DCT

1:17-cv-00462

Bayer IP GmbH v. Taro Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Bayer IP GmbH v. Taro Pharmaceutical Industries Ltd., 1:17-cv-00462, D. Del., 04/21/2017
  • Venue Allegations: Venue is asserted based on Defendant’s intent to market and sell the accused products throughout the United States, including in Delaware, and on Defendant’s consent to personal jurisdiction in Delaware for the purposes of the case.
  • Core Dispute: Plaintiffs allege that Defendant’s filing 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 once-daily method of treatment.
  • Technical Context: The technology relates to oral factor Xa inhibitors, a class of drugs used for the treatment and prevention of thromboembolic disorders (blood clots).
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendant’s submission of an ANDA containing a Paragraph IV certification. This certification asserts that U.S. Patent No. 9,539,218 is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the generic drug for which the ANDA was submitted. Plaintiffs received a notice letter from Defendant regarding the ANDA submission on March 8, 2017. The patent-in-suit 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
2017-03-08 Taro Notice Letter Sent to Plaintiffs
2017-04-21 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 disadvantages of prior art anticoagulants, such as heparin and vitamin K antagonists (e.g., warfarin) (’218 Patent, col. 2:1-4). These older therapies are described as having drawbacks including non-selective action, slow onset, a narrow therapeutic index, and the need for frequent, time-consuming patient monitoring (’218 Patent, col. 2:5-18).
  • The Patented Solution: The invention is a method of treatment using a once-daily oral administration of a specific direct factor Xa inhibitor, rivaroxaban. This is presented as a surprising and advantageous finding because the drug's short plasma half-life (less than 10 hours) would conventionally suggest a twice-daily or thrice-daily dosing regimen to maintain therapeutic effect (’218 Patent, Abstract; col. 2:64-col. 3:3). The patent discloses clinical trial data suggesting that once-daily administration was as effective and safe as twice-daily administration (’218 Patent, col. 9:18-col. 10:62).
  • Technical Importance: A once-daily oral dosing regimen offers significant improvements in patient convenience and compliance, addressing a key limitation of older anticoagulant therapies (’218 Patent, col. 2:38-40).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶35).
  • 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 does not explicitly reserve the right to assert dependent claims, but the allegation of infringement of "at least claim 1" suggests this possibility.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Taro's 10 mg, 15 mg, and 20 mg rivaroxaban tablets ("Taro's ANDA Products"), for which Taro submitted ANDA No. 208557 to the FDA for marketing approval (Compl. ¶10, ¶13).

Functionality and Market Context

  • The products are generic versions of Plaintiffs' XARELTO® tablets (Compl. ¶30). Infringement is predicated on the act of submitting the ANDA, and on the intended use of the products post-approval (Compl. ¶46). The complaint alleges that the proposed labeling for Taro's ANDA Products will instruct medical professionals and patients to administer the drug for indications and according to a dosing schedule that falls within the scope of the asserted patent claims (Compl. ¶33).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary

The complaint provides a narrative infringement theory, which can be summarized as follows for the lead asserted claim.

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... Taro's ANDA Products contain rivaroxaban, the specific compound identified in the claim. ¶31 col. 11:63-12:4
...no more than once daily for at least five consecutive days... The proposed labeling for Taro's ANDA Products allegedly directs a course of treatment that satisfies the "no more than once daily for at least five consecutive days" requirement. ¶33 col. 11:1-2
...in a rapid-release tablet... In its notice letter, Taro allegedly stated that the dosage form of its ANDA Products is tablets and that this form satisfies the "rapid-release tablet" requirement of claim 1. ¶32 col. 8:19-24
...wherein the thromboembolic disorder is selected from the group consisting of pulmonary embolisms, deep vein thromboses, and stroke. The proposed labeling for Taro's ANDA Products directs use for indications that include the treatment of deep vein thrombosis and pulmonary embolism, which are among the disorders specified in the claim. ¶33 col. 12:4-6

Identified Points of Contention

  • Legal Question: The primary issue in this Hatch-Waxman case is one of induced infringement. The central question will be whether the language of the final, FDA-approved label for Taro's generic product will actively encourage or instruct physicians and patients to prescribe and use the drug in a manner that directly practices the patented method defined in the claims.
  • Technical Question: While the complaint alleges that Taro stated its product meets the "rapid-release tablet" requirement (Compl. ¶32), a potential point of dispute could involve factual evidence demonstrating whether the dissolution profile of Taro's ANDA product meets the specific standard defined in the patent's specification.

V. Key Claim Terms for Construction

  • The Term: "rapid-release tablet"
  • Context and Importance: This term defines the claimed dosage form. Its construction is critical because infringement requires that the accused generic product be administered in this specific form. Practitioners may focus on this term because pharmaceutical formulations can have varying release profiles, and a mismatch could be a basis for a non-infringement argument.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue for the term's plain and ordinary meaning as understood by a person of ordinary skill in the art of pharmaceutical formulation.
    • Evidence for a Narrower Interpretation: The patent specification provides an explicit 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. 8:19-24). This specific, technical definition provided by the patentee is likely to be a controlling piece of intrinsic evidence.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement, stating that Taro plans and intends for its proposed product labeling to instruct physicians and patients to use the generic drug in a manner that directly infringes the ’218 patent (Compl. ¶33, ¶40). The complaint also pleads contributory infringement, alleging Taro knows its product is especially adapted for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶41).
  • Willful Infringement: While not using the word "willful," the complaint alleges that Taro has knowledge of the ’218 patent and, notwithstanding this knowledge, intends to engage in infringing activities immediately upon FDA approval of its ANDA (Compl. ¶39). Plaintiffs also request a declaration that this is an "exceptional case" and an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Prayer for Relief, (d)).

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

  • A core issue will be one of induced infringement: will the final, FDA-approved label for Taro's generic rivaroxaban product contain instructions that affirmatively direct, encourage, or recommend that physicians and patients use the drug in a manner that satisfies every step of the asserted method claim, particularly the "no more than once daily" limitation for the specified disorders?
  • A key evidentiary question will be one of technical compliance: can Plaintiffs prove, and will Defendants dispute, that Taro's proposed generic tablet is in fact a "rapid-release tablet" as that term is specifically defined within the '218 patent's specification? The outcome may depend on whether Defendant's alleged pre-litigation statement on this matter is binding.