On February 11, 2026, Formycon AG and Lotus Pharmaceutical announced the execution of an exclusive license agreement directed to Formycon’s pembrolizumab biosimilar candidate, FYB206. ...more
On December 4, 2025, the FDA approved a new indication for Bristol Myer Squibb’s BREYANZI (lisocabtagene maraleucel) for the treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed...more
On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny). STARJEMZA references Janssen’s STELARA, and is indicated for the...more
On September 29, 2025, Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announced that the FDA approved their biosimilar denosumab...more
On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include treatment of cytokine release syndrome (CRS) in...more
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
On September 13, 2024, the World Health Organization (WHO) announced that it added the first vaccine against monkeypox (mpox) to its prequalification list. The vaccine, MVA-BN, is manufactured by Bavarian Nordic A/S....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
On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the...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
On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA. SCD is a group of inherited...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 July 20, 2023, Sandoz announced that it plans to invest approximately $90 million to build a Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026. The facility will be used to manufacture both drug...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
Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint...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
The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars. Here we report on the results of two recently completed studies....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
On July 5, Mylan announced another voluntary recall of a batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens “due to the potential for the label to be missing on some pens.” ...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)
Outlook Therapeutics announced today that the FDA has requested additional information in order to complete the filing of the company’s BLA for LYTENAVA. LYTENAVA, or ONS-5010, is an ophthalmic intravitreal injection...more
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