DCT

1:17-cv-00560

Bayer IP GmbH v. Micro Labs Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00560, D. Del., 05/12/2017
  • Venue Allegations: Venue is alleged to be proper based on general federal venue statutes, as well as Defendant's consent to jurisdiction in prior cases in the district and the anticipated marketing and sale of the accused products within Delaware.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) for generic versions of the anticoagulant drug XARELTO® constitutes an act of infringement of a patent covering a specific method of treatment using the drug.
  • Technical Context: The lawsuit concerns factor Xa inhibitors, a class of anticoagulant medications used to prevent and treat thromboembolic disorders such as deep vein thrombosis and to reduce the risk of stroke.
  • Key Procedural History: The complaint notes that Defendants have previously consented to jurisdiction in Delaware in prior cases involving the same ANDA, specifically referencing C.A. No. 15-902, which may have procedural implications for the current case. The current action arises from a Paragraph IV certification filed by Defendants, a formal declaration that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2005-01-31 U.S. Patent No. 9,539,218 Priority Date
2017-01-10 U.S. Patent No. 9,539,218 Issues
2017-03-30 Defendants send Notice Letter regarding ANDA submission
2017-05-12 Complaint Filed

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 the state of anticoagulant therapy as being dominated by agents with significant drawbacks ('218 Patent, col. 2:2-19). Heparin, for example, is non-selective and carries a high risk of bleeding, while vitamin K antagonists like warfarin have a very slow onset of action and a narrow therapeutic index, requiring time-consuming patient monitoring ('218 Patent, col. 2:2-19).
  • The Patented Solution: The invention is a method of treatment using a direct factor Xa inhibitor, rivaroxaban. The patent asserts the surprising discovery that this compound, despite having a relatively short plasma half-life that would typically suggest twice-daily (bid) or thrice-daily (tid) dosing, is effective when administered orally just once per day ('218 Patent, col. 2:64-col. 3:1). The method involves administering a "rapid-release tablet" containing the compound once daily to treat specific thromboembolic disorders ('218 Patent, col. 3:2-15).
  • Technical Importance: This once-daily oral dosing regimen offers a significant improvement in convenience and potential patient compliance compared to older anticoagulants and even compared to what would be expected for a drug with this compound's pharmacokinetic profile ('218 Patent, col. 2:35-40).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 (Compl. ¶33).
  • Independent Claim 1 requires:
    • 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 does not explicitly reserve the right to assert other claims, but alleges infringement of "at least claim 1" (Compl. ¶33).

III. The Accused Instrumentality

Product Identification

  • "Micro Labs' ANDA Products," specifically 10 mg, 15 mg, and 20 mg rivaroxaban tablets, for which Defendants submitted ANDA No. 208334 to the FDA (Compl. ¶9, ¶12).

Functionality and Market Context

  • The accused products are generic versions of Plaintiffs' XARELTO® tablets (Compl. ¶28). As part of the ANDA process, the proposed generic product is intended to have the same active ingredient, dosage form, and strength, and to be bioequivalent to the branded drug.
  • The complaint alleges that the proposed labeling for the ANDA products will direct their use for the same indications as XARELTO®, including the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the reduction of stroke risk in certain patients (Compl. ¶31). These indications directly overlap with the disorders recited in the asserted patent claim.
  • 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. Defendants' proposed product labeling allegedly directs the use of its ANDA Products for indications that include the treatment of DVT, PE, and the reduction of stroke risk, which are among the disorders recited in the claim. ¶31 col. 11:2-5
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 Defendants' ANDA and Notice Letter allegedly state that the accused ANDA Products contain rivaroxaban, the chemical compound recited in the claim. ¶29 col. 11:5-9
no more than once daily for at least five consecutive days The proposed labeling for the ANDA Products allegedly directs administration in a manner satisfying the "no more than once daily for at least five consecutive days" requirement. ¶31 col. 12:1-2
in a rapid-release tablet The dosage form of the ANDA Products is tablets, which, on information and belief, allegedly satisfy the "rapid-release tablet" requirement of the claim. ¶30 col. 12:2-3
to a patient in need thereof, The proposed labeling directs use for patients with the specified medical conditions, thus identifying them as patients in need of the treatment. ¶31 col. 12:3-4
  • Identified Points of Contention:
    • Technical Questions: A central question will be whether the Defendants' proposed tablets meet the definition of a "rapid-release tablet" as required by the claim. The complaint's allegation on this point is based on "information and belief" (Compl. ¶30), indicating that the specific dissolution profile and formulation characteristics of the ANDA product will be a key area of discovery and dispute.
    • Scope Questions: The interpretation of the term "rapid-release tablet" will be critical. The case may turn on whether this term is given its plain and ordinary meaning in the pharmaceutical arts or whether it is limited by more specific language found within the patent's specification.

V. Key Claim Terms for Construction

  • The Term: "rapid-release tablet"
  • Context and Importance: This term is a specific limitation on the dosage form required by the asserted claim. Proving that the accused ANDA product is a "rapid-release tablet" is essential to Plaintiffs' infringement case. Conversely, if Defendants' product falls outside the proper construction of this term, it cannot infringe. Practitioners may focus on this term because its definition appears to be directly addressed in the patent's detailed description.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue that "rapid-release" should be given its plain and ordinary meaning to a person of skill in the pharmaceutical arts, without being constrained by any single example in the specification. The specification describes tablets "releasing the active compound rapidly" as a preference, which could be argued as descriptive rather than strictly definitional (e.g., '218 Patent, col. 8:17-19).
    • Evidence for a Narrower Interpretation: The specification provides a highly specific, quantitative description: "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. 8:19-23). A party will likely argue that this sentence constitutes a clear definition that limits the scope of the term to tablets meeting this specific dissolution test standard.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b) (Compl. ¶38, ¶47). The factual basis for this allegation is that Defendants' proposed product labeling for the ANDA product will allegedly instruct physicians and patients to administer the drug in a manner that directly practices the steps of the claimed method (Compl. ¶31, ¶33).
  • Willful Infringement: The complaint alleges that Defendants have knowledge of the '218 patent, citing the Paragraph IV certification and the notice letter sent to Plaintiffs on March 30, 2017 (Compl. ¶28, ¶34, ¶37). The complaint further alleges that despite this knowledge, Defendants intend to engage in infringing activities immediately upon FDA approval, and that such infringement will be willful (Compl. ¶36, ¶37).

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

This ANDA litigation appears to center on a combination of claim construction and technical fact-finding. The key questions for the court will likely be:

  1. A dispositive issue of claim construction: Does the phrase "rapid-release tablet" carry a broad, ordinary meaning, or is its scope limited by the patent’s explicit reference to a specific 75% dissolution value under the USP paddle test method? The outcome of this construction could determine the entire case.
  2. An evidentiary question of infringement: Assuming the claim is construed, does the formulation described in Micro Labs' confidential ANDA submission actually meet the technical requirements of a "rapid-release tablet"? The answer will depend on technical data regarding the proposed generic product's dissolution profile.