DCT

1:17-cv-00584

Bayer IP GmbH v. Mylan Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00584, D. Del., 05/19/2017
  • Venue Allegations: Venue is alleged to be proper in Delaware because Mylan has registered to do business in the state, appointed an agent for service of process, and its Abbreviated New Drug Application (ANDA) filing will lead to marketing and sales activities having a substantial effect in Delaware.
  • Core Dispute: Plaintiffs allege that Defendant's filing of an ANDA to market a generic version of the anticoagulant drug XARELTO® (rivaroxaban) constitutes an act of infringement of a patent covering a specific method of treatment using the drug.
  • Technical Context: The technology relates to oral anticoagulants, specifically Factor Xa inhibitors, used for the prevention and treatment of thromboembolic disorders such as deep vein thrombosis and stroke.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, prompted by Mylan's submission of ANDA No. 208561 with a Paragraph IV certification against U.S. Patent No. 9,539,218 (’218 Patent). The '218 Patent is listed in the FDA's "Orange Book" for Plaintiffs' XARELTO® product. Mylan provided notice of its ANDA filing via a letter dated April 6, 2017.

Case Timeline

Date Event
2005-01-31 '218 Patent Priority Date
2017-01-10 '218 Patent Issue Date
2017-04-06 Mylan sends Paragraph IV Notice Letter
2017-05-19 Complaint Filing Date

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

  • 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 disadvantages of prior art anticoagulants. For instance, heparin 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. 2:1-18).
  • The Patented Solution: The invention is a method for treating specific thromboembolic disorders by administering the direct Factor Xa inhibitor rivaroxaban. The core of the claimed method is a "no more than once daily" dosing regimen (’218 Patent, col. 11:1-5). The specification suggests it was surprising that a once-daily administration of a compound with a relatively short plasma half-life (which would typically require twice-daily dosing) could be effective, representing a significant improvement in patient convenience and compliance (’218 Patent, col. 2:35-44; col. 3:1-4).
  • Technical Importance: The development of an effective, orally administered, once-daily anticoagulant that does not require frequent monitoring was a significant advance in the treatment and prevention of blood clots (’218 Patent, col. 2:56-62).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶30).
  • 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

The accused instrumentalities are Mylan's generic 10 mg, 15 mg, and 20 mg rivaroxaban tablets ("Mylan's ANDA Products"), for which Mylan seeks FDA approval via ANDA No. 208561 (Compl. ¶7).

Functionality and Market Context

The filing of the ANDA is the statutory act of infringement (Compl. ¶41). Mylan's ANDA Products are intended to be generic versions of Plaintiffs' XARELTO® (Compl. ¶25). The complaint alleges that the proposed labeling for Mylan's ANDA Products will direct their use for the same indications as XARELTO®, including the treatment of deep vein thrombosis and pulmonary embolism and the reduction of stroke risk (Compl. ¶17, ¶28). The act of seeking approval to market these products for these indications forms the basis of the infringement claim.

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 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 Mylan's ANDA Products allegedly directs its use for treating deep vein thrombosis (DVT) and pulmonary embolism (PE), and reducing the risk of stroke. ¶28 col. 11:3-5
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 Mylan's ANDA Products are alleged to contain rivaroxaban, the chemical compound specified in the claim. ¶26 col. 12:64-col. 13:1
no more than once daily for at least five consecutive days The proposed labeling for Mylan's ANDA Products allegedly directs administration in a manner that satisfies the "no more than once daily for at least five consecutive days" requirement. ¶28 col. 11:1-2
in a rapid-release tablet Mylan's ANDA Products are tablets, and the complaint alleges on information and belief that they satisfy the "rapid-release tablet" requirement. ¶27 col. 11:2

Identified Points of Contention

  • The complaint alleges that Mylan "did not contest infringement of any claim of the '218 patent" in its notice letter (Compl. ¶29). This suggests the primary legal battle may concern patent validity rather than infringement.
  • Technical Questions: A potential point of dispute, should Mylan contest infringement, is whether its formulation meets the claim's "rapid-release tablet" limitation. The complaint makes this allegation on "information and belief" (Compl. ¶27). The case could raise the question of what evidence demonstrates that Mylan's product meets the specific dissolution profile for a "rapid-release" tablet as potentially defined by the patent's specification.

V. Key Claim Terms for Construction

  • The Term: "rapid-release tablet"
  • Context and Importance: This term defines the formulation of the drug. Its construction is important because the complaint alleges compliance on "information and belief," signaling a potential area where factual proof will be required. The definition will determine whether Mylan's specific tablet formulation falls within the scope of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The parties could argue the term should be given its plain and ordinary meaning, covering any tablet that is not explicitly formulated for modified, delayed, or extended release.
    • Evidence for a Narrower Interpretation: The specification provides a potentially 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. 8:20-23). This language may be used to argue for a specific, quantitative standard that the accused product must meet.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b). The factual basis is Mylan's proposed product labeling, which allegedly instructs physicians and patients to administer the generic drug in a manner that directly practices the method of claim 1 (Compl. ¶28, ¶35). The complaint also pleads contributory infringement under § 271(c), alleging Mylan's products are especially made for infringing use and are not suitable for a substantial non-infringing use (Compl. ¶36).
  • Willful Infringement: The complaint does not explicitly use the term "willful infringement." However, it alleges that Mylan has knowledge of the '218 patent and its claims and, notwithstanding this knowledge, intends to infringe (Compl. ¶34). The prayer for relief requests a declaration that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285, which are remedies often associated with findings of egregious infringement (Compl., p. 9).

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

  • A core issue will be one of induced infringement: will Mylan's proposed product label, which is central to the ANDA, be found to inevitably instruct users to perform each step of the method claimed in the '218 patent? The complaint's allegations suggest a direct mapping between the label's instructions and the claim elements, making this a central question of fact and law for the court.
  • A key evidentiary question will be one of technical compliance: does Mylan's tablet formulation meet the '218 patent's "rapid-release tablet" limitation? The complaint's reliance on "information and belief" for this element, combined with the specification's precise technical definition, suggests that the outcome of this issue may depend on expert testimony and the results of dissolution testing of Mylan's product.
  • The ultimate question, underlying the entire ANDA proceeding, will be one of patent validity: although not detailed in the infringement complaint, the foundational dispute in a Paragraph IV case is whether the asserted patent claims are valid and enforceable. The resolution of the infringement claims is contingent upon the '218 patent surviving Mylan's anticipated validity challenges.