DCT

1:18-cv-01926

Bayer IP GmbH v. Teva Pharma USA Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01926, D. Del., 12/05/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva USA is a Delaware corporation, and Defendant Teva Ltd. is a foreign entity not resident in the United States.
  • Core Dispute: Plaintiffs allege that Defendant's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant drug XARELTO® constitutes an act of infringement of a patent covering a method of treating specific thromboembolic disorders with a once-daily dosing regimen.
  • Technical Context: The technology concerns oral anticoagulants known as direct factor Xa inhibitors, which are used for the prevention and treatment of blood clots that can lead to conditions such as stroke, deep vein thrombosis, and pulmonary embolism.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter, dated October 22, 2018, in which Teva informed Plaintiffs of its ANDA filing containing a Paragraph IV certification against the patent-in-suit. The patent is listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book) in connection with XARELTO®.

Case Timeline

Date Event
2005-01-31 '218 Patent Priority Date
2017-01-10 '218 Patent Issue Date
2018-10-22 Teva ANDA Notice Letter Sent to Plaintiffs
2018-12-05 Complaint Filing Date

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 Invention Explained

  • Problem Addressed: The patent's background describes the significant drawbacks of prior art anticoagulants, such as heparin and warfarin, which include non-selective action, high bleeding risks, slow onset of action, and the need for frequent and inconvenient patient monitoring ('218 Patent, col. 2:1-17). A specific challenge identified is the difficulty of creating a convenient once-daily oral dosing regimen for drugs that possess a short plasma half-life, which would ordinarily suggest more frequent administration ('218 Patent, col. 2:35-43).
  • The Patented Solution: The patent claims to have surprisingly discovered that a direct factor Xa inhibitor with a short plasma half-life (10 hours or less) can be administered effectively and safely on a "no more than once daily" basis to treat certain thromboembolic disorders ('218 Patent, Abstract; col. 3:1-17). This method provides the clinical efficacy required for treatment while offering the improved patient convenience and compliance associated with a once-daily schedule ('218 Patent, col. 2:35-43).
  • Technical Importance: The described method addressed a key challenge in pharmaceutical therapy by enabling a simple once-daily dosing schedule for a class of drugs whose pharmacokinetic properties would otherwise point toward a more frequent and less convenient administration regimen ('218 Patent, col. 2:35-43).

Key Claims at a Glance

  • The complaint asserts independent claim 1 ('Compl. ¶33).
  • The essential elements of independent claim 1 are:
    • 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 (rivaroxaban),
    • no more than once daily,
    • for at least five consecutive days,
    • in a rapid-release tablet,
    • to a patient in need thereof,
    • wherein the thromboembolic disorder is selected from the group consisting of pulmonary embolisms, deep vein thromboses, and stroke.
  • The complaint alleges infringement of "at least claim 1," thereby reserving the right to assert other claims, including dependent claims ('Compl. ¶33).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Teva's proposed generic rivaroxaban tablets in 10 mg, 15 mg, and 20 mg dosage strengths, as described in ANDA No. 212247 (the "Teva ANDA Products") (Compl. ¶9).

Functionality and Market Context

The complaint alleges that the Teva ANDA Products are generic versions of Plaintiffs' XARELTO® product (Compl. ¶28). The functionality relevant to the infringement allegations is defined by the proposed product labeling, which allegedly instructs administration for indications that include the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and the reduction of stroke risk (Compl. ¶31). The complaint further alleges that the proposed labeling directs a dosing regimen that satisfies the "no more than once daily for at least five consecutive days" limitation and that the product is formulated as a tablet that satisfies the "rapid-release tablet" limitation (Compl. ¶30, 31).

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
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 Teva’s ANDA Products contain rivaroxaban, the active ingredient specified in the claim. ¶29 col. 11:51-57
no more than once daily for at least five consecutive days The proposed labeling for Teva's ANDA Products allegedly directs administration in a manner that satisfies this dosing frequency and duration. ¶31 col. 11:58-59
in a rapid-release tablet The dosage form of Teva’s ANDA Products is tablets, which allegedly satisfies the "rapid-release tablet" requirement. ¶30 col. 11:60
wherein the thromboembolic disorder is selected from the group consisting of pulmonary embolisms, deep vein thromboses, and stroke The proposed labeling for Teva's ANDA Products allegedly directs use for indications including the treatment of PE, DVT, and stroke. ¶31 col. 11:62-65

Identified Points of Contention

  • Technical Question: The complaint alleges that Teva's product is a "rapid-release tablet" but provides no specific technical data to support this conclusion (Compl. ¶30). The patent provides a specific technical definition for this term ('218 Patent, col. 8:19-24). A key question for the court will be whether Teva’s proposed product meets this specific definition, which may require evidence beyond the general fact that it is a tablet.
  • Scope Questions: Infringement of this method claim is predicated on the instructions for use in Teva's proposed product label. An issue may arise as to whether the language of the final, FDA-approved label will direct or "encourage" administration for the specific combination of indications, dosage, and duration required by claim 1.

V. Key Claim Terms for Construction

  • The Term: "rapid-release tablet"

  • Context and Importance: The definition of this term is critical, as Teva’s product must meet this limitation for a finding of infringement. Practitioners may focus on this term because the patent provides a specific, quantitative definition that may serve as a clear basis for distinguishing infringing from non-infringing products.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party could argue that, in the absence of a specific definition, the term should be given its plain and ordinary meaning, which might encompass any standard oral tablet that is not an extended- or delayed-release formulation.
    • Evidence for a Narrower Interpretation: The specification provides a highly specific definition: "In the context of the present invention, 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. 8:19-24). This language provides strong intrinsic evidence for a narrow construction tied to a specific dissolution test standard.

  • The Term: "treating"

  • Context and Importance: This term defines the purpose of the claimed method. In an ANDA case, the indications for use on the proposed label must fall within the scope of "treating" the claimed disorders.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent acts as its own lexicographer, stating: "The term 'treatment' includes the therapeutic and/or prophylactic treatment of thromboembolic disorders." ('218 Patent, col. 7:25-27). This express definition supports a broad construction covering both active therapy and preventative (prophylactic) use.
    • Evidence for a Narrower Interpretation: A party could argue that within the context of the entire patent, the "treatment" of different disorders (e.g., active DVT versus risk reduction for stroke) implies different clinical actions, potentially raising arguments about whether a label's specific indication for "risk reduction" constitutes "treatment" of the underlying disorder itself.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement, asserting that Teva’s proposed product labeling will instruct physicians to prescribe and patients to use the generic drug in a manner that directly infringes the '218 patent (Compl. ¶38, 40). It also alleges contributory infringement, stating that the Teva ANDA Products are "especially made or adapted for use in infringing" and are "not suitable for substantial noninfringing use" (Compl. ¶39).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Teva had knowledge of the '218 patent via its listing in the FDA's Orange Book and through Plaintiffs' pre-suit communications (Compl. ¶27, 28, 37). The pleading asserts that Teva intends to infringe despite this knowledge, which may form the basis for a future claim of willful infringement or a finding that the case is exceptional under 35 U.S.C. § 285 (Compl. ¶37; Prayer for Relief ¶(d)).

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

  • A central issue will be one of claim construction and technical proof: can Plaintiffs prove that Teva’s proposed generic tablet meets the specific, quantitative definition of a "rapid-release tablet" provided in the '218 patent's specification? The outcome may depend on dissolution testing data for Teva’s product.
  • A key legal and evidentiary question will be one of induced infringement: does the precise language of Teva's proposed product label—which will be subject to FDA approval—inevitably instruct or encourage medical professionals and patients to perform every step of the claimed method for the specified disorders, thereby making Teva liable for inducing infringement?