DCT

1:25-cv-00694

Bayer Pharma AG v. Apotex Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00694, D. Del., 06/05/2025
  • Venue Allegations: Venue is alleged to be proper as Defendant Apotex Corp. is a Delaware corporation and Defendant Apotex Inc. is subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendant’s generic rivaroxaban tablets, when used according to their FDA-approved label, infringe a patent covering a method of treatment that combines rivaroxaban and aspirin to reduce the risk of cardiovascular events.
  • Technical Context: The technology concerns a combination drug therapy in the field of anticoagulants, a major pharmaceutical market aimed at preventing blood clots in high-risk patient populations.
  • Key Procedural History: The complaint notes that in a prior, related litigation over the same patent, Apotex stipulated that the use of its product in accordance with its labeling would infringe claims 1-4. That litigation was consolidated and is currently stayed pending the appeal of a related inter partes review (IPR) proceeding at the Patent Trial and Appeal Board. This new suit follows the FDA's final approval and Apotex's alleged commercial launch of the generic product.

Case Timeline

Date Event
2018-02-02 ’310 Patent Priority Date
2020-11-10 ’310 Patent Issue Date
2022-10-31 Apotex sends Paragraph IV Notice Letter regarding the ’310 Patent
2022-12-14 Plaintiffs file initial infringement suit against Apotex
2023-06-20 Apotex stipulates to infringement in prior litigation
2025-05-02 Apotex’s generic product receives final FDA approval
2025-06-05 Complaint Filing Date

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

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

  • Patent Identification: U.S. Patent No. 10,828,310, “Reducing the Risk of Cardiovascular Events,” issued November 10, 2020. (Compl. ¶29).

The Invention Explained

  • Problem Addressed: The patent describes the significant risk of major adverse cardiovascular events (e.g., heart attack, stroke) faced by patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) (’310 Patent, col. 1:49-2:2). Previous antithrombotic therapies, such as combining high-intensity warfarin with aspirin, did not sufficiently reduce these events and, critically, increased the risk of life-threatening bleeding. (’310 Patent, col. 2:8-15).
  • The Patented Solution: The invention is a specific combination therapy method that balances efficacy and safety. It involves administering a low dose of the Factor Xa inhibitor rivaroxaban (2.5 mg twice daily) together with a low dose of aspirin (75-100 mg daily) (’310 Patent, Abstract). The patent explains that this particular regimen was found, through the large-scale COMPASS clinical trial, to be effective in reducing cardiovascular events without causing an unacceptably high risk of fatal or critical organ bleeding. (’310 Patent, col. 3:50-58).
  • Technical Importance: The claimed method provided a novel treatment that successfully addressed the central therapeutic challenge of maximizing antithrombotic protection while minimizing bleeding risk for a large patient population. (’310 Patent, col. 3:50-58).

Key Claims at a Glance

  • The complaint asserts at least claim 1. (Compl. ¶46).
  • Independent Claim 1 requires:
    • 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 in a human patient with coronary artery disease and/or peripheral arterial disease,
    • 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 also notes a prior stipulation covered claims 1-4. (Compl. ¶39).

III. The Accused Instrumentality

Product Identification

  • Apotex's 2.5 mg rivaroxaban tablets, the subject of Abbreviated New Drug Application (ANDA) No. 217810. (Compl. ¶¶2, 36).

Functionality and Market Context

  • The accused product is a generic version of Plaintiffs’ XARELTO® 2.5 mg tablets. (Compl. ¶1). The complaint alleges that Apotex is now commercially manufacturing, importing, and selling this product in the United States following final FDA approval. (Compl. ¶¶42-43). The complaint alleges that Apotex prominently lists its "Rivaroxaban Tablets" for sale on its website, referencing an online exhibit (Compl. ¶43, Ex. B). The core of the infringement allegation is that the product's FDA-approved label instructs healthcare professionals and patients to co-administer the 2.5 mg rivaroxaban tablet twice daily with 75-100 mg of aspirin daily to reduce the risk of major cardiovascular events in patients with CAD or PAD, thereby directing users to perform the patented method. (Compl. ¶44).

IV. Analysis of Infringement Allegations

'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... The approved labeling for Apotex's product allegedly directs a method for reducing the risk of major cardiovascular events, including stroke and myocardial infarction. ¶44 col. 4:1-9
...in a human patient with coronary artery disease and/or peripheral artery disease... The product labeling allegedly directs use in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶44 col. 4:1-9
...comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective... The approved labeling allegedly directs the co-administration of Apotex's rivaroxaban product and aspirin in amounts that are clinically proven effective for the claimed indication. ¶44 col. 4:5-11
...wherein rivaroxaban is administered in an amount of 2.5 mg twice daily... Apotex’s product is a 2.5 mg tablet of rivaroxaban, and its approved labeling allegedly directs administration twice daily. ¶¶36, 44 col. 4:9-11
...and aspirin is administered in an amount of 75-100 mg daily. The approved labeling for Apotex’s product allegedly directs that it be administered with aspirin in a daily amount of 75-100 mg. This allegation is supported by reference to the product's approved labeling. ¶44 col. 4:11-12

Identified Points of Contention

  • Validity, Not Infringement: Given Apotex’s prior stipulation that its product label infringes claims 1-4 of the ’310 patent (Compl. ¶39), the central dispute in the case is highly likely to be over the patent's validity, not infringement. The complaint’s reference to a pending appeal of an IPR proceeding underscores that validity remains a contested issue. (Compl. ¶41).
  • Scope Questions: A potential, albeit likely secondary, point of contention could revolve around the claim phrase "clinically proven effective." The question for the court could be whether a generic product, approved based on bioequivalence to an innovator product, meets a claim limitation requiring its use to be "clinically proven effective" when the proof derives from the innovator's trials, not the generic's.

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"
  • Context and Importance: This term appears in claim 1 and links the administration of the two drugs to a specific, demonstrated outcome. Practitioners may focus on this term because Apotex could argue its generic product was not itself the subject of the large-scale clinical trials described in the patent, but was approved on the basis of bioequivalence. The construction of this term will determine whether the claim requires efficacy data from the specific product administered or from the method generally.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification repeatedly equates "clinically proven effective" with the results of the COMPASS trial, describing specific hazard ratios and P-values that define the effective outcome (e.g., a 24% reduction in the primary composite outcome). (’310 Patent, col. 16:3-9). A party could argue that any method that achieves this benchmark, or any product labeled for that method based on the innovator's data, satisfies the term.
    • Evidence for a Narrower Interpretation: The detailed description states, "The findings presented herein were obtained from the phase III COMPASS trial" (’310 Patent, col. 3:26-28), and the discussion of efficacy is tied directly to the trial data. A party could argue this language limits the "proof" to the specific formulation and context of that trial, potentially creating a distinction from a generic's product.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement under 35 U.S.C. § 271(b) on the basis that Apotex’s approved product labeling instructs and encourages healthcare professionals to perform the patented method. (Compl. ¶¶44, 48). It also alleges contributory infringement under § 271(c), stating the product is not a staple article of commerce, has no substantial non-infringing use with its label, and is a material part of the invention. (Compl. ¶45).
  • Willful Infringement: The complaint alleges that Apotex's infringement is willful. (Compl. ¶49). This allegation is supported by Apotex’s alleged knowledge of the ’310 patent from prior litigation that began on December 14, 2022, well before the alleged commercial launch. (Compl. ¶49).

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

  • A core issue will be one of patent validity: Can Apotex invalidate the asserted claims of the ’310 patent, likely on grounds of obviousness, which is the central issue being contested in the related IPR appeal mentioned in the complaint? The outcome of this case may depend heavily on the outcome of that appeal.
  • A second key issue will be one of willfulness and damages: Given that Apotex previously stipulated to infringement and allegedly launched its generic product "at risk" while validity is still under appeal, a central question for the court will be whether this conduct constitutes willful infringement, potentially exposing Apotex to enhanced damages if the patent is ultimately found valid and infringed.