DCT

1:23-cv-01196

Bayer Pharma AG v. Cipla Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01196, D. Del., 10/20/2023
  • Venue Allegations: Venue is asserted against Cipla Ltd., an Indian corporation, based on its being subject to personal jurisdiction in Delaware. Venue is asserted against Cipla USA Inc. based on its incorporation in Delaware.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs' 2.5 mg XARELTO® (rivaroxaban) product constitutes an act of patent infringement.
  • Technical Context: The lawsuit concerns a patented combination therapy using a low-dose anticoagulant (rivaroxaban) and aspirin to reduce the risk of major cardiovascular events in patients with coronary or peripheral artery disease.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendants' notification to Plaintiffs of their ANDA filing, which included a Paragraph IV certification challenging U.S. Patent No. 10,828,310. The patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for XARELTO®. A Supplemental Examination Certificate was issued for the patent on February 10, 2021, which concluded that no substantial new question of patentability was raised in that proceeding.

Case Timeline

Date Event
2018-02-02 ’310 Patent Priority Date
2020-11-10 ’310 Patent Issue Date
2023-09-05 Date of Cipla's Notice Letter to Janssen
2023-10-20 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.

The Invention Explained

  • Problem Addressed: The patent describes a need for improved therapies for patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD), who are at high risk for major adverse cardiovascular events. (’310 Patent, col. 2:1-4). It notes that prior antithrombotic regimens had not been shown to be superior to standard antiplatelet therapy or were associated with unacceptably high rates of major bleeding. (’310 Patent, col. 2:5-22).
  • The Patented Solution: The invention is a method of treatment using a specific combination therapy: the factor Xa inhibitor rivaroxaban at a low dose (2.5 mg twice daily) co-administered with a low dose of aspirin (75-100 mg daily). (’310 Patent, col. 3:56-4:11). This specific regimen is asserted to be effective at reducing the risk of myocardial infarction, stroke, or cardiovascular death, based on findings from the Phase III COMPASS clinical trial, without an unacceptably high risk of fatal bleeding or bleeding in critical organs. (’310 Patent, Abstract; col. 3:26-44).
  • Technical Importance: The claimed method provided a dual-pathway antithrombotic approach that demonstrated a net clinical benefit in a large-scale clinical trial for a patient population where previous attempts with other anticoagulants had not established a favorable risk-benefit profile. (’310 Patent, col. 2:23-30).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1. (Compl. ¶39).
  • 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 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.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Cipla's ANDA Product," identified as a generic version of the 2.5 mg strength of XARELTO® tablets (rivaroxaban) under ANDA No. 218768. (Compl. ¶1, ¶9, ¶33).

Functionality and Market Context

  • The infringement allegation is not based on a currently marketed product but on the act of filing the ANDA under 35 U.S.C. § 271(e)(2). (Compl. ¶43). The complaint alleges that the proposed labeling for Cipla's ANDA Product will direct medical professionals and patients to use the generic rivaroxaban tablets in a way that practices the method of the ’310 patent. (Compl. ¶36). Specifically, the complaint alleges the label will direct administration of 2.5 mg rivaroxaban twice daily with 75-100 mg of aspirin daily to reduce the risk of major cardiovascular events in patients with chronic CAD or PAD. (Compl. ¶36).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary

’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 proposed labeling for Cipla’s ANDA Product allegedly directs a method of reducing the risk of major cardiovascular events, including cardiovascular death, myocardial infarction (MI), and stroke. ¶36 col. 3:56-61
...in a human patient with coronary artery disease and/or peripheral artery disease... The proposed labeling allegedly directs this method for use in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶36 col. 3:58-61
...comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective... Cipla’s ANDA Product contains rivaroxaban, and its proposed labeling allegedly directs co-administration with aspirin in amounts that are clinically proven effective for the claimed indication. ¶35, ¶36 col. 4:1-8
...wherein rivaroxaban is administered in an amount of 2.5 mg twice daily... Cipla's ANDA is for a 2.5 mg rivaroxaban tablet, and the proposed label allegedly directs that it be administered twice daily. ¶9, ¶36 col. 4:8-11
...and aspirin is administered in an amount of 75-100 mg daily. The proposed label allegedly directs that aspirin be administered in a daily amount of 75-100 mg. ¶36 col. 4:10-11

Identified Points of Contention

  • Scope Questions: A central question may be whether the phrase "clinically proven effective" requires proof based on the specific COMPASS trial data disclosed in the patent, or if it has a broader meaning, such as being proven effective to the satisfaction of a regulatory body like the FDA. The answer could impact both infringement and validity analyses.
  • Technical Questions: As the proposed label for Cipla's ANDA product is not an exhibit to the complaint, a key evidentiary issue will be whether the specific text of that label's "Indications and Usage" section constitutes active inducement by directly encouraging or instructing the patented method.

V. Key Claim Terms for Construction

The Term

  • "clinically proven effective"

Context and Importance

  • This term, located in the body of claim 1, appears to qualify the entire combination therapy. Practitioners may focus on this term because its construction will determine what standard of proof is required to meet the limitation. It connects the legal scope of the claim to the real-world clinical data that underpins the patent.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The term itself is general and could be interpreted to mean effectiveness that is established through any valid clinical means recognized in the field, including gaining FDA approval for a specific indication. The patent's background discusses multiple prior clinical trials and therapeutic approaches, suggesting "clinically proven" is a general standard. (’310 Patent, col. 2:1-3:25).
  • Evidence for a Narrower Interpretation: The patent specification is heavily centered on the results of the COMPASS trial. It states, "The findings presented herein were obtained from the phase III COMPASS trial" and repeatedly links the efficacy of the claimed 2.5 mg rivaroxaban plus aspirin regimen to that specific trial's outcomes. (’310 Patent, col. 3:26-30; col. 15:24-16:22). This could support an argument that "clinically proven effective" implicitly refers to the proof provided within the patent's own disclosure.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b). The factual basis is the allegation that Cipla’s proposed product labeling will instruct physicians and patients to practice the patented method. (Compl. ¶36). The complaint alleges Cipla has knowledge of the ’310 patent and specifically intends for its product to be used in an infringing manner upon approval. (Compl. ¶40, ¶41).

Willful Infringement

  • The complaint does not contain an explicit count for willful infringement. However, it alleges that Cipla has knowledge of the ’310 patent and intends to infringe. (Compl. ¶40). In the prayer for relief, Plaintiffs seek a declaration that this is an "exceptional case" and an award of attorneys' fees pursuant to 35 U.S.C. § 285. (Compl. p. 12, ¶(e)).

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

  • A core issue will be one of claim construction: Can the term "clinically proven effective" be defined by the specific clinical trial data disclosed in the patent's specification, or does it carry a broader meaning tied to regulatory approval or general acceptance in the medical community? The resolution of this question will significantly influence both the infringement and validity analyses.
  • A key evidentiary question will be one of inducement: Assuming the patent is valid, the case will turn on whether the precise language in the "Indications and Usage" and "Dosage and Administration" sections of Cipla's proposed generic drug label actively encourages or instructs medical professionals to prescribe the drug in the exact manner claimed by the patent.
  • A central, albeit unstated in the complaint, dispute will be validity: The ultimate outcome will likely depend on whether the claimed method is deemed non-obvious over prior art. The defense will likely argue that combining a known anticoagulant with aspirin at low doses was an obvious therapeutic strategy to try, while the plaintiff will point to the specific, successful results of the COMPASS trial and the patent's Supplemental Examination Certificate as evidence of non-obviousness.