The complaint filed by Ionis Pharmaceuticals, Inc. against Arrowhead Pharmaceuticals, Inc. alleges patent infringement of U.S. Patent No. 9,593,333 ("'333 patent") related to the development of ApoCIII inhibitors for the treatment of hypertriglyceridemia and familial chylomicronemia syndrome (FCS).
Ionis developed volanesorsen, an antisense oligonucleotide designed to target ApoCIII messenger RNA ("mRNA") to reduce the production of the ApoCIII protein, thereby allowing lipoprotein lipase ("LPL") to break down triglycerides more effectively. The therapy demonstrated promising results, leading to its approval in Europe for the treatment of FCS. Additionally, Ionis developed a next-generation ApoCIII inhibitor, olezarsen, which received FDA approval under the brand name Tryngolza® in December 2024.
The lawsuit alleges that Arrowhead Pharmaceuticals wrongfully capitalized on Ionis's research and development efforts by developing a similar antisense ApoCIII inhibitor, plozasiran, for the treatment of FCS. Arrowhead's application for FDA approval of plozasiran was filed in January 2025, and if approved, it would compete with Ionis's established products.
Ionis's groundbreaking research and development efforts resulted in the issuance of the '333 patent, which covers the invention of targeting ApoCIII mRNA for the treatment of hypertriglyceridemia and FCS. The complaint emphasizes the significant impact of Ionis's therapies on patients' lives, citing remarkable reductions in triglyceride levels and the relief from potentially life-threatening acute pancreatitis events.
The lawsuit seeks to enforce Ionis's patent rights and alleges that Arrowhead's actions constitute patent infringement. The complaint outlines the jurisdiction and venue for the legal action and provides factual allegations to support Ionis's claims.
The press release provides a detailed account of Ionis's innovative research, development, and the regulatory milestones achieved, as well as the alleged infringement by Arrowhead Pharmaceuticals. It underscores the transformative impact of Ionis's therapies on patients with hypertriglyceridemia and FCS, highlighting the significance of the '333 patent in protecting Ionis's intellectual property rights. The market has reacted to these announcements by moving the company's shares 0.0% to a price of $29.72. For the full picture, make sure to review ARROWHEAD PHARMACEUTICALS, INC.'s 8-K report.
