DCT

1:25-cv-00523

Boehringer Ingelheim Pharma Inc v. Biocon Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00523, D. Del., 04/30/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Biocon Pharma, Inc. is a Delaware corporation and therefore resides 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 infringement of four U.S. patents.
  • Technical Context: The patents relate to methods of treating type 2 diabetes mellitus with DPP-IV inhibitors, particularly in patient populations for whom metformin, a standard first-line therapy, is contraindicated or causes intolerable side effects.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification, which asserted that Plaintiff’s patents are invalid. The complaint details pre-suit negotiations regarding Plaintiff’s access to the confidential ANDA materials, a standard procedural step in such litigation that determines the scope of early infringement analysis.

Case Timeline

Date Event
2008-08-06 Earliest Priority Date for ’156, ’526, and ’877 Patents
2008-10-16 Earliest Priority Date for ’388 Patent
2014-10-07 U.S. Patent No. 8,853,156 Issues
2016-11-08 U.S. Patent No. 9,486,526 Issues
2018-07-31 U.S. Patent No. 10,034,877 Issues
2024-02-27 U.S. Patent No. 11,911,388 Issues
2025-03-18 Plaintiff receives Defendant’s Paragraph IV Certification letter
2025-03-27 Plaintiff requests access to complete ANDA, DMF, and samples
2025-04-17 Defendant agrees to provide access to complete ANDA
2025-04-21 Parties execute Offer of Confidential Access (OCA)
2025-04-22 Defendant provides Plaintiff access to complete ANDA
2025-04-30 Complaint Filing Date

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

U.S. Patent No. 8,853,156 - Treatment for Diabetes in Patients Inappropriate for Metformin Therapy

  • Patent Identification: U.S. Patent No. 8,853,156, "Treatment for Diabetes in Patients Inappropriate for Metformin Therapy," issued October 7, 2014. (Compl. ¶32).

The Invention Explained

  • Problem Addressed: The patent addresses the need for effective and safe diabetes therapies for patients who cannot take metformin, a widely used antihyperglycemic agent. Metformin therapy can be inappropriate due to contraindications, such as renal disease, or due to intolerable side effects, particularly gastrointestinal symptoms (’156 Patent, col. 1:45-2:4).
  • The Patented Solution: The invention is a method of treating or preventing metabolic diseases in this specific patient population by orally administering a DPP-IV inhibitor. The patent describes this as providing an efficacious and tolerable alternative for diabetic patients who are ineligible for standard metformin therapy (’156 Patent, col. 2:5-11; Abstract).
  • Technical Importance: The claimed method provides a therapeutic pathway for a significant sub-population of diabetic patients who are excluded from the benefits of the standard first-line treatment.

Key Claims at a Glance

  • The complaint identifies Claim 1 as a representative asserted claim (Compl. ¶57).
  • Essential elements of Independent Claim 1:
    • A method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin
    • comprising orally administering to the patient a DPP-IV inhibitor
    • wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance.
  • The complaint does not explicitly reserve the right to assert dependent claims but states infringement of "at least one claim" (Compl. ¶66).

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. (Compl. ¶33).

The Invention Explained

  • Problem Addressed: This patent, like the ’156 Patent, addresses the treatment of diabetic patients for whom metformin is not appropriate. It particularly focuses on the challenge of treating patients who have both diabetes and renal impairment, a common comorbidity (’526 Patent, col. 1:45-2:4).
  • The Patented Solution: The invention is a specific method for treating type 2 diabetes in patients with moderate to severe chronic renal impairment or end-stage renal disease. The method comprises administering a specific DPP-4 inhibitor, 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine (linagliptin), at a specific oral dose of 5 mg per day (’526 Patent, col. 12:59-13:4).
  • Technical Importance: The invention provides a precise dosing regimen for a specific drug in a vulnerable patient sub-population, which is significant because renal impairment can alter drug metabolism and excretion, often requiring dose adjustments.

Key Claims at a Glance

  • The complaint identifies Claim 1 as a representative asserted claim (Compl. ¶59).
  • Essential elements of Independent Claim 1:
    • A method for treating and/or preventing 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 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 asserts infringement of "at least one claim" of the ’526 Patent (Compl. ¶76).

U.S. Patent No. 10,034,877 - Treatment for Diabetes in Patients Inappropriate for Metformin Therapy

  • Patent Identification: U.S. Patent No. 10,034,877, "Treatment for Diabetes in Patients Inappropriate for Metformin Therapy," issued July 31, 2018 (Compl. ¶34).
  • Technology Synopsis: The patent claims a method of treating metabolic diseases in patients for whom metformin is inappropriate by orally administering 5 mg per day of linagliptin. A key aspect of the patented solution is the discovery that no adjustment of the daily dose is required for patients with various levels of renal impairment, simplifying treatment for this population (’877 Patent, Abstract; col. 13:35-46).
  • Asserted Claims: The complaint identifies Claim 1 as representative (Compl. ¶61).
  • Accused Features: The prescribing label for Defendant’s ANDA Product is alleged to instruct clinicians to administer linagliptin to patients with renal impairment for whom metformin is inappropriate, and to do so without dose adjustment, thereby causing infringement (Compl. ¶62).

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

  • Patent Identification: 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 February 27, 2024 (Compl. ¶35).
  • Technology Synopsis: The patent claims a method for treating type 2 diabetes in a specific patient population: those with renal impairment who also exhibit insufficient glycemic control despite already being on other antidiabetic therapies (such as metformin monotherapy or metformin combined with insulin). The patented solution is the administration of a 5 mg daily oral dose of linagliptin to these patients (’388 Patent, Abstract; col. 29:1-21).
  • Asserted Claims: The complaint identifies Claim 1 as representative (Compl. ¶63).
  • Accused Features: The prescribing label for Defendant’s ANDA Product is alleged to instruct clinicians to administer linagliptin to this specific patient population (renal impairment with insufficient glycemic control on existing therapy), thereby causing infringement (Compl. ¶64).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendant’s proposed 5 mg linagliptin tablet product, which is the subject of Abbreviated New Drug Application (ANDA) No. 220117 ("the Biocon ANDA Product") (Compl. ¶15).

Functionality and Market Context

  • The Biocon ANDA Product is a generic version of Plaintiff’s TRADJENTA® product (Compl. ¶1). Linagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor for the treatment of type 2 diabetes mellitus (Compl. ¶57). The infringement action is based on the submission of the ANDA itself, which seeks FDA approval to market the generic product prior to the expiration of the patents-in-suit (Compl. ¶1, ¶66). The complaint alleges that the ANDA contains data demonstrating bioequivalence to TRADJENTA® (Compl. ¶47) and that its proposed prescribing label will instruct healthcare providers and clinicians to use the product in a manner that infringes the patents-in-suit (Compl. ¶¶58, 60, 62, 64). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,853,156 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin... The prescribing label for the Biocon ANDA Product allegedly instructs clinicians to administer linagliptin to treat type 2 diabetes mellitus in patients for whom metformin is inappropriate due to renal disease, impairment or dysfunction. ¶58 col. 1:66-2:4
...comprising orally administering to the patient a DPP-IV inhibitor... The Biocon ANDA Product is an oral tablet containing linagliptin, which is a DPP-IV inhibitor, and its label allegedly instructs oral administration. ¶58 col. 2:5-7
...wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance. The proposed prescribing label allegedly instructs use in patients with renal disease, renal impairment, or renal dysfunction, which is a contraindication listed in the claim. ¶58 col. 2:50-58

U.S. Patent No. 9,486,526 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating and/or preventing type 2 diabetes mellitus in a patient having moderate or severe chronic renal impairment or end-stage renal disease... The prescribing label for the Biocon ANDA Product allegedly instructs administration of linagliptin to patients with moderate or severe chronic renal impairment or end-stage renal disease. ¶60 col. 3:39-45
...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 pharmaceutically acceptable salt thereof... The Biocon ANDA Product is an oral tablet containing linagliptin, the specific DPP-4 inhibitor recited in the claim. ¶60 col. 12:62-67
...wherein said DPP-4 inhibitor is administered in an oral dose of 5 mg per day to said patient... The Biocon ANDA Product is a 5 mg tablet, and its label allegedly instructs administration of a 5 mg daily dose. ¶60 col. 13:1-2
...wherein metformin therapy for said patient is ineligible due to contraindication against metformin. The prescribing label allegedly instructs use in patients who are ineligible for metformin therapy due to a contraindication against metformin. ¶60 col. 13:3-4
  • Identified Points of Contention:
    • Scope Questions: In ANDA litigation, infringement is often a secondary issue to validity. The primary question of scope will be whether the patient population and treatment instructions described in Defendant's final approved FDA label fall within the boundaries of the asserted claims. For example, does the label's definition of "moderate or severe chronic renal impairment" align with the meaning of that term as understood in the context of the ’526 Patent?
    • Technical Questions: The central evidentiary question is what the proposed prescribing label for the Biocon ANDA Product contains. The complaint alleges on "information and belief" that the label’s instructions will cause infringement by directing medical professionals to perform the claimed methods (Compl. ¶¶58, 60). The content of this label, once produced in discovery, will be the key evidence for the infringement analysis.

V. Key Claim Terms for Construction

  • The Term: "a patient for whom metformin therapy is inappropriate" (’156 Patent, Claim 1).

  • Context and Importance: This term defines the target patient population and is the primary point of novelty asserted for the method. The patentability of the claim may depend on whether this population was recognized as a distinct group needing a specific treatment solution. Practitioners may focus on this term because its breadth or narrowness is central to both infringement and validity analyses.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states that such patients include those for whom metformin is "inappropriate due to intolerability or contraindication" and provides examples of gastrointestinal side effects as a basis for intolerability (’156 Patent, col. 1:66-2:4; col. 2:59-65). This could support a construction that includes a wide range of patients beyond just those with formal contraindications.
    • Evidence for a Narrower Interpretation: The claim itself recites "inappropriate due to at least one contraindication against metformin" and then provides a specific Markush group of five contraindications (’156 Patent, col. 12:43-52). A party could argue that for the purposes of this specific claim, "inappropriate" is expressly limited to the listed contraindications, excluding patients who only experience "intolerability."

  • The Term: "no adjustment of the daily dose is required" (’877 Patent, Claim 1).

  • Context and Importance: This negative limitation is a key feature of the invention, distinguishing it as a simpler treatment regimen for patients with renal impairment, a condition that typically requires careful dose adjustments for other drugs. Infringement requires that the accused product's instructions direct a single, non-adjusted dose.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent repeatedly frames this as a core benefit, stating that linagliptin is "primarily eliminated via the liver and only to a minor extent... via the kidney," making it suitable for this patient group without dose modification (’877 Patent, col. 23:7-14). This suggests any label that prescribes a flat 5 mg dose for patients with and without renal impairment would meet this limitation.
    • Evidence for a Narrower Interpretation: A defendant could argue that any cautionary language on its product label, such as a recommendation for physicians to monitor renal function or exercise clinical judgment, constitutes an implicit instruction for potential "adjustment," thereby designing around the express "no adjustment... is required" language.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement against Defendant for all four patents-in-suit. The basis for these allegations is that Defendant’s promotional activities and the package inserts for its ANDA Product will instruct and encourage healthcare providers to prescribe and administer the generic linagliptin product in a manner that directly infringes the claims (Compl. ¶¶ 71, 81, 91, 101).
  • Willful Infringement: The complaint does not contain a formal count for willful infringement. However, it alleges that Defendant had knowledge of the patents-in-suit at least as of the date of its Paragraph IV certification letter (Compl. ¶¶ 48, 70). Based on this and other alleged conduct, the complaint asserts that this is an "exceptional case" under 35 U.S.C. § 285, which would warrant an award of attorney fees (Compl. ¶¶ 73, 83, 93, 103).

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

  • A central issue will be one of patent validity, specifically obviousness. Given that DPP-IV inhibitors were a known class of drugs for treating diabetes, the key question for the court will be whether it was obvious to use them to treat the specific patient sub-populations recited in the claims (e.g., those for whom metformin is inappropriate) using the claimed dosages and regimens. Defendant's Paragraph IV certification explicitly challenges the patents on this basis (Compl. ¶48).
  • A secondary, but critical, question will be one of claim construction. The outcome of the case may turn on the scope afforded to defining phrases such as "inappropriate for metformin therapy" and "no adjustment of the daily dose is required." The construction of these terms will determine the precise boundaries of the claimed invention, which will in turn dictate the analyses of both infringement and validity.