Pharmacosmos v. Daiichi Sankyo: Injectafer® Patent Infringement Action Transferred to Newark
Pharmacosmos Holding A/S, a Danish pharmaceutical company holding multiple patents on ferric carboxymaltose formulations, brought an infringement action against Daiichi Sankyo over the Injectafer® intravenous iron product. Filed in New Jersey and asserting four US patents, the case was administratively transferred to the Newark division within 87 days.
Four-Patent Injectafer® Suit Redirected to Newark Before Substantive Hearings
On September 22, 2025, Pharmacosmos Holding A/S — a Danish specialty pharma company with a substantial intravenous iron patent portfolio — filed an infringement action against Daiichi Sankyo in the District of New Jersey. The complaint asserted four US patents: US11806329B2, US12295934B2, US11020369B2, and US12303486B2, all directed to ferric carboxymaltose formulations and methods of use underlying the Injectafer® product. Daiichi Sankyo is the US commercial partner for Injectafer®, a product used for iron deficiency in adults who cannot tolerate or have not responded to oral iron.
The case did not proceed to substantive merits. On December 18, 2025 — 87 days after filing — the court transferred the matter to the Newark division of the same district, assigning it a new case number, 2:25-cv-15857. A case transfer within a district is an administrative procedural step; it does not dismiss or resolve any claims, and the infringement allegations and all four patents remain live in the new proceeding. Both parties’ legal teams, including Gibson, Dunn & Crutcher and McCarter & English for the defendant, remain engaged.
The brevity of the initial docket period suggests the transfer was likely initiated early in the case’s lifecycle, possibly due to divisional assignment rules or the location of the parties or evidence. No merits briefing, claim construction schedule, or substantive rulings appear to have been issued before transfer. The commercial stakes are significant: Injectafer® is a high-value IV iron product, and four concurrent patent assertions signal Pharmacosmos is pursuing a broad enforcement strategy around its ferric carboxymaltose IP. The outcome of the substantive litigation now depends on proceedings under case 2:25-cv-15857.
Filing to Case Transferred in 87 days
87 days from filing to transfer — a rapid procedural resolution before substantive litigation began
Case transferred to Newark: what this procedural move means for both parties
Intra-district transfer moves the case, not the claims
A transfer to a different division within the same district court — here from the original assignment to the Newark division — is an administrative procedural step. It does not resolve, dismiss, or narrow any of the four asserted patents. The case continues under new case number 2:25-cv-15857 with the same parties, claims, and counsel. No merits determination has been made.
Procedural — no merits rulingPharmacosmos: all four patents remain fully in play
For Pharmacosmos, the transfer is neutral. All four asserted patents — covering ferric carboxymaltose formulations and methods — survive intact and the infringement claims proceed before a Newark judge. The plaintiff’s enforcement strategy is uninterrupted; if anything, an early transfer before costly discovery may allow for a cleaner scheduling order in the new division.
Patent holder: position unchangedDaiichi Sankyo faces full litigation in Newark division
Daiichi Sankyo has not secured any dismissal or limitation of the asserted claims. The defendant must now respond to all four patents in the Newark proceeding. With Gibson, Dunn & Crutcher leading the defence, a vigorous challenge to validity and non-infringement is expected. However, no substantive defence victories have been recorded at this stage.
Defendant: no claims eliminatedHigh-value IV iron market faces prolonged patent uncertainty
Injectafer® is a commercially significant intravenous iron product, and a four-patent assertion by the originating IP holder signals a broad enforcement perimeter. Companies active in IV iron therapy, ferric carboxymaltose formulation, or adjacent iron deficiency treatments should monitor case 2:25-cv-15857 closely. The outcome could affect market access and licensing norms across the sector.
IV iron sector: watch Newark docketFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | PHARMACOSMOS HOLDING A/S | Individual | Danish specialty pharma company — holder of US11806329B2 and related ferric carboxymaltose patentsSearch in Eureka ↗ |
| Defendant | Daiichi Sankyo | Individual | Daiichi Sankyo — US commercial partner for Injectafer® intravenous iron therapySearch in Eureka ↗ |
| Plaintiff counsel | JEANELLY NUNEZ | Attorney | Counsel for PHARMACOSMOS HOLDING A/SSearch in Eureka ↗ |
| Plaintiff counsel | JEFFREY OELKE | Attorney | Counsel for PHARMACOSMOS HOLDING A/SSearch in Eureka ↗ |
| Plaintiff counsel | JENNY CHUNG | Attorney | Counsel for PHARMACOSMOS HOLDING A/SSearch in Eureka ↗ |
| Plaintiff counsel | VANESSA PARK-THOMPSON | Attorney | Counsel for PHARMACOSMOS HOLDING A/SSearch in Eureka ↗ |
| Plaintiff law firm | CHIESA SHAHINIAN & GIANTOMASI PC | Law Firm | Representing PHARMACOSMOS HOLDING A/SSearch in Eureka ↗ |
| Defendant counsel | BRENDAN ASHE | Attorney | Counsel for Daiichi SankyoSearch in Eureka ↗ |
| Defendant counsel | Cynthia Stencel Betz | Attorney | Counsel for Daiichi SankyoSearch in Eureka ↗ |
| Defendant counsel | JANE M. LOVE | Attorney | Counsel for Daiichi SankyoSearch in Eureka ↗ |
| Defendant counsel | Mark M. Makhail | Attorney | Counsel for Daiichi SankyoSearch in Eureka ↗ |
| Defendant counsel | MICHAEL FREDERICK WERNO | Attorney | Counsel for Daiichi SankyoSearch in Eureka ↗ |
| Defendant counsel | MICHELLE J. ZHU | Attorney | Counsel for Daiichi SankyoSearch in Eureka ↗ |
| Defendant counsel | ROBERT W. TRENCHARD | Attorney | Counsel for Daiichi SankyoSearch in Eureka ↗ |
| Defendant law firm | Gibson, Dunn & Crutcher, LLP | Law Firm | Representing Daiichi SankyoSearch in Eureka ↗ |
| Defendant law firm | McCarter & English, LLP | Law Firm | Representing Daiichi SankyoSearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The transfer order records that the case was moved to the Newark division and assigned new case number 2:25-cv-15857. This is a purely procedural disposition: no infringement finding, validity ruling, or damages determination has been made. The phrasing ‘Case transferred’ confirms all claims survive and the litigation continues. For both parties, the substantive contest — including claim construction, infringement, and validity of all four ferric carboxymaltose patents — begins fresh in Newark.
US11806329B2 — Ferric Carboxymaltose IV Iron Deficiency Treatment
The four asserted patents — US11806329B2, US12295934B2, US11020369B2, and US12303486B2 — cover ferric carboxymaltose (FCM) formulations and related methods of use underlying the Injectafer® intravenous iron product. FCM is a complex iron carbohydrate used to treat iron deficiency in adults. The application dates span multiple years (application numbers US16/822911 through US18/502240), suggesting a continuation or family strategy by Pharmacosmos designed to extend patent protection across successive claim generations covering both the composition and therapeutic methods.
The breadth of Pharmacosmos’s FCM patent portfolio is strategically significant. By asserting patents from different application generations and covering both formulation and method claims, the plaintiff is attempting to create an enforcement perimeter that is difficult to design around or challenge in a single IPR proceeding. For competitors, biosimilar developers, or licensing candidates in the IV iron space, this portfolio represents a high-priority FTO target. Any company developing FCM-based iron therapies — or closely adjacent IV iron compositions — should assess exposure against all four asserted patents before regulatory filing.
Should you run an FTO against the Pharmacosmos ferric carboxymaltose patents?
If your organisation is developing, manufacturing, or commercialising an intravenous iron product — particularly one based on ferric carboxymaltose or structurally adjacent iron carbohydrate complexes — you face direct FTO risk from this patent family. Pharmacosmos has demonstrated willingness to enforce broadly, asserting four patents simultaneously against a major commercial partner. R&D teams and regulatory affairs professionals in the IV iron space should prioritise analysis of US11806329B2, US12295934B2, US11020369B2, and US12303486B2 before IND filing, NDA submission, or licensing discussions.
PatSnap Eureka’s FTO Search Agent can map your product’s technical features against the claim scope of all four asserted patents, identify prosecution history estoppel, and surface related applications still pending in the Pharmacosmos family. Eureka’s citation and family analysis tools enable your IP team to quickly assess whether continuation applications could extend risk beyond the currently asserted grants, and to benchmark claim scope against prior art already cited in prosecution. Start your IV iron FTO analysis directly in Eureka.
Run a freedom-to-operate analysis on US11806329B2 to assess your product’s exposure
Run FTO in Eureka →Similar IV Iron and Specialty Pharma Patent Cases in New Jersey District Court
Explore comparable infringement actions involving intravenous iron, ferric carboxymaltose, and specialty pharma formulation patents litigated in the District of New Jersey.
What this case signals for the IV iron and specialty pharma IP landscape
A four-patent assertion over a high-value branded IV iron product is a clear enforcement signal from a major specialty pharma IP holder.
Multi-patent assertion creates layered invalidity risk for defendants
Asserting four patents simultaneously — spanning multiple application dates and claim scopes — makes it harder for a defendant to invalidate the entire enforcement position in a single IPR or district court motion. Daiichi Sankyo will likely need to mount parallel validity challenges across all four patents, increasing litigation cost and complexity.
Transfer within New Jersey signals early case management, not weakness
Intra-district transfers in New Jersey are often driven by judge assignment protocols or local rules rather than party motions. The speed of transfer — 87 days, before any substantive briefing — suggests routine case management. Neither party should read strategic significance into the venue shift; the substantive fight begins in Newark.
A/S v Daiichi — key questions answered
Pharmacosmos Holding A/S filed a patent infringement action against Daiichi Sankyo in the District of New Jersey on September 22, 2025, asserting four patents over the Injectafer® intravenous iron product. The case was transferred to the Newark division on December 18, 2025, receiving new case number 2:25-cv-15857. No merits ruling was issued.
Pharmacosmos asserted US11806329B2, US12295934B2, US11020369B2, and US12303486B2. All four patents relate to ferric carboxymaltose (FCM) formulations and methods of use underlying the Injectafer® intravenous iron deficiency therapy. The patents derive from application numbers spanning US16/822911 through US18/502240, suggesting a continuation family strategy.
The transfer is an administrative procedural step within the District of New Jersey. It does not dismiss any claims or resolve any patent dispute. The infringement allegations across all four patents survive and proceed under the new case number 2:25-cv-15857. All counsel remain engaged and substantive litigation — including claim construction and validity proceedings — begins in Newark.
Injectafer® (ferric carboxymaltose) is an intravenous iron replacement product approved for treating iron deficiency in adults who cannot tolerate or have not adequately responded to oral iron. It is a commercially significant product in the specialty pharma space. Pharmacosmos, as the originating IP holder, is asserting its patent portfolio against Daiichi Sankyo, the US commercial partner for the product.
Pharmacosmos is represented by Chiesa Shahinian & Giantomasi PC, with counsel including Jeffrey Oelke and Vanessa Park-Thompson. Daiichi Sankyo is represented by Gibson, Dunn & Crutcher LLP and McCarter & English LLP, with counsel including Robert W. Trenchard, Jane M. Love, and Mark M. Makhail, among others. The depth of defendant’s counsel suggests preparation for substantive, high-stakes proceedings.
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