Amarin Pharma Inc., Amarin Pharmaceuticals Ireland Ltd., and Mochida Pharmaceutical Co. Ltd. filed a complaint Monday in the District of Delaware against Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC, alleging direct and induced patent infringement of Amarin’s Vascepa, a product meant to reduce risk of cardiovascular disease.
The complaint explained that both Amarin and Hikma led clinical trials for their eicosapentaenoic acid-based drugs (EPA), with Hikma’s trials taking place in Japan in the 1990s and early 2000s preceding Amarin’s. Hikma’s trials yielded results that found its EPA-based drug lowered the risk of major coronary events. According to the complaint, Amarin’s results, released in 2018, “were hailed as one of the most important developments in the prevention and treatment of cardiovascular disease since statins.”
The United States Patent and Trademark Office (USPTO) issued the patents-in-suit– ’077, ’537, and ’861 – assigned to Mochida and exclusively licensed to Amarin, on Feb. 4, 2014, July 11, 2017, and Feb. 25, 2020, respectively. The patents-in-suit all cover Vascepa, the complaint noted, as listed in the Orange Book, which “provides notice concerning patents covering FDA-approved drugs.” Each patent was listed in the Orange Book before or on March 20, 2020, according to the complaint.
On May 21, 2020, the Food and Drug Administration (FDA) approved the defendants’ abbreviated new drug application for its generic version of Vascepa, icosapent ethyl capsules; on Nov. 5, 2020, Hikma began selling the generic drug in the United States.
The plaintiffs invoked the Hatch-Waxman Act, saying that when a generic manufacturer is seeking ANDA approval, it must use the Orange Book to “make certain certifications with respect to each patent listed for the branded drug”: that “no patent information appears in the Orange Book … that the listed patent has already expired … that the applicant will not market the generic version before the date on which the patent will expire … or that the patent is invalid or will not be infringed by the manufacture, use, or sale of the drug for which the ANDA is submitted.”
The patents-in-suit are “method-of-use patents”; the complaint says any generic applicant may seek FDA approval to label the drug only for “uses not covered by the patent” with submission of a “Section viii statement” which may stand in for the aforementioned patent certifications. Hikma did submit such statements in regard to the patents-in-suit before the approval of its ANDA, the complaint said.
However, the plaintiffs asserted that the official label for Hikma’s generic drug intentionally omitted the cardiovascular (CV) “Limitation of Use,” which the plaintiffs’ Vascepa also omits, “so that healthcare providers and patients would believe that Hikma’s generic icosapent ethyl capsules could be and should be used just like VASCEPA®, including to reduce the risk of CV events per the CV Indication awarded to VASCEPA®.”
The plaintiffs alleged both direct infringement as well as induced infringement of the patents and claimed that as a result, they have “suffered damages, including lost profits.” They requested judgment confirming the induced and direct infringement of the patents, an award of sufficient damages and reasonable relief, and a jury trial.
The plaintiffs are represented by Fish & Richardson PC.