US 11344552

An analysis of US Patent 11,344,552 reveals a targeted therapy for pancreatic cancer, currently facing legal challenges.

Patent Details:

• Title: Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin.
• Assignee: Ipsen Biopharm Ltd.
• Inventors: Eliel Bayever, Sarah F. Blanchette, Jonathan Basil Fitzgerald, Daniel F. Gaddy, Bart S. Hendriks, Ashish Kalra, and Helen Lee.
• Filing Date: November 10, 2017.
• Issue Date: May 31, 2022.
• Abstract: The patent describes combination therapy regimens for treating pancreatic cancer, specifically for patients with previously untreated metastatic adenocarcinoma of the pancreas. The treatment involves administering liposomal irinotecan, oxaliplatin, and 5-fluorouracil, with the option of also including leucovorin, on a bi-weekly schedule.

Independent Claims:

The patent includes two independent claims that outline a specific method for treating a particular type of pancreatic cancer.

• Claim 1: This claim details a method for treating metastatic adenocarcinoma of the pancreas in patients who have not previously received antineoplastic agents for this condition. The method involves administering a specific combination of drugs every two weeks: 60 mg/m² of liposomal irinotecan, 60 mg/m² of oxaliplatin, 200 mg/m² of the (l)-form of leucovorin or 400 mg/m² of the racemic form of leucovorin, and 2,400 mg/m² of 5-fluorouracil.
• Claim 12: This claim is similar to claim 1, but it specifies that the patient has not previously received gemcitabine for the treatment of metastatic adenocarcinoma of the pancreas. The treatment regimen is identical to that described in claim 1.

Litigation:

As of the current date, US Patent 11,344,552 is the subject of two pending Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office. These IPRs, initiated by CSPC Pharmaceutical Group Ltd., CSPC Ouyi Pharmaceutical Co., Ltd., and Conjupro Biotherapeutics, Inc. (IPR2025-00505) and another by "Unified Patents" (IPR2025-01531), challenge the validity of the patent's claims, asserting that the claimed invention would have been obvious in light of prior art. The petitioners argue that the combination of liposomal irinotecan with existing chemotherapy regimens like FOLFIRINOX was a predictable development.

There is no information publicly available regarding any appeals of these IPR decisions to the Court of Appeals for the Federal Circuit (CAFC) at this time.