DCT

3:23-cv-04085

Genentech Inc v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:23-cv-04085, D.N.J., 07/31/2023
  • Venue Allegations: Venue is alleged to be proper for Sandoz based on its principal place of business and regular and established place of business within New Jersey. For Lek, a foreign corporation, venue is alleged to be proper in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants’ generic pirfenidone tablets infringe a patent directed to a novel pharmaceutical formulation designed to improve manufacturing and patient compliance.
  • Technical Context: The technology concerns oral tablet formulations for pirfenidone, a drug for treating idiopathic pulmonary fibrosis (IPF), a rare and fatal lung disease.
  • Key Procedural History: The complaint notes prior Abbreviated New Drug Application (ANDA) litigation involving the parties concerning different patents for pirfenidone. The patent-in-suit, issued during that prior litigation, was not asserted. Defendants allegedly provided a Paragraph IV certification regarding the patent-in-suit on December 17, 2020, asserting invalidity but not non-infringement, before launching their accused products.

Case Timeline

Date Event
2014-10-15 FDA approves Genentech's NDA for Esbriet® capsules
2016-03-29 ’637 Patent Priority Date
2017-01-11 FDA approves Genentech's NDA for Esbriet® tablets
2019-01-29 ’637 Patent Issue Date
2020-12-17 Sandoz provides Paragraph IV certification notice for '637 patent
2022-05-12 Defendants launch Accused Products (generic pirfenidone tablets)
2023-07-31 Complaint Filing Date

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

U.S. Patent No. 10,188,637 - Granulate Formulation of 5-Methyl-1-Phenyl-2-(1H)-Pyridone and Method of Making the Same

The Invention Explained

  • Problem Addressed: The patent and complaint describe challenges in formulating pirfenidone, an active ingredient with poor powder flowability (Compl. ¶8; ’637 Patent, col. 4:9-12). The high dosage required for treating idiopathic pulmonary fibrosis (IPF) leaves little room for excipients that would normally be added to improve flow during manufacturing (Compl. ¶9). This made developing a high-dose tablet to reduce patient pill burden—which was up to nine capsules per day—a significant technical hurdle (Compl. ¶6).
  • The Patented Solution: The invention is a granulate formulation that incorporates a glidant (a flow-enhancing agent) both "intragranular" (inside the granules with the active ingredient) and "extragranular" (outside the granules) (Compl. ¶12). The patent explains that the inclusion of an intragranular glidant was a surprising discovery, as glidants were conventionally used only extragranularly. This dual-location approach is described as improving the flow of powder components during the granulation process itself, leading to stable, high-dose tablets suitable for commercial manufacturing (’637 Patent, col. 5:40-49).
  • Technical Importance: This formulation technology enabled the development of a patient-friendly, high-dose pirfenidone tablet, reducing the daily pill count and thereby potentially increasing patient compliance with the demanding treatment regimen (Compl. ¶13).

Key Claims at a Glance

  • The complaint asserts independent claim 1 ('637 Patent, col. 27:50-57; Compl. ¶45).
  • The essential elements of claim 1 are:
    • A granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone, comprising:
    • granules comprising 5-methyl-1-phenyl-2-(1H)-pyridone and a glidant; and,
    • one or more extragranular excipients comprising an extragranular glidant.
  • The complaint reserves the right to allege infringement of other claims (Compl. ¶49).

III. The Accused Instrumentality

Product Identification

  • The Accused Products are Defendants' generic pirfenidone tablets in 267 mg and 801 mg dosage strengths (Compl. ¶2).

Functionality and Market Context

  • The complaint identifies the Accused Products as generic versions of Esbriet® tablets (Compl. ¶17). Their functionality is described by reference to their listed ingredients, which include the active ingredient pirfenidone as well as inactive ingredients such as croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, and silicon dioxide (Compl. ¶51).
  • The complaint alleges the Accused Products' launch significantly harmed Plaintiffs by "eviscerated Genentech's share of the pirfenidone market" (Compl. ¶21). The complaint contains a table from the original Esbriet® capsule prescribing information to illustrate the high pill burden the patented tablet formulation was designed to alleviate (Compl. ¶5, Table 1). Table 1 shows that patients were required to titrate up to a dosage of three capsules taken three times per day (Compl. ¶5).

IV. Analysis of Infringement Allegations

Claim Chart Summary

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone, comprising: The Accused Products are alleged to be a granulate formulation of pirfenidone, the chemical name for 5-methyl-1-phenyl-2-(1H)-pyridone. ¶¶50-51 col. 2:50-54
granules comprising 5-methyl-1-phenyl-2-(1H)-pyridone and a glidant; The Accused Products are alleged to include granules containing pirfenidone and a glidant, with silicon dioxide identified as the glidant. ¶52 col. 5:21-23
one or more extragranular excipients comprising an extragranular glidant. The Accused Products are alleged to include an extragranular glidant, with silicon dioxide also identified as the extragranular glidant. ¶53 col. 5:35-39

Identified Points of Contention

  • Factual Question: The central issue appears to be factual. The complaint alleges that a single ingredient, silicon dioxide, satisfies two distinct claim limitations: the "intragranular glidant" and the "extragranular glidant." A primary question for the court will be what evidence proves that silicon dioxide is present in both locations—inside the granules and outside the granules—in the accused manufacturing process and final product.
  • Scope Question: A potential dispute may arise over whether the mere presence of silicon dioxide is sufficient to meet the "glidant" limitation. Does the term "glidant," as used in the patent, require proof that the substance performs a specific flow-improving function in the accused process, or is it defined simply by its chemical identity as a substance known to have such properties?

V. Key Claim Terms for Construction

The Term: "glidant"

  • Context and Importance: This term appears in both core limitations of the asserted claim and is central to the patent's novelty. The infringement theory hinges on silicon dioxide meeting this definition in two different physical locations within the formulation. Practitioners may focus on this term because its construction—whether it requires a specific function or is met by mere presence of a known agent—will be critical.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent provides a list of exemplary glidants, including "silica, fumed silica, silicified cellulose," and others, suggesting the term encompasses a class of known chemical agents ('637 Patent, col. 8:43-49).
    • Evidence for a Narrower Interpretation: The specification repeatedly links the "glidant" to its purpose, stating the invention includes "an effective amount of intragranular glidant to improve powder and/or granule flow characteristics" ('637 Patent, col. 5:28-30). This language may support an argument that the term implies a functional requirement, not just a chemical identity.

The Term: "granules comprising...a glidant"

  • Context and Importance: This phrase captures the "intragranular" requirement, which the patent describes as the key inventive concept. The dispute will turn on whether the accused granules are proven to contain a glidant.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The word "comprising" is a term of art in patent law that is presumptively open-ended, meaning the granules need only contain pirfenidone and a glidant, but may also contain other unlisted components.
    • Evidence for a Narrower Interpretation: The patent’s narrative about the "advantageously and surprisingly discovered" benefit of an intragranular glidant ('637 Patent, col. 5:40-49) could be used to argue that the term requires the glidant to be included in a manner sufficient to achieve the stated technical benefits of improved flow and processability.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement. For inducement, it alleges Defendants had knowledge of the ’637 patent from prior litigation and a specific notice letter, and intended to cause infringement by physicians and patients (Compl. ¶46). For contributory infringement, it alleges Lek manufactures and imports the Accused Products, which are a material part of the invention, not a staple commodity, and are especially adapted for infringement (Compl. ¶47).

Willful Infringement

  • Willfulness allegations are based on pre-suit knowledge of the ’637 patent. The complaint emphasizes that Defendants received a notice letter in December 2020 and launched their products in May 2022 "despite having knowledge of the '637 patent and lacking any noninfringement position" (Compl. ¶¶ 19, 55).

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

  • A central factual question will be one of composition and location: What evidence will be required to establish that the silicon dioxide listed as an ingredient in the Accused Products is present both "inside" the pirfenidone granules and "outside" of them, thereby satisfying the two separate "glidant" limitations of Claim 1?
  • A key issue for claim construction will be one of functional definition: Does the term "glidant," as defined by the patent, simply refer to a substance from a known class of flow-enhancing agents, or must a party prove that the substance actually performs a specific flow-improving function in the context of the accused manufacturing process?