Defendant
3 cases as defendant.
Company overview. Hetero Labs Limited Unit-V is a manufacturing division of Hetero Labs Limited, the flagship of India's privately held Hetero group. Hetero Labs was incorporated on 10 March 1989 and is headquartered at Sanath Nagar, Hyderabad, Telangana; Unit-V sits at the TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Telangana. It is a closely held, unlisted public limited company (no ticker). Third-party Indian registry/EPFO data (via The Company Check) puts Hetero Labs' FY2025 revenue near ₹16,500 crore and headcount around 7,300; group-wide employee estimates vary widely by source.
Operations. Unit-V is an oral solid-dose finished-formulation plant — tablets, hard capsules and powders — serving regulated and semi-regulatory export markets, with WHO prequalification and EU-GMP inspections on record. Its sister Unit-VI at Jadcherla handles oncology dosage forms. GMP-certified product scopes include antiretrovirals (lamivudine; efavirenz/emtricitabine/tenofovir combinations), oncology agents (lenalidomide, bortezomib, azacitidine, pemetrexed, gefitinib) and cardiovascular/CNS generics. The wider group makes APIs, generics and biosimilars and offers custom pharma services. Unit-V received an FDA warning letter in August 2017 following a December 2016 inspection.
Litigation posture. Operating company, purely on the defense. All three tracked cases are Celgene Corporation v. Hetero Labs Limited et al., filed in the U.S. District Court for the District of New Jersey (2017, 2019, 2020); Hetero appears only as a defendant and has no tracked plaintiff-side filings. These are Hatch-Waxman ANDA actions brought by the brand owner — not NPE suits — and they cluster in D.N.J., Celgene's home district, rather than plaintiff-friendly venues such as the Eastern District of Texas.
Notable cases. The 2017 suit (No. 17-cv-3387) asserted pomalidomide (Pomalyst) patents, including REMS/delivery-method claims. The 2020 action (No. 2:20-cv-14389) concerned lenalidomide (Revlimid) crystal-form and method patents. A September 2021 consent judgment in that case barred Hetero from marketing generic lenalidomide in the U.S. until specified Celgene patents expire.
Celgene sued Hetero entities for ANDA patent infringement in D.N.J. This follow-on to Celgene v. Hetero (2:18-cv-17463) is linked to 8,648,095; consent judgment entered 2021-09-27 with marketing injunction and confidential terms.
Hatch-Waxman ANDA infringement action filed by Celgene against Hetero entities; the complaint expressly asserts the '647, '648, and '649 patents. Consolidated with related 2019 cases before Judge Esther Salas / M.J. Michael A. Hammer and docket shows termination Oct. 28, 2020.
Celgene sued Hetero entities; aggregator data lists patent 7,119,106 as involved in this case, but the narrative flags this as unverified and notes the published opinions centered primarily on Pomalyst and later-expiring Revlimid patents rather than the expired '106 patent.