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Bayer & Janssen v. Auson Pharmaceuticals — Rivaroxaban Patent Transfer | PatSnap
Patent Litigation

Bayer & Janssen v. Auson Pharmaceuticals: Rivaroxaban Patent Action Transferred to Delaware MDL

Bayer AG, Bayer Pharma AG, and Janssen Pharmaceuticals sued Auson Pharmaceuticals over alleged infringement of two patents covering rivaroxaban (Xarelto) tablets. The New Jersey District Court transferred the case after just 126 days to MDL No. 3017 in Delaware, consolidating it with parallel Xarelto patent litigation.

Resolution time
126days
126 days from filing to transfer — resolved at jurisdictional stage before fact discovery closed
Patents asserted
2
US9539218B2 and US10828310B2 — rivaroxaban (Xarelto) thromboembolic and cardiovascular patents
Outcome
Case Transferred
Transferred to MDL No. 3017, District of Delaware, Judge Richard G. Andrews, for consolidated pretrial proceedings
Cost ruling
Not recorded
No cost or fee ruling recorded in the available case record at the time of transfer
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Xarelto Generic Challenge Consolidated into Delaware MDL

On June 1, 2023, Bayer AG, Bayer Pharma AG, and Janssen Pharmaceuticals, Inc. filed suit in the U.S. District Court for the District of New Jersey against Auson Pharmaceuticals, Inc. and Auson Pharmaceuticals Co., Ltd. (Shanghai), alleging infringement of U.S. Patent Nos. US9539218B2 and US10828310B2 in connection with Auson's New Drug Application to manufacture and sell 2.5 mg rivaroxaban tablets — the generic equivalent of Xarelto.

The recorded basis of termination is Case Transferred. The Panel order states that the action was transferred under 28 U.S.C. § 1407 to the District of Delaware and assigned to Judge Richard G. Andrews for inclusion in the coordinated or consolidated pretrial proceedings of MDL No. 3017 (In re Xarelto (Rivaroxaban) ('310) Patent Litigation). The transfer was ordered over Auson's opposition, with the Panel finding common factual questions with the MDL actions, principally concerning alleged infringement of the '310 patent (US10828310B2).

The transfer occurred at a distinctive juncture: the PTAB had issued a July 2023 inter partes review ruling invalidating all claims of the '310 patent, yet plaintiffs had appealed to the Federal Circuit and continued to assert validity in the MDL. The pretrial schedule in the MDL had been stayed pending that Federal Circuit appeal, meaning the substantive merits — including Auson's anticipated motion to dismiss based on carve-out arguments — remain to be resolved by the transferee court. The specific litigation terms and any subsequent resolution are not disclosed in the available record.

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Case at a glance
PlaintiffBayer AG
CourtNew Jersey District Court
JudgeN/A
FiledJune 1, 2023
ClosedOctober 5, 2023
Duration126 days
OutcomeCase Transferred
Verdict causeInfringement Action
BasisCase Transferred
Prior Art Intelligence
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Case timeline

Filing to Case Transferred in 126 days

126 days from filing to transfer — resolved at jurisdictional stage before fact discovery closed

Case timeline: Complaint filed JUN 1 2023 — 126 days total Horizontal timeline showing the three key events in Bayer AG v Auson Pharmaceuticals, Inc. from filing to resolution. Source: PACER, New Jersey District Court. JUN 1 2023 Complaint filed Pre-trial proceedings OCT 5 2023 Case Transferred 126 DAYS TOTAL
Patent at issue

US9539218B2 & US10828310B2 — Rivaroxaban (Xarelto) Treatment Patents

Publication No.US9539218B2
Application No.US11/883218
Patent details
Productprevention and treatment of thromboembolic disorders — rivaroxaban formulation
Cited in actionJune 1, 2023

Publication No.US10828310B2
Application No.US16/264032
Patent details
Productreducing the risk of cardiovascular events — 2.5 mg rivaroxaban tablets (Xarelto)
Cited in actionJune 1, 2023
Technical brief · sourced from PatSnap patent database
Representative claim (1 of 1 independent)
1. A method of treating a thromboembolic disorder comprising administering a direct factor Xa inhibitor that is 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide no more than once daily for at least five consecutive days in a rapid-release tablet to a patient in need thereof, wherein the thromboembolic disorder is selected from the group consisting of pulmonary embolisms, deep vein thromboses, and stroke.
Technical background
The present invention relates to the field of blood coagulation, more specifically it relates to a method of treating a thromboembolic disorder by administering a direct factor Xa inhibitor once daily in oral dosage form to a patient in need thereof, wherein the factor Xa inhibitor has a plasma concentration half life indicative of a bid or tid administration interval, e.g. of 10 hours or less. Blood coagulation is a protective mechanism of the organism which helps to “seal” defects in the wall of the blood vessels…
Patent family
51 family members across 36 jurisdictions (SG, AR, EP, NO, HR, TR, AT, DK, PL, CY, NZ, CA)
PatSnap Eureka · FTO Search Agent
Should you run an FTO against US10828310B2 and US9539218B2?

Any pharmaceutical company developing, filing an NDA for, or commercialising a 2.5 mg rivaroxaban tablet — or adjacent oral anticoagulant formulations targeting thromboembolic or cardiovascular indications — should conduct a freedom-to-operate analysis against both patents. The PTAB invalidity ruling on US10828310B2 is under Federal Circuit appeal, meaning the patent's enforceability remains uncertain and litigation risk persists. US9539218B2 adds a further layer of independent exposure not shared by other MDL defendants.

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Official verdict

Official order — verbatim text

Before the Panel: Defendants Auson Pharmaceuticals Inc. and Shanghai Auson Pharmaceuticals Co., Ltd. (together, “Auson”) move under Panel Rule 7.1 to vacate the Panel order conditionally transferring the action listed on Schedule A (Auson) to MDL No. 3017. Plaintiffs Bayer Pharma AG, Bayer AG, Bayer Intellectual Property GmbH, and Janssen Pharmaceuticals, Inc., oppose the motion and support transfer. After considering the argument of counsel, we find that this action involves common questions of fact with the actions transferred to MDL No. 3017, and that transfer under 28 U.S.C. § 1407 will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The actions in MDL No. 3017 involve common factual questions concerning alleged infringement of U.S. Patent No. 10,828,310, entitled “Reducing the Risk of Cardiovascular Events” (the ’310 patent), as a result of various pharmaceutical company applications to the FDA to manufacture and sell a drug product that allegedly is a generic version of Xarelto – specifically, 2.5 mg rivaroxaban tablets. See In re Xarelto (Rivaroxaban) ('310) Patent Litig., 577 F. Supp. 3d 1377, 1378 (J.P.M.L. 2021). Like the actions in the MDL, the Auson action involves alleged infringement of the ’310 patent in connection with a company’s application to manufacture and sell 2.5 mg rivaroxaban tablets and thus is appropriate for transfer. In opposition to transfer, defendants principally argue that (1) Auson lacks common factual questions because plaintiffs’ claims concerning the ’310 patent, in their view, likely will be dismissed; (2) there is an additional patent at issue in Auson that is not shared with the other MDL actions; and (3) transfer would not be efficient considering the advanced posture of the MDL and the recent inter partes review by the Patent Trial and Appeal Board (“PTAB”), which held all claims in the ’310 patent invalid. These arguments are unpersuasive. First, we observe that the Auson complaint on its face asserts that Auson’s New Drug Application infringes the ’310 patent. Auson’s assertion of no shared factual issues is premised on the success of its anticipated motion to dismiss, which Auson states will argue that all patented uses of the ’310 patent were specifically carved out of its NDA, and hence there can be no infringement. But the Panel has long held that “Section 1407 [does] not contemplate that the Panel would decide the merits of the actions before it,” in deciding the question of transfer. See In re Maxim Integrated Prods., Inc., Patent Litig., 867 F. Supp. 2d 1333, 1335 (J.P.M.L. 2012). Additionally, the Panel routinely transfers actions with anticipated or pending motions to dismiss, 10/04/2023 s/ smg Case 2:23-cv-03020-EP-LDW Document 17 Filed 10/05/23 Page 1 of 3 PageID: 256 -2- as such motions can be resolved by the transferee court. See, e.g., In re Blackbaud, Inc., Customer Data Sec. Breach Litig., MDL No. 2972, Transfer Order, at 2 (J.P.M.L. Mar. 30, 2021) (“[Defendant’s] pending motion to dismiss does not weigh against transfer. The Panel routinely transfers actions with pending motions to dismiss, as those motions can be decided by the transferee court.”). Second, the involvement of an additional non-overlapping patent is no obstacle to transfer. The shared factual questions presented by a single overlapping patent may warrant transfer even where additional case-specific patents are asserted. See, e.g., In re Proven Networks, LLC, Patent Litig., 492 F. Supp. 3d 1338, 1339 (J.P.M.L. 2020) (“although different combinations of patents are asserted in the actions, there is substantial overlap in the asserted patents”). Additionally, the record indicates that transfer will promote the just and efficient conduct of the litigation. Fact discovery in the MDL is still open, and expert discovery has not begun. And the July 2023 PTAB order on the ’310 patent did not end the MDL, as Auson suggests. Plaintiffs have appealed the decision to the Federal Circuit, and they also have continued to assert the validity of the ’310 patent in the actions in the MDL. Thus, the transferee judge likely will be called upon to decide the course of pretrial proceedings in the constituent actions while that appeal is pending. Auson’s assertion that transfer will require it to prepare for trial in the MDL in just a few months is not supported by the record. As a threshold matter, transfer under Section 1407 is only for pretrial proceedings; thus, Auson will not face trial in the MDL absent its consent to trial in the transferee district. In any event, discovery remains open, as discussed above, and the pretrial schedule in the MDL has been stayed pending resolution of the Federal Circuit appeal.1 IT IS THEREFORE ORDERED that the action listed on Schedule A is transferred to the District of Delaware and, with the consent of that court, assigned to the Honorable Richard G. Andrews for inclusion in the coordinated or consolidated pretrial proceedings.
Source: PACER Docket, Case 2:23-cv-03020, New Jersey District Court

The Panel order transfers the action to MDL No. 3017 on the basis of common factual questions concerning the '310 patent (US10828310B2) and efficiency under 28 U.S.C. § 1407. The order expressly declines to adjudicate Auson's anticipated motion to dismiss or the merits of its carve-out argument, leaving those issues for the transferee court, Judge Richard G. Andrews in the District of Delaware.

PACER case 2:23-cv-03020 · Public docket record Explore in Eureka ↗

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Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffBayer AGCompany/Search in Eureka ↗
Co-PlaintiffJanssen Pharmaceuticals, Inc.CompanySearch in Eureka ↗
Co-PlaintiffBayer Pharma AGCompanySearch in Eureka ↗
Co-PlaintiffBayer AGCompanySearch in Eureka ↗
DefendantAuson Pharmaceuticals, Inc.Company/Search in Eureka ↗
Co-DefendantAuson Pharmaceuticals Co., Ltd.CompanySearch in Eureka ↗
Plaintiff counselKeith J. MillerAttorneyCounsel for Bayer AGSearch in Eureka ↗
Plaintiff law firmRobinson Miller LLCLaw FirmRepresenting Bayer AGSearch in Eureka ↗
Defendant counselGerard P. NortonAttorneyCounsel for Auson Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselJonathan R. LagarenneAttorneyCounsel for Auson Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselPaul W. KalishAttorneyCounsel for Auson Pharmaceuticals, Inc.Search in Eureka ↗
Defendant law firmFox Rothschild LLPLaw FirmRepresenting Auson Pharmaceuticals, Inc.Search in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
R&D signals

R&D signals in the rivaroxaban and oral anticoagulant patent space

Patent and innovation intelligence derived from Bayer, Janssen, and Auson's positions in the rivaroxaban and cardiovascular pharmaceutical landscape.

Patent portfolio

Bayer & Janssen's Xarelto IP enforcement depth

Bayer and Janssen's joint assertion of two patents with different application lineages — one thromboembolic, one cardiovascular risk reduction — suggests a layered portfolio strategy around rivaroxaban. Monitoring Bayer Pharma AG and Bayer Intellectual Property GmbH's continuation and divisional filings in this family may reveal further enforcement vectors for generic entrants to assess.

Bayer Xarelto patent family
Technology landscape

Filing trends in oral anticoagulant cardiovascular risk patents

The '310 patent's focus on cardiovascular event risk reduction with 2.5 mg rivaroxaban dosing reflects a wave of indication-expansion filing strategies in the anticoagulant space. Analysing filing trends around Factor Xa inhibitor dosing regimens and cardiovascular secondary prevention may reveal competitor white space or crowded claim areas relevant to next-generation anticoagulant development.

Factor Xa inhibitor filing trends
Competitor IP posture

Auson Pharmaceuticals' patent and NDA strategy in the U.S. market

Auson's NDA filing for 2.5 mg rivaroxaban tablets — and its carve-out strategy to exclude patented indications — signals an active push into the U.S. cardiovascular generics market. Tracking Auson Pharmaceuticals Co., Ltd.'s (Shanghai) patent filings and U.S. regulatory submissions may indicate their next therapeutic target areas and IP positioning for future generic launches.

Auson generic cardiovascular pipeline
White space opportunity

Adjacent cardiovascular dosing and formulation white space near the '310 patent

The '310 patent's claim scope targets specific rivaroxaban dosing regimens for cardiovascular risk reduction. Formulation innovations targeting different dose strengths, delivery mechanisms, or combination therapies for secondary cardiovascular prevention may represent white space outside the asserted claim boundaries — particularly relevant if the Federal Circuit narrows or invalidates the '310 patent claims on appeal.

Cardiovascular formulation white space
Related litigation

Similar rivaroxaban & oral anticoagulant patent cases in the U.S. federal courts

Explore parallel Xarelto patent actions and related ANDA/NDA pharmaceutical infringement cases consolidated in MDL No. 3017 in the District of Delaware.

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Bayer AG patent enforcement history, New Jersey District Court case history, Bayer AG's full IP portfolio, and comparable case analysis
Other Xarelto MDL defendantsRivaroxaban ANDA litigationPTAB appeal outcomesCardiovascular drug patent cases
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Strategic implications

What this transfer signals for the rivaroxaban generic IP landscape

The MDL consolidation of Auson's case reflects the breadth of Bayer and Janssen's multi-front enforcement strategy around Xarelto.

PTAB invalidity ruling did not stop MDL — Federal Circuit appeal keeps '310 patent alive

The July 2023 PTAB decision invalidating all claims of US10828310B2 did not terminate MDL No. 3017. Plaintiffs appealed to the Federal Circuit, and the MDL pretrial schedule was stayed pending that outcome. Generic entrants and their counsel should monitor the Federal Circuit appeal closely — it will determine whether the '310 patent remains an enforcement tool.

Carve-out strategies are not a transfer shield — the Panel will not prejudge merits

Auson argued its NDA carve-out eliminated shared factual issues with the MDL, but the Panel declined to assess the merits of that position before transferring. Companies relying on label carve-outs as a litigation defense should expect transfer to MDL proceedings regardless — those arguments will be tested only by the transferee court.

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Federal Circuit appeal statusCarve-out precedent riskMDL pretrial schedule
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Frequently asked questions

Bayer v Auson — key questions answered

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Track Xarelto patent MDL and Federal Circuit appeal outcomes

PatSnap Eureka monitors MDL No. 3017 docket activity, Federal Circuit appeal filings on US10828310B2, and Bayer–Janssen portfolio enforcement moves. Set up real-time alerts to stay ahead of the next ruling.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

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