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Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”)...more

Issue 45: PTAB Trial Tracker

In Pfizer Inc., v. Sanofi Pasteur Inc., SK Chems Co. Ltd., v. Vidal, 2019-1871 (March 5, 2024), the Federal Circuit affirmed the Board’s conclusions that claims 1–45 of U.S. Patent No. 9,492,559 were unpatentable due to...more

Federal Circuit Dismisses Appeals in Regeneron v. Mylan (Aflibercept) BPCIA Litigation

​​​​​​​As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’...more

Issue 44: PTAB Trial Tracker

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This periodic digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Updates on Aflibercept BPCIA Litigation - March 2024

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...more

Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation

Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed - As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan...more

Updates on Aflibercept BPCIA Litigation - February 2024

On Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an ex parte application for a scheduling order setting the schedule for preliminary injunction proceedings or, in the alternative, an emergency...more

Issue 43: PTAB Trial Tracker

Petitioner Allowed to Proceed in “Understudy Role” - In American Honda Motor Co., Inc. v. Neo Wireless, LLC, IPR2023-0791 (P.T.A.B. March 30, 2023), American Honda Motor Co., Inc. (“Honda”) filed a “copycat” Petition...more

Issue 42: PTAB Trial Tracker

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This periodic digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Celltrion and Samsung File IPR Petitions on Aflibercept Patents

​​​​​​​Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept. Specifically, Celltrion and Samsung have each filed petitions...more

Celltrion Files IPR Petition on Aflibercept Patent

Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of claims 1-18 of U.S. Patent No. 10,464,992 (“the ’992 patent”), assigned to Regeneron Pharmaceuticals, Inc. According to the Petition, the...more

Fintiv 2.0: USPTO Director Issues Guidance Softening Risk of Discretionary Denial

Newly appointed USPTO Director Kathi Vidal issued a set of interim procedures clarifying how the Patent Trial and Appeal Board (PTAB or Board) should apply its Fintiv decision going forward. Vidal’s guidance, which will...more

Issue 37: PTAB Trial Tracker

Expert Testimony Alone Insufficient to Show Examiner's Material Error in Considering Prior Art - In Nespresso USA, Inc. v. K-fee System GmbH, IPR2021-01222, Paper 9, at 25 (PTAB Jan. 18, 2022), the Board denied...more

Issue 36: PTAB Trial Tracker

FORUM SELECTION CLAUSES MAY OR MAY NOT PRECLUDE PTAB REVIEW - In Kannuu Pty Ltd. v. Samsung Electronics Co., Ltd. & Samsung Electronics America, Inc., No. 21-1638 (Fed. Cir. Oct. 7, 2021), the Federal Circuit considered...more

Final Judgment and Order of Permanent Injunction Entered in Immunex v. Samsung Bioepis Etanercept Biosimilar Litigation

The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO...more

Issue 35: PTAB Trial Tracker

TIMING OF REQUEST KEY FOR BOARD DECISIONS ON MOTIONS TO TERMINATE - In Ocado Group PLC v. AutoStore Technology AS, PGR2021-00038 (July 30, 2021), Petitioner moved to withdraw its petition, arguing that efficiency favored...more

Issue 34: PTAB Trial Tracker

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Issue 32: PTAB Trial Tracker

APPLICATION OF NHK/FINTIV ANALYSIS CONTINUES TO EVOLVE - The Board’s application of its precedential NHK and Fintiv decisions to deny petitions based on parallel litigation continues to develop. The Board recently...more

PTAB Introduces Precedential Opinion Recommendation Portal

As a result of feedback it received, the PTAB introduced a new web portal that allows any member of the public to nominate a decision for precedential or informative designation. The request must provide information about the...more

The PTAB Trial Tracker

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Issue Twenty-Nine: PTAB Trial Tracker

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Issue Twenty-Eight: PTAB Trial Tracker

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

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