Merck Sharp & Dohme Corp. v. Watson Laboratories, Inc. et al.
settled- Docket:
- 1:19-cv-00317-RGA
- Filed:
- 2019-02-13
Action asserting the '708 patent; settled. Teva/Watson nonetheless petitioned for IPR.
Defendant
13 cases as defendant.
Company overview. Teva Pharmaceuticals USA, Inc. is the U.S. subsidiary of Teva Pharmaceutical Industries Ltd., the Israeli pharmaceutical group (NYSE/TASE: TEVA) founded in 1901 and headquartered in Tel Aviv. Teva USA, incorporated in 1985, houses the group's North American operations and moved its U.S. headquarters from North Wales, Pennsylvania, to Parsippany, New Jersey, around 2020. The parent is a public company with roughly 32,000–37,000 employees worldwide and annual revenue of about $16–17 billion (2021–2025), with a market cap in the low-to-mid $20 billion range in 2025.
Products / operations. Teva is the world's largest manufacturer of generic pharmaceuticals, with a portfolio of roughly 1,800 molecules. Teva USA manufactures and markets generic drugs in oral, injectable, and other dosage forms and distributes generic, biosimilar, and OTC products to retail pharmacies, chains, hospitals, and physician offices across the U.S. The group also sells innovative specialty medicines (including CNS products such as Austedo and Uzedy), biosimilars, and active pharmaceutical ingredients to third parties.
Patent-litigation posture. Teva is clearly an operating company, not an NPE: its two tracked appearances are classic Hatch-Waxman/ANDA disputes with Novartis. It appears once as a plaintiff-side petitioner — joining Actavis Elizabeth LLC in an inter partes review (IPR2017-01946) at the PTAB challenging Novartis's U.S. Patent 9,187,405 — and once as a defendant in Novartis Pharmaceuticals Corp. v. Teva Pharmaceuticals USA, Inc. in the District of Delaware, a venue common for ANDA suits (no Eastern District of Texas involvement). This two-way pattern is typical of a generic manufacturer both attacking and defending branded-drug patents.
Notable cases / context. The tracked cases center on Novartis's Gilenya (fingolimod) franchise: the IPR challenged the S1P-receptor-modulator patent covering a 0.5 mg daily dosing regimen for relapsing-remitting multiple sclerosis, and the Delaware suit was Novartis's ANDA infringement action tied to Teva's generic filing, which Teva answered with counterclaims. The IPR was joined with a parallel Apotex proceeding and appealed to the Federal Circuit; Teva's and Novartis's related disputes over the same franchise continued in later Delaware ANDA cases (e.g., 2022 and 2025 filings).
Action asserting the '708 patent; settled. Teva/Watson nonetheless petitioned for IPR.
Action asserting the '708 patent; settled. Teva/Watson separately petitioned for IPR.
Hatch-Waxman/ANDA suit filed by Adapt Pharma and Opiant against Teva, triggered by Teva's Paragraph IV notice regarding ANDA No. 211561 for generic NARCAN 2 mg/spray. The case asserted U.S. 9,480,644 and U.S. 9,707,226. On July 28, 2020, the court stayed the case pending resolution of the related 4 mg Naloxone Case appeal; the final docket entry is dated July 27, 2022.
Hatch-Waxman ANDA litigation. Consolidated for claim construction with 17-cv-03387. Terminated around 2019-02-06.
Adapt and Opiant sued Teva in D.N.J. asserting NARCAN naloxone nasal spray patents. The district court found the asserted patents invalid for obviousness on June 5, 2020, with judgment entered June 26, 2020; the Federal Circuit affirmed on Feb. 10, 2022. The '570 patent was not asserted but was cited as prior art (Wyse). Consolidated/related docket numbers included 2:17-cv-00864, 2:17-cv-02877, 2:17-cv-05100, 2:18-cv-09880; related Perrigo action 2:18-cv-15287.
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.
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.
ANDA suit against Teva (ANDA No. 208008) asserting the '405 patent; filed around 2018-07-16 and settled.
Federal Circuit appeal of the D.N.J. consolidated action; reversed the district court and held asserted claims of the '724, '725, '424, and '219 patents invalid under the on-sale bar.
Listed as a related consolidated action involving Teva Pharmaceuticals USA, Inc., et al.; no further details provided.
Federal Circuit appeal from the D.N.J. invalidity judgment. On February 10, 2022, the court affirmed, finding no error in the obviousness conclusion as to the asserted claims including U.S. 9,629,965 claims 21, 24, and 25; Newman, J., dissented.
Federal Circuit appeal from the D.N.J. Hatch-Waxman decision. The court affirmed the invalidity/obviousness holding on February 10, 2022 (Opinion by Stoll, joined by Prost; Newman dissenting). The narrative notes the appellate opinion discusses the '747 patent and does not confirm the '253 patent's role.
Hatch-Waxman ANDA action by Celgene against Teva; consolidated with the 2:19-cv-05797/05799/05802 group; later resolved by a Celgene-Teva settlement in March 2021.