Defendant

Alvogen Pine Brook, LLC

2 cases as defendant.

Cases
2
Active
1
1 closed
Filed
2017
Top venue
D. New Jersey
1 case

Company profile

Alvogen Pine Brook LLC is a U.S. operating subsidiary of Alvogen, a privately held pharmaceutical company founded in 2009 by Icelandic entrepreneur Róbert Wessman. Alvogen is headquartered in Pine Brook, New Jersey (with corporate offices listed in nearby Morristown, NJ), and has been majority-owned since 2015 by private equity firm CVC Capital Partners and Singapore's Temasek Holdings. Wikipedia cites roughly 2,800 employees and about $1.1 billion in 2017 revenue; third-party data aggregators list employee counts in the 500–2,800 range, so current figures are not reliably verifiable. Alvogen Pine Brook LLC is a Delaware LLC whose registered address is 10 Bloomfield Avenue, Building B, Pine Brook, NJ.

Alvogen develops, manufactures, and sells generic, branded, OTC, and biosimilar pharmaceuticals. It focuses on niche and complex generics — oral solids, modified-release tablets, soft-gel capsules, transdermals, creams, and injectables (its injectables business is called Almaject). It operates a large U.S. manufacturing site in Norwich, NY (built on Norwich Pharmaceuticals, a 130-year-old contract manufacturer), plus development hubs abroad. Alvogen Pine Brook LLC specifically functions as the U.S. regulatory agent and ANDA applicant/holder for products filed with the FDA and as a U.S. agent for affiliates such as Alvogen Malta Operations Ltd.

Patent-litigation posture: The tracked data show Alvogen Pine Brook LLC as a defendant in one case and a plaintiff in none. That is the profile of an operating generics company defending Hatch-Waxman/ANDA patent suits brought by brand manufacturers — not a non-practicing entity. The venue is the District of Delaware, the leading venue for ANDA litigation, rather than an NPE-favored venue such as the Eastern District of Texas. In its ANDA cases the company has also filed declaratory-judgment counterclaims of non-infringement and invalidity, making it an active two-way participant in the underlying disputes even where it is nominally only a defendant.

Notable case: Merck Sharp & Dohme Corp. v. Alvogen Pine Brook LLC et al., No. 1:19-cv-00310 (D. Del., filed Feb. 13, 2019), an ANDA infringement action concerning U.S. Patent No. 7,326,708 and the sitagliptin product Janumet XR; Alvogen counterclaimed for declaratory judgment. The tracked record reflects only this one appearance; broader litigation outside this database is not captured here.

Celgene Corp. v. Lotus Pharmaceutical Co., Ltd. et al.

settled/consent judgment
Docket:
2:17-cv-06842
Filed:
2017-09-06
Terminated:
2019-09-05

Celgene sued Lotus and Alvogen in D.N.J. asserting a portfolio including US 8,626,531. The court bifurcated and stayed claims as to several patents, and a consent judgment/injunction was entered; the case terminated Sept. 5, 2019.

Celgene Corporation v. Lotus Pharmaceutical Co., Ltd. et al.

active
Docket:
2:17-cv-06842-SDW-LDW
Filed:
2017-09-06

Celgene action against Lotus and Alvogen over lenalidomide ANDA No. 210480. The narrative states the '018 patent was not listed among the patents challenged; the Rule 12(c) challenge involved the REMS patents '720, '977, '784, '886 and '531. The motion for judgment on the pleadings was denied without prejudice on December 14, 2018.