Defendant

Handa Neuroscience, LLC

2 cases as defendant.

Cases
2
Active
1
1 closed
Filed
2021
Top venue
D. Delaware
1 case

Company profile

Company overview. Handa Neuroscience, LLC is a California LLC incorporated on July 17, 2020, with its principal place of business in San Jose, California, where it shares an office with affiliated Handa entities. It is a 100% indirectly held subsidiary of Handa Pharmaceuticals, Inc. (漢達生技醫藥, ticker 6620), a Taiwan-based specialty pharmaceutical company listed on the Taipei Exchange's emerging-stock board; Handa Pharma, Inc. is its direct U.S. parent. The parent group is small — roughly 31 employees in Taiwan and about 9 at Handa Pharma — and no standalone headcount for Neuroscience is published.

Products / operations. Handa Neuroscience is the group's central-nervous-system brand-drug subsidiary. It owns and sponsored TASCENSO ODT (HND-020), a 505(b)(2) orally disintegrating tablet reformulation of Novartis's Gilenya (fingolimod) capsules for relapsing multiple sclerosis, developed for patients with swallowing difficulty. The FDA granted final approval for the 0.25 mg strength in December 2021 and the 0.5 mg strength in December 2022. U.S. commercialization is exclusively licensed to Cycle Pharmaceuticals Ltd., which launched the product in the U.S. in February 2023. In August 2024, the Taiwanese parent transferred the U.S. market IP rights and obligations for Tascenso ODT to Handa Neuroscience for US$20 million in an intercompany transaction.

Patent-litigation posture. Handa Neuroscience is an operating company, not an NPE: it has zero plaintiff cases and one defendant case in our tracked data. The suit is Novartis Pharmaceuticals Corp. v. Handa Neuroscience, LLC et al., filed May 4, 2021, in the District of Delaware (1:21-cv-00645), a Hatch-Waxman ANDA/patent case in which Novartis asserted U.S. Patent Nos. 9,187,405 and 10,543,179 covering Gilenya against Neuroscience as NDA sponsor, together with three Handa affiliates; Novartis also filed a parallel "safety" suit in the Northern District of California. Venue was Delaware, not a plaintiff-friendly Texas court.

Notable context. The litigation was resolved by a settlement signed October 24, 2022, after which Novartis withdrew the suits and Handa agreed to pay Novartis a royalty on certain U.S. net sales of Tascenso ODT. The settlement cleared the path to final FDA approval and U.S. launch. The dispute reflects routine 505(b)(2) patent-challenge litigation rather than assertion activity by the company.

Novartis Pharmaceuticals Corporation v. Handa Neuroscience, LLC et al.

dismissed
Docket:
3:21-cv-03397 / 5:21-cv-03397
Filed:
2021-05-06

Protective safety suit filed in the Northern District of California two days after the Delaware Handa suit, asserting the same two patents. Dismissed after the October 2022 Handa settlement.

Novartis Pharmaceuticals Corp. v. Handa Neuroscience, LLC et al.

Discovery active through mid-2022; final disposition unverified
Docket:
1:21-cv-00645

Suit against Handa entities asserting the '405 patent and also US 10,543,179. Handa sought summary judgment on the '405 patent after the Federal Circuit's June 2022 invalidation; final disposition not verified.