Defendant

HEC Pharm Co., Ltd.

3 cases as defendant.

Cases
3
Active
1
2 closed
Filed
2020
Top venue
Fed. Cir.
1 case

Company profile

Company overview. HEC Pharm Co., Ltd. is a Chinese pharmaceutical manufacturer and a core operating entity of the privately held HEC Group. It is headquartered in Yidu, Yichang, Hubei Province, China, with U.S. operations run through subsidiary HEC Pharm USA Inc. (Princeton, New Jersey). Group roots date to the early 2000s (HEC Pharm commonly dated to 2002; affiliate Yichang Changjiang Pharmaceutical was incorporated in 2001). HEC Pharm is privately held; no public company owns 10% or more of it, per filings. Directory estimates put HEC Pharm at roughly $500M–$1B revenue and 2,000–5,000 employees; the affiliated, Hong Kong-listed Sunshine Lake Pharma Co., Ltd. (6887.HK) separately reports about 6,350 employees and ~HKD 5.6B trailing revenue (FT).

Products / operations. HEC develops and manufactures generic and branded drugs, active pharmaceutical ingredients (APIs), insulin, and biosimilars. Its portfolio spans anti-infectives — oseltamivir phosphate (Kewei, for influenza), hepatitis C treatments, macrolide antibiotics (erythromycin, azithromycin, clarithromycin), and cephalosporins — plus cardiovascular, diabetes, and oncology products. Production bases in Songshan Lake (Dongguan, Guangdong) and Yidu (Hubei) hold Chinese, EU, and U.S. GMP certifications; the company has launched first generics in the U.S. and runs overseas clinical programs.

Patent-litigation posture. HEC is an operating company defending against brand-name patent claims — not an NPE. Its two tracked appearances are both as defendant (0 as plaintiff), in Hatch-Waxman/ANDA litigation brought by Novartis over HEC's generic fingolimod (Gilenya) for relapsing-remitting multiple sclerosis. The cases sit at the Federal Circuit and Supreme Court rather than in plaintiff-friendly district venues.

Notable cases. In Novartis Pharmaceuticals Corp. v. HEC Pharm Co., Ltd. (Sup. Ct. No. 22-671) and Novartis v. Accord Healthcare, Inc. et al. (Fed. Cir.), the Federal Circuit, on rehearing, invalidated Novartis's method-of-treatment patent for lack of adequate written description under 35 U.S.C. §112. Novartis petitioned the Supreme Court, and the dispute drew attention when Chief Justice Roberts granted an emergency stay of the Federal Circuit's mandate in 2022, briefly blocking generic entry.

Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. et al.

active
Docket:
1:20-cv-00133
Filed:
2020-01-28

Hatch-Waxman/ANDA patent infringement action by Novartis against HEC and related entities concerning generic fingolimod 0.5 mg capsules. Consolidated with 1:21-cv-01530 and 1:23-cv-00026; claim construction was decided on April 6, 2023 and merits briefing was ongoing.

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. et al.

Reversed on rehearing; claims invalid
Docket:
21-1070
Patents:9187405

Appeal from D. Del. 1:18-cv-01043. The Federal Circuit first affirmed validity and infringement on January 3, 2022, then on rehearing vacated and reversed, holding the '405 patent claims invalid for lack of written description (38 F.4th 1013). Rehearing en banc was denied and mandate issued approximately October 18, 2022.