Regeneron’s request for multi-district litigation
As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a motion seeking to establish a multi-district litigation (“MDL”) encompassing the aflibercept BPCIA cases it has filed in the U.S. District Court for the Northern District of West Virginia and transfer its case against Amgen, Inc. (“Amgen”) in the U.S. District Court for the Central District of California for “coordinated pretrial proceedings with five cases filed by Regeneron that are already pending before Chief Judge Kleeh in the Northern District of West Virginia.” On February 2, 2024, Samsung Bioepis Co., LTD (“Samsung Bioepis”), Celltrion, Inc. (“Celltrion”), and Formycon AG (“Formycon”) filed a joint opposition to Regeneron’s motion to transfer pretrial proceedings to an MDL in the Northern District of West Virginia. The same day, Biocon Biologics Inc. (“Biocon”) and Mylan Pharmaceuticals Inc. (“Mylan”) also filed an opposition to Regeneron’s motion to transfer, as did Amgen. Among other things, the defendants argued that Regeneron has not established that the Section 1407 conditions of common factual questions, efficiencies or judicial economy, or the convenience of parties and witnesses, are satisfied.
On February 9, 2024, Regeneron filed a consolidated reply brief in support of its motion to transfer to the Northern District of West Virginia. In its reply brief, Regeneron states, “[D]efendants envision a world where Regeneron is forced to litigate the same patents and present practically identical evidence and arguments relating to the meaning of those patents, the validity of those patents, and the irreparable harm that will flow from infringement of those patents, in no fewer than four different jurisdictions, all in parallel. The MDL process was designed to avoid the very chaos, duplication (or quintuplication) and inefficiency that Defendants propose to create.”
The Judicial Panel on Multidistrict Litigation has scheduled a hearing regarding Regeneron’s MDL request for March 28, 2024.
PTAB issues an Adverse Judgment in Celltrion/ Samsung Bioepis IPRs after Regeneron filed a statutory disclaimer
As we previously reported, Regeneron’s formulation patent 10,464,992 (the “’992 patent) has been challenged in multiple proceedings before the PTAB, including IPR2023-01312 (brought by Celltrion), which was joined with IPR2023-00462 (brought by Samsung Bioepis). On December 11, 2023, the Board instituted inter partes review of the challenged claims of the ’992 patent. On January 17, 2024, Regeneron filed a statutory disclaimer of all claims of the ’992 patent. In view of the disclaimer, Regeneron filed an unopposed motion to terminate proceeding in IPR2023-00462 on January 22, 2024.
On February 21, 2024, the Board entered an Adverse Judgment, stating that “[b]ecause Patent Owner has disclaimed all claims of the ’992 patent, we construe this disclaimer as a request for adverse judgment, and we enter adverse judgment against the Patent Owner with respect to claims 1–18 of the ’992 patent.”
As we previously reported, in response to other IPR petitions, Regeneron has disclaimed one of its patents directed to method of manufacturing VEG-F antagonists (U.S. Patent No. 10,406,226), one of its dosing regimen patents (U.S. Patent No. 10,857,205) one of its formulation patents (U.S. Patent No. 10,957,231), as well as some claims from its dosing regimen patent U.S. Patent No. 10,888,601.
Order of dismissal of claims based on three patents that Regeneron disclaimed in Regeneron v. Mylan (aflibercept) BPCIA litigation
On January 26, 2024, Biocon and Mylan filed a motion for summary judgment on Regeneron’s claims of infringement of three patents (the ’226, ’992, and ’205 patents) that Regeneron has disclaimed since filing the original complaint against Mylan. On February 16, 2024, Regeneron filed its response, asserting that the proper procedure is dismissal rather than summary judgment. On March 7, 2024, Judge Kleeh issued an order of dismissal with respect to the three disclaimed patents.
Court sets schedule for Regeneron’s motion for a permanent injunction against Biocon
As we previously reported, on January 9, 2024, the U.S. District Court for the Northern District of West Virginia set a schedule for preliminary injunction proceedings in Regeneron’s aflibercept BPCIA litigations against Celltrion (No. 23-CV-89), Samsung Bioepis (No. 23-CV-94 and No. 23-CV-106), and Formycon (No. 23-CV-97). On March 5, 2024, in Regeneron’s litigation against Mylan/Biocon (No. 22-CV-61), the court issued an order setting deadlines related to the pending motion for a permanent injunction that Regeneron filed against Mylan/Biocon following the court’s post-trial ruling that Mylan/Biocon infringe U.S. Patent No. 11,084,865 and had failed to prove the claims are invalid.
The order adopts the proposed agreed-upon schedule submitted by the parties the previous day and schedules a May 2, 2024 hearing date followed by an in-person status conference on May 13, 2024. Regulatory exclusivity is set to expire on May 18, 2024.
Regeneron files notices of appeal from Final Written Decisions regarding two of Regeneron’s aflibercept dosing patents
As we previously reported, on January 9, 2024, the PTAB issued final written decisions in IPR2022-01225 and IPR2022-01226, filed by Mylan on two Regeneron patents directed to dosing of aflibercept — U.S. Patent Nos. 10,130,681 and 10,888,601. The PTAB ruled that all challenged claims of the ’681 patent (claims 1, 3-11, 13, 14, 16-24, and 26) and the ’601 patent (claims 1-9, 34-39, 41-43, and 45) are invalid as anticipated by the same prior art reference.
On March 12, 2024, Regeneron filed notices of appeal in IPR2022-01225 and IPR2022-01226. The notice of appeal in IPR2022-01225 provides: “Among the issues for appeal are (1) the Board’s construction of ‘method for treating’; (2) the Board’s application of the printed matter doctrine; (3) the Board’s determination that claims 1, 3-11, 13, 14, 16-24, and 26 of the ’681 Patent are inherently anticipated by Dixon; (4) the Board’s incorporation by reference of flawed reasoning from an earlier decision and (5) the Board’s decision denying-in-part and dismissing-in-part PO’s motion to exclude.” The notice of appeal in IPR2022-01226 states, “Among the issues for appeal are (1) the Board’s construction of ‘effective sequential dosing regimen’; (2) the Board’s application of the printed matter doctrine; (3) the Board’s determination that claims 1-9, 34-39, 41-43, and 45 of the ’601 Patent are inherently anticipated by Dixon; (4) the Board’s ruling regarding the Best Corrected Visual Accuity limitation in claims 5 and 6; (5) the Board’s experimental use ruling; (6) the Board’s incorporation by reference of flawed reasoning from an earlier decision; and (7) the Board’s decision denying-in-part and dismissing-in-part Patent Owner’s motion to exclude.”
***
Check out our PTAB Tracker for information on pending and concluded IPRs on aflibercept and other biosimilar products, and stay tuned to Big Molecule Watch for more updates on these litigations.
The post Updates on Aflibercept BPCIA Litigation appeared first on Big Molecule Watch.