not “specifically encourage” or “require” a physician to prescribe their ANDA products for more than 12 weeks. Although the court agreed with defendants that the law requires the label to “encourage[], recommend[], or promote[] infringement”, the court found this requirement was met by defendants labels despite the labels not explicitly requiring or suggesting the treatment be provided for 12 weeks.

The court found that the clinical trials identified on the labels would cause the ANDA products to be prescribed for more than 12 weeks “a sufficient percentage of the time for the Court to conclude Defendants will induce infringement of this claim limitation”.  Specifically, the Clinical Studies section of Defendants’ labels reported the results of a study wherein the patients were administered the drug for 12 weeks.  The court found this portion of the label induced infringement based on expert testimony that including this clinical trial in the label would cause physicians to prescribe the drug for 12 weeks before reassessing the effectiveness of the treatment.

Even if the Federal Circuit decides an appeal on this decision, it may not be required to reach the infringement issue.  Therefore, we may never know whether the Federal Circuit would have agreed with the district court’s application of this label to the induced infringement analysis.  Nevertheless, this decision highlights an issue that ANDA filers should consider when deciding whether their proposed ANDA is likely to infringe.  If the label will cause some physicians to prescribe a drug in an infringing manner, it may be held to induce infringement even if it does not specifically advise the physician to prescribe it in that manner.