DCT

1:23-cv-01103

Bayer IP GmbH v. Auson Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01103, 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 not a U.S. resident but is subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of a New Drug Application (NDA) to the FDA for generic versions of Plaintiffs' XARELTO® (rivaroxaban) anticoagulant medication constitutes an act of infringement of two patents covering specific methods of use.
  • Technical Context: The patents relate to methods for using rivaroxaban, a direct Factor Xa inhibitor, to treat or prevent thromboembolic and cardiovascular events, a cornerstone of modern anticoagulant therapy.
  • Key Procedural History: The complaint notes that the patents-in-suit are listed in the FDA's "Orange Book" for XARELTO®. It also discloses extensive related litigation concerning the '310 patent, including a multi-district litigation (MDL) and several inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB), which may have implications for claim construction and validity arguments in this case.

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 Notifies Plaintiffs of NDA Submission
2023-06-01 Complaint Filing Date

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

U.S. Patent No. 9,539,218 - "Prevention and Treatment of Thromboembolic Disorders" (Issued Jan. 10, 2017)

The Invention Explained

  • Problem Addressed: The patent describes a need for improved anticoagulant therapies, noting that prior options like heparin and vitamin K antagonists suffer from drawbacks such as non-selective action, high bleeding risks, and inconvenient administration routes. (’218 Patent, col. 2:1-21).
  • The Patented Solution: The invention claims a specific method of treatment using the direct Factor Xa inhibitor rivaroxaban. The innovation lies not in the compound itself, but in the dosing regimen: administering the drug "no more than once daily for at least five consecutive days in a rapid-release tablet" to treat specific thromboembolic disorders like deep vein thrombosis and pulmonary embolism. (’218 Patent, Abstract; col. 11:11-17). The patent is based on clinical trial data suggesting this once-daily regimen is effective. (’218 Patent, col. 9:41-51).
  • Technical Importance: The invention provided a simplified, oral, once-daily treatment protocol for a direct-acting anticoagulant, offering a potential improvement in convenience and patient compliance compared to older injectable or more frequently dosed therapies. (’218 Patent, col. 8:35-44).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶45).
  • 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 Nov. 10, 2020)

The Invention Explained

  • Problem Addressed: The patent identifies the persistent high risk of major adverse cardiovascular events (myocardial infarction, stroke, death) in patients with coronary artery disease (CAD) or peripheral artery disease (PAD), even with existing antiplatelet therapies. (’310 Patent, col. 2:1-5). It notes that previous attempts to combine anticoagulants with antiplatelets often led to unacceptably high rates of major bleeding. (’310 Patent, col. 2:5-15).
  • The Patented Solution: The patent claims a method of reducing cardiovascular risk by administering a specific combination therapy: a low dose of rivaroxaban (2.5 mg twice daily) together with a low dose of aspirin (75-100 mg daily). (’310 Patent, Abstract; col. 4:1-14). The patent specification is based on the results of the large-scale COMPASS clinical trial, which demonstrated the efficacy of this specific dual-pathway approach. (’310 Patent, col. 3:26-40).
  • Technical Importance: This combination therapy established a new treatment paradigm that successfully reduced major cardiovascular events in a high-risk population by targeting both coagulation (Factor Xa) and platelet aggregation pathways at specific low doses, achieving a favorable balance between efficacy and safety. (’310 Patent, col. 12:43-52).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶52).
  • 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 said risk,
    • 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 NDA No. 217062 to the FDA. (Compl. ¶10). These are identified as generic versions of Plaintiffs' XARELTO® products. (Compl. ¶37).

Functionality and Market Context

  • The infringement allegation is not based on the composition of the tablets alone, but on their intended use as will be described in their proposed product labeling. (Compl. ¶40). The complaint alleges the proposed label for the 10 mg product will direct its use for indications and at a frequency that infringes the ’218 Patent. (Compl. ¶44). It further alleges the proposed label for the 2.5 mg product will induce its use in combination with aspirin in a manner that infringes the ’310 Patent. (Compl. ¶51).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’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 product allegedly directs its use for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), among other indications. ¶44 col. 11:14-17
... 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... Auson's product is a rivaroxaban tablet, the chemical compound recited in the claim. ¶38 col. 3:15-24
... no more than once daily for at least five consecutive days... The proposed labeling allegedly directs the use of the 10 mg product in a manner satisfying the "no more than once daily for at least five consecutive days" requirement. ¶44 col. 11:12-14
... in a rapid-release tablet... Auson's product is a tablet, and the complaint alleges on information and belief that it satisfies the "rapid-release tablet" requirement. ¶43 col. 8:10-15

’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... Auson's proposed labeling for its 2.5 mg product will allegedly induce its administration with aspirin to reduce the risk of MI, stroke or CV death in patients with CAD and/or PAD. ¶51 col. 4:1-9
... comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective... The complaint alleges Auson will induce the administration of its 2.5 mg rivaroxaban product with aspirin in amounts that are clinically proven effective for the recited indication. ¶51 col. 4:4-9
... 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 alleges that through its marketing and proposed labeling, Auson will induce the administration of its 2.5 mg product twice daily in combination with aspirin at 75-100 mg daily. ¶51 col. 4:9-14

Identified Points of Contention

  • Scope Questions: For the ’218 patent, a primary point of contention may be the term "rapid-release tablet." The complaint's allegation is made on "information and belief" (Compl. ¶43), suggesting that whether Auson's formulation meets the specific dissolution profile defined in the patent (’218 Patent, col. 8:10-15) will be a key factual and legal dispute.
  • Technical Questions: For the ’310 patent, the central issue is inducement. The case will depend on the specific language of Auson's proposed product label. The question for the court will be whether that language instructs, encourages, or promotes the specific combination therapy recited in claim 1, or whether it merely mentions the possibility of co-administration without rising to the level of active inducement.

V. Key Claim Terms for Construction

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

  • Context and Importance: This term defines the formulation of the drug. Infringement of the ’218 patent hinges on whether Auson's generic tablet has the specific technical characteristic of being a "rapid-release tablet" as understood in the context of the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not provide a basis for this analysis. A party might argue for a general understanding of "rapid-release" as simply being an immediate-release formulation.
    • Evidence for a Narrower Interpretation: The ’218 patent specification appears to act as its own lexicographer, 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. 8:12-15). This provides a specific, testable definition that will likely be central to claim construction.

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

  • Context and Importance: This term links the claimed method to a standard of evidence. Practitioners may focus on this term because a defendant could argue its generic product, not having undergone its own large-scale efficacy trials, has not been "clinically proven effective."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The ’310 patent is based on the COMPASS clinical trial, and its specification is replete with data from that trial. (’310 Patent, Figs. 1-9; col. 3:26-34). Plaintiffs will likely argue that "clinically proven effective" refers to this body of evidence for the rivaroxaban/aspirin combination, and a bioequivalent generic product practices the method proven effective by that trial.
    • Evidence for a Narrower Interpretation: The complaint does not provide a basis for this analysis. A party might argue the term requires that the specific product being administered has itself been the subject of clinical proof, a standard a generic product would not meet.

VI. Other Allegations

Indirect Infringement

  • The complaint explicitly alleges active inducement of infringement for both patents. The factual basis for inducement is Auson's alleged intent to market its products with proposed labeling that will instruct and encourage physicians and patients to use the drugs in the patented methods. (Compl. ¶¶48, 54).

Willful Infringement

  • The complaint does not use the word "willful" in its counts for relief. However, it alleges that Auson has had knowledge of the patents since at least the date of its notice letter (Compl. ¶¶47, 53) and requests a declaration that the case is "exceptional" and an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. p. 17(h)), which often accompanies allegations of egregious conduct.

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

  • A core issue will be one of technical equivalence: Does Auson’s 10 mg tablet formulation meet the specific quantitative definition of a "rapid-release tablet" provided in the ’218 patent’s specification, or is there a technical mismatch that allows for a non-infringement defense?
  • A second key question will be one of induced infringement: Will the specific instructions and indications in Auson's final, FDA-approved labeling for its 2.5 mg product be found to actively encourage and promote the specific combination therapy claimed in the ’310 patent, thereby satisfying the legal standard for inducement?
  • A significant background factor will be the impact of parallel proceedings: How will the outcomes of the multiple IPRs and the ongoing MDL litigation involving the ’310 patent, as noted in the complaint, influence the court’s analysis of claim construction and validity in this case?