News & Analysis as of

Patent Litigation Patents BPCIA

Goodwin

Alexion and Samsung Settle Eculizumab BPCIA Case

Goodwin on

​​​​​​​On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more

Venable LLP

Spotlight On: Biosimilar Litigations - September 2024

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Goodwin

Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar

Goodwin on

On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv)....more

Venable LLP

Regeneron Files BPCIA Complaint Against Sandoz’s EYLEA® Biosimilar Enzeevu™ Following FDA Approval

Venable LLP on

Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv).  The Complaint alleges infringement of 46 of...more

Morgan Lewis

Blockbuster Biologics - Review Issue 24

Morgan Lewis on

Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more

Goodwin

Amgen Files BPCIA Complaint Against Samsung Bioepsis Regarding Denosumab

Goodwin on

On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and...more

Goodwin

Eculizumab BPCIA Litigation Update: Court Denies Alexion’s Motion for an Injunction Pending Appeal

Goodwin on

​​​​​​​As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court...more

Goodwin

Update on Aflibercept BPCIA Litigation

Goodwin on

In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation. ...more

Goodwin

Amgen Files BPCIA Complaint Against Celltrion Regarding Denosumab

Goodwin on

On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA. This is the second BPCIA litigation regarding...more

Venable LLP

Amgen Files BPCIA Lawsuit Against Celltrion’s Proposed Prolia® / Xgeva® (Denosumab) Biosimilar CT-P41

Venable LLP on

On May 28, 2024, Amgen filed a BPCIA litigation, Case No. 1:24-cv-06497 (D.N.J.), against Celltrion’s proposed Prolia® / Xgeva® (denosumab) biosimilar CT-P41 alleging infringement of 29 of Amgen’s patents, including one...more

Venable LLP

Regeneron Files Second BPCIA Complaint Against Celltrion’s Proposed EYLEA® Biosimilar CT-P42

Venable LLP on

On May 17, 2024, Regeneron filed a second infringement litigation against Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42, Case No. 1:24-cv-00053 (N.D.W. Va.). The aBLA for CT-P42 was submitted to the FDA in June...more

Goodwin

Court Cancels Injunction Hearings In Aflibercept BPCIA Litigation; Regeneron May Seek Temporary Restraining Orders

Goodwin on

As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation....more

Goodwin

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

Goodwin on

​​​​​​​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

Goodwin

Genentech and Dr. Reddy’s Settle BPCIA Rituximab Litigation

Goodwin on

Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy’s Laboratories (“DRL”) and Fresenius Kabi...more

Venable LLP

EYLEA® Proposed Biosimilar M710 BPCIA Appeals Dismissed for Lack of Jurisdiction

Venable LLP on

On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more

Goodwin

MDL Panel Grants Transfer of Aflibercept BPCIA Case

Goodwin on

As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against...more

Goodwin

Updates on Aflibercept BPCIA Litigation - March 2024

Goodwin on

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

Venable LLP

The First Prolia® / Xgeva® Biosimilar Approvals in the U.S.

Venable LLP on

On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more

Goodwin

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

Goodwin on

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

Venable LLP

Chugai, Genentech, and Hoffmann-La Roche Dismiss Appeals of Actemra® Patent IPR Final Written Decisions

Venable LLP on

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche (Roche) filed a motion to voluntarily dismiss CAFC Appeals 24-1111 and 24-1115, appealing the Final Written Decisions (FWDs) in IPR2022-00578 and IPR2022-00579,...more

Venable LLP

The PTAB Finds Claims of Two EYLEA® Patents Unpatentable and Regeneron Files its Sixth Complaint Against a Proposed EYLEA®...

Venable LLP on

The new year has brought a wave of activity for EYLEA® (aflibercept) biosimilars. Following up on our previous report (EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates, December 31, 2023), in...more

Goodwin

Updates on Aflibercept BPCIA Litigation - February 2024

Goodwin on

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

Kilpatrick

10 Key Takeaways - Navigating Litigation Under the Biologics Price Competition and Innovation Act BPCIA

Kilpatrick on

On January 11, 2024, Kilpatrick Partner April Isaacson and Counsel Yifan Mao presented “Navigating Litigation Under the Biologics Price Competition and Innovation Act (BPCIA)” to entrepreneurs in the Chinese life science...more

Goodwin

Biosimilar Regulatory Updates - February 2024

Goodwin on

On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references Genentech’s ACTEMRA, an interleukin 6 receptor...more

Goodwin

Alexion Sues Samsung over Proposed Eculizumab Biosimilar

Goodwin on

Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd. (“Samsung”) in the U.S. District Court for the...more

279 Results
 / 
View per page
Page: of 12

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide