Boehringer Ingelheim Pharma Inc v. Mylan Pharma Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Case Name: Boehringer Ingelheim Pharmaceuticals Inc., et al. v. Mylan Pharmaceuticals Inc., et al.
  • Plaintiff’s Counsel: Schrader BYRD & Companion PLLC; Kirkland & Ellis LLP (Of Counsel)
• Case Identification: 1:20-cv-00019, N.D. W. Va., 02/05/2020
• Venue Allegations: Plaintiff alleges venue is proper because Defendant Mylan has committed acts of infringement and maintains a regular and established place of business in the district. It is also noted that Mylan has previously litigated Hatch-Waxman disputes in the district.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff’s TRADJENTA® (linagliptin) tablets constitutes an act of patent infringement.
• Technical Context: The technology relates to methods of treating type 2 diabetes, specifically using the DPP-4 inhibitor linagliptin in patient populations for whom metformin, a first-line therapy, is considered inappropriate.
• Key Procedural History: The complaint notes that Mylan provided a Paragraph IV certification letter on or about March 15, 2017, asserting that the patent-in-suit is either invalid or would not be infringed by its proposed generic product. The complaint also states that an identical action was previously filed in the District of Delaware, and the instant suit was filed to preserve rights in the event of a jurisdictional challenge in that court.

Case Timeline

Date	Event
2008-08-06	Earliest Priority Date for U.S. Patent No. 9,486,526
2016-11-08	U.S. Patent No. 9,486,526 Issues
2017-03-15	Plaintiff receives Mylan's Paragraph IV certification letter
2019-09-20	Complaint filed in the District of Delaware
2020-02-05	Complaint Filing Date

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

U.S. Patent No. 9,486,526 - "Treatment for Diabetes in Patients Inappropriate for Metformin Therapy"

• Patent Identification: U.S. Patent No. 9,486,526, "Treatment for Diabetes in Patients Inappropriate for Metformin Therapy", issued November 8, 2016.

The Invention Explained

• Problem Addressed: The patent addresses the challenge of treating type 2 diabetes in patients for whom metformin, a standard therapy, is not appropriate due to contraindications (such as renal impairment) or intolerability (such as gastrointestinal side effects) (’526 Patent, col. 1:44-2:8). Metformin is contraindicated in patients with renal disease or impairment because it is eliminated by the kidneys, creating a risk of accumulation and lactic acidosis (’526 Patent, col. 1:56-65).
• The Patented Solution: The invention is a method of treatment using a specific DPP-4 inhibitor, linagliptin, for this patient population (’526 Patent, Abstract). The patent asserts that certain DPP-4 inhibitors are particularly suitable for these patients, including those with renal impairment, because they are primarily eliminated via hepatic metabolism or biliary excretion, not the kidneys, potentially avoiding the need for dose adjustments common with other diabetes drugs (’526 Patent, col. 13:38-45; col. 23:7-15).
• Technical Importance: This approach provides a therapeutic option for a significant sub-population of diabetic patients who cannot safely or tolerably use the most common first-line oral antidiabetic agent (’526 Patent, col. 2:1-8).

Key Claims at a Glance

• The complaint alleges infringement of "at least one claim" without specifying which claims are asserted (Compl. ¶42). Independent claim 1 is representative:
• Independent Claim 1:
  • A method for treating type 2 diabetes mellitus
  • in a patient having moderate or severe chronic renal impairment or end-stage renal disease
  • comprising orally administering to the patient 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 (linagliptin) or a pharmaceutically acceptable salt thereof,
  • wherein said DPP-4 inhibitor is administered in an oral dose of 5 mg per day to said patient,
  • wherein metformin therapy for said patient is ineligible due to contraindication against metformin.
• The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation of infringing "at least one claim" preserves this option.

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is the "Mylan ANDA Product," identified as Mylan's 5 mg linagliptin tablets for which it seeks FDA approval under ANDA No. 208431 (Compl. ¶15). The act of infringement is the submission of the ANDA itself (Compl. ¶42).

Functionality and Market Context

• The complaint alleges that Mylan’s ANDA Product refers to and relies upon Plaintiff's TRADJENTA® New Drug Application (NDA) (Compl. ¶40). Mylan has allegedly represented that its product is bioavailable or bioequivalent to TRADJENTA® (Compl. ¶40). The product is intended to be a generic pharmaceutical drug for oral use (Compl. ¶8, ¶15).

IV. Analysis of Infringement Allegations

The complaint does not specify asserted claims or provide detailed infringement allegations beyond the statutory cause of action for an ANDA filing. The infringement theory is that Mylan's proposed generic product, when used according to its proposed labeling, will infringe one or more method claims of the ’526 Patent. The following chart analyzes the infringement allegations for representative Claim 1 based on the general assertions in the complaint.

No probative visual evidence provided in complaint.

'526 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method for treating type 2 diabetes mellitus...	The complaint alleges that Mylan's ANDA seeks approval to market a generic version of TRADJENTA®, which is used to treat type 2 diabetes (Compl. ¶1, ¶34). Mylan's proposed product, when used as directed, would allegedly be used for this purpose (Compl. ¶45).	¶1, ¶45	col. 29:40-49
in a patient having moderate or severe chronic renal impairment or end-stage renal disease	The complaint alleges that the proposed Mylan ANDA Product, when used as directed, would be administered in a manner that infringes the patent (Compl. ¶45). This implies an allegation that the proposed label will instruct or encourage use in a patient with the claimed level of renal impairment.	¶45, ¶49	col. 3:35-49
comprising orally administering to the patient 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 salt thereof	The Mylan ANDA Product is identified as a 5 mg linagliptin tablet, which is the chemical compound specified in the claim (Compl. ¶15). The ANDA necessarily seeks approval for the same active ingredient as the reference listed drug, TRADJENTA® (Compl. ¶40).	¶15, ¶40	col. 22:40-50
wherein said DPP-4 inhibitor is administered in an oral dose of 5 mg per day to said patient	The Mylan ANDA Product is identified as a 5 mg linagliptin tablet, matching the claimed dosage (Compl. ¶15).	¶15	col. 29:46-48
wherein metformin therapy for said patient is ineligible due to contraindication against metformin.	The complaint alleges that the use of the Mylan ANDA Product would infringe the patent (Compl. ¶45, ¶49). This suggests an allegation that Mylan’s proposed label will direct its use in patients for whom metformin is contraindicated, thereby inducing infringement of this method limitation.	¶45, ¶49	col. 2:51-60

• Identified Points of Contention:
  • Scope Questions: A central dispute may be the proper construction of "ineligible due to contraindication against metformin." The parties may dispute what specific conditions or label warnings qualify as a "contraindication" versus a "precaution" or simple "intolerability," which the patent specification lists as a separate basis for being "ineligible" (’526 Patent, col. 2:44-65).
  • Technical Questions: A key evidentiary question will concern the content of Mylan's proposed product label. The case will hinge on whether the label's instructions and indications for use will actively encourage or instruct physicians to prescribe the generic drug to the specific patient population defined in the claims, thereby satisfying the requirements for induced infringement.

V. Key Claim Terms for Construction

• The Term: "a patient having moderate or severe chronic renal impairment or end-stage renal disease"

• Context and Importance: This term defines the specific patient sub-population for the claimed method. The scope of this term is critical because metformin is often contraindicated in this very population, which is the central premise of the invention. Whether a patient falls within this definition will be a threshold question for infringement.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The claim language itself is disjunctive ("or"), suggesting any one of the listed conditions is sufficient. The specification uses the terms generally in the background section, potentially supporting a plain and ordinary meaning consistent with medical practice at the time (’526 Patent, col. 1:56-65).
  • Evidence for a Narrower Interpretation: The specification provides specific definitions based on glomerular filtration rate (GFR), which a party may argue limits the claim scope. For example, it defines moderate renal impairment as GFR 30-59 ml/min, severe as GFR 15-30 ml/min, and end-stage as requiring dialysis or GFR <15 ml/min (’526 Patent, col. 3:35-49).

• The Term: "ineligible due to contraindication against metformin"

• Context and Importance: This limitation distinguishes the claimed method from standard diabetes treatment algorithms where metformin is a first-line therapy. The entire infringement theory depends on whether Mylan's product is intended for use in patients who are "ineligible" for metformin on this basis. Practitioners may focus on this term because it links the patient's condition directly to the reason for using the patented method instead of the standard of care.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification lists "renal disease, renal impairment or renal dysfunction" as a primary example of a contraindication, along with "unstable or acute congestive heart failure" and "acute or chronic metabolic acidosis" (’526 Patent, col. 2:51-60). A party could argue this list is exemplary, not exhaustive.
  • Evidence for a Narrower Interpretation: The patent explicitly distinguishes between patients for whom metformin is "contraindicated" and those who have "intolerable side effects" (’526 Patent, col. 2:44-65). A defendant could argue that the claim is narrowly limited to formal contraindications as listed on a metformin label, and does not cover patients who simply cannot tolerate the drug due to side effects like nausea.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Mylan knows or should know that its promotional activities and package inserts will aid and abet infringement (Compl. ¶48) and will actively induce infringement of at least one claim (Compl. ¶49). This is the core theory of a method-of-use patent case against an ANDA filer.
• Willful Infringement: The complaint alleges Mylan had knowledge of the ’526 Patent, citing the Paragraph IV certification letter it sent to Plaintiffs on or about March 15, 2017 (Compl. ¶41, ¶48). It further alleges this is an exceptional case warranting attorneys' fees under 35 U.S.C. § 285 (Compl. ¶51).

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

The resolution of this ANDA litigation will likely depend on two central questions:

1. A core issue will be one of induced infringement: Can Boehringer prove that the language of Mylan's proposed product label will inevitably lead physicians to prescribe the generic drug for the claimed method—that is, for treating type 2 diabetes in patients with specific levels of renal impairment for whom metformin is contraindicated?
2. A key legal question will be one of definitional scope: How will the court construe the patient population defined by the claim terms "moderate or severe chronic renal impairment or end-stage renal disease" and "ineligible due to contraindication against metformin"? The outcome of this construction will determine the size and characteristics of the patient group in which infringement could occur.