US pharmaceuticals company Arrowhead has countersued rival Ionis in their burgeoning patent battle over competing drugs used to treat a rare genetic condition.
On 10 September, Arrowhead filed a declaratory judgment action in a Delaware district court against Ionis, seeking a ruling that the patent at issue is invalid and not infringed by its drug plozasiran.
Ionis had originally filed a lawsuit saying that Arrowhead’s plozasiran infringed its US patent 9,593,333 (’333 patent).
Both US pharmaceutical companies specialise in developing drugs for hard-to-treat conditions. Arrowhead’s plozasiran, which is currently under US Food and Drug Administration (FDA) review, is used to treat a rare genetic condition known as familial chylomicronemia (FCS); Ionis already has a rival product called Tryngolza on the market.
Arrowhead said in a statement that it believes the infringement allegations are “baseless and is confident it will prove the ’333 patent is invalid and not infringed”.
Christopher Anzalone, president and CEO at Arrowhead, accused Ionis of putting “corporate goals ahead of the needs of patients with FCS”.
He added: “Arrowhead has multiple issued US patents that cover plozasiran for the treatment of patients with FCS based entirely on work developed internally at Arrowhead, which Ionis was not involved with and provided no contribution to whatsoever.”
Arrowhead is not seeking monetary relief in this action, but rather a declaratory decree establishing that the ’333 patent is invalid and not infringed by the manufacture, use, sale or offer for sale of plozasiran.
Plozasiran has been granted breakthrough therapy designation, orphan drug designation and fast track designation by the FDA and orphan medicinal product designation by the European Medicines Agency.
Ionis commented: “At Ionis, we welcome new advances that can help raise awareness of FCS and improve the lives of people in need. Importantly, we are not seeking to block patient access to this potential new therapy. We are confident in our IP around FCS and will vigorously defend our patent position. Protecting our intellectual property enables us to continue advancing innovation for patients who are counting on us.”
The dispute highlights the intense competition in biotech innovation for rare diseases, particularly in the realm of mRNA and genetic technologies.
FCS is characterised by extremely high levels of triglyceride, which can lead to acute and potentially fatal pancreatitis, chronic abdominal pain and diabetes, among others symptoms. Both products use the mRNA interference mechanism that inhibits the expression of a specific gene to lower the levels of triglyceride in the blood.
The FDA approved Ionis’ tryngolza in December 2024 for the treatment of FCS, the first ever FDA-approved treatment for the rare disease.
Email your news and story ideas to: [email protected]
