Federal Judge Invalidates Icosapent Ethyl Patents – But Based on a Common Statistical Mistake

Abstract

In a recent decision that stunned many in the legal and pharmaceutical communities, the chief judge of the U.S. District Court of the District of Nevada in Las Vegas, Judge Miranda Du, struck down 6 key method-of-use patents for the omega-3 fatty acid preparation, icosapent ethyl (Vascepa®). If this judgment is allowed to stand on appeal in Amarin Pharma, Inc., v. Hikma Pharmaceuticals USA, Inc., et al., it will have major implications not only for the patent protection of this drug but for pharmaceutical patents and biomedical innovation more generally. We review the background of this judicial opinion and suggest the decision should be reversed on appeal. The Judge based her opinion on her conclusion that the patents, at the time of the invention, would have been obvious to a person having ordinary skill in the art (35 U.S.C. § 103). As we will show, a key piece of the prior art, which was central to this case, included an incorrect conclusion based on a common statistical error. Our central argument is that prior art that is scientifically incorrect should not be an acceptable basis for invalidating patents as obvious.