DCT

1:17-cv-00648

Bayer IP GmbH v. Sigmapharm Laboratories LLC

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00648, D. Del., 05/26/2017
  • Venue Allegations: Defendant has represented that it consents to venue in the District of Delaware for the purposes of this case.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' XARELTO® product constitutes an act of infringement of a patent covering a method of treating thromboembolic disorders.
  • Technical Context: The technology relates to oral anticoagulants, specifically direct factor Xa inhibitors, which are used to prevent and treat blood clots in various medical conditions.
  • Key Procedural History: The complaint notes that Defendant has consented to jurisdiction in Delaware in prior cases, including Case No. 15-902, which involved the same ANDA at issue in this litigation.

Case Timeline

Date Event
2005-01-31 ’218 Patent Priority Date
2017-01-10 ’218 Patent Issue Date
2017-04-12 Sigmapharm Notice Letter sent to Plaintiffs
2017-05-26 Complaint Filing Date

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

U.S. Patent No. 9,539,218 - "Prevention and Treatment of Thromboembolic Disorders"

The Invention Explained

  • Problem Addressed: The patent describes disadvantages with prior art anticoagulants, such as heparin and vitamin K antagonists. These older treatments are often non-selective, have a slow onset of action, carry a high risk of bleeding, and require time-consuming individual patient monitoring and dose adjustment (’218 Patent, col. 8:1-20).
  • The Patented Solution: The invention is a method for treating thromboembolic disorders by administering a specific direct factor Xa inhibitor, rivaroxaban, in a rapid-release oral tablet no more than once daily. The patent asserts the surprising discovery that a once-daily regimen is effective, even though the compound has a short plasma half-life that would typically suggest twice-daily (bid) or thrice-daily (tid) administration (’218 Patent, col. 8:31-40, 65 - col. 9:4).
  • Technical Importance: This approach offers a simplified, oral, once-daily treatment regimen that potentially improves patient compliance and provides an effective therapy for serious thromboembolic disorders (’218 Patent, col. 8:35-40).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶18).
  • 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
    • 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 dependent claims.

III. The Accused Instrumentality

Product Identification

Sigmapharm's ANDA No. 208546 for 10 mg, 15 mg, and 20 mg rivaroxaban tablets ("Sigmapharm's ANDA Products") (Compl. ¶7).

Functionality and Market Context

The accused products are generic versions of Plaintiffs’ XARELTO® product (Compl. ¶23). The infringement allegation is based on the submission of the ANDA itself, which seeks FDA approval to market these generic tablets prior to the expiration of the ’218 Patent (Compl. ¶1, ¶29). The complaint alleges that the proposed labeling for Sigmapharm's ANDA Products directs their use for treating conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE), and for reducing the risk of stroke, mirroring the indications for XARELTO® (Compl. ¶15, ¶26).

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 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 Sigmapharm’s ANDA Products are alleged to contain rivaroxaban, which is the chemical compound recited in the claim. ¶24 col. 9:17-23
no more than once daily for at least five consecutive days The proposed labeling for Sigmapharm's ANDA Products allegedly directs use in a manner that satisfies the "no more than once daily for at least five consecutive days" requirement. ¶26 col. 8:65-col. 9:4
in a rapid-release tablet Sigmapharm's ANDA Products are tablets, and the complaint alleges on information and belief that this dosage form satisfies the "rapid-release tablet" requirement. ¶25 col. 11:19-24
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 proposed labeling for Sigmapharm's ANDA Products allegedly directs their use for indications including the treatment of deep vein thrombosis and pulmonary embolism, and reducing the risk of stroke. ¶26 col. 12:4-6

Identified Points of Contention

  • Scope Questions: A central question will be whether the acts of physicians and patients, following the instructions on Sigmapharm's proposed label, will meet every limitation of the claimed method. The dispute will likely focus on whether the label induces infringement of the complete method claim.
  • Technical Questions: What evidence supports the allegation that Sigmapharm's product is a "rapid-release tablet" as specifically defined in the patent? The patent provides a technical definition involving a specific dissolution rate (Q value of 75% in 30 minutes), and infringement will depend on whether Sigmapharm's formulation meets this standard (col. 11:19-24).

V. Key Claim Terms for Construction

  • Term for Construction: "rapid-release tablet"
  • Context and Importance: This term is critical because infringement hinges on whether Sigmapharm’s physical product meets this specific formulation requirement. Practitioners may focus on this term because the patent provides a potentially limiting definition, creating a specific technical hurdle for the plaintiff to prove is met by the accused product.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of arguments for a broader interpretation. A party might argue that the term should encompass any tablet generally understood by a person of ordinary skill in the art as being rapid-release, not just those strictly meeting the Q-value test.
    • Evidence for a Narrower Interpretation: The specification provides an explicit 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. 11:19-24). This language may be argued to act as a clear definitional statement by the patentee, limiting the claim scope to tablets that meet this specific dissolution profile.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement, stating that Sigmapharm plans to market its ANDA Products with proposed labeling that directs and instructs users (e.g., physicians and patients) to perform the patented method (Compl. ¶26, ¶32). The complaint also alleges contributory infringement, asserting that the ANDA Products are especially made or adapted for infringing the ’218 Patent and are not suitable for substantial noninfringing use (Compl. ¶33).
  • Willful Infringement: The complaint does not use the word "willful," but it alleges that Sigmapharm has knowledge of the ’218 Patent and, notwithstanding this knowledge, "specifically intends to infringe" (Compl. ¶31). Plaintiffs request that the court declare the case "exceptional" and award attorneys' fees pursuant to 35 U.S.C. § 285 (Compl., Prayer for Relief ¶(d)).

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

  • A core issue will be one of technical proof: can Plaintiffs demonstrate that Sigmapharm’s generic product, as described in its ANDA, meets the specific dissolution profile required by the patent’s definition of a “rapid-release tablet”? The outcome may depend on the precise formulation data contained within the confidential ANDA filing.
  • A second key question will be one of induced infringement: does the language of Sigmapharm’s proposed product label, which will govern how physicians prescribe and patients use the drug, contain sufficient instruction to actively encourage the performance of every step of the claimed method, thereby holding Sigmapharm liable for the actions of end-users?
  • Finally, the case raises a strategic question stemming from the patent’s core assertion: was it truly non-obvious and surprising to find that a once-daily dose of rivaroxaban was effective for these indications? While the complaint focuses on infringement, the ultimate resolution of the dispute may turn on the validity of the patent in view of the state of the art at the time of the invention.