Regeneron filed a Complaint on November 8 against Celltrion in the U.S. District Court for the Northern District of West Virginia, alleging infringement of thirty-eight patents under the BPCIA based on Celltrion’s submission of an aBLA for CT-P42, a proposed biosimilar of EYLEA (aflibercept), and Celltrion’s provision of Notice of Commercial Marketing with respect to the same. This is the second infringement suit under the BPCIA concerning a proposed biosimilar of EYLEA, after Regeneron sued Mylan on August 3, 2022. Regeneron stated in the Complaint that it was served with a copy of Celltrion’s aBLA for CT-P42 on September 13, 2023. The Complaint is silent about the timing of Celltrion’s Notice of Commercial Marketing, but Regeneron alleges that the day before the suit was filed, Regeneron provided Celltrion with the “3A” list of patents for which Regeneron believed a claim of patent infringement could reasonably be asserted.
Regeneron’s Complaint asserts that (1) use of Celltrion’s CT-P42 infringes eight patents which are generally directed to methods of administering aflibercept on specified dosing schedules to treat certain angiogenic eye disorders and/or to patients who have been determined to have certain polymorphisms, (2) Celltrion’s CT-P42 formulation infringes four patents, which are generally directed to stable formulations of aflibercept, (3) Celltrion’s process for manufacturing CT-P42 infringes, or leads CT-P42 to infringe, twenty-five patents, and (4) the proposed container-closure system for CT-P42 infringes one patent. Specifically, Regeneron has asserted the following patents.
- Eight method of treatment patents alleged to be infringed by use of CT-P42: U.S. Patent Nos. 9,254,338; 10,130,681; 10,828,345; 10,888,601; 11,253,572; 11,559,564; 11,707,506; and 11,769,597.
- Four formulation patents alleged to be infringed by CT-P42: U.S. Patent Nos. 10,464,992; 11,066,458; 11,084,865; and 11,732,024.
- Twenty-five patents alleged to be infringed by the process for CT-P42’s manufacture or by CT-P42 as a result of the process for its manufacture: U.S. Patent Nos. 7,070,959; 9,222,106; 9,315,281; 9,816,110; 10,415,055; 10,669,594; 10,927,342; 11,053,280; 11,104,715; 11,174,283; 11,299,532; 11,306,135; 11,312,936; 11,332,771; 11,459,374; 11,472,861; 11,485,770; 11,505,593; 11,525,833; 11,535,663; 11,542,317; 11,548,932; 11,555,176; 11,753,459 and 11,788,102.
- One patent alleged to be infringed by CT-P42’s container closure system: U.S. Patent No. 11,793,926.
In its counts for infringement of certain patents, Regeneron has alleged that “at least some” importation of CT-P42 “was done for commercial purposes” (see, e.g., Complaint at ¶ 13). As we previously reported, the ’601 and ’572 dosing patents and the ’865 formulation patent were recently asserted at trial between Regeneron and Mylan, also in the Northern District of West Virginia. Regeneron seeks a judgment that Celltrion has infringed the asserted patents, monetary damages, fees and costs, a declaration that the case is exceptional, a judgment of willful infringement and enhanced damages, an award for an accounting of damages, and equitable relief including a preliminary and permanent injunction.
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