DCT

1:25-cv-01429

Bayer IP GmbH v. Mankind Pharma Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01429, D. Del., 11/24/2025
  • Venue Allegations: Venue is alleged to be proper because the defendant is not a resident of the United States and is subject to personal jurisdiction in the District of Delaware.
  • Core Dispute: Plaintiffs allege that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic versions of the anticoagulant XARELTO® constitutes an act of patent infringement.
  • Technical Context: The lawsuit concerns a patented method for treating and preventing blood clots (thromboembolic disorders) using the active ingredient rivaroxaban, a direct factor Xa inhibitor.
  • Key Procedural History: The action was triggered by Defendant's submission of ANDA No. 220874 and its associated Paragraph IV Certification, which challenges U.S. Patent No. 9,539,218. The complaint notes that Defendant has previously consented to personal jurisdiction in Delaware in other ANDA-related cases.

Case Timeline

Date Event
2005-01-31 '218 Patent Priority Date
2017-01-10 U.S. Patent No. 9,539,218 Issues
2025-10-15 Defendant Sends Notice Letter of ANDA Filing
2025-11-24 Complaint Filed

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

U.S. Patent No. 9,539,218 - Prevention and Treatment of Thromboembolic Disorders

  • Patent Identification: U.S. Patent No. 9,539,218 (Prevention and Treatment of Thromboembolic Disorders), issued January 10, 2017 (the "’218 Patent").

The Invention Explained

  • Problem Addressed: The patent's background describes significant disadvantages with prior art anticoagulants, such as heparin, which is non-selective and requires injection, and vitamin K antagonists like warfarin, which have a slow onset of action, a high risk of bleeding, and require time-consuming patient monitoring (’218 Patent, col. 2:1-19).
  • The Patented Solution: The invention is a method of treatment using a specific direct factor Xa inhibitor, rivaroxaban, administered "no more than once daily" (’218 Patent, col. 2:64-66). The specification suggests it was surprising that a compound with a relatively short plasma concentration half-life—which would typically require twice- or thrice-daily dosing to maintain efficacy—could be effective and safe when administered in a once-daily regimen (’218 Patent, col. 2:56-63).
  • Technical Importance: This approach offers a simplified, oral, once-daily treatment regimen that enhances patient convenience and compliance compared to older, more complex anticoagulant therapies (’218 Patent, col. 2:35-40).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶34).
  • The essential elements of independent claim 1 are:
    • A method of treating a specific thromboembolic disorder
    • Comprising administering the direct factor Xa inhibitor rivaroxaban (identified by its chemical name)
    • No more than once daily
    • For at least five consecutive days
    • In a rapid-release tablet
    • To a patient in need thereof
    • Wherein the disorder is selected from pulmonary embolisms, deep vein thromboses, and stroke.

III. The Accused Instrumentality

Product Identification

Defendant’s proposed generic 10 mg, 15 mg, and 20 mg rivaroxaban tablets, which are the subject of ANDA No. 220874 ("Mankind's ANDA Products") (Compl. ¶7).

Functionality and Market Context

  • The accused products are generic versions of Plaintiffs' XARELTO® tablets and contain the same active pharmaceutical ingredient, rivaroxaban (Compl. ¶26, ¶27).
  • The infringement allegation is based on 35 U.S.C. § 271(e)(2), where the submission of an ANDA to obtain approval for a patented method of use is a statutory act of infringement (Compl. ¶42).
  • The complaint alleges that the proposed labeling for Mankind's ANDA Products will direct physicians and patients to use the tablets for indications covered by the ’218 Patent, including the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of stroke (Compl. ¶33).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’218 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
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... Mankind’s ANDA Products contain rivaroxaban, the chemical compound recited in the claim. ¶27 col. 3:19-24
...no more than once daily for at least five consecutive days... The proposed labeling for Mankind's ANDA Products allegedly directs administration in a manner that satisfies the "no more than once daily for at least five consecutive days" requirement. ¶33 col. 3:4-6
...in a rapid-release tablet to a patient in need thereof... The dosage form of Mankind's ANDA Products is a tablet that allegedly satisfies the "rapid-release tablet" requirement. ¶32 col. 8:19-23
...wherein the thromboembolic disorder is selected from the group consisting of pulmonary embolisms, deep vein thromboses, and stroke. The proposed labeling for Mankind's ANDA Products directs use for the treatment of DVT and PE and for stroke risk reduction, which are among the disorders recited in the claim. ¶33 col. 8:1-5

Identified Points of Contention

  • Scope Questions: The dispute will likely involve the construction of the claim terms based on the patent's specification. A primary question is whether Mankind's proposed generic product, as defined in its ANDA, meets the specific definition of a "rapid-release tablet" provided in the patent.
  • Technical Questions: While the complaint focuses on infringement, the Defendant’s Paragraph IV certification suggests it will challenge the patent’s validity. This raises the question of whether a once-daily dosing regimen for rivaroxaban was obvious in light of its known pharmacokinetic properties, specifically its short half-life, which might have pointed away from such a regimen.

V. Key Claim Terms for Construction

"rapid-release tablet"

  • Context and Importance: This term defines the required dosage form. Infringement hinges on whether the formulation described in Defendant's ANDA meets this definition. The patentability of the claim could also be linked to unexpected results achieved with this specific formulation type.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term itself, without context, could be argued to have a plain and ordinary meaning understood in the pharmaceutical arts.
    • Evidence for a Narrower Interpretation: The specification provides a precise, technical definition: "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. 8:19-23). This explicit definition is likely to be central to any claim construction dispute.

"no more than once daily"

  • Context and Importance: This dosing frequency is the core of the claimed method and the primary distinction over treatment paradigms that might require more frequent administration for a drug with a short half-life. Practitioners may focus on this term because the patent's alleged novelty and non-obviousness rest heavily on the discovery that this specific frequency was effective.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue this term simply means the total dosage for a 24-hour period is administered at one time, allowing for some flexibility.
    • Evidence for a Narrower Interpretation: The patent emphasizes this regimen in contrast to twice-daily (bid) administration, and the clinical trial data presented compares "od" (once daily) dosing directly with "bid" dosing, suggesting the term implies a strict regimen of one administration event per day (’218 Patent, col. 9:1-8).

VI. Other Allegations

Indirect Infringement

The complaint alleges active inducement of infringement, stating that Defendant knows of the ’218 Patent and intends for its proposed product labeling to instruct and encourage medical professionals and patients to perform the patented method (Compl. ¶36). The complaint also pleads contributory infringement, alleging the ANDA products are "especially made or adapted for use in infringing" the patent and are not suitable for substantial noninfringing use (Compl. ¶37).

Willful Infringement

While the word "willful" is not used, the complaint alleges that Defendant has "knowledge of the claims of the '218 patent" and "specifically intends to infringe" based on its actions after receiving notice (Compl. ¶35). This provides a factual basis for a potential future claim of willful infringement, which could support a request for enhanced damages.

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

  • A central question, inherent in the Paragraph IV certification that prompted the suit, will be one of validity: does the ’218 Patent’s clinical data demonstrate a surprising and unexpected result sufficient to overcome a potential defense that a "once daily" dosing regimen for an oral anticoagulant like rivaroxaban was obvious to try for a skilled artisan?
  • A key infringement question will be one of induced infringement based on the proposed label: will the final FDA-approved labeling for Defendant's generic product contain instructions that direct users to perform every step of the claimed method, particularly concerning the administration of a "rapid-release tablet" for one of the three specific disorders recited in Claim 1?