DCT

2:23-cv-03020

Bayer IP GmbH v. Auson Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-03020, D.N.J., 06/01/2023
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Auson Pharmaceuticals Inc. is a New Jersey corporation, and Defendant Auson Pharmaceuticals Co., Ltd. is a foreign entity subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of a New Drug Application to the FDA for generic versions of Plaintiffs’ XARELTO® anticoagulant infringes two patents covering specific dosing regimens and combination therapies.
  • Technical Context: The technology relates to methods of using rivaroxaban, a direct factor Xa inhibitor, to treat or prevent thromboembolic disorders (i.e., blood clots) and reduce the risk of major cardiovascular events.
  • Key Procedural History: The complaint notes that this action arises from Defendants’ April 17, 2023 notice letter, which contained a Paragraph IV Certification challenging the asserted patents. The complaint also certifies that the patents-in-suit are the subject of extensive, multi-district litigation against numerous other generic drug manufacturers, as well as multiple Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board, indicating the patents have been and continue to be heavily contested.

Case Timeline

Date Event
2005-01-31 ’218 Patent Priority Date
2017-01-10 ’218 Patent Issue Date
2018-02-02 ’310 Patent Priority Date
2020-11-10 ’310 Patent Issue Date
2023-04-17 Auson Notice Letter sent to Plaintiffs
2023-06-01 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

No probative visual evidence provided in complaint.

U.S. Patent No. 9,539,218 - "Prevention and Treatment of Thromboembolic Disorders"

(Issued January 10, 2017)

The Invention Explained

  • Problem Addressed: Prior anticoagulant therapies like heparin or vitamin K antagonists suffered from significant drawbacks, including a high risk of bleeding, a slow onset of action, or the need for inconvenient parenteral administration and frequent monitoring (’218 Patent, col. 2:1-19).
  • The Patented Solution: The patent describes a method of treatment using rivaroxaban, an oral direct factor Xa inhibitor. The invention is based on the discovery that a "no more than once daily" administration is effective, which was unexpected for a compound with a short plasma half-life (10 hours or less) that would typically suggest a twice- or thrice-daily dosing regimen (’218 Patent, col. 2:60-67). This regimen provides a more convenient and effective treatment for specific thromboembolic disorders like pulmonary embolisms and deep vein thromboses (’218 Patent, col. 3:3-9; col. 12:4-6).
  • Technical Importance: The invention provided a simplified and effective oral, once-daily treatment protocol for serious thromboembolic conditions, improving patient convenience and compliance compared to older anticoagulants.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶ 27).
  • The essential elements of claim 1 are:
    • 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 (rivaroxaban)
    • 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.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,828,310 - "Reducing the Risk of Cardiovascular Events"

(Issued November 10, 2020)

The Invention Explained

  • Problem Addressed: Patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) remain at high risk for major adverse cardiovascular events despite existing antiplatelet therapies. Previous attempts to combine anticoagulants with antiplatelet agents often resulted in unacceptably high rates of major bleeding without a clear benefit (’310 Patent, col. 2:1-29).
  • The Patented Solution: The patent discloses a specific combination therapy of low-dose rivaroxaban (2.5 mg twice daily) and low-dose aspirin (75-100 mg daily). This dual-pathway inhibition was found to be effective in reducing the risk of myocardial infarction, stroke, and cardiovascular death in CAD/PAD patients without causing an unacceptably high risk of fatal bleeding or bleeding in critical organs (’310 Patent, col. 3:46-55). The specification presents extensive clinical trial data to support this balance of efficacy and safety (’310 Patent, Tables 2 & 3).
  • Technical Importance: This specific low-dose combination therapy provided a new, clinically-supported option for long-term risk reduction in a large population of patients with stable atherosclerotic vascular disease.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶ 33).
  • The essential elements of claim 1 are:
    • A method of reducing the risk of myocardial infarction, stroke or cardiovascular death
    • in a human patient with coronary artery disease and/or peripheral artery disease
    • comprising administering to the human patient rivaroxaban and aspirin
    • in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death
    • wherein rivaroxaban is administered in an amount of 2.5 mg twice daily
    • and aspirin is administered in an amount of 75-100 mg daily.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

Auson’s 2.5 mg and 10 mg rivaroxaban tablet products, for which it submitted New Drug Application (NDA) No. 217062 to the FDA (Compl. ¶ 10).

Functionality and Market Context

The accused products are generic versions of Plaintiffs’ XARELTO® tablets (Compl. ¶ 37). The 10 mg product is a tablet intended for indications that include treating deep vein thrombosis (DVT) and pulmonary embolism (PE) (Compl. ¶ 44). The 2.5 mg product is intended for use in combination with aspirin to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) (Compl. ¶ 51). The complaint alleges that upon FDA approval, Auson will market these products throughout the United States (Compl. ¶ 12).

IV. Analysis of Infringement Allegations

’218 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a thromboembolic disorder ... wherein the thromboembolic disorder is selected from the group consisting of pulmonary embolisms, deep vein thromboses, and stroke. The proposed labeling for Auson's 10 mg NDA Product directs its use for treating deep vein thrombosis (DVT) and pulmonary embolism (PE). ¶44 col. 11:3-6
administering a direct factor Xa inhibitor that is 5-Chloro-N-...-2-thiophenecarboxamide Auson's 10 mg NDA Product contains rivaroxaban. ¶38 col. 3:17-24
no more than once daily for at least five consecutive days The proposed labeling for the 10 mg product directs its use in a manner that satisfies the "no more than once daily for at least five consecutive days" requirement. ¶44 col. 3:4-6
in a rapid-release tablet Auson stated its 10 mg NDA Product is a tablet, and the complaint alleges on information and belief that this dosage form satisfies the "rapid-release tablet" requirement. ¶43 col. 8:16-21

’310 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease The proposed labeling for Auson's 2.5 mg product will induce and/or contribute to administration for reducing the risk of MI, stroke or CV death in a human patient with CAD and/or PAD. ¶51 col. 3:56-65
comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective The proposed labeling for Auson's 2.5 mg product will induce and/or contribute to the co-administration of the rivaroxaban product and aspirin. ¶51 col. 4:1-11
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily The proposed labeling will direct that Auson's 2.5 mg NDA Product be administered twice daily. ¶51 col. 4:8-10
and aspirin is administered in an amount of 75-100 mg daily The proposed labeling will direct that aspirin be administered in an amount of 75-100 mg daily. ¶51 col. 4:10-11

Identified Points of Contention

  • Scope Questions: For the ’310 patent, a potential dispute surrounds the term "clinically proven effective." A central question for the court may be whether this phrase simply serves to describe the specific dosages recited later in the claim (2.5 mg rivaroxaban, 75-100 mg aspirin), or if it imposes a separate, functional limitation on the required efficacy that must be demonstrated for infringement to occur.
  • Technical Questions: For the ’218 patent, infringement of claim 1 depends on whether Auson’s generic formulation qualifies as a "rapid-release tablet" as understood in the patent. The complaint alleges this "upon information and belief" (Compl. ¶43), suggesting that the specific dissolution profile and characteristics of Auson’s actual tablet will be a key factual question requiring evidence beyond the pleadings.

V. Key Claim Terms for Construction

The Term: "rapid-release tablet" (’218 Patent, Claim 1)

  • Context and Importance: This term is critical because infringement of the asserted claim of the ’218 patent hinges on whether Auson’s accused 10 mg product meets this definition. Practitioners may focus on this term because the allegation in the complaint is based on "information and belief," indicating it is an anticipated area of dispute.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of evidence supporting a broader interpretation.
    • Evidence for a Narrower Interpretation: The specification provides a specific, technical definition, stating that "rapid-release tablets are in particular those which, according to the USP release method using apparatus 2 (paddle), have a Q value (30 minutes) of 75%" (’218 Patent, col. 8:16-21). This language may support a narrow construction tied to a specific, measurable dissolution standard.

The Term: "clinically proven effective" (’310 Patent, Claim 1)

  • Context and Importance: The construction of this term is central to the scope of the ’310 patent. Whether it is a functional requirement or merely descriptive of the claimed dosages will significantly impact the infringement analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue the term is antecedent basis for the specific dosages that follow in the claim ("wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75-100 mg daily"). Under this view, the patent itself establishes these amounts as "clinically proven effective," and any product administered at these dosages would meet the limitation. The specification repeatedly links these exact dosages to the positive clinical trial results (’310 Patent, col. 4:8-11; col. 12:40-44).
    • Evidence for a Narrower Interpretation: A party could argue the term imposes an independent efficacy requirement. The detailed description is replete with data from the COMPASS clinical trial showing specific hazard ratios and levels of statistical significance (’310 Patent, col. 11:1-12:51). This extensive data could be used to argue that "clinically proven effective" requires a showing of a particular level of efficacy, potentially creating a higher bar for infringement.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement for both patents. The inducement theory is based on the allegation that Auson’s proposed product labeling will instruct physicians and patients to administer the products in an infringing manner (Compl. ¶¶ 44, 48, 51, 54). The contributory infringement theory is based on the allegation that Auson’s products are especially made or adapted for an infringing use and are not suitable for substantial noninfringing use (Compl. ¶¶ 49, 55).

Willful Infringement

The complaint alleges that Auson has knowledge of the patents-in-suit, at least as of its receipt of the April 17, 2023 notice letter, and specifically intends to infringe (Compl. ¶¶ 47, 53). While not using the term "willful," the prayer for relief requests a declaration that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285, which encompasses claims for enhanced damages based on willful or egregious infringement (Compl., p. 17, ¶(h)).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A key evidentiary question will be one of technical compliance: does the formulation of Auson’s 10 mg generic product meet the specific dissolution profile for a "rapid-release tablet" as defined by the intrinsic evidence of the ’218 patent?
  • A central claim construction dispute will concern the definitional scope of the term "clinically proven effective" in the ’310 patent. The court will need to determine whether this phrase merely describes the specific dosages that follow it in the claim, or if it imposes a separate, heightened standard of efficacy that must be met for infringement to be found.
  • Given the extensive history of litigation and IPR proceedings involving these patents, a significant question will be what estoppel effects, if any, arise from prior claim construction rulings or validity determinations in those other legal forums.