Plaintiff
15 cases as plaintiff.
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Roche Palo Alto LLC is a wholly owned subsidiary of Roche Holdings, Inc.; its ultimate parent is Roche Holding Ltd., the Basel-based pharmaceutical group traded on the Swiss exchange (SIX: ROG). Its registered address is 3431 Hillview Avenue, Palo Alto, California. The entity traces to Syntex Corp. / Syntex (U.S.A.) LLC, the Palo Alto pharmaceutical and diagnostics company Roche acquired in 1994 and renamed Roche Bioscience in 1995 before it later took the Roche Palo Alto name. Roche confirmed in September 2008 that it would close the roughly 1-million-square-foot Palo Alto campus — then about 1,000 employees — in connection with its Genentech acquisition, relocating inflammation work to New Jersey and virology work to South San Francisco. Roche does not publish standalone headcount or revenue for this subsidiary.
Operations: The Palo Alto site was a drug-discovery and development organization focused on inflammation, viral diseases (including HCV/HIV), and related therapeutic areas. It had no independent commercial product line of its own; commercialization of relevant products runs through Roche and licensing partners such as Helsinn and Eisai.
Litigation posture: All five tracked cases are as plaintiff and none as defendant — the profile of a patent owner enforcing IP, not a defensive target or an NPE. Every tracked suit is a Hatch-Waxman action (ANDA or 505(b)(2) filings) brought jointly with Helsinn Healthcare S.A., asserting Orange Book-listed palonosetron formulation patents covering Aloxi (palonosetron HCl injection). Venues are D.N.J. and D. Delaware, not the Eastern District of Texas.
Notable cases: Helsinn Healthcare S.A. et al. v. Dr. Reddy's Laboratories (D.N.J., 2011); v. Cipla (D. Del., 2013); v. Mylan Institutional (D. Del., 2014); and v. Hospira (D. Del., 2015), plus an untitled 2013 D. Del. case. Roche Palo Alto is a co-assignee on patents in the family, including U.S. 7,947,724; 7,947,725; 7,960,424; 8,518,981; 8,598,219; and 8,729,094. In the Teva appeal (Fed. Cir. 2016-1284), Roche Palo Alto assigned its rights in the appealed patents to Helsinn and withdrew as a party; the Federal Circuit later reversed the district court's judgment. Patent-office records list continued Roche Palo Alto assignment activity in later years.
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ANDA action asserting U.S. 7,947,724 and U.S. 9,066,980. Stayed pending resolution of Civil Action No. 14-4274; ended by stipulated dismissal without prejudice after Actavis withdrew its NDA.
DRL's 505(b)(2) NDA No. 203050 for generic palonosetron injection led to this D.N.J. action, which the PTAB identified as the district-court assertion of U.S. Patent 9,173,942. The narrative confirms the filing and '942 assertion but could not independently confirm the final disposition.
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.
Helsinn and Roche asserted U.S. Patents 7,947,724; 8,518,981; 8,598,218; 9,066,980; and 9,125,905 against Fresenius Kabi in D. Del. based on Fresenius's Notice Letter regarding NDA No. 208109 for palonosetron HCl IV. Helsinn voluntarily dismissed the action without prejudice on 2015-12-01, and it was essentially refiled in New Jersey.
Delaware Hatch-Waxman ANDA action asserting the '424 patent against Hospira Inc.; terminated in 2018.
Complaint contains a distinct Count V for infringement of the '094 patent, alleging Hospira's ANDA No. 207005 (0.25 mg/5 mL and 0.075 mg/1.5 mL) infringed the '094 patent.
FDA's NDA review document states a lawsuit was filed on July 7, 2014 for patent 8729094. Helsinn sought a preliminary injunction based on claim 4 of the '094 patent, which was denied; Teva later launched generic palonosetron at-risk on 2018-03-23.
Delaware Hatch-Waxman ANDA action asserting the '424 patent against Mylan Institutional LLC (per '094 docket); terminated in 2015.
Delaware Hatch-Waxman ANDA action asserting the '424 patent; defendant not retrieved; terminated in 2015.
Delaware Hatch-Waxman ANDA action asserting the '424 patent against Cipla Ltd.; terminated in 2015.
Consolidated Hatch-Waxman ANDA action in D.N.J. (lead case 3:11-cv-03962, consolidated with 3:11-cv-05579 and 3:13-cv-05815) asserting the '724, '725, '424, and '219 patents. District court found claims valid and infringed, but the Federal Circuit reversed under the on-sale bar and the Supreme Court affirmed invalidity.
Listed as a related family case in the District of New Jersey; no further details provided.
Listed as a related consolidated action involving Teva Pharmaceuticals USA, Inc., et al.; no further details provided.
Listed as a related family case involving GAVIS Pharma LLC; no further details provided.
The April 5, 2016 opinion denied Hospira's motion to dismiss for lack of jurisdiction; the patents-in-suit included the '724 patent.