Merck Sharp & Dohme Corp. v. Alvogen Pine Brook LLC et al.
settled- Docket:
- 1:19-cv-00310-RGA
- Filed:
- 2019-02-13
Action asserting the '708 patent against Alvogen entities; resolved by consent judgment/settlement.
Defendant
9 cases as defendant.
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.
Action asserting the '708 patent against Alvogen entities; resolved by consent judgment/settlement.
Celgene obtained a consent judgment against Lotus and Alvogen in a REVLIMID ANDA case. The Mar. 29, 2019 judgment enjoined defendants from marketing ANDA No. 210480 until expiration of the patents-in-suit, which expressly included U.S. 7,977,357, and dismissed all claims with prejudice under a confidential settlement license.
16-count complaint with the '740 patent among patents-in-suit; motion for judgment on the pleadings on REMS patents denied without prejudice Dec 14, 2018. Later settled March 30, 2019, with Lotus/Alvogen licensed to sell a limited-volume generic after March 2022.
Celgene sued Lotus and Alvogen, asserting the '717 patent among 16 patents. A consent judgment/injunction was entered on March 29, 2019, enjoining Lotus/Alvogen until expiration of the patents-in-suit, including the '717 patent.
Celgene sued Lotus Pharmaceutical and Alvogen Pine Brook in a D.N.J. ANDA action involving ANDA No. 210480; the case settled with a consent judgment/injunction on March 29, 2019, including a volume-limited licence.
Celgene sued Lotus and Alvogen in D.N.J. over generic lenalidomide. The case resolved by consent judgment on March 29, 2019, with the '621 patent expressly among the patents-in-suit and an injunction barring generic launch until expiry except as licensed.
Celgene sued Lotus Pharmaceutical and Alvogen Pine Brook in D.N.J. (2:17-cv-06842), with U.S. 7,855,217 among the patents-in-suit. A consent judgment was entered on March 29, 2019, after Celgene withdrew an earlier covenant not to sue on '217.
Celgene sued Lotus Pharmaceutical and Alvogen Pine Brook for ANDA patent infringement in D.N.J. Consent judgment entered 2019-03-29 named 8,648,095 among patents-in-suit, dismissed with prejudice and enjoined Lotus ANDA No. 210480.
Celgene lenalidomide ANDA suit against Lotus and Alvogen; the '517 patent was expressly named among the patents-in-suit. A consent judgment entered March 29, 2019, included an injunction and dismissal with prejudice, with settlement allowing generic lenalidomide launch after March 2022 under volume limits.