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
9/6/2024
/ Administrative Review ,
America Invents Act ,
Claim Construction ,
Interim Guidance ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
USPTO
Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI...more
As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea...more
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
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
4/5/2024
/ Amgen v Sanofi ,
Comment Period ,
Confidential Information ,
Daubert Ruling ,
Enablement Inquiries ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
NPRM ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Prior Art ,
USPTO
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
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
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
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
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 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
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
Fate of Fintiv -
As discussed in our Client Alert, “Fintiv 2.0: USPTO Director Issues Guidance Softening Risk of Discretionary Denial,” USPTO Director Kathi Vidal issued a set of interim procedures clarifying how the PTAB...more
On August 30, 2022, Outlook Therapeutics, Inc. announced that it has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, “an investigational ophthalmic therapy which, if approved, will be...more
On August 23, 2022, Amgen announced positive top-line results from a phase 3 study of ABP 959, Amgen’s proposed biosimilar to SOLIRIS (eculizumab). Amgen noted that the study was “a randomized, double-blind,...more
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
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
6/15/2022
/ Estoppel ,
Expert Testimony ,
Inter Partes Review (IPR) Proceeding ,
Patent Examinations ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Prior Art ,
PTAB Precedential Opinion Panel (POP)
On May 16, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). Alvotech notes that the study...more
Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to treat patients...more
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
12/17/2021
/ Administrative Procedure Act ,
Admissible Evidence ,
Evidence ,
Ex Partes Reexamination ,
Federal Rules of Evidence ,
Final Written Decisions ,
Forum Selection ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
Motion to Exclude ,
Non-Disclosure Agreement ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
USPTO
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
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
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
8/20/2021
/ Administrative Patent Judges ,
Appointments Clause ,
Covered Business Method Patents ,
Denial of Institution ,
Director of the USPTO ,
Discovery ,
Evidence ,
Executive Branch ,
Executive Powers ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Parallel Proceedings ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Prior Art ,
SCOTUS ,
Service by Mail ,
United States v Arthrex Inc ,
USPTO
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
12/31/2020
/ Administrative Procedure Act ,
Attorney's Fees ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Inter Partes Review (IPR) Proceeding ,
Parallel Proceedings ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Precedential Opinion ,
Real Party in Interest
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
11/2/2020
/ Clerical Errors ,
Estoppel ,
Exclusive Licenses ,
Motion to Amend ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Portal ,
Precedential Opinion ,
Prior Art ,
Real Party in Interest