As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against its competitors.
In a series of lawsuits filed this year, Novartis has alleged that several rivals have infringed on patents for one or both of its commercial radioligand therapies Pluvicto and Lutathera. The lawsuits have targeted Eli Lilly, together with its newly acquired Point Biopharma and its collaborator Lantheus, as well as Europe’s Curium Pharma.
The lawsuits came as Novartis worked to grow the reach of Pluvicto in prostate cancer and Lutathera in neuroendocrine tumors. Pluvicto just crossed the blockbuster sales threshold by generating $1.04 billion in the first nine months of 2024. And Lutathera has been delivering double-digit sales increases, partly thanks to increased adoption in the first-line setting.
In one lawsuit filed in June in the U.S. District Court for the Southern District of Indiana, Novartis joined hands with the Purdue Research Foundation, alleging that Point’s PNT2002 steps on U.S. Patent 10,624,970. The patent describes PSMA-binding conjugates and related pharmaceutical formulations and methods to treat prostate cancer, according to a complaint.
The patent was issued to Purdue in 2020 and subsequently licensed to Novartis’ subsidiary Endocyte.
By targeting PSMA-positive prostate cancer, PNT2002 and Pluvicto would compete directly, although phase 3 data unveiled in December 2023 didn’t show any differentiation for the Point candidate from the Novartis incumbent. PNT2002 is a key asset in Lilly’s $1.4 billion acquisition of Point last year and one component in a potentially $2 billion strategic collaboration between Point and Lantheus two years ago.
In a recent setback for Novartis, U.S. Magistrate Judge Tim Baker last month granted the defendants’ motion for a stay of litigation pending a decision on their request to dismiss the lawsuit. To make its case, Lilly and other defendants noted that PNT2002 is nowhere near commercialization and that an original target approval date in June 2025 is not realistic at this point.
PNT2002 is currently in similar shoes as Pluvicto was more than a year ago—immature overall survival data from a phase 3 trial are preventing Lilly from filing for an FDA approval.
As for the other two lawsuits, Novartis has sued Point/Lantheus and Curium for making versions of its Lutathera before the expiration of certain patents.
For Point and Lantheus, PNT2003, a generic to Lutathera, is the other piece in their potentially $2 billion deal. Novartis launched litigation efforts in January shortly after the FDA accepted Lantheus’ generic filing for PNT2003. As the first application to have filed a complete generic application, Lantheus could be eligible for a 180-day generic market exclusivity in the U.S.
The argument centers on U.S. Patent No. 10,596,276, which Point/Lantheus argue is “invalid, unenforceable, and/or will not be infringed” by PNT2003, according to a complaint filed in Delaware. The patent, issued in 2020, relates to radionuclide therapies with high concentration and high chemical stability for use for diagnostic or therapeutic purposes. The formulation patent expires in 2038.
As to the most recent lawsuit against Curium, the October complaint followed Curium’s FDA new drug application for Lutetium Lu-177 dotatate, a version of Lutathera.
In addition to the ’276 patent, Curium is challenging Novartis patents No. 10,596,278 and No. 11,904,027. The patents, granted in 2020 and 2024, respectively, describe “stable, concentrated radionuclide complex solutions.”
Novartis had previously sued Curium in Missouri, the location of the defendant’s North American headquarters. The two sides recently agreed to voluntarily dismiss that case to focus on litigation in Delaware as the proper venue.