In 2024, the Federal Circuit held—for the second time—that a generic pharmaceutical company could, under certain circumstances, be liable for inducing infringement of a method of use patent for a carved out indication.  Hikma, the aggrieved generic, has petitioned to the Supreme Court.  On June 23, the Supreme Court took an interest by soliciting the views of the United States.  If left to stand, the growing precedent over inducement for section viii indications may stifle investment into generic drugs.  Will the Supreme Court save lower-cost medications from inducement by skinny labels?

The battle continues. We previously wrote about the Federal Circuit’s decision in the case (GlaxoSmithKline v. Teva) and how that case may offer Amarin another chance to bar generics from the market for Vascepa®. Sure enough, on November 30, Amarin filed suit against Hikma asserting three patents covering use of EPA to treat cardiovascular events. What are the takeaways from this suit?

Amarin’s appeal of the district court’s decision invalidating the Marine patents is now fully briefed. Amarin’s reply brief is strong, but does it tip the odds in favor of Amarin prevailing on the appeal?

Hikma and Dr. Reddy’s have filed their appellate brief defending Judge Du’s decision invalidating the Marine patents. What does it say?

On May 12, 2020, Amarin ($AMRN) filed its opening appeal brief in its appeal of the decision by the District of Nevada wherein the Honorable Miranda M. Du invalidated six patents that were asserted against prospective generics, Hikma and Dr. Reddy’s. What does the brief say?

Amarin ($AMRN) has lost its trial against Hikma and Dr. Reddy’s. On March 30, the Honorable Miranda M. Du from the United States District Court for the District of Nevada issued a bench order following a multi-day trial in January. Judge Du held that although Amarin had proven that the generics would induce infringement of the asserted patents by selling their prospective generic versions of Vacepa®, all of the patents were nonetheless invalid as obvious. As a result, Judge Du denied an injunction against Hikma and Dr. Reddy’s for selling generic versions of Vascepa®. What happens now?

We previously blogged about the upcoming litigation trial between Amarin Pharmaceuticals ($AMRN) and Dr. Reddy’s and Hikma, which are two prospective generics for Amarin’s Vascepa®.  While that blog post provided a general overview of the issues to be litigated at the upcoming trial, there are numerous other issues and questions around the upcoming trial.  This post will focus on how the REDUCE-IT trial may impact Amarin’s fight with the existing generics, if at all.

Amarin Pharmaceuticals ($AMRN) will be going to trial soon to protect Vascepa® against generic competition.  Amarin has asserted 15 claims from six patents against ANDAs filed by Hikma, Dr. Reddy’s and Teva.  What are the issues to be addressed at trial?