DCT

1:24-cv-00082

Boehringer Ingelheim Pharma Inc v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00082, N.D.W. Va., 09/09/2024
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant Mylan Pharmaceuticals Inc. is incorporated in and maintains its principal place of business in the district, and the Mylan Defendants have a regular and established place of business in the district and have litigated prior patent disputes there.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of Abbreviated New Drug Applications (ANDAs) to market generic versions of the diabetes drugs TRADJENTA® and JENTADUETO® infringes patents related to specific pharmaceutical formulations and methods of treating type 2 diabetes.
  • Technical Context: The technology concerns oral treatments for type 2 diabetes using linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, which helps improve glycemic control.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of Paragraph IV certification letters from Defendant dated December 3, 2021, and July 18, 2024. The complaint notes an ongoing, related patent infringement action between the parties concerning the same ANDAs in the same judicial district.

Case Timeline

Date Event
2006-05-04 U.S. Patent No. 11,033,552 Priority Date
2008-10-16 U.S. Patent No. 11,911,388 Priority Date
2021-06-15 U.S. Patent No. 11,033,552 Issues
2021-12-03 Plaintiff receives Paragraph IV letter regarding the ’552 Patent
2024-02-27 U.S. Patent No. 11,911,388 Issues
2024-07-18 Plaintiff receives Paragraph IV letters regarding the ’388 Patent
2024-09-09 Complaint Filed

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

U.S. Patent No. 11,911,388 - Treatment for Diabetes in Patients with Insufficient Glycemic Control Despite Therapy with an Oral or Non-Oral Antidiabetic Drug (Issued Feb. 27, 2024)

The Invention Explained

  • Problem Addressed: The patent describes the progressive nature of type 2 diabetes, where conventional therapies such as metformin or sulfonylureas often fail to maintain long-term glycemic control, leading to a high rate of therapeutic failure and associated chronic complications (’388 Patent, col. 2:1-11). This is particularly challenging in patient subpopulations, such as those with renal impairment, where treatment options may be limited (’388 Patent, col. 4:39-44).
  • The Patented Solution: The invention is a method of treatment for a specific patient group: type 2 diabetes patients who have renal impairment and still exhibit insufficient glycemic control even while on metformin therapy. The claimed solution is the administration of a 5 mg oral daily dose of the DPP-4 inhibitor linagliptin in combination with metformin to treat this patient population (’388 Patent, Abstract; Compl. ¶49).
  • Technical Importance: This method provides a specific therapeutic regimen for a difficult-to-treat patient population for whom standard therapies have proven inadequate, addressing a need for more effective long-term glycemic management.

Key Claims at a Glance

  • The complaint asserts at least one claim and identifies independent claim 1 as representative (Compl. ¶49, 52).
  • Essential elements of independent claim 1 include:
    • A method for treating metabolic diseases in type 2 diabetes patients with both renal impairment and insufficient glycemic control despite ongoing metformin therapy.
    • The method comprises administering the specific DPP-4 inhibitor linagliptin, or a salt thereof.
    • The administration is an oral daily amount of 5 mg.
    • The linagliptin is used in combination with metformin.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 11,033,552 - DPP IV Inhibitor Formulations (Issued Jun. 15, 2021)

The Invention Explained

  • Problem Addressed: The patent explains that DPP-IV inhibitors containing a primary or secondary amino group, such as linagliptin, are chemically unstable in the presence of many common pharmaceutical excipients. These active ingredients can react with components like reducing sugars or with acidic groups on the surface of other materials, leading to degradation and formulation challenges, particularly for low-dose tablets (’552 Patent, col. 1:25-44).
  • The Patented Solution: The patent claims a stable, solid-form pharmaceutical composition that avoids these incompatibilities by using a specific combination of excipients. The claimed formulation comprises the active ingredient, a first diluent (mannitol), a second diluent (pregelatinized starch), a binder (copovidone), a disintegrant (corn starch), and a lubricant (magnesium stearate) within a specified weight percentage range for the active ingredient (’552 Patent, col. 1:56-col. 2:28).
  • Technical Importance: This invention provided a chemically stable oral formulation for a potent class of DPP-4 inhibitors, enabling the reliable delivery of a low-dose active ingredient in a solid tablet form.

Key Claims at a Glance

  • The complaint asserts at least one claim and identifies independent claim 1 as representative (Compl. ¶45, 63).
  • Essential elements of independent claim 1 include:
    • A solid-form pharmaceutical composition comprising 5 mg of a specific DPP-4 inhibitor (linagliptin), identified by the chemical structure shown in the complaint (Compl. ¶45), or a salt thereof.
    • The composition includes a first diluent (mannitol), a second diluent (pregelatinized starch), a binder (copovidone), a disintegrant (corn starch), and a lubricant (magnesium stearate).
    • The active ingredient is present in an amount of 0.5-7.0% based on the total weight of the active ingredient and the five listed excipient categories.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Mylan's proposed generic drug products submitted to the FDA via ANDA No. 208431 ("Mylan Linagliptin ANDA Product") and ANDA No. 208430 ("Mylan Linagliptin/Metformin Hydrochloride ANDA Product") (Compl. ¶14).
  • Functionality and Market Context: The Mylan ANDA Products are generic versions of Boehringer's TRADJENTA® and JENTADUETO® tablets (Compl. ¶1, 43). The Mylan Linagliptin ANDA Product contains 5 mg of linagliptin, and the Mylan Linagliptin/Metformin Hydrochloride ANDA Product contains 2.5 mg linagliptin and 500 mg metformin hydrochloride (Compl. ¶14). The complaint alleges Mylan intends to manufacture, market, and sell these products in the United States upon receiving FDA approval (Compl. ¶15, 44, 47-48).

IV. Analysis of Infringement Allegations

11,911,388 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating metabolic diseases in type 2 diabetes patients with renal impairment and with insufficient glycemic control despite either metformin monotherapy or therapy with metformin in combination with an insulin or an insulin analogue... The complaint alleges Mylan's product labels will instruct healthcare providers and patients to use the generic products for treating type 2 diabetes in this specific patient population. ¶50 col. 2:1-44
...the method comprising administering a DPP-4 inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, or a pharmaceutically acceptable salt thereof... Mylan's ANDA Products contain linagliptin, the DPP-4 inhibitor specified in the claim. ¶50 col. 5:1-33
...in an oral daily amount of 5 mg... The proposed product labels will allegedly instruct administration of linagliptin at the claimed 5 mg daily dosage. ¶49-50 col. 7:42-45
...wherein said...inhibitor...is used in combination with either metformin monotherapy or metformin in combination with an insulin or an insulin analogue. The proposed labels will allegedly instruct co-administration with metformin, as the accused products are generic versions of drugs used in this manner. ¶50 col. 2:45-53
  • Identified Points of Contention:
    • Scope Questions: A central issue will be one of induced infringement. The analysis will depend on whether Mylan’s final, FDA-approved label instructs, encourages, or suggests administering the generic product specifically to the claimed patient population (those with renal impairment and insufficient glycemic control on metformin).
    • Technical Questions: The definitions of clinical terms such as "renal impairment" and "insufficient glycemic control" will be critical. The dispute may turn on whether the patient population described on Mylan's label squarely meets the definitions of these terms as construed from the patent.

11,033,552 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A solid-form pharmaceutical composition comprising as an active ingredient 5 mg of a DPP IV inhibitor compound of formula [structure]... Mylan's Linagliptin ANDA Product is alleged to be a solid-form composition containing 5 mg of linagliptin, which is the compound identified by the chemical structure provided in the complaint. The complaint includes a visual of this structure. ¶45-46 col. 2:29-32
...a first diluent, a second diluent, a binder, a disintegrant and a lubricant...wherein the first diluent is mannitol, the second diluent is pregelatinized starch, the binder is copovidone, the disintegrant is corn starch, and the lubricant is magnesium stearate... Mylan's ANDA Product is a leged to contain this specific combination of five excipients. ¶45-46 col. 1:56-2:20
...and wherein the DPP IV inhibitor compound is present in an amount 0.5-7.0% based on the total weight of DPP IV inhibitor compound, first diluent, second diluent, binder, disintegrant and lubricant. The complaint alleges that the amount of linagliptin in Mylan's ANDA Product falls within this specified weight percentage range relative to the other listed components. ¶45-46 col. 2:51-57
  • Identified Points of Contention:
    • Scope Questions: The complaint redacts Mylan’s asserted basis for non-infringement (Compl. ¶46). This suggests the dispute may focus on whether one of the excipients in Mylan's formulation is technically different from what is claimed, or if the term "comprising" allows for additional, unlisted excipients that alter the properties or weight percentage calculation.
    • Technical Questions: An evidentiary question will be whether Mylan's formulation literally meets every element. The analysis will likely focus on the precise chemical identity of each excipient and the exact calculation of the 0.5-7.0% weight percentage.

V. Key Claim Terms for Construction

  • Term ('388 Patent): "renal impairment"

    • Context and Importance: This term defines the specific patient population for the method claim. Its construction will be critical to determining the scope of the claim and whether Mylan’s product label will induce infringement by describing use in patients falling within that scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself is not explicitly limited to a specific stage of impairment.
      • Evidence for a Narrower Interpretation: The specification suggests specific clinical metrics, stating that renal impairment can be "suggested by elevated serum creatinine levels...or abnormal creatinine clearance (e.g. glomerular filtration rate (GFR) ≤ 30-60 ml/min)" (’388 Patent, col. 4:39-51). This language may be used to argue for a definition tied to specific, measurable clinical criteria.

  • Term ('552 Patent): "based on the total weight of DPP IV inhibitor compound, first diluent, second diluent, binder, disintegrant and lubricant"

    • Context and Importance: This phrase defines the basis for the critical 0.5-7.0% weight percentage limitation. Practitioners may focus on this term because the infringement analysis could turn on whether the "total weight" includes only these six listed categories or if the presence of any other unlisted substance (e.g., a glidant, which is mentioned as optional in the specification) would affect the calculation and move the accused product outside the claimed range.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: An argument could be made that "total weight" refers to the entire composition, even if other minor components are present, as long as the six listed components are there.
      • Evidence for a Narrower Interpretation: The claim explicitly lists the six components that form the basis of the calculation. This suggests that the "total weight" for the purpose of this limitation is the sum of the weights of only those six components, providing a precise and limited basis for the percentage calculation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Mylan's proposed product labels for its ANDA Products will instruct healthcare providers and clinicians on how to administer the drugs in a manner that infringes the method claims of the ’388 Patent, constituting active inducement (Compl. ¶50, 59). It also alleges contributory and induced infringement for both patents (Compl. ¶56-59, 67-70).
  • Willful Infringement: The complaint alleges Mylan had knowledge of the patents-in-suit at least as of the dates of its Paragraph IV notification letters (Compl. ¶44, 47-48, 58, 69). The complaint further alleges this is an "exceptional case" warranting attorneys' fees under 35 U.S.C. § 285, which is often tied to findings of willful infringement or litigation misconduct (Compl. ¶61, 72).

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

  • A core issue will be one of induced infringement: Will Mylan's final, FDA-approved product label contain instructions that actively encourage physicians to prescribe the generic drug for the specific patient population—those with both renal impairment and insufficient glycemic control on metformin—as claimed by the ’388 patent?
  • A key evidentiary question will be one of compositional identity: Does Mylan's proposed generic formulation literally contain the exact combination of six excipients and the specific 0.5-7.0% active ingredient weight range required by Claim 1 of the ’552 patent, or does a technical distinction in the formulation place it outside the literal scope of the claim?
  • The case may also turn on a question of clinical claim construction: How will the court define the term "renal impairment" from the ’388 patent? Will it be defined broadly, or will it be limited to the specific clinical metrics mentioned in the patent’s specification, thereby narrowing the scope of potential infringement?