GE Healthcare v. Jubilant Draximage: Consent Judgment & Injunction in Tc99m ANDA Dispute
GE Healthcare Limited and Medi-Physics Inc. brought an ANDA infringement action against Jubilant Draximage over US9,549,999, protecting the MYOVIEW 30mL technetium Tc99m tetrofosmin injection kit. The parties resolved the case in 261 days via a consent judgment that permanently enjoins Jubilant from commercialising its ANDA product without authorisation.
Hatch-Waxman Consent Judgment Blocks Generic Tc99m Tetrofosmin Entry
GE Healthcare Limited and its affiliate Medi-Physics Inc. (collectively GE Healthcare) filed this Hatch-Waxman paragraph IV infringement action on 28 May 2024 in the District of New Jersey against Jubilant Draximage Inc., doing business as Jubilant Radiopharma. The asserted patent, US9,549,999, covers the MYOVIEW 30mL product — a kit for preparing technetium Tc99m tetrofosmin for injection, a radiopharmaceutical used in myocardial perfusion imaging. Jubilant had filed ANDA No. 217224 seeking FDA approval to market a generic equivalent, triggering GE Healthcare’s statutory right to sue.
The case closed on 13 February 2025 via a stipulated consent judgment — a negotiated resolution in which Jubilant consented to entry of judgment and a permanent injunction. The injunction bars Jubilant and its affiliates, successors, and assigns from making, using, selling, offering to sell, importing, or distributing the ANDA product without authorisation. All claims were dismissed with prejudice, meaning Jubilant cannot re-litigate the same infringement dispute. No costs or attorneys’ fees were awarded to either side.
At 261 days, the resolution is notably swift for Hatch-Waxman litigation, suggesting the parties reached commercial alignment well before any substantive merits rulings. The consent judgment preserves Jubilant’s ability to maintain its Paragraph IV certification and pursue FDA approval — a carve-out that is commercially significant and typically signals a licensing framework or agreed entry date exists in a confidential side agreement, though the public record does not confirm this.
Filing to Consent Judgment in 261 days
261 days — faster than the median Hatch-Waxman ANDA district court case
Consent judgment entered: what the injunction and dismissal mean for both parties
Consent judgment: a negotiated court order with binding force
A consent judgment is a court-ordered resolution agreed to by both parties — it carries the full force of a judicial ruling without a merits trial. Here, Jubilant stipulated to entry of judgment and a permanent injunction, effectively conceding the enforceability of US9,549,999 for the purpose of this ANDA product. The District Court retains jurisdiction to enforce compliance, giving GE Healthcare a direct contempt mechanism if Jubilant launches at risk.
Dismissed with prejudiceGE Healthcare secures injunction without full trial
GE Healthcare obtained its primary commercial objective — a permanent injunction blocking Jubilant’s ANDA product — in under nine months and without costs. The with-prejudice dismissal prevents Jubilant from reviving the same infringement claims. US9,549,999 exits the litigation untested on the merits, which preserves its enforceability against other potential ANDA filers in the Tc99m tetrofosmin space.
Patent enforceability preservedJubilant retains Paragraph IV rights and FDA approval pathway
Despite consenting to the injunction, Jubilant secured an explicit carve-out: it may continue to maintain its Paragraph IV certification and pursue final FDA approval of ANDA No. 217224. This is a meaningful preservation of future commercial optionality — consistent with a negotiated licensed entry date or royalty framework in a confidential agreement. The no-costs provision also limited Jubilant’s immediate financial exposure.
FDA approval pathway retainedTc99m tetrofosmin generic market entry deferred, not necessarily barred
The consent judgment delays but may not permanently foreclose generic competition in the Tc99m tetrofosmin kit market. The retained Paragraph IV certification and FDA approval pathway suggests Jubilant could enter the market at a future date — potentially under licence. For other radiopharmaceutical companies monitoring this ANDA space, the case signals that US9,549,999 is being actively enforced and that GE Healthcare will litigate to protect the MYOVIEW franchise.
Generic entry deferredFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | GE HEALTHCARE LIMITED | Individual | Radiopharmaceutical innovator — holder of US9549999B2 covering MYOVIEW Tc99m tetrofosmin kitsSearch in Eureka ↗ |
| Co-Plaintiff | MEDI-PHYSICS INC., DBA GE HEALTHCARE | Company | Search in Eureka ↗ |
| Defendant | JUBILANT DRAXIMAGE, Inc. | Company | Jubilant Draximage Inc. (dba Jubilant Radiopharma) — ANDA filer seeking generic Tc99m tetrofosmin approvalSearch in Eureka ↗ |
| Plaintiff counsel | Douglas Robert Weider | Attorney | Counsel for GE HEALTHCARE LIMITEDSearch in Eureka ↗ |
| Plaintiff law firm | Greenberg Traurig LLP | Law Firm | Representing GE HEALTHCARE LIMITEDSearch in Eureka ↗ |
| Defendant counsel | Ian Scott | Attorney | Counsel for JUBILANT DRAXIMAGE, Inc.Search in Eureka ↗ |
| Defendant law firm | Taft, Stettinius & Hollister LLP | Law Firm | Representing JUBILANT DRAXIMAGE, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The consent judgment is precise in its commercial architecture: it imposes a permanent injunction on the specific ANDA product while explicitly preserving Jubilant’s FDA regulatory pathway. The with-prejudice dismissal forecloses re-litigation of these infringement claims, but the Paragraph IV carve-out in paragraph 7 is significant — it suggests the parties contemplated a future commercial relationship. The no-costs provision indicates a balanced negotiation rather than a concession under duress.
US9549999B2 — MYOVIEW 30mL technetium Tc99m tetrofosmin injection kit
US9,549,999 (application number US12/677528) protects the MYOVIEW 30mL product — a kit formulation for preparing technetium Tc99m tetrofosmin, a radiopharmaceutical agent used in single-photon emission computed tomography (SPECT) myocardial perfusion imaging. Tetrofosmin is a diphosphine ligand that coordinates with the Tc99m radioisotope to create a lipophilic cation that localises in myocardial tissue, enabling cardiac stress testing. The patent covers specific formulation and kit preparation parameters critical to the product’s commercial manufacture and regulatory approval.
US9,549,999 is listed in the FDA Orange Book in connection with NDA No. 20372 for MYOVIEW, meaning any ANDA filer must certify against it under the Hatch-Waxman framework. This listing gives GE Healthcare automatic 30-month stay protection upon filing suit — a powerful tool for managing generic entry timing. The patent’s enforceability in this case was never challenged on the merits, meaning it exits the litigation with full presumptive validity intact, creating material risk for any other company developing a competing Tc99m tetrofosmin kit product.
Should you run an FTO against US9549999B2 before developing a Tc99m tetrofosmin kit?
Any company developing, manufacturing, or commercialising a kit for the preparation of technetium Tc99m tetrofosmin for injection — whether for a new ANDA, a 505(b)(2) application, or a research-use product — should conduct a freedom-to-operate analysis against US9,549,999. This case confirms GE Healthcare actively enforces this patent against ANDA filers and obtained a permanent injunction without a merits trial. The patent’s claims were never invalidated or narrowed in this proceeding.
PatSnap Eureka’s FTO Search Agent can map the claim scope of US9,549,999 against your product formulation parameters, identify prior art relevant to any invalidity arguments, and flag related GE Healthcare Orange Book patents that may create additional clearance obligations. R&D and regulatory teams working on radiopharmaceutical kit products should integrate this analysis before ANDA filing to assess litigation exposure and inform Paragraph IV certification strategy.
Run a freedom-to-operate analysis on US9549999B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman radiopharmaceutical patent cases in New Jersey District Court
Explore comparable ANDA infringement actions involving radiopharmaceutical formulation patents litigated in the District of New Jersey, including consent judgment and injunction outcomes.
What this case signals for the radiopharmaceutical IP landscape
GE Healthcare’s swift consent judgment reinforces the potency of Hatch-Waxman enforcement in the radiopharmaceutical sector.
Consent judgments with injunctions are powerful Hatch-Waxman tools
This outcome demonstrates that a consent judgment — rather than a full trial — can fully satisfy the innovator’s enforcement objective. GE Healthcare blocked generic entry, preserved patent validity, and avoided the uncertainty of litigation, all in under nine months. Innovators holding ANDA-exposed patents should consider consent judgment structures as a primary resolution strategy.
Paragraph IV carve-outs signal a likely confidential licence
Jubilant’s retained right to maintain its Paragraph IV certification and pursue FDA approval is not boilerplate — it is commercially purposeful. In Hatch-Waxman practice, this structure typically accompanies a side agreement governing a future licensed entry date or royalty. Competitors and investors should model generic entry scenarios that include a negotiated launch window rather than assuming permanent exclusion.
LIMITED v JUBILANT — key questions answered
The consent judgment permanently enjoins Jubilant Draximage and its affiliates from making, using, selling, offering to sell, importing, or distributing the ANDA No. 217224 product without authorisation. All claims were dismissed with prejudice. Jubilant retained the right to maintain its Paragraph IV certification and pursue FDA final approval of the ANDA.
The patent at issue is US9,549,999 (application no. US12/677528), referred to in the consent judgment as the ‘Licensed Patent.’ It covers the MYOVIEW 30mL product — a kit for the preparation of technetium Tc99m tetrofosmin for injection — and is listed in the FDA Orange Book in connection with NDA No. 20372.
Not necessarily permanently. The consent judgment explicitly permits Jubilant to maintain its Paragraph IV certification and pursue final FDA approval of ANDA No. 217224. This carve-out is consistent with a confidential side agreement governing a future licensed entry date, though no such agreement is confirmed in the public record. The injunction blocks unlicensed commercialisation, not FDA regulatory activity.
Dismissed with prejudice means Jubilant cannot re-file or re-litigate the same infringement claims in this action. It is a final adjudication on those claims. However, it does not prevent Jubilant from challenging US9,549,999 through other mechanisms such as IPR proceedings at the USPTO, provided it meets standing and timing requirements.
The District of New Jersey is the primary venue for Hatch-Waxman ANDA litigation in the United States, partly due to the concentration of pharmaceutical companies in the region and established local precedent. GE Healthcare’s filing there is consistent with standard practice for innovator companies asserting Orange Book-listed patents against ANDA filers.
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