Defendant

Qilu Pharmaceutical Co., Ltd.

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
2015
Top venue
D N J Reported Variously As 3 15 Cv 08132 And 2 15 Cv 08132
1 case

Company profile

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Qilu Pharmaceutical Co., Ltd. (齐鲁制药有限公司) is a Chinese pharmaceutical manufacturer headquartered in Jinan, Shandong. It was founded in 1958 and is a wholly owned subsidiary of Qilu Pharmaceutical Group Co., Ltd., a privately held group (not publicly listed) controlled by the Li family, with Li Yan (李燕) as legal representative/chairman. Group revenue was roughly RMB 35–39 billion (about US$5 billion) in recent years, and the group reports about 39,000 employees across 12 subsidiaries; the Co., Ltd. manufacturing entity itself reports roughly 6,000+ employees on its own website. Sources: qilu-pharma.com, Baidu Baike, and Chinese industrial rankings.

Operations. Qilu is one of China's largest generic-drug makers and a major active-pharmaceutical-ingredient (API) supplier. Its portfolio spans oncology, cardiovascular, anti-infective, psychiatric, neurological, and ophthalmic therapies, with marketed small-molecule generics and injectables plus biosimilars (e.g., ranibizumab, denosumab) and complex formulations (microspheres, liposomes, soft capsules, ophthalmic emulsions). It is also expanding into innovative drugs, including ADCs, trispecific antibodies, and siRNA platforms. The company exports formulations and APIs to more than 100 countries, including the US, EU, and Japan.

Litigation posture. This is an operating company, not an NPE. Across the tracked data it appears in exactly one case — as a defendant and never as plaintiff — which is consistent with a manufacturer responding to Hatch-Waxman patent suits rather than asserting patents. The single venue, the District of New Jersey, is a routine forum for ANDA litigation tied to New Jersey-based brand owners and generic filers, not an NPE-favored district such as the Eastern District of Texas.

Notable case. Helsinn Healthcare S.A. et al. v. Qilu Pharmaceutical Co., Ltd. et al. (D.N.J., filed 2015-11-17; docketed variously as 3:15-cv-08132 and 2:15-cv-08132) arose from Qilu's Paragraph IV challenge to Helsinn's Orange Book palonosetron patents covering the anti-nausea drug Aloxi. Qilu had submitted ANDA 205648 for generic palonosetron hydrochloride injection (0.25 mg/5 mL and 0.075 mg/1.5 mL), which FDA found bioequivalent to Aloxi but could not finally approve pending exclusivity. No further tracked litigation involving Qilu appears in the data.

Helsinn Healthcare S.A. et al. v. Qilu Pharmaceutical Co., Ltd. et al.

closed/dismissed
Docket:
15-cv-08132
Filed:
2015-11-17

Helsinn and Roche filed a patent-infringement action against Qilu in D.N.J. after Qilu's Paragraph IV letter regarding the '905 patent. The case was closed/dismissed, but the narrative notes uncertainty whether the '905 patent itself was pleaded; FDA's tentative-approval letter described the Qilu litigation as asserting the '724, '094, '980, and '942 patents instead.