DCT

2:24-cv-00423

Heron Therap Inc v. Slayback Pharma LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-00423, D.N.J., 01/24/2024
  • Venue Allegations: Venue is alleged in the District of New Jersey based on Slayback LLC’s principal place of business and acts of infringement within the district. Venue over Slayback Pharma India LLP is alleged on the basis that it is not a resident of the United States.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of a New Drug Application to the U.S. Food and Drug Administration for a generic version of Plaintiff's Cinvanti® product constitutes an act of infringement of ten U.S. patents related to injectable emulsion formulations of the anti-emetic drug aprepitant.
  • Technical Context: The technology concerns stable oil-in-water emulsions for intravenous administration of aprepitant, a drug used to prevent nausea and vomiting associated with cancer chemotherapy.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' submission of New Drug Application No. 218754 with a Paragraph IV certification, asserting that the patents-in-suit are invalid or would not be infringed. Plaintiff certifies that this matter is related to other patent infringement actions it has filed against different defendants concerning overlapping patents in the District of Delaware.

Case Timeline

Date Event
2014-09-19 Patent Priority Date for all Patents-in-Suit
2017-02-07 U.S. Patent No. 9,561,229 Issue Date
2017-11-07 U.S. Patent No. 9,808,465 Issue Date
2017-11-09 Plaintiff's Cinvanti® (NDA No. 209296) FDA Approval Date
2018-05-22 U.S. Patent No. 9,974,742 Issue Date
2018-05-22 U.S. Patent No. 9,974,793 Issue Date
2018-05-22 U.S. Patent No. 9,974,794 Issue Date
2019-12-10 U.S. Patent No. 10,500,208 Issue Date
2020-04-21 U.S. Patent No. 10,624,850 Issue Date
2021-03-23 U.S. Patent No. 10,953,018 Issue Date
2021-11-16 U.S. Patent No. 11,173,118 Issue Date
2023-09-05 U.S. Patent No. 11,744,800 Issue Date
2023-12-12 Plaintiff receives Slayback's Notice Letter regarding NDA submission
2024-01-24 Complaint Filing Date

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

U.S. Patent No. 9,561,229 - “Emulsion Formulations of Aprepitant”

  • Patent Identification: U.S. Patent No. 9,561,229, titled “Emulsion Formulations of Aprepitant,” issued February 7, 2017 (Compl. ¶27).

The Invention Explained

  • Problem Addressed: The patent describes the challenge of administering aprepitant, an anti-emetic drug, to patients undergoing chemotherapy who experience nausea and vomiting, making oral capsules unsuitable (’229 Patent, col. 1:40-48). Aprepitant's poor water solubility makes it difficult to formulate as a liquid for intravenous administration, which requires stable, small-droplet emulsions to prevent capillary blockage ('229 Patent, col. 1:49-67).
  • The Patented Solution: The invention is a stable, oil-in-water pharmaceutical emulsion suitable for intravenous injection ('229 Patent, Abstract). Aprepitant is dissolved into an oil phase containing an emulsifier (lecithin) and a co-surfactant; this oil phase is then dispersed within an aqueous phase containing water, a tonicity agent, and a pH-adjusting agent ('229 Patent, col. 2:41-47). The formulation's stability is attributed to specific concentrations and ratios of its components ('229 Patent, col. 10:21-31).
  • Technical Importance: The technology provides a non-oral delivery route for a critical supportive care drug for cancer patients, addressing the limitations of the existing oral formulation ('229 Patent, col. 1:43-48).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, with Independent Claim 1 being representative of the core composition ('229 Patent, col. 23:12-23).
  • Essential Elements of Independent Claim 1:
    • An injectable pharmaceutical emulsion comprising:
    • 0.4 wt/wt % to 1.0 wt/wt % aprepitant;
    • 13 wt/wt % to 15 wt/wt % egg yolk lecithin;
    • 9 wt/wt % to 10 wt/wt % soybean oil; and
    • a pH modifier, wherein the pH modifier is sodium oleate;
    • wherein the pH of the emulsion ranges from 7.5 to 9.0.
  • The complaint states that the accused product meets or embodies all elements of one or more claims of the ’229 Patent (Compl. ¶49).

U.S. Patent No. 9,808,465 - “Emulsion Formulations of Aprepitant”

  • Patent Identification: U.S. Patent No. 9,808,465, titled “Emulsion Formulations of Aprepitant,” issued November 7, 2017 (’465 Patent; Compl. ¶28).

The Invention Explained

  • Problem Addressed: This patent, from the same family as the ’229 Patent, addresses the identical technical problem: the need for a non-oral, injectable formulation of the poorly soluble drug aprepitant for patients unable to tolerate oral medication due to nausea ('465 Patent, col. 1:40-48).
  • The Patented Solution: The patent claims a method of preventing or treating emesis by administering an injectable, physically stable aprepitant emulsion ('465 Patent, Abstract). The composition of the emulsion is defined by its components and their ratios, including aprepitant, an emulsifier, an oil, a co-emulsifier, a tonicity modifier, and a pH modifier ('465 Patent, col. 2:41-47, col. 21:56-67).
  • Technical Importance: This patent protects the specific use of the aprepitant emulsion technology for treating patients, complementing the composition claims of related patents ('465 Patent, col. 21:56-59).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, with Independent Claim 1 being representative of the claimed method ('465 Patent, col. 21:56-col. 22:9).
  • Essential Elements of Independent Claim 1:
    • A method for preventing or treating a subject at risk of or suffering from emesis, comprising administering a composition comprising an injectable physically stable emulsion, wherein the emulsion comprises:
    • aprepitant;
    • 11 wt/wt % to 15 wt/wt % of an emulsifier; an oil;
    • a co-emulsifier which is an alcohol; a tonicity modifier;
    • a pH modifier; and water;
    • wherein the ratio of emulsifier:aprepitant ranges from about 18:1 to 22:1; and
    • wherein the pH of the emulsion ranges from about 7.5 to 9.0.
  • The complaint alleges the accused product meets or embodies all elements of one or more claims of the ’465 Patent (Compl. ¶58).

Multi-Patent Capsules

  • U.S. Patent No. 9,974,742: “Emulsion Formulations of an NK-1 Receptor Antagonist and Uses Thereof,” issued May 22, 2018 (Compl. ¶29).

    • Technology Synopsis: This patent describes injectable oil-in-water emulsions of a neurokinin-1 (NK-1) receptor antagonist (a class of drugs that includes aprepitant) for treating emesis, particularly in cancer patients. It covers specific component ratios and pH ranges to ensure stability.
    • Asserted Claims: One or more unspecified claims (Compl. ¶67).
    • Accused Features: The complaint alleges the composition and manufacture of the Proposed Slayback Product infringe the patent (Compl. ¶67).

  • U.S. Patent No. 9,974,793: “Emulsion Formulations of Aprepitant,” issued May 22, 2018 (Compl. ¶30).

    • Technology Synopsis: This patent covers a physically stable pharmaceutical composition comprising aprepitant, an emulsifier, oil, and water, defined by specific ratios of emulsifier-to-aprepitant and oil-to-aprepitant.
    • Asserted Claims: One or more unspecified claims (Compl. ¶76).
    • Accused Features: The complaint alleges the composition and manufacture of the Proposed Slayback Product infringe the patent (Compl. ¶76).

  • U.S. Patent No. 9,974,794: “Emulsion Formulations of Aprepitant,” issued May 22, 2018 (Compl. ¶31).

    • Technology Synopsis: This patent claims a specific physically stable pharmaceutical composition comprising aprepitant, egg yolk lecithin, and soybean oil, where the ratios of lecithin-to-aprepitant and oil-to-aprepitant are fixed at 20:1 and 13:1, respectively.
    • Asserted Claims: One or more unspecified claims (Compl. ¶85).
    • Accused Features: The complaint alleges the composition and manufacture of the Proposed Slayback Product infringe the patent (Compl. ¶85).

  • U.S. Patent No. 10,500,208: “Emulsion Formulations of Aprepitant,” issued December 10, 2019 (Compl. ¶32).

    • Technology Synopsis: This patent claims a method for preparing a pharmaceutical emulsion by combining specific oil and aqueous phases and processing them through homogenization to create a stable final product for injection.
    • Asserted Claims: One or more unspecified claims (Compl. ¶94).
    • Accused Features: The complaint alleges the manufacture of the Proposed Slayback Product infringes the patent (Compl. ¶94).

  • U.S. Patent No. 10,624,850: “Emulsion Formulations of an NK-1 Receptor Antagonist and Uses Thereof,” issued April 21, 2020 (Compl. ¶33).

    • Technology Synopsis: This patent claims a method of treating emesis by administering an injectable emulsion containing an NK-1 receptor antagonist, where the composition is defined by specific component categories and ratios.
    • Asserted Claims: One or more unspecified claims (Compl. ¶103).
    • Accused Features: The complaint alleges the intended use of the Proposed Slayback Product will infringe the patent (Compl. ¶103).

  • U.S. Patent No. 10,953,018: “Emulsion Formulations of Aprepitant,” issued March 23, 2021 (Compl. ¶34).

    • Technology Synopsis: This patent claims a method of treating nausea and vomiting by administering a physically stable emulsion comprising aprepitant, an emulsifier, oil, and water, with specific ratios between the components.
    • Asserted Claims: One or more unspecified claims (Compl. ¶112).
    • Accused Features: The complaint alleges the intended use of the Proposed Slayback Product will infringe the patent (Compl. ¶112).

  • U.S. Patent No. 11,173,118: “Emulsion Formulations of an NK-1 Receptor Antagonist and Uses Thereof,” issued November 16, 2021 (Compl. ¶35).

    • Technology Synopsis: This patent claims an injectable pharmaceutical emulsion comprising an NK-1 receptor antagonist, an emulsifier, and an oil, defined by specific component ratios.
    • Asserted Claims: One or more unspecified claims (Compl. ¶121).
    • Accused Features: The complaint alleges the composition and manufacture of the Proposed Slayback Product infringe the patent (Compl. ¶121).

  • U.S. Patent No. 11,744,800: “Methods of Use of Emulsion Formulations of an NK-1 Receptor Antagonist,” issued September 5, 2023 (Compl. ¶36).

    • Technology Synopsis: This patent claims a method for preventing post-operative nausea and vomiting by administering an injectable emulsion containing aprepitant, egg lecithin, and soybean oil in specific concentrations and ratios.
    • Asserted Claims: One or more unspecified claims (Compl. ¶130).
    • Accused Features: The complaint alleges the intended use of the Proposed Slayback Product will infringe the patent (Compl. ¶130).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is the "Proposed Slayback Product," an injectable emulsion containing 130mg/18mL (7.2 mg/mL) of the active ingredient aprepitant, for which Defendants submitted New Drug Application ("NDA") No. 218754 to the FDA (Compl. ¶¶13, 18).
  • Functionality and Market Context: The Proposed Slayback Product is a generic version of Plaintiff’s Cinvanti® product (Compl. ¶¶4, 37). The complaint alleges it has the same active ingredient as Cinvanti®, as well as the same or substantially the same indications and proposed labeling (Compl. ¶42). It is intended for the prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy (Compl. ¶38). The complaint alleges that the product has the "same or equivalent ingredients in the same or equivalent amounts" as the claimed compositions and "performs substantially the same function, in substantially the same way, to achieve substantially the same result" as Cinvanti® (Compl. ¶¶41).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that the submission of the Slayback NDA was an act of infringement under 35 U.S.C. § 271(e)(2)(A) and that commercialization of the Proposed Slayback Product would infringe one or more claims of the patents-in-suit (Compl. ¶¶48, 51). The complaint does not contain specific factual allegations mapping elements of the accused product to claim limitations, instead alleging on "information and belief" that the product meets all claim elements (Compl. ¶41, 45).

'229 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable pharmaceutical emulsion comprising: The complaint alleges the Proposed Slayback Product is an injectable emulsion with the same or equivalent ingredients as the claimed composition. ¶41, 49 col. 23:12
0.4 wt/wt % to 1.0 wt/wt % aprepitant; The complaint alleges the Proposed Slayback Product contains aprepitant in an equivalent amount. ¶41, 49 col. 23:13
13 wt/wt % to 15 wt/wt % egg yolk lecithin; The complaint alleges the Proposed Slayback Product contains an emulsifier (such as egg yolk lecithin) in an equivalent amount. ¶41, 49 col. 23:14
9 wt/wt % to 10 wt/wt % soybean oil; and The complaint alleges the Proposed Slayback Product contains an oil (such as soybean oil) in an equivalent amount. ¶41, 49 col. 23:16
a pH modifier, wherein the pH modifier is sodium oleate; The complaint alleges the Proposed Slayback Product contains equivalent excipients, including a pH modifier. ¶41, 49 col. 23:17-18
wherein the pH of the emulsion ranges from 7.5 to 9.0. The complaint alleges the Proposed Slayback Product has the same or equivalent properties as the claimed composition. ¶41, 49 col. 23:19-20

'465 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for preventing or treating...emesis, comprising administering to the subject a composition comprising an injectable physically stable emulsion The complaint alleges Defendants' proposed labeling will direct users to administer the Proposed Slayback Product to prevent chemotherapy-induced emesis. ¶42, 60 col. 21:56-59
wherein the emulsion comprises: aprepitant; 11 wt/wt % to 15 wt/wt % of an emulsifier; an oil; a co-emulsifier which is an alcohol; a tonicity modifier; a pH modifier; and water The complaint alleges the Proposed Slayback Product has the same or equivalent ingredients in the same or equivalent amounts as the claimed composition. ¶41, 58 col. 21:60-64
wherein the ratio of emulsifier:aprepitant ranges from about 18:1 to 22:1, and The complaint alleges the Proposed Slayback Product meets all elements of one or more claims of the patent. ¶58 col. 22:5-7
wherein the pH of the emulsion ranges from about 7.5 to 9.0. The complaint alleges the Proposed Slayback Product has the same or equivalent properties as the claimed composition. ¶41, 58 col. 22:8-9
  • Identified Points of Contention:
    • Factual Questions: Given the pleading standard, a primary point of contention will be factual. The complaint does not provide the specific formulation of the Proposed Slayback Product. The central question will be whether discovery reveals that the product's composition, including the identity and concentration of its excipients, falls within the scope of the asserted claims.
    • Scope Questions: The analysis may turn on the construction of terms defining the composition's properties and components. For the '229 Patent, a question may be whether the term "egg yolk lecithin" reads on the specific emulsifier used in the accused product. For the '465 Patent, the interpretation of "physically stable emulsion" will be critical, as it is defined in the specification with reference to specific criteria that the accused product must meet ('465 Patent, col. 8:5-21).

V. Key Claim Terms for Construction

  • The Term: "physically stable" (from Claim 1 of the '465 Patent)

    • Context and Importance: This term is a functional limitation central to the patentability and infringement of the claimed method. Practitioners may focus on this term because infringement will depend on whether the accused product meets the specific stability criteria defined in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The parties may argue that "physically stable" should be given its plain and ordinary meaning in the context of pharmaceutical emulsions, which might encompass general stability without strict adherence to every definitional detail.
      • Evidence for a Narrower Interpretation: The specification provides an explicit definition, stating that "physically stable" emulsions "will meet the criteria under USP <729>" for droplet size and will have "no visible aprepitant crystals upon storage" for a designated time ('465 Patent, col. 8:5-21). This language may support a narrower construction that requires adherence to these specific, testable criteria.

  • The Term: "egg yolk lecithin" (from Claim 1 of the '229 Patent)

    • Context and Importance: The identity and concentration of the emulsifier are described as critical to achieving a stable emulsion. The dispute may center on whether the emulsifier in the accused product is technically "egg yolk lecithin" as claimed, especially if it is a synthetic or modified version, or derived from a different source.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes "lecithin" as including "egg yolk-, egg-, soybean-, and corn-derived lecithin" ('229 Patent, col. 9:43-46), suggesting the term is meant to be inclusive of lecithin from that source.
      • Evidence for a Narrower Interpretation: The examples repeatedly refer to a specific commercial product, "LIPOID E 80," as the egg lecithin used ('229 Patent, col. 16:8-9). A defendant may argue this ties the claim term to the properties of that specific product, potentially narrowing its scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for the asserted method patents, including the '465 Patent. This allegation is based on the assertion that Defendants' proposed labeling for the product will instruct and encourage healthcare providers to administer it in a manner that directly infringes the claimed methods (Compl. ¶¶ 51, 60).
  • Willful Infringement: The complaint alleges that Defendants were aware of the existence of each patent-in-suit and were aware that the filing of the Slayback NDA constituted an act of infringement (Compl. ¶¶ 55, 64, 73, 82, 91, 100, 109, 118, 127, 136). This allegation is based on pre-suit knowledge, stemming from the requirement that a generic applicant filing a Paragraph IV certification be aware of the patents listed in the FDA's Orange Book for the branded drug.

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

  • A core issue will be one of evidentiary proof: can Plaintiff substantiate its "information and belief" allegations through discovery? The case will likely hinge on a factual comparison of the precise, confidential formulation of the Proposed Slayback Product against the specific quantitative limitations recited in the asserted composition claims.
  • A central legal question will be one of claim scope: how will the court construe claim terms that define the formulation's components and properties, such as "egg yolk lecithin" and "physically stable"? The outcome may depend on whether the court adopts constructions tied to the specific examples and definitions in the patents or broader interpretations based on the terms' ordinary meaning in the art.
  • A key question for the method claims will be one of induced infringement: does the language of the proposed label for the Slayback product direct, encourage, or instruct end-users to perform each and every step of the claimed methods for treating chemotherapy-induced nausea and vomiting?