DCT

1:21-cv-00314

Bayer Pharma AG v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-00314, D. Del., 03/01/2021
  • Venue Allegations: Venue is alleged to be proper for Lupin Pharmaceuticals, Inc. because it is a Delaware corporation, and for Lupin Limited because it is subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) for a generic version of the 2.5 mg XARELTO® product constitutes an act of patent infringement.
  • Technical Context: The technology concerns a combination drug therapy, using the anticoagulant rivaroxaban and the antiplatelet aspirin at specific dosages, to reduce the risk of major cardiovascular events in patients with chronic coronary or peripheral artery disease.
  • Key Procedural History: The action arises from Lupin's filing of ANDA No. 208555 with a Paragraph IV Certification, challenging U.S. Patent No. 10,828,310 (’310 patent) which is listed in the FDA's Orange Book for XARELTO®. Plaintiffs received a notice letter regarding the ANDA filing on January 15, 2021. Notably, a Supplemental Examination Certificate for the '310 patent was issued on February 10, 2021, which concluded that no substantial new question of patentability was raised during that proceeding.

Case Timeline

Date Event
2018-02-02 '310 Patent Priority Date
2020-11-10 '310 Patent Issue Date
2021-01-15 Plaintiffs Receive Lupin's ANDA Notice Letter
2021-02-10 '310 Patent Supplemental Examination Certificate Issued
2021-03-01 Complaint Filing Date

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

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 the significant risk of major adverse cardiovascular events, such as heart attack and stroke, for patients with coronary artery disease (CAD) or peripheral artery disease (PAD). It notes that prior attempts to combine anticoagulants with standard antiplatelet therapy (like aspirin) were often unsuccessful, as they tended to cause unacceptably high rates of major bleeding. (’310 Patent, col. 2:1-29).
  • The Patented Solution: The invention is a specific method of treatment using a low-dose combination therapy: the Factor Xa inhibitor rivaroxaban at 2.5 mg twice daily, co-administered with low-dose aspirin at 75-100 mg daily. This particular dosing regimen, derived from the COMPASS clinical trial, is described as effectively reducing the risk of cardiovascular events without causing an unacceptably high risk of fatal bleeding or bleeding in critical organs. (’310 Patent, col. 3:44-55, col. 16:5-10).
  • Technical Importance: The claimed method provided a new therapeutic option that demonstrated a favorable benefit-risk profile, succeeding where other antithrombotic combinations had previously failed to show a clear net clinical benefit for this patient population. (’310 Patent, col. 18:3-9).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1. (Compl. ¶38).
  • The essential elements of independent 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 artery 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

Lupin's ANDA Product, a generic version of the 2.5 mg rivaroxaban tablet, submitted to the FDA under ANDA No. 208555. (Compl. ¶9).

Functionality and Market Context

The infringement allegation is not based on the tablet itself, but on its proposed use. The complaint alleges that the proposed product labeling for Lupin's ANDA Product will instruct physicians and patients to use the generic rivaroxaban tablets in a manner that directly corresponds to the patented method—specifically, for reducing the risk of major cardiovascular events in patients with CAD or PAD, which involves co-administration with aspirin. (Compl. ¶35). The act of filing the ANDA with such a label is the statutory act of infringement under 35 U.S.C. § 271(e)(2).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,828,310 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 Lupin's ANDA Product allegedly directs a method of reducing the risk of major cardiovascular events in patients with chronic CAD or PAD. ¶35 col. 3:56-61
...comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective... The proposed labeling allegedly directs the administration of Lupin's rivaroxaban product along with aspirin to achieve the claimed risk reduction. ¶35 col. 3:61-63
...wherein rivaroxaban is administered in an amount of 2.5 mg twice daily... Lupin's ANDA Product is a 2.5 mg tablet, and its proposed labeling allegedly directs twice-daily administration for the indicated use. ¶9, ¶35 col. 4:8-10
...and aspirin is administered in an amount of 75-100 mg daily. The proposed labeling allegedly directs the co-administration of aspirin in a daily amount of 75-100 mg. ¶35 col. 4:10-11
  • Identified Points of Contention:
    • Factual Question: The complaint makes a significant allegation that in its notice letter, "Lupin did not contest that the use of Lupin's ANDA Product in accordance with its proposed labeling would infringe the '310 patent, assuming the patent is valid" (Compl. ¶39). A primary question for the court will be the legal effect of this statement. If deemed an admission, the focus of the case may shift almost entirely from infringement to the patent's validity.
    • Scope Questions: Should Lupin contest infringement, the analysis would focus on whether the proposed label induces infringement. This raises the question of whether the label directs, encourages, or recommends the patented method to the exclusion of any substantial non-infringing uses. The complaint alleges the product and its label are "not suitable for substantial noninfringing use" (Compl. ¶42), a key element for contributory infringement that will be scrutinized.

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"
  • Context and Importance: This term appears in the "comprising" clause of claim 1 and links the administration of the drugs to a required outcome standard. Practitioners may focus on this term because its definition could be critical for both infringement and validity. A defendant may argue the term is indefinite or, for infringement, that its proposed label does not guarantee the "clinically proven" efficacy required by the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term is used generally in the summary of the invention to describe the goal of the method (e.g., "amounts that are clinically proven effective"). (’310 Patent, col. 3:61-62). A party could argue this suggests the plain and ordinary meaning, not one tied to a single clinical trial.
    • Evidence for a Narrower Interpretation: The patent specification is based almost entirely on the results of the COMPASS clinical trial. (’310 Patent, col. 3:26-34, col. 13-18). A party could argue that "clinically proven effective" is implicitly defined by and limited to the specific patient population, endpoints, and statistical results reported for that trial, as described in detail throughout the patent.

VI. Other Allegations

  • Indirect Infringement: The core of the case is indirect infringement. The complaint alleges that Lupin will actively induce infringement by physicians and patients through the instructions on its proposed product label (Compl. ¶41, ¶46). It further alleges contributory infringement, stating that Lupin's product, with its proposed label, is "especially made or adapted for use in infringing" the patent and lacks substantial non-infringing uses. (Compl. ¶42).
  • Willful Infringement: The complaint alleges that Lupin had knowledge of the '310 patent through its listing in the FDA's Orange Book and, at the latest, upon sending its notice letter. (Compl. ¶30, ¶32, ¶40). The allegation is that Lupin's intent to market its product with an infringing label despite this knowledge supports a claim for willful infringement.

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

  • A central issue will be one of patent validity versus admitted infringement. Given the complaint's allegation that Lupin did not contest infringement in its notice letter (Compl. ¶39), the case may pivot primarily to Lupin's ability to prove the '310 patent is invalid (e.g., for obviousness). The patent's survival of a Supplemental Examination will be a significant factor in this dispute.
  • A second key question will concern induced infringement and label interpretation. If infringement is contested, the case will turn on whether Lupin’s proposed label instructs or encourages an infringing use, and whether that label carves out any substantial, commercially significant non-infringing uses for a 2.5 mg rivaroxaban tablet.
  • Finally, a key legal question may be the scope of "clinically proven effective." The court’s construction of this term—whether it is limited to the specific outcomes of the COMPASS trial disclosed in the patent or has a broader meaning—could create different pathways for either party to argue infringement or invalidity.