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On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA...more
On February 4, 2025, HyClone Laboratories, LLC (“HyClone”), a cell culture media supplier, filed a Motion to Quash a subpoena issued by Amgen, Inc. (“Amgen”). The underlying subpoena was issued in Amgen’s ongoing denosumab...more
On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and...more
On October 4, 2024, Amgen filed Case No. 1:24-cv-09555 (N.D. Ill.) against Fresenius Kabi, alleging FKS518 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 33 of Amgen’s patents....more
On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the...more
On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed...more
On March 3, 2022, the PTAB instituted another inter partes review of U.S. Patent Nos. 8,580,264 (“the ’264 patent”), owned by Chugai and Roche. Fresenius filed a petition for inter partes review of the ‘264 patent,...more
Last week, the PTAB instituted inter partes review of two Chugai patents directed to methods of treating rheumatoid arthritis with a combination of tocilizumab and methotrexate. Fresenius filed petitions for inter partes...more
Fresenius launches suit against Gland Pharma over pain management drug patent - In a case before the U.S. District Court for the District of New Jersey, Fresenius alleges Gland Pharma infringed on its patent for the pain...more
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322 (Fed. Cir. Jan. 9, 2020) (Circuit Judges Lourie, Dyk, and Moore presiding; Opinion by Lourie, J.) (Appeal from N.D. Ill., Pallmeyer, J.)....more
As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of...more
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, Civ. Nos. 16 C 651, 17 C 7903, 2018 U.S. Dist. LEXIS 212916 (N.D. Ill. Dec. 17, 2018) (Pallmeyer, J.)....more
Case Name: Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC, Civ. No. 15-1102-GMS, 2018 U.S. Dist. LEXIS 93911 (D. Del. June 5, 2018) (Sleet, J.)....more
Case Name: Fresenius Kabi USA, LLC v. Fera Pharms., LLC, No. 15-cv-3654 (KM)(MAH), 2016 U.S. Dist. LEXIS 128126 (D.N.J. Sept. 20, 2016) (McNulty, J.) - Drug Product and Patent(s)-in-Suit: Levothyroxine Sodium for...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Fresenius Kabi USA, LLC et al. v. Mylan Laboratories Ltd. et al. 1:15-cv-00942; filed October 19, 2015 in the District...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Millennium Pharmaceuticals Inc. v. Dr. Reddys Laboratories, Ltd. et al. 1:15-cv-00539; filed June 25, 2015 in the District...more
Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more
Appellate Decision Sets Stage for Next Skirmish In The Apple vs. Samsung Smart Phone Wars - A unanimous panel of the U.S. Court of Appeals for the Federal Circuit has concluded that the district court was within its...more
When the Federal Circuit denied Baxter’s petition for panel rehearing and rehearing en banc in Fresenius USC, Inc. v. Baxter International, Inc., Judge Dyk wrote an opinion concurring in the denial that was joined by Judge...more
The Federal Circuit’s recent decision in Fresenius USA, Inc. v. Baxter Int’l, Inc., illustrates the potential value of challenging a patent's validity through administrative proceedings in the U.S. Patent & Trademark Office...more
In a case that raises important issues of perhaps Constitutional dimensions (at least in Circuit Court Judge Newman's view), the Biotechnology Industry Organization (BIO) urged the Federal Circuit to rehear the panel decision...more
In This Issue: • Cancellation of Claims by PTO Binding on District Court • Claims Reciting Method Free of an Agent is Invalid Where Patent Does Not Mention Agent • Defendant Did Not Have Proper Notice of Products...more
Just before the July 4th holiday, the Federal Circuit issued its ruling in Fresenius USA, Inc. v. Baxter International, Inc. ("Fresenius II"). The Federal Circuit framed the question at issue as: "Whether under the reexam...more