News & Analysis as of

Bristol-Myers Squibb Food and Drug Administration (FDA)

Goodwin

FDA Approves BMS and J&J CAR-T Cell Therapies for the Earlier Treatment of Multiple Myeloma

Goodwin on

On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after...more

Kramer Levin Naftalis & Frankel LLP

Recent Updates on CAR T-Cell Therapy: FDA Approvals and Patent Litigation

On Feb. 5, 2021, the Food and Drug Administration (FDA) granted approval for a new CAR T-cell therapy, Breyanzi® (lisocabtagene maraleucel), to Juno Therapeutics, a subsidiary of Bristol-Myers Squibb (BMS). Breyanzi® is...more

Robins Kaplan LLP

Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc.

Robins Kaplan LLP on

Eliquis®/apixaban - Case Name: Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., No. 17-374-LPS (Consolidated), 2020 WL 4500226 (D. Del. Aug. 5, 2020) (Stark, J.)...more

Dunlap Bennett & Ludwig PLLC

Bristol-Myers and Pfizer Win Over Eliquis Patents

 On August 5, 2020, Bristol-Myers Squibb Co. and Pfizer Inc. obtained a federal court ruling upholding two patents on their best-selling blood-thinner medication Eliquis. Bristol-Myers Squibb Co. and Pfizer Inc. entered into...more

Mintz - Intellectual Property Viewpoints

ANDA Applicant Dismissed for Lack of Venue Under § 1400(b) as District of New Jersey Departs from its own and the District of...

On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over...more

Robins Kaplan LLP

Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc.

Robins Kaplan LLP on

Case Name: Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., C.A. No. 17-374-LPS (Consolidated), 2018 U.S. Dist. LEXIS 179154 (D. Del. Oct. 18, 2018) (Stark, J.)....more

McDermott Will & Emery

Anticipated Acts of Infringement May Establish Venue for Hatch-Waxman

McDermott Will & Emery on

Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware if a generic drug company has permanent and continuous presence in Delaware...more

Goodwin

Bristol-Myers Squibb announces new pediatric subcutaneous administration option for Orencia® (abatacept)

Goodwin on

We previously reported that the PTAB upheld the validity of Bristol-Myers Squibb’s ‘239 patent covering their rheumatoid arthritis agent Orencia® (abatacept). Since 2008, Orencia® has only been approved for use in patients 6...more

Saul Ewing LLP

Court enforces False Claims Act’s first-to-file rule to bar complaint alleging details of off-label promotion scheme about which...

Saul Ewing LLP on

In Brief - When an alleged scheme to market drugs for unapproved “off-label” uses had already been identified by an earlier complaint, a later complaint providing additional details, but alleging the same “essential...more

Robins Kaplan LLP

Personalized Medicine and Patent Eligibility under 35 U.S.C. § 101

Robins Kaplan LLP on

Double-digit growth is predicted for the molecular diagnostic market in the next several years, driven in part by an increased demand for personalized medicine—medical decisions and therapeutic products tailored to address...more

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