Novo Nordisk v. ScinoPharm Taiwan: Liraglutide ANDA Case Dismissed Without Prejudice
Novo Nordisk filed suit against ScinoPharm Taiwan in New Jersey over two liraglutide patents — US8,114,833 and US9,265,893 — after ScinoPharm submitted ANDA No. 217612 for a generic liraglutide 18 mg/3 ml injection. The parties resolved the action in 127 days, with dismissal without prejudice and each side bearing its own costs.
Swift ANDA resolution in the GLP-1 liraglutide patent space
On October 5, 2023, Novo Nordisk A/S filed suit against ScinoPharm Taiwan Ltd. in the United States District Court for the District of New Jersey, asserting infringement of US Patent Nos. 8,114,833 and 9,265,893. The trigger was ScinoPharm’s submission of ANDA No. 217612 seeking FDA approval to commercially manufacture and sell a generic liraglutide solution injection at 18 mg/3 ml (6 mg/ml) — a direct equivalent to Novo Nordisk’s branded liraglutide product — prior to expiration of the asserted patents.
The case closed on February 9, 2024, just 127 days after filing, via a court-approved stipulation. All claims, counterclaims, and affirmative defenses between the parties were dismissed without prejudice. Notably, the stipulation explicitly preserves ScinoPharm’s right to maintain a Paragraph IV certification in its ANDA and does not prevent the FDA from granting final approval of ANDA No. 217612. Each party agreed to bear its own attorneys’ fees and costs.
A resolution in under five months is unusually fast for Hatch-Waxman litigation, which routinely extends to multi-year proceedings. The speed, combined with the without-prejudice dismissal and the explicit preservation of ScinoPharm’s ANDA rights, is consistent with a negotiated settlement — potentially including a licensing arrangement or agreed entry date — though the specific commercial terms are not disclosed in the public record. The open question is whether and when ScinoPharm’s ANDA will receive final FDA approval, and on what market-entry timeline.
Filing to voluntary dismissal in 127 days
127 days — faster than most Hatch-Waxman ANDA patent litigations, which typically run 2–4 years
What the without-prejudice dismissal means for Novo Nordisk and ScinoPharm
Dismissed without prejudice — claims can be refiled
A dismissal without prejudice means the court has not adjudicated the merits. Novo Nordisk’s patent infringement claims were not decided in ScinoPharm’s favour, and Novo Nordisk is not barred from asserting the same patents — US8,114,833 and US9,265,893 — against ScinoPharm again if circumstances warrant. This preserves optionality for the patent holder while formally closing the current docket.
No merits rulingWithout vs. with prejudice: a critical legal line
Had this been dismissed with prejudice, Novo Nordisk would have been permanently barred from bringing the same claims against ScinoPharm. Dismissal without prejudice carries no such finality — it is procedurally neutral. The public record confirms only that the action was resolved and dismissed without prejudice; the specific commercial terms driving that resolution (if any) are not disclosed in the court filings.
No refiling barScinoPharm’s Paragraph IV certification explicitly preserved
The stipulation includes an unusual and commercially significant carve-out: it expressly does not prohibit ScinoPharm from maintaining its Paragraph IV certification in ANDA No. 217612, and does not prevent the FDA from granting final approval. This means generic market entry remains a live possibility for ScinoPharm, subject to FDA review and any patent exclusivity periods that may still apply.
ANDA rights intactEach party bears its own costs — no prevailing-party award
The stipulation provides that each party will bear its own attorneys’ fees and costs. In Hatch-Waxman cases, this is a standard term in negotiated resolutions and is consistent with a settlement where neither side sought to characterise itself as a clear winner. It also avoids the threshold for exceptional-case fee-shifting under 35 U.S.C. § 285, which requires a formal finding by the court.
Symmetric cost splitFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Novo Nordisk A/S | Company | Multinational pharmaceutical innovator — holder of US8,114,833 and US9,265,893 (liraglutide)Search in Eureka ↗ |
| Defendant | Scinopharm Taiwan, Ltd. | Company | Taiwan-based API and finished-dose manufacturer seeking FDA approval for generic liraglutide injectionSearch in Eureka ↗ |
| Plaintiff counsel | Alexander Lee Callo | Attorney | Counsel for Novo Nordisk A/SSearch in Eureka ↗ |
| Plaintiff counsel | Charles Michael Lizza | Attorney | Counsel for Novo Nordisk A/SSearch in Eureka ↗ |
| Plaintiff counsel | Sarah Ann Sullvian | Attorney | Counsel for Novo Nordisk A/SSearch in Eureka ↗ |
| Plaintiff counsel | William C. Baton | Attorney | Counsel for Novo Nordisk A/SSearch in Eureka ↗ |
| Defendant counsel | Karen A. Confoy | Attorney | Counsel for Scinopharm Taiwan, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge / | Chief Judge | New Jersey District Court — Chief JudgeSearch in Eureka ↗ |
Stipulation of dismissal — official text
The stipulated order resolves all claims without a merits adjudication. The explicit retention of ScinoPharm’s Paragraph IV certification rights and the FDA approval pathway — combined with a symmetric cost split — indicates a negotiated exit rather than capitulation by either party. Novo Nordisk preserves its right to refile; ScinoPharm preserves its path to market. The public record does not disclose whether a licensing arrangement, agreed entry date, or other commercial terms accompanied this stipulation.
US8,114,833 & US9,265,893 — Liraglutide Formulation Patents
US8,114,833B2 (application No. 11/435,977) and US9,265,893B2 (application No. 12/525,976) are Novo Nordisk patents covering formulation aspects of liraglutide — a GLP-1 receptor agonist used in the treatment of type 2 diabetes and obesity. Liraglutide is the active ingredient in Novo Nordisk’s Victoza and Saxenda products. These patents are listed in the FDA’s Orange Book against Novo Nordisk’s liraglutide NDA(s), making them the statutory basis for triggering 30-month stay provisions when a generic filer submits a Paragraph IV certification.
For generic manufacturers and competing pharmaceutical companies, these two patents represent core IP barriers to liraglutide market entry. With GLP-1 receptor agonists commanding significant commercial value, Novo Nordisk’s formulation patent estate is a high-stakes enforcement target. Any company filing or planning to file an ANDA for liraglutide injection must assess the scope of these patents and any related continuations or divisionals that may extend exclusivity beyond the expiration of the base patents.
Should your pipeline include an FTO analysis against US8,114,833 and US9,265,893?
Any pharmaceutical company developing or supplying a generic liraglutide solution injection — or any GLP-1 formulation that could be considered substantially equivalent — should treat US8,114,833 and US9,265,893 as mandatory FTO checkpoints. This case demonstrates that Novo Nordisk actively monitors ANDA filings and is willing to assert these patents within the Hatch-Waxman framework. API suppliers, CDMO partners, and finished-dose manufacturers in the GLP-1 space are all potentially in scope.
PatSnap Eureka’s FTO Search Agent allows R&D and regulatory teams to map claim scope across the liraglutide formulation patent family, identify related continuations and divisionals, and track expiration timelines in a single workflow. Claim-level monitoring can alert your team to any new patent grants or Orange Book listings that could affect your ANDA strategy before a 30-month stay is triggered.
Run a freedom-to-operate analysis on US9265893B2 to assess your product’s exposure
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What this case signals for the GLP-1 and liraglutide IP landscape
A 127-day Hatch-Waxman resolution involving two liraglutide formulation patents warrants close attention from any company tracking GLP-1 generic entry.
Fast Hatch-Waxman resolutions often signal undisclosed licensing terms
When ANDA litigation closes in under five months without a merits ruling, the most probable explanation is a negotiated commercial resolution — potentially an authorised generic deal or agreed market-entry date. Companies monitoring GLP-1 generic competition should watch for ScinoPharm’s ANDA final approval status as a downstream signal of any agreed entry timeline.
Paragraph IV preservation is a meaningful concession by the patent holder
Novo Nordisk’s agreement not to block ScinoPharm’s Paragraph IV certification or FDA approval pathway is a substantive concession. It suggests Novo Nordisk’s primary objective may not have been to permanently exclude ScinoPharm, but to manage entry timing or secure other commercial terms. This pattern is worth tracking across the broader liraglutide ANDA landscape.
Novo v Scinopharm — key questions answered
Novo Nordisk asserted US Patent Nos. 8,114,833 and 9,265,893 — both covering liraglutide formulation technology. The suit was triggered by ScinoPharm’s filing of ANDA No. 217612 seeking approval for generic liraglutide solution injection 18 mg/3 ml before the expiration of these patents.
The parties filed a joint stipulation stating they had ‘resolved the Action,’ leading to dismissal without prejudice. The specific commercial terms of the resolution are not public. Dismissal without prejudice means no merits ruling was made, and Novo Nordisk retains the right to refile the same claims if warranted.
Yes. The dismissal stipulation explicitly states that nothing therein prohibits ScinoPharm from maintaining its Paragraph IV certification in ANDA No. 217612, and the FDA is not prevented from granting final approval of the ANDA. ScinoPharm’s path to market remains open subject to FDA review and any applicable patent exclusivity periods.
The case lasted 127 days — filed October 5, 2023 and closed February 9, 2024. This is notably faster than the typical Hatch-Waxman litigation timeline, which often extends two to four years. The rapid resolution is consistent with a negotiated settlement reached before substantive litigation milestones.
A Paragraph IV certification is a statement by an ANDA filer that the listed patents are invalid, unenforceable, or will not be infringed by the generic product. Filing such a certification is treated as an act of infringement under Hatch-Waxman, allowing the patent holder — here, Novo Nordisk — to sue and trigger a 30-month FDA approval stay. ScinoPharm filed a Paragraph IV to US8,114,833 and US9,265,893, prompting this lawsuit.
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