Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶19

But that decision did not spell doom for Amarin. In 2019, before the invalidation of Amarin’s SH-indication patents, and while Hikma’s ANDA remained pending, the FDA approved Vascepa for a second, much more common use: as a treatment to reduce cardiovascular risk in hypertriglyceridemia patients who already take statins (the “CV indication”). Id., at 1372. Amarin removed the CV Limitation of Use from Vascepa’s label and obtained two method-of-use patents for the CV indication. Ibid.

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