DCT

3:20-cv-00783

Merck Sharp & Dohme Corp v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:20-cv-00783, D.N.J., 01/23/2020
  • Venue Allegations: Venue is asserted based on Defendant Sandoz Inc. having a principal place of business in New Jersey and allegedly committing acts of infringement within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of the antifungal oral suspension NOXAFIL® constitutes an act of infringement of a patent covering the drug's formulation.
  • Technical Context: The technology concerns pharmaceutical formulations designed to enhance the stability and bioavailability of posaconazole, a poorly water-soluble antifungal compound.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 202481 with a Paragraph IV certification. This certification asserts that Plaintiff’s U.S. Patent No. 8,263,600, which is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for NOXAFIL®, is invalid, unenforceable, or will not be infringed by the proposed generic product. Plaintiff received Defendant's notice letter on December 13, 2019, and filed this suit within the statutory 45-day period.

Case Timeline

Date Event
2001-04-03 U.S. Patent No. 8,263,600 Priority Date
2006-09-15 FDA approved marketing of NOXAFIL®
2012-09-11 U.S. Patent No. 8,263,600 Issue Date
2019-12-13 Plaintiff received Defendant's Paragraph IV Notice Letter
2020-01-23 Complaint Filing Date

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

U.S. Patent No. 8,263,600 - Antifungal Composition with Enhanced Bioavailability

The Invention Explained

  • Problem Addressed: The patent's background section states that the active antifungal compound, posaconazole, is "highly lipophilic, and has an extremely low water solubility" ('600 Patent, col. 2:37-38). This property results in aqueous oral compositions having "reduced anti-fungal activity and/or bioavailability," creating a need for a formulation with "enhanced bioavailability and improved stability characteristics" ('600 Patent, col. 2:39-44).
  • The Patented Solution: The invention is a stable liquid suspension that uses micronized particles of posaconazole combined with specific excipients, including a non-ionic surfactant and thickening agents ('600 Patent, Abstract). This formulation is designed to improve the homogeneity and dispersibility of the suspension, preventing the solids from forming a "solid cake that is difficult to re-disperse" and thereby ensuring a patient receives an effective dose ('600 Patent, col. 2:32-34).
  • Technical Importance: This formulation technology enabled the creation of a reliable and effective oral liquid dosage form for a potent antifungal agent, which is particularly important for patients who may have difficulty swallowing solid tablets or capsules ('600 Patent, col. 2:39-49).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of "one or more claims" ('Compl. ¶37). Independent claim 2 is representative of the invention described in the complaint.
  • The essential elements of independent claim 2 include:
    • A liquid suspension comprising:
    • 40 mg/ml of a micronized compound of formula I (posaconazole) having a mean particle size of about 1000 nm to about 1800 nm;
    • Polysorbate 80;
    • An effective amount of a buffer system comprising sodium citrate and citric acid sufficient to maintain a pH in the range of about 4.0 to about 6.0;
    • A combination of thickening agents comprising xanthan gum and liquid sugar; and
    • A pharmaceutically acceptable liquid carrier comprising glycerin.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the generic posaconazole oral suspension, 40 mg/mL, described in Sandoz’s ANDA No. 202481 ("Sandoz's Infringing ANDA Product") (Compl. ¶¶1, 22).

Functionality and Market Context

The complaint alleges that Sandoz's product is a "liquid suspension comprising micronized posaconazole, Polysorbate 80, a buffer system, thickening agents, and a liquid carrier" (Compl. ¶36). The product is intended to be a generic version of, and bioequivalent to, Merck’s branded NOXAFIL® oral suspension, which is used to treat and prevent serious fungal infections (Compl. ¶¶1, 17).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that the submission of Sandoz’s ANDA constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) because the product described therein will, upon approval, infringe one or more claims of the ’600 Patent (Compl. ¶34).

’600 Patent Infringement Allegations

| Claim Element (from Independent Claim 2) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|:------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|:----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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|:--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |:----------------------|:--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| A liquid suspension comprising: 40 mg/ml of a micronized compound... [posaconazole] ... wherein the micronized compound... has a mean particle size of about 1000 nm to about 1800 nm | Sandoz's product is an oral suspension of posaconazole at a concentration of 40 mg/mL and is alleged to contain micronized posaconazole. | ¶23, ¶36 | col. 14:57-59 |
| Polysorbate 80 | The accused product is a liquid suspension that comprises Polysorbate 80. | ¶36 | col. 14:61 |
| an effective amount of a buffer system comprising sodium citrate and citric acid sufficient to maintain a pH in the range of about 4.0 to about 6.0 | The accused product is a liquid suspension that comprises a buffer system. | ¶36 | col. 14:62-64 |
| a combination of thickening agents comprising xanthan gum and liquid sugar | The accused product is a liquid suspension that comprises thickening agents. | ¶36 | col. 14:65-67 |
| a pharmaceutically acceptable liquid carrier comprising glycerin | The accused product is a liquid suspension that comprises a liquid carrier. | ¶36 | col. 14:68-col. 15:1 |

  • Identified Points of Contention:
    • Technical Questions: A central question will be whether the specific formulation detailed in Sandoz's confidential ANDA contains every component as claimed. While the complaint alleges the presence of "a buffer system" and "thickening agents" (Compl. ¶36), the claims recite a specific "buffer system comprising sodium citrate and citric acid" and "a combination of thickening agents comprising xanthan gum and liquid sugar." Discovery will be required to determine if the accused formulation meets these specific compositional requirements.
    • Scope Questions: The interpretation of the term "about" in the context of the "mean particle size of about 1000 nm to about 1800 nm" and the pH range of "about 4.0 to about 6.0" may become a focal point. The parties may dispute whether the particle size or pH of the Sandoz product, if not strictly within the numerical ranges, falls within the scope afforded by "about."

V. Key Claim Terms for Construction

  • The Term: "micronized ... has a mean particle size of about 1000 nm to about 1800 nm"

  • Context and Importance: This limitation is a core technical feature of the invention intended to enhance bioavailability. Infringement will depend on whether Sandoz's product particle size falls within this claimed range, including any breadth afforded by the word "about."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes microfluidization as a preferred method to achieve the desired particle size but does not limit the claims to a specific manufacturing process ('600 Patent, col. 6:49-56). The use of the word "about" suggests the numerical values are not absolute and can encompass values reasonably close to the stated range.
    • Evidence for a Narrower Interpretation: The specification discloses a preferred range of "about 1200 nm to about 1600 nm" and a most preferred size of "about 1400 nm" ('600 Patent, col. 6:42-44). A party could argue these specific embodiments should inform and potentially narrow the scope of the claimed range.

  • The Term: "a combination of thickening agents comprising xanthan gum and liquid sugar"

  • Context and Importance: This term defines a specific combination of excipients. The complaint's general allegation of "thickening agents" (Compl. ¶36) raises the question of whether Sandoz's product contains this exact combination, which is critical for a finding of literal infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The open-ended term "comprising" means that the presence of other, unlisted thickening agents in addition to xanthan gum and liquid sugar would not preclude infringement.
    • Evidence for a Narrower Interpretation: The claim requires the presence of both xanthan gum and liquid sugar. The specification identifies this pairing as the "most preferred" combination ('600 Patent, col. 7:24-26). A defendant could argue that a formulation lacking either one of these specific components, or using a different combination entirely, falls outside the claim scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Sandoz will induce infringement by distributing its product with a label and product insert containing instructions for use that are "substantially similar" to those for NOXAFIL®. It is alleged that following these instructions will cause healthcare professionals and patients to directly infringe one or more claims of the ’600 Patent (Compl. ¶39).
  • Willful Infringement: The complaint alleges that Sandoz had "actual and constructive notice" of the ’600 Patent and proceeded to file its ANDA "without adequate justification for asserting the '600 Patent to be invalid, unenforceable, and/or not infringed" (Compl. ¶¶40, 42). This conduct is alleged to render the case "exceptional" under 35 U.S.C. § 285, which forms the basis for a request for attorneys' fees (Compl. ¶53).

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

  • A primary issue will be one of compositional identity: does the specific formulation disclosed in Sandoz's confidential ANDA literally meet every limitation of the asserted claims? In particular, does it contain the exact "combination of thickening agents comprising xanthan gum and liquid sugar" and the "buffer system comprising sodium citrate and citric acid" recited in the patent?
  • A key legal question will be one of definitional scope: how will the court construe the term "about" as applied to the claimed particle size and pH ranges? The outcome may depend on whether Sandoz's formulation, if not strictly within the recited numerical boundaries, is nonetheless found to be equivalent or reasonably within the scope of the term.
  • An evidentiary question will center on inducement: assuming direct infringement by end-users, does the proposed product label for the Sandoz generic actively encourage or instruct users to perform the patented method in a way that demonstrates Sandoz's specific intent to cause infringement?