DCT

1:20-cv-00090

Boehringer Ingelheim Pharma Inc v. Mylan Pharma

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Boehringer Ingelheim Pharmaceuticals Inc., et al. v. Mylan Pharmaceuticals Inc., et al., 1:20-cv-00090, N.D. W. Va., 05/08/2020
  • Venue Allegations: Venue is alleged to be proper based on Defendant Mylan having committed acts of infringement and maintaining a regular and established place of business in the district.
  • Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Plaintiff's JENTADUETO® diabetes medication constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical formulations for treating type 2 diabetes by combining a DPP-IV inhibitor (linagliptin) with a further antidiabetic agent (metformin) into a stable, single-tablet fixed-dose combination.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of an ANDA to the FDA. The complaint notes that Plaintiff received Paragraph IV certification letters from Defendant asserting that the patents-in-suit are invalid or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2008-04-03 Earliest Priority Date for ’016 and ’379 Patents
2016-08-16 U.S. Patent No. 9,415,016 Issued
2017-03-07 Plaintiff allegedly receives Paragraph IV letter regarding ’016 Patent
2018-07-17 U.S. Patent No. 10,022,379 Issued
2018-11-02 Plaintiff allegedly receives Paragraph IV letter regarding ’379 Patent
2020-05-08 Complaint Filed

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

U.S. Patent No. 9,415,016 - "DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation"

The Invention Explained

  • Problem Addressed: The patent addresses the chemical incompatibility and degradation that occurs when formulating DPP-IV inhibitors that contain a primary or secondary amino group. These compounds are described as reacting with common pharmaceutical excipients (such as reducing sugars) and other drug substances, leading to instability in solid oral dosage forms like tablets (’379 Patent, col. 5:7-27).
  • The Patented Solution: The invention claims to solve this stability problem by including a "nucleophilic and/or basic agent," such as the amino acid L-arginine, in the formulation. This agent acts as a stabilizer or buffering agent, protecting the DPP-IV inhibitor from chemical degradation and allowing for the creation of a stable fixed-dose combination tablet (’379 Patent, col. 5:36-51, col. 6:20-27).
  • Technical Importance: Creating a stable fixed-dose combination of multiple therapeutic agents simplifies treatment regimens, which can improve patient adherence and clinical outcomes.

Key Claims at a Glance

  • The complaint does not identify the specific claims asserted against the Mylan ANDA Product, alleging only infringement of "at least one claim" of the ’016 Patent (Compl. ¶41).

U.S. Patent No. 10,022,379 - "DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation"

The Invention Explained

  • Problem Addressed: As with the related ’016 Patent, this patent addresses the chemical instability of DPP-IV inhibitors containing primary or secondary amino groups when formulated in a fixed-dose combination with other drugs and excipients (’379 Patent, col. 5:7-27).
  • The Patented Solution: The solution is the use of a stabilizing agent, specifically a nucleophilic and/or basic agent such as L-arginine, to prevent degradation of the DPP-IV inhibitor within the solid dosage form (’379 Patent, col. 5:36-51).
  • Technical Importance: This technology enables the development of stable oral combination therapies for diabetes, which are commercially valuable for their potential to improve patient compliance over multi-tablet regimens.

Key Claims at a Glance

  • The complaint does not identify the specific claims asserted against the Mylan ANDA Product, alleging only infringement of "at least one claim" of the ’379 Patent (Compl. ¶55).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant's proposed generic linagliptin/metformin hydrochloride tablets in 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1000 mg dosages, for which Defendant submitted ANDA No. 208430 to the FDA (the "Mylan ANDA Product") (Compl. ¶15).

Functionality and Market Context

The Mylan ANDA Product is a proposed generic version of Plaintiff's JENTADUETO® tablets, a treatment for type 2 diabetes (Compl. ¶1). The complaint alleges that Mylan's ANDA relies on the JENTADUETO® New Drug Application and contains data intended to demonstrate the bioequivalence of the Mylan ANDA Product to JENTADUETO® (Compl. ¶39, 53). The act of infringement alleged is the submission of the ANDA itself, which seeks FDA approval to manufacture and sell this generic product before the expiration of the patents-in-suit (Compl. ¶¶ 41, 55). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or sufficient technical detail to construct a meaningful summary of the infringement allegations on a claim-element-by-claim-element basis. The infringement counts are based on the statutory act of filing an ANDA under 35 U.S.C. § 271(e)(2), which constitutes a technical act of infringement for jurisdictional purposes if the product described in the ANDA would infringe an existing patent upon commercialization (Compl. ¶¶ 41, 55). The substantive infringement analysis will depend on the specific formulation detailed in Mylan's confidential ANDA submission.

  • Identified Points of Contention:
    • Technical Questions: A central technical question, once the composition of the Mylan ANDA Product is known, will be whether its formulation contains a "nucleophilic and/or basic agent" that functions as a stabilizer in the manner claimed by the patents. The dispute may turn on whether the excipients used by Mylan, even if different from the preferred embodiments like L-arginine, meet the functional requirements of the asserted claims.

V. Key Claim Terms for Construction

The complaint does not identify any specific asserted claims from the patents-in-suit. This precludes an analysis of key claim terms that may be subject to construction.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Mylan will induce infringement by others (e.g., patients and physicians) through its promotional activities and package inserts, which will allegedly instruct on an infringing use of the Mylan ANDA Product (Compl. ¶¶ 47-48, 61-62). The complaint also alleges contributory infringement, asserting that the Mylan ANDA Product is not a staple article of commerce suitable for substantial non-infringing use and is especially made or adapted for infringing the patents (Compl. ¶¶ 45-46, 59-60).
  • Willful Infringement: The complaint does not use the term "willful infringement" but alleges the case is "exceptional" under 35 U.S.C. § 285, warranting an award of attorneys' fees (Compl. ¶¶ 50, 64). The basis for this allegation appears to be Mylan's alleged knowledge of the patents, evidenced by its submission of Paragraph IV certification letters to Boehringer on or about March 7, 2017 (for the ’016 Patent) and November 2, 2018 (for the ’379 Patent) (Compl. ¶¶ 40, 54).

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

  • A core issue will be one of infringement: once the formulation of the Mylan ANDA Product is disclosed, does it contain a stabilizing agent that falls within the scope of the asserted patent claims, either literally or under the doctrine of equivalents? The case will likely involve a detailed comparison of the excipients and chemical environment within Mylan's proposed tablet against the specific limitations of the patents' claims.
  • A second key issue will be one of validity: as indicated by Mylan’s Paragraph IV certifications, the validity of the asserted claims will be challenged. This challenge may focus on whether it would have been obvious to a person of ordinary skill in the art of pharmaceutical formulation to use a basic agent, such as an amino acid, to stabilize a DPP-IV inhibitor in a fixed-dose combination with metformin at the time the invention was made.