On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however,...more
7/31/2025
/ Biosimilars ,
Fresenius ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Regeneron
There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the District of New Jersey before...more
Last week, GlaxoSmithKline and Northwestern University filed separate lawsuits against Moderna, accusing its mRNA-based vaccines of patent infringement....more
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
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
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
On March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654,...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
Mylan recently filed two IPR petitions seeking cancellation of various claims of patents assigned to Regeneron relating to dosing regimens for EYLEA® (aflibercept): IPR2022-01225 challenging claims 1, 3-11, 13-14, 16-24, and...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)
Celltrion recently announced that it will start selling Yuflyma, an adalimumab biosimilar, in the U.S. in July 2023. The announcement stems from Celltrion’s recently inked patent agreement with AbbVie which allows Celltrion...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