DCT

1:21-cv-01742

Bayer Pharma AG v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-00099, N.D. W. Va., 07/22/2021
  • Venue Allegations: Venue is alleged to be proper as Defendant Mylan Pharmaceuticals Inc. is a West Virginia corporation, and Defendant Mylan Inc. has previously consented to venue in the district, is registered to do business there, and allegedly directed substantial preparation of the underlying regulatory application within the district.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic version of the 2.5 mg XARELTO® product constitutes an act of infringement of a patent covering a method of using rivaroxaban and aspirin in combination to reduce the risk of certain cardiovascular events.
  • Technical Context: The technology involves a specific combination drug therapy using a factor Xa inhibitor (rivaroxaban) and a common antiplatelet agent (aspirin) for long-term prevention of major adverse cardiovascular events in high-risk patient populations.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 212220 to the FDA. The ANDA included a Paragraph IV certification, asserting that U.S. Patent No. 10,828,310 is invalid. The lawsuit was filed within the 45-day window triggered by Plaintiffs' receipt of Defendants' notice letter, which imposes an automatic 30-month stay on FDA approval of the generic product.
  • Case Timeline:
Date Event
2018-02-02 ’310 Patent Priority Date
2020-11-10 ’310 Patent Issued
2021-06-01 Mylan sends Paragraph IV Notice Letter
2021-07-22 Complaint Filed

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 a need for improved therapies for patients with coronary artery disease (CAD) or peripheral artery disease (PAD), who remain at high risk for major adverse cardiovascular events like heart attack and stroke. (’310 Patent, col. 2:1-4). Existing antithrombotic therapies were described as either failing to show superiority over aspirin alone or presenting an unacceptably high risk of major bleeding. (’310 Patent, col. 2:5-29).
  • The Patented Solution: The invention is a method of treatment using a specific, low-dose combination therapy: the factor Xa inhibitor rivaroxaban (2.5 mg twice daily) co-administered with low-dose aspirin (75-100 mg daily). (’310 Patent, col. 3:59-65). This regimen is described as the outcome of the COMPASS clinical trial, which allegedly demonstrated that this particular combination provides a significant reduction in cardiovascular events without the "unacceptably high risk of fatal bleeding or bleeding in critical organs" associated with other anticoagulant strategies. (’310 Patent, col. 3:51-58).
  • Technical Importance: The claimed method purports to offer a novel balance of efficacy and safety, providing a dual-pathway antithrombotic benefit that was previously elusive for the long-term treatment of this stable, high-risk patient population. (’310 Patent, col. 18:41-52).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert additional claims. (Compl. ¶23, 35).
  • Independent Claim 1:
    • 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. (’310 Patent, col. 18:57 - col. 19:2).

III. The Accused Instrumentality

Product Identification

"Mylan's ANDA Product," which is a proposed 2.5 mg rivaroxaban tablet submitted for FDA approval under ANDA No. 212220. (Compl. ¶9).

Functionality and Market Context

The product is a generic version of Plaintiffs’ XARELTO® 2.5 mg tablets. (Compl. ¶1). The infringement allegation is not based on the composition of the tablet itself, but on the method of use for which Mylan is seeking FDA approval. The complaint alleges that the proposed product labeling for Mylan's generic rivaroxaban will direct physicians and patients to administer it in combination with aspirin for the same indication and at the same dosages recited in the asserted patent claims. (Compl. ¶32).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

  • Claim Chart Summary:
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 Mylan's product allegedly directs a method for reducing the risk of major cardiovascular events, including myocardial infarction (MI), stroke, and cardiovascular (CV) death. ¶32 col. 3:51-55
in a human patient with coronary artery disease and/or peripheral artery disease, Mylan's proposed labeling allegedly directs this method for use in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶32 col. 3:59-62
comprising administering to the human patient rivaroxaban and aspirin The proposed labeling allegedly directs the administration of Mylan's rivaroxaban product in combination with aspirin. ¶32 col. 3:51-53
in amounts that are clinically proven effective... The complaint alleges the proposed labeling directs administration in amounts that are clinically proven effective for the specified patient population and indication. ¶32 col. 3:59-65
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily Mylan's ANDA product is a 2.5 mg tablet, and its proposed labeling allegedly directs twice-daily administration. ¶32 col. 4:9-11
and aspirin is administered in an amount of 75-100 mg daily. The proposed labeling for Mylan's product allegedly directs co-administration with aspirin in a daily amount of 75-100 mg. ¶32 col. 4:9-11
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges that Mylan's notice letter did not contest infringement on any basis other than invalidity. (Compl. ¶36). This suggests infringement may not be the primary dispute. However, should infringement be contested, a question may arise regarding the scope of the term "clinically proven effective." Does this functional language require a specific type of proof that is defined by the patent's specification, or does it refer to a broader industry or regulatory standard?
    • Technical Questions: A central evidentiary question will be whether the specific language in Mylan's proposed product label instructs or encourages physicians to perform each and every step of the claimed method, thereby supporting a finding of induced infringement.

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"
  • Context and Importance: This term appears in the fourth limitation of independent claim 1. It is a functional limitation that could be a focal point of claim construction. Its definition is critical because it sets the standard of proof required to meet this claim element. Practitioners may focus on this term because it is less concrete than the specific dosage elements and could be a target for an indefiniteness or non-infringement argument.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party arguing for a broader meaning could point out that the patent does not provide an explicit definition for the term, suggesting it should be given its plain and ordinary meaning as understood by a person of ordinary skill in the art (e.g., proven effective through any well-controlled clinical trial). (Compl. ¶23).
    • Evidence for a Narrower Interpretation: A party arguing for a narrower meaning would likely contend that the patent itself acts as its own lexicographer by implicitly defining the term. The specification is built almost entirely around the results of the COMPASS clinical trial, which is presented as the "discovery" that makes the invention work. (’310 Patent, col. 3:26-34, col. 11:1-21, col. 12:41-43). This suggests "clinically proven effective" may be construed to mean "proven effective by the clinical data disclosed in this patent."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both active inducement and contributory infringement. Inducement is based on the allegation that Mylan's proposed labeling will instruct medical professionals and patients to use its product in an infringing manner. (Compl. ¶38). Contributory infringement is based on the allegation that Mylan's product, with its proposed labeling, is especially adapted for an infringing use and is not suitable for a substantial non-infringing use. (Compl. ¶39).
  • Willful Infringement: The complaint alleges that Mylan has knowledge of the ’310 patent and its claims, yet intends to engage in infringing activities immediately upon FDA approval. (Compl. ¶37). While the term "willful" is not used, Plaintiffs seek a declaration of an "exceptional case" and attorneys' fees, which is the relief associated with such conduct. (Compl., Prayer for Relief (e)).

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

  • A central issue will be one of patent validity. Based on the complaint's characterization of Mylan's Paragraph IV notice letter (Compl. ¶36), the case will likely focus on whether the claimed method was obvious over the prior art, specifically whether a person of ordinary skill would have been motivated to combine low-dose rivaroxaban and aspirin for this indication with a reasonable expectation of success.
  • A secondary legal question will be the construction of functional claim language: what is the proper scope of the term "clinically proven effective"? Is its meaning tethered to the clinical trial data disclosed in the patent, or does it carry a broader meaning that could alter the infringement analysis?
  • Finally, a key evidentiary question standard in ANDA litigation will be one of inducement: does the precise language of Mylan’s proposed product label, once revealed in discovery, provide sufficient evidence that Mylan will induce medical providers to prescribe its product in a manner that directly infringes every limitation of the asserted claims?