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
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...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
The Supreme Court recently denied Chrimar Systems, Inc. (Chrimar)’s petition for certiorari seeking to overturn the Federal Circuit’s “Fresenius/Simmons preclusion principle,” under which Chrimar’s district court victory...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
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
Versata Software, Inc. et al. v. SAP America, Inc. et al., Case No. 2:07cv153-RSP (E.D. Tex.) - Versata v. SAP has been a dispute that the patent bar has followed with interest because it spawned the very first Covered...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
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
A recent Federal Circuit ruling will likely increase the chances of obtaining a stay of a patent litigation if there is a concurrent proceeding in the Patent Office. ...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