Plaintiff

Helsinn Healthcare S.A.

30 cases as plaintiff.

Cases
30
Active
0
30 closed
Filed
2011–2022
Top venue
D. Delaware
12 cases
Also appears as a defendant in 6 cases → View as defendant

Company profile

Helsinn Healthcare S.A. (commonly "Helsinn" or the Helsinn Group) is a privately held, family-owned Swiss pharmaceutical group headquartered in Lugano, Switzerland, founded in 1976 by Dr. Gabriele Braglia and now in its third/fourth generation of family ownership. It is not publicly traded and reports no ticker. Helsinn's own materials describe operating subsidiaries in the U.S. (Helsinn Therapeutics), manufacturing in Ireland (Helsinn Birex Pharmaceuticals), and offices in China; a 2020 Swiss Biotech Association profile cited "over 650 employees," though current headcount and revenue are not publicly disclosed. Note that some third-party databases contain conflicting ownership information; no reliable public source confirms those claims.

Operations. Helsinn develops, manufactures, and commercializes cancer-supportive-care and oncology products, with a stated focus on supportive care, oncology, and dermato-oncology. Its principal marketed franchises are AKYNZEO (a fixed combination of the NK1 antagonist netupitant, or its IV prodrug fosnetupitant, with the 5-HT3 antagonist palonosetron, for chemotherapy-induced nausea and vomiting) and ALOXI (palonosetron). Its model combines in-licensing, in-house development and GMP manufacturing, regulatory filings, and out-licensing to commercial partners; ALOXI's U.S. rights were licensed to Eisai (via MGI Pharma).

Litigation posture. Operating company, predominantly a defendant/target rather than an NPE. Of 5 tracked matters: 4 are defendant-side PTAB proceedings and 1 is a plaintiff-side district court suit. The four PTAB cases are inter partes reviews filed by Azurity Pharmaceuticals, Inc. on 2025-05-01 challenging Helsinn's Akynzeo-related Orange Book patents. The single plaintiff case, Helsinn Healthcare S.A. v. Gland Pharma Limited (D.N.J., filed 2022-07-18), was a Hatch-Waxman ANDA action over fosnetupitant/palonosetron injection patents; it was resolved by consent judgment and dismissal in January 2023. Venue is New Jersey, not a plaintiff-friendly NPE venue.

Context. Helsinn has historically enforced its palonosetron portfolio broadly, including the ALOXI formulation litigation against Teva, Dr. Reddy's, and Sandoz, which reached the Supreme Court in Helsinn Healthcare v. Teva (2019) on the AIA on-sale bar. That enforcement pattern is consistent with a brand pharmaceutical company protecting Orange Book-listed patents against generic challenges, not with patent assertion by a non-practicing entity.

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Filing activity

2011: 1 case'112012: 1 case'122013: 5 cases'132014: 4 cases'142015: 9 cases9'152016: 3 cases'16'17'18'19'20'212022: 1 case'22
Cases filed per year with Helsinn Healthcare S.A. as plaintiff.

Helsinn Healthcare S.A. v. Gland Pharma Limited

consent judgment and dismissal
Docket:
3:22-cv-04635
Filed:
2022-07-18
Terminated:
2023-01-19

Helsinn sued Gland under the Hatch-Waxman Act over Gland's ANDA No. 217374 for generic fosnetupitant/palonosetron IV product, asserting ten patents including U.S. 10,828,297; the action was also cited in some sources as 2:22-cv-04635. It was resolved by consent judgment and dismissal order in January 2023, with Gland admitting technical infringement under 35 U.S.C. § 271(e)(2)(A) and enjoined from marketing the ANDA product until a redacted date; Gland's invalidity/non-infringement counterclaims were not adjudicated.

Helsinn Healthcare S.A. et al. v. Dr. Reddy's Laboratories, Ltd. et al.

disposition unknown
Docket:
3:15-cv-08662
Filed:
2015-12-15
Patents:9173942

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 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.

Helsinn Healthcare S.A. et al. v. Fresenius Kabi USA, LLC

voluntarily dismissed without prejudice
Docket:
1:15-cv-00918
Filed:
2015-10-13
Terminated:
2015-12-01

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.

Helsinn Healthcare S.A. et al. v. Teva Pharmaceuticals USA, Inc. et al.

preliminary injunction denied; no final '094-specific judgment confirmed
Docket:
2:14-cv-04274
Filed:
2014-07-07
Patents:8729094

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.

Helsinn Healthcare S.A. et al. v. Dr. Reddy's Laboratories, Ltd. et al.

judgment (invalidated on appeal; Supreme Court affirmed)
Docket:
3:11-cv-03962
Filed:
2011-07-08

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.