DCT

1:17-cv-01047

Bayer IP GmbH v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01047, D. Del., 07/28/2017
  • Venue Allegations: Venue is asserted in Delaware based on Lupin Pharmaceuticals, Inc. being a Delaware corporation and having appointed a registered agent in the state. Jurisdiction over the foreign parent, Lupin Limited, is alleged based on its filing of an Abbreviated New Drug Application (ANDA) for the purpose of marketing and selling products in Delaware, and alternatively under Fed. R. Civ. P. 4(k)(2).
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an ANDA to market a generic version 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 technology relates to oral anticoagulant therapies, specifically methods of using direct factor Xa inhibitors to treat and prevent thromboembolic disorders such as deep vein thrombosis and stroke.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act, following Lupin's submission of ANDA No. 208555 to the FDA. The complaint states that Lupin filed a Paragraph IV Certification, asserting that U.S. Patent No. 9,539,218 is invalid, unenforceable, or will not be infringed by its proposed generic product. The patent-in-suit is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for Plaintiffs' XARELTO® product.

Case Timeline

Date Event
2005-01-31 '218' Patent Priority Date
2017-01-10 '218 Patent Issue Date
2017-06-13 Lupin sends Paragraph IV Notice Letter
2017-07-28 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 describes the state of the art in anticoagulants, noting that prior therapies such as heparin and vitamin K antagonists suffered from significant drawbacks. These included a high risk of bleeding, a slow onset of action, and the need for frequent, time-consuming patient monitoring and dose adjustments ('218 Patent, col. 2:1-18).
  • The Patented Solution: The invention is a method of treatment using a direct factor Xa inhibitor, specifically rivaroxaban, that is administered orally no more than once daily. The patent asserts the surprising discovery that a once-daily regimen is safe and effective, even though the compound's plasma half-life of 10 hours or less would typically suggest a more frequent, twice-daily (bid) or thrice-daily (tid) dosing schedule was necessary ('218 Patent, Abstract; col. 3:1-4).
  • Technical Importance: The claimed once-daily oral administration method offered a significant improvement in convenience and potential patient compliance over older anticoagulants and even over the expected dosing frequency for this class of drugs, simplifying the management of serious thromboembolic conditions ('218 Patent, col. 2:35-44).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶34, 48).
  • The essential elements of independent 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 rivaroxaban (identified by its chemical name);
    • The administration is "no more than once daily";
    • The administration occurs "for at least five consecutive days";
    • The administration is "in a rapid-release tablet";
    • The administration is to a "patient in need thereof".
  • The complaint does not specify whether dependent claims will be asserted.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Lupin's ANDA Products," comprising 10 mg, 15 mg, and 20 mg rivaroxaban tablets for which Lupin seeks FDA approval via ANDA No. 208555 (Compl. ¶9, 31). The infringement is the statutory act of filing the ANDA to seek approval for future commercial activity (Compl. ¶45).

Functionality and Market Context

  • The functionality of the accused products is defined by Lupin's proposed product labeling submitted with its ANDA (Compl. ¶33).
  • The complaint alleges this labeling will direct physicians and patients to use the generic tablets to treat thromboembolic disorders, including those specified in claim 1 (Compl. ¶33).
  • The complaint further alleges, on information and belief, that the proposed label will direct a dosing regimen that meets the "no more than once daily for at least five consecutive days" limitation, and that the tablet formulation will satisfy the "rapid-release tablet" requirement of the claim (Compl. ¶32-33).
  • The accused products are generic versions of XARELTO®, which is identified as a factor Xa inhibitor for treating various thromboembolic disorders (Compl. ¶22, 30).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'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. Lupin's proposed product labeling allegedly directs the use of its generic product for indications that include deep vein thrombosis (DVT), pulmonary embolism (PE), and reducing the risk of stroke. ¶33 col. 12:2-5
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 Lupin stated in its notice letter that its ANDA Products contain rivaroxaban, the compound identified in the claim. ¶31 col. 3:19-25
no more than once daily for at least five consecutive days On information and belief, the proposed labeling for Lupin's ANDA Products allegedly directs a use that "satisfies the 'no more than once daily for at least five consecutive days' requirement" of the claim. ¶33 col. 11:2-3
in a rapid-release tablet Lupin's ANDA Products are tablets. On "information and belief," the complaint alleges this dosage form satisfies the "rapid-release tablet" requirement. ¶32 col. 8:12-24
to a patient in need thereof The proposed labeling directs use for patients with the specified thromboembolic disorders. ¶33 col. 11:4
  • Identified Points of Contention:
    • Scope Questions: A central dispute may concern the meaning of "rapid-release tablet". The complaint pleads infringement of this element "on information and belief," which may suggest that Plaintiffs lack full details on the formulation of Lupin's proposed product. The case will raise the question of whether Lupin's tablet formulation falls within the scope of this term as it is used and potentially defined in the patent.
    • Technical Questions: Since this is a method-of-use claim asserted in an ANDA context, the primary infringement theory is inducement. A key question for the court will be whether the instructions in Lupin's proposed product label will inevitably lead medical providers to prescribe, and patients to take, the drug in a manner that practices every element of the claimed method for the specified disorders.

V. Key Claim Terms for Construction

  • The Term: "rapid-release tablet"
  • Context and Importance: This term defines the physical dosage form of the drug. Its construction is critical because infringement of this element is pleaded "on information and belief" (Compl. ¶32), signaling it as a potential area of disagreement. Whether Lupin's proposed generic tablet is a "rapid-release tablet" will be a determinative issue for infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue for a plain and ordinary meaning, where any conventional tablet not explicitly formulated for extended or modified release would qualify. The specification lists "tablets releasing the active compound rapidly" as one of several possible "oral dosage forms" ('218 Patent, col. 8:16-19), which might support an argument that the term should not be narrowly confined.
    • Evidence for a Narrower Interpretation: The specification includes a sentence that may be construed as a 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. 8:21-24). A party could argue that this language establishes a specific, limiting technical standard that a product must meet to be considered "rapid-release" for the purposes of the patent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Lupin will actively induce infringement of the '218 patent upon approval of its ANDA. The basis for this allegation is that Lupin's proposed product labeling will instruct physicians and patients to use the generic drug in a manner that directly infringes the patented method (Compl. ¶39). The complaint alleges Lupin has knowledge of the patent and specifically intends for its product to be used in an infringing manner (Compl. ¶38).
  • Willful Infringement: While the complaint does not explicitly use the term "willful," it requests a declaration that the case is "exceptional" and an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl., Prayer for Relief (d)). This claim is predicated on allegations that Lupin has knowledge of the '218 patent and its claims yet has persisted in seeking approval for its ANDA products (Compl. ¶38).

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

  • A core issue will be one of claim construction and factual proof: Does the term "rapid-release tablet" require adherence to the specific dissolution profile ("Q value (30 minutes) of 75%") described in the patent specification, and does the defendant's proposed generic product meet this standard?
  • A key question of induced infringement will turn on the specific language of the defendant's proposed product label: Do the instructions on the label, taken as a whole, direct or encourage medical professionals and patients to perform every step of the patented method for the claimed indications, or does the label permit substantial non-infringing uses?