DCT

1:17-cv-01129

Bayer IP GmbH v. Breckenridge Pharmaceutical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01129, D. Del., 08/11/2017
  • Venue Allegations: Venue is asserted in Delaware based on allegations that Defendant is registered to do business in the state, has appointed a registered agent for service of process, and intends to market and sell the accused products in Delaware, thereby deriving substantial revenue from the state. The complaint also notes Defendant has consented to jurisdiction in Delaware in prior cases involving the same Abbreviated New Drug Application (ANDA).
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the FDA seeking approval to market generic versions of Plaintiff's XARELTO® product constitutes an act of patent infringement under the Hatch-Waxman Act.
  • Technical Context: The technology concerns pharmaceutical methods for treating and preventing thromboembolic disorders (blood clots) using a specific oral anticoagulant.
  • Key Procedural History: The lawsuit was triggered by Defendant’s submission of ANDA No. 208220 with a Paragraph IV certification, asserting that its generic product would not infringe the patent-in-suit or that the patent is invalid. The complaint notes prior litigation concerning the same ANDA.

Case Timeline

Date Event
2005-01-31 '218' Patent Priority Date
2017-01-10 '218 Patent Issue Date
2017-06-29 Date of Breckenridge's Notice Letter regarding ANDA filing
2017-08-11 Complaint Filing Date

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

U.S. Patent No. 9,539,218 - Prevention and Treatment of Thromboembolic Disorders, issued January 10, 2017

The Invention Explained

  • Problem Addressed: The patent describes drawbacks of prior art anticoagulants. It notes that agents like heparin are non-selective and must be administered parenterally, while oral vitamin K antagonists (e.g., warfarin) have a slow onset of action and a narrow therapeutic index, requiring frequent patient monitoring to avoid complications like bleeding ('218 Patent, col. 2:1-19).
  • The Patented Solution: The invention is a method of treatment using a direct Factor Xa inhibitor, rivaroxaban, which has a relatively short plasma half-life of 10 hours or less. The patent teaches that, counterintuitively, administering this short-half-life drug in an oral, once-daily dosage regimen is an effective method for treating serious thromboembolic disorders ('218 Patent, Abstract; col. 2:64-col. 3:4). This regimen provides the convenience of oral, once-daily dosing without the monitoring requirements of older drugs.
  • Technical Importance: The claimed method sought to provide a more convenient and potentially safer oral anticoagulant therapy, improving upon injectable treatments and oral treatments that require complex dose adjustments and monitoring ('218 Patent, col. 2:35-40).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶28).
  • The essential elements of Claim 1 are:
    • A method of treating a thromboembolic disorder selected from pulmonary embolisms, deep vein thromboses, and stroke;
    • Comprising administering the specific direct Factor Xa inhibitor 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide (rivaroxaban);
    • To a patient in need thereof;
    • In a "rapid-release tablet";
    • Administered "no more than once daily";
    • For "at least five consecutive days."

III. The Accused Instrumentality

Product Identification

Breckenridge's ANDA Products, which are proposed generic versions of XARELTO® containing rivaroxaban in 10 mg, 15 mg, and 20 mg tablets (Compl. ¶7). The act of infringement alleged is the submission of ANDA No. 208220 to the FDA for approval to market these products (Compl. ¶1, ¶39).

Functionality and Market Context

The complaint alleges that Breckenridge's products contain the same active ingredient, rivaroxaban, as the patented method (Compl. ¶24). It further alleges, upon information and belief, that the proposed product labeling directs administration for indications covered by the patent, such as treatment of deep vein thrombosis and pulmonary embolism, and for reduction of stroke risk (Compl. ¶26). The complaint also asserts that the proposed labeling directs a dosing regimen that meets the "no more than once daily for at least five consecutive days" requirement of the patent's claims (Compl. ¶26). 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 ... wherein the thromboembolic disorder is selected from the group consisting of pulmonary embolisms, deep vein thromboses, and stroke. The proposed labeling for the ANDA product allegedly directs its use for indications including the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and to reduce the risk of stroke. ¶26 col. 8:31-36
...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... The Breckenridge ANDA products are alleged to contain rivaroxaban, the chemical compound recited in the claim. ¶24 col. 3:17-23
...no more than once daily for at least five consecutive days... The proposed product labeling is alleged to direct administration in a manner that satisfies the once-daily dosing requirement for at least five days. ¶26 col. 2:64-66
...in a rapid-release tablet... The dosage form is tablets, which the complaint alleges on information and belief satisfy the "rapid-release tablet" requirement. ¶25 col. 8:12-20
  • Identified Points of Contention:
    • Scope Questions: The complaint's allegation that the accused product is a "rapid-release tablet" is made "on information and belief" (Compl. ¶25). This suggests a potential dispute over whether the formulation of Breckenridge's generic tablet falls within the scope of this claim term as it is defined and used in the '218 patent.
    • Technical Questions: A central evidentiary question in this Hatch-Waxman case will be whether the specific instructions in Breckenridge's proposed (and ultimately approved) product label will induce physicians and patients to use the drug in the exact manner claimed by the patent—specifically, for the claimed disorders and according to the claimed once-daily regimen (Compl. ¶26).

V. Key Claim Terms for Construction

  • The Term: "rapid-release tablet"

    • Context and Importance: This term defines the physical dosage form of the drug. Infringement of claim 1 hinges on whether Breckenridge's generic tablet meets this definition. Practitioners may focus on this term because the allegation is made "on information and belief," indicating it is a likely point of future discovery and dispute (Compl. ¶25).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party could argue the term should be given its plain and ordinary meaning as understood by a person of ordinary skill in the art of pharmaceutical formulation.
      • Evidence for a Narrower Interpretation: The specification provides an explicit and limiting definition, stating that "rapid-release tablets are 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. 8:17-20). This language may strongly support a narrow construction tied to a specific dissolution profile.

  • The Term: "treating"

    • Context and Importance: This term defines the action of the claimed method. Its scope is critical for determining whether the indications listed on the accused product's label constitute inducement of an infringing use.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification explicitly defines the term to include both "the therapeutic and/or prophylactic treatment of thromboembolic disorders" ('218 Patent, col. 7:25-27). This could support an interpretation that covers both active treatment and prevention.
      • Evidence for a Narrower Interpretation: A party might argue that, regardless of the specification's definition, the term's scope in Claim 1 is expressly limited by the claim language itself to only the three disorders listed: "pulmonary embolisms, deep vein thromboses, and stroke" ('218 Patent, col. 12:4-6).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Breckenridge will induce infringement of the '218 patent. The basis for this allegation is the proposed product labeling, which allegedly instructs and encourages physicians and patients to use the generic product in a manner that directly infringes at least Claim 1 (Compl. ¶26, ¶33).
  • Willful Infringement: The complaint alleges that Breckenridge has "knowledge of the claims of the '218 patent" from at least the date of its notice letter and "specifically intends to infringe" (Compl. ¶32). While the term "willful" is not used, these allegations of knowledge and intent lay the foundation for a claim of willful infringement and a request for enhanced damages. The prayer for relief requests a finding that the case is "exceptional" under 35 U.S.C. § 285 (Compl., p. 10, ¶(d)).

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

  • A core issue will be one of induced infringement: Does the language of the proposed product label for Breckenridge's generic rivaroxaban actively instruct or encourage medical professionals and patients to administer the drug in a manner that satisfies every limitation of the patented method claim?
  • A key technical question will be one of definitional scope: Does Breckenridge's tablet formulation meet the specific dissolution criteria for a "rapid-release tablet" as explicitly defined in the '218 patent's specification? The answer to this could be dispositive for the infringement analysis.