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American Regent v. SterIScience: Selenious Acid Patent Consent Judgment | PatSnap
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Case ID2:24-cv-07809
FiledJul 2024
ClosedSep 2024
Patent Litigation

American Regent v. SterIScience: Consent Judgment in 58 Days Over Selenious Acid Patent

American Regent, Inc. filed suit against SterIScience Pte. Ltd in the District of New Jersey alleging infringement of US11998565, covering selenious acid injectable products, in connection with SterIScience’s ANDA No. 219492. The case resolved in just 58 days via a negotiated consent judgment that permanently enjoins SterIScience from commercialising its generic product in the United States.

Resolution time
58days
58 days — well below the median ANDA patent litigation duration, suggesting early settlement pressure
Patents asserted
1
US11998565 — selenious acid injectable formulation (600 mcg Selenium/10 mL)
Outcome
Consent Judgment
Injunction entered by court order; claims dismissed without prejudice per settlement agreement
Cost ruling
No Costs
Parties stipulated no costs, disbursements or attorneys’ fees awarded to either side
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

ANDA Infringement Action Ends in Swift Injunction for American Regent

American Regent, Inc. (ARI), a pharmaceutical company and holder of US11998565, filed suit on 16 July 2024 in the United States District Court for the District of New Jersey against SterIScience Pte. Ltd, a Singapore-based entity that had filed ANDA No. 219492 seeking approval to market a generic version of ARI’s selenious acid injectable product (600 mcg Selenium/10 mL). The asserted patent covers the selenious acid formulation at the heart of ARI’s branded product line.

The case closed on 12 September 2024 — just 58 days after filing — through a consent judgment entered by the court. Under the judgment, SterIScience and its affiliates, successors and assigns are permanently enjoined from making, using, selling, offering to sell, importing or distributing the ANDA product in the United States. All claims, counterclaims and affirmative defenses were dismissed without prejudice, and no costs or attorneys’ fees were awarded to either party, consistent with a negotiated resolution rather than a contested merits ruling.

The 58-day resolution is notably fast for ANDA patent litigation, which typically extends well beyond a year when contested. The speed suggests the parties reached agreement shortly after service and before substantive motion practice, consistent with SterIScience accepting the injunction in exchange for confidential settlement terms referenced in the consent judgment. The underlying settlement agreement is not public, leaving open questions about whether any licence period, launch date, or royalty arrangement was privately agreed.

Case at a glance
Case no.2:24-cv-07809
CourtNew Jersey
JudgeN/A
FiledJuly 16, 2024
ClosedSeptember 12, 2024
Duration58 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
Prior Art Intelligence
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Case data sourced from PACER / New Jersey District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 58 days

58 days — well below the median ANDA patent litigation duration, suggesting early settlement pressure

Case timeline: Complaint filed JUL 16 2024, AUG–SEP — 58 days total Horizontal timeline showing the three key events in American Regent, Inc. v STERISCIENCE PTE. LTD from filing to resolution. Source: PACER, New Jersey District Court. JUL 16 2024 Complaint filed Pre-trial proceedings SEP 12 2024 Consent Judgment 58 DAYS TOTAL
Dismissal terms

Consent judgment entered: injunction, no costs, claims dismissed without prejudice

Legal mechanism

Consent judgment is a court-enforceable settlement

A consent judgment is a formal court order entered by agreement of the parties. It carries full judicial authority — meaning SterIScience’s compliance can be enforced by the court, not merely pursued through contract claims. Here, the court retained jurisdiction to supervise performance under both the judgment and the underlying settlement agreement, giving ARI a direct enforcement pathway if SterIScience violates the injunction.

Court-ordered settlement
Dismissal nuance

Claims dismissed without prejudice — with an injunction in place

The dismissal is ‘without prejudice,’ meaning claims are not extinguished on the merits and could theoretically be refiled. However, the simultaneous injunction makes this distinction largely academic for the current ANDA product: SterIScience is already barred from commercialising it. Without prejudice language in consent judgments typically preserves ARI’s ability to return to court for enforcement or to address future ANDA amendments or new products not covered by the current order.

Without prejudice + injunction
Defendant outcome

SterIScience enjoined; ANDA product blocked from US market

SterIScience, including all affiliates, successors and assigns, is permanently enjoined from any commercialisation activity relating to ANDA No. 219492 in the United States. The broad scope — covering making, having made, using, selling, offering to sell, importing and distributing — forecloses all near-term routes to market for the generic product. Any confidential licence or entry date agreed in the settlement agreement would be the only pathway to eventual US market access.

US market access blocked
Commercial implications

ARI’s selenious acid exclusivity reinforced through patent lifecycle

The consent judgment effectively extends ARI’s market exclusivity for its selenious acid injectable line for as long as US11998565 remains enforceable. The swift resolution limits litigation costs and sets a precedent signal to other potential ANDA filers in this product space. Companies holding or monitoring competing formulation patents in the parenteral nutrition and trace element sector should note that ARI has demonstrated willingness to litigate rapidly and secure injunctive relief early in the ANDA challenge process.

Exclusivity maintained
Legal analysis based on PACER docket records for case 2:24-cv-07809 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAmerican Regent, Inc.CompanyPharmaceutical company — holder of US11998565 covering selenious acid injectablesSearch in Eureka ↗
DefendantSTERISCIENCE PTE. LTDCompanySingapore-based generic pharmaceutical company; ANDA filer for selenious acid injectionSearch in Eureka ↗
Plaintiff counselCharles H. ChevalierAttorneyCounsel for American Regent, Inc.Search in Eureka ↗
Plaintiff counselChristine A. GaddisAttorneyCounsel for American Regent, Inc.Search in Eureka ↗
Plaintiff counselDennies VarugheseAttorneyCounsel for American Regent, Inc.Search in Eureka ↗
Plaintiff law firmGibbons PCLaw FirmRepresenting American Regent, Inc.Search in Eureka ↗
Plaintiff law firmSterne Kessler Goldstein & FoxLaw FirmRepresenting American Regent, Inc.Search in Eureka ↗
Defendant counselMelissa Ellen FlaxAttorneyCounsel for STERISCIENCE PTE. LTDSearch in Eureka ↗
Defendant law firmCarella Byrne Cecchi Olstein Brody & Agnello, PCLaw FirmRepresenting STERISCIENCE PTE. LTDSearch in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“American Regent, Inc. ("ARI") and Steriscience Pte. Ltd ("Steriscience"), parties in the above-captioned action, have resolved this litigation for good cause and valuable consideration recognized by ARI and Steriscience. Now the parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and an injunction in the action, as follows: IT IS this 12th day of SEPTEMBER 2024;ORDERED, ADJUDGED AND DECREED as follows: This District Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties. As used in this Consent Judgment, (i) the term "Steriscience Product" shall mean the drug product manufactured, sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 219492 (including any supplements, or modification or amendments thereto or replacements thereof) ("Steriscience’s ANDA"); (ii) the term "Licensed ARI Patent" shall mean United States Patent No. 11,998,565 ("the ‘565 patent"); and (iii) the term "Affiliate" shall mean any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with Steriscience; for purposes of this definition, "control" means: (a) ownership, directly or through one or more intermediaries, of: (1) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (2) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership; or (b) any other arrangement whereby an entity or person has the right to elect a majority of the Board of Directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity. 3. Agreement or by 35 U.S.C. § 271(e)(1), Steriscience, including any of its Affiliates, successors and assigns, is enjoined from infringing the Licensed ARI Patent, on its own part or through any Affiliate, by making, having made, using, selling, offering to sell, importing or distributing of the Steriscience Product in the United States. Compliance with this Consent Judgment may be enforced by ARI, its successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment and the Settlement Agreement. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed without prejudice and without costs, disbursements or attorneys’ fees to any party.”
Source: PACER Docket, Case 2:24-cv-07809, New Jersey District Court

The consent judgment’s language is notably comprehensive: it defines ‘Steriscience Product’ by reference to the specific ANDA number (including future supplements, modifications and amendments), ensuring the injunction cannot be circumvented through minor product reformulations filed under the same ANDA. The phrase ‘good cause and valuable consideration’ signals a negotiated quid pro quo, though the consideration provided to SterIScience remains confidential. ARI’s enforcement and assignment rights are expressly preserved, suggesting the patent may be monetised or licensed to third parties in future.

PACER case 2:24-cv-07809 · Public docket record Explore in Eureka ↗
Patent at issue

US11998565 — Selenious Acid Injectable Formulation

Publication No.US11998565B2
Application No.US18/124391
Patent details
ProductSelenious acid injectable formulation for parenteral selenium supplementation
Cited in actionJuly 16, 2024

US11998565 (application no. US18/124391) covers ARI’s selenious acid injectable product — a parenteral formulation delivering 60 mcg selenium per mL (600 mcg/10 mL vial). Selenium is an essential trace element administered intravenously to patients who cannot receive adequate nutrition orally, making this formulation clinically significant in critical care and long-term parenteral nutrition settings. The patent’s relatively recent grant date places it well within its enforcement lifecycle, giving ARI a substantial remaining exclusivity runway.

For generic pharmaceutical companies, US11998565 represents a direct barrier to ANDA-based entry into the selenious acid injectable market. The swift enforcement action and resulting injunction demonstrate ARI’s intent to defend this asset aggressively. Companies active in the parenteral nutrition, trace element, or IV micronutrient space — particularly those with pending ANDAs or 505(b)(2) applications — should assess whether their formulations fall within the claims of this patent before committing to regulatory timelines or manufacturing investment.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should your ANDA team run an FTO against US11998565?

Any pharmaceutical company developing, manufacturing or planning to commercialise a selenious acid injectable product in the United States should treat US11998565 as a priority FTO target. The SterIScience case demonstrates that ARI will litigate immediately upon ANDA notification and seek injunctive relief. Given the patent’s application number (US18/124391), R&D and regulatory teams should also examine the prosecution history and any continuation or divisional applications that may broaden the claim landscape.

PatSnap Eureka’s FTO Search Agent can map the full claim scope of US11998565 against your product specifications, identify prior art that may support invalidity arguments, and surface any related ARI family patents that could create additional infringement exposure. Eureka also monitors new ANDA filings and litigation activity in the parenteral nutrition space, enabling your IP team to stay ahead of enforcement risk before regulatory investment is locked in.

PatSnap Eureka FTO Search

Run a freedom-to-operate analysis on US11998565B2 to assess your product’s exposure

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Related litigation

Similar ANDA Patent Cases: Selenious Acid and Parenteral Nutrition Formulations

Related ANDA infringement actions involving parenteral nutrition formulation patents litigated in the District of New Jersey and comparable Hatch-Waxman venues.

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American Regent, Inc. patent enforcement history, New Jersey case history, American Regent, Inc.’s full IP portfolio, and comparable case analysis
Other ARI enforcement actionsSelenious acid ANDA disputesNJ District consent judgmentsParenteral nutrition patent cases
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Strategic implications

What this case signals for the parenteral nutrition IP landscape

ARI’s rapid enforcement of US11998565 via consent judgment sends a clear signal to generic filers in the selenious acid injectable space.

ANDA filers should treat this patent as an active enforcement risk

ARI filed suit within the standard 45-day Hatch-Waxman window and secured an injunction in under two months. Any company with a pending or planned ANDA referencing selenious acid products should conduct a thorough FTO analysis against US11998565 before investing further in development or regulatory preparation.

Consent judgments with retained jurisdiction amplify post-settlement risk

The court’s retained jurisdiction to enforce the settlement agreement means SterIScience faces contempt exposure — not merely breach of contract liability — for any future violation. Companies negotiating consent judgments in ANDA cases should scrutinise scope language covering affiliates, successors and ANDA amendments before execution.

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Frequently asked questions

American v STERISCIENCE — key questions answered

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PatSnap Eureka tracks US11998565 and related ARI family patents in real time. Run an FTO analysis against your injectable selenium formulation and receive enforcement alerts before your ANDA investment is committed.

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