DCT

1:23-cv-00750

Abraxis Bioscience LLC v. Hainan Shuangcheng Pharma Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00750, D.N.J., 02/08/2023
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation that may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff’s Abraxane® product constitutes an act of infringement of eleven patents related to pharmaceutical compositions and cancer treatment methods.
  • Technical Context: The patents relate to nanoparticle-based drug delivery formulations, specifically for the cancer drug paclitaxel, designed to improve solubility and reduce side effects associated with conventional solvent-based formulations.
  • Key Procedural History: The complaint's certification references prior patent infringement lawsuits filed by Abraxis concerning the same drug product (Abraxane®) and certain of the same patents against other generic drug manufacturers, including Actavis, Cipla, HBT Labs, and Jiangsu Hengrui, between 2016 and 2022. All prior cases were noted as dismissed, which may indicate settlements or other resolutions that could provide context for the current litigation strategy.

Case Timeline

Date Event
2002-12-09 Priority Date for ’788, ’536, ’229, ’156, ’318 Patents
2005-02-18 Priority Date for ’891, ’375, ’348, ’543, ’046, ’409 Patents
2010-07-20 Issue Date: U.S. Patent No. 7,758,891
2010-10-26 Issue Date: U.S. Patent No. 7,820,788
2011-04-12 Issue Date: U.S. Patent No. 7,923,536
2011-10-11 Issue Date: U.S. Patent No. 8,034,375
2012-03-20 Issue Date: U.S. Patent No. 8,138,229
2012-09-18 Issue Date: U.S. Patent No. 8,268,348
2012-11-20 Issue Date: U.S. Patent No. 8,314,156
2015-08-11 Issue Date: U.S. Patent No. 9,101,543
2016-07-19 Issue Date: U.S. Patent No. 9,393,318
2016-12-06 Issue Date: U.S. Patent No. 9,511,046
2017-03-21 Issue Date: U.S. Patent No. 9,597,409
2022-12-27 Defendant sends Paragraph IV Certification Notice Letter
2023-02-08 Complaint Filing Date

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

U.S. Patent No. 7,758,891 - "Combinations and Modes of Administration of Therapeutic Agents and Combination Therapy," Issued July 20, 2010 (’891 Patent)

The Invention Explained

  • Problem Addressed: The patent's background describes the failure of many tumors to respond to conventional drug and radiation therapy, as well as the severe side effects and drug resistance associated with traditional chemotherapy (US 7,758,891 B2, col. 1:26-34).
  • The Patented Solution: The invention proposes a combination therapy for treating proliferative diseases like cancer. This involves a first therapy administering a taxane (such as paclitaxel) formulated in a nanoparticle composition, and a second therapy that can be radiation, surgery, or another chemotherapeutic agent (US 7,758,891 B2, Abstract; col. 5:56-65). This approach aims to be more effective than single-agent therapies.
  • Technical Importance: The use of combination therapies is a cornerstone of modern oncology, aimed at overcoming drug resistance and targeting cancer cells through multiple mechanisms, which was a significant focus of cancer research at the time of the invention (US 7,758,891 B2, col. 2:40-43).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the patent (Compl. ¶35). Independent claim 1 is representative of the invention's method claims.
  • Independent Claim 1:
    • A method of treating a proliferative disease in an individual, comprising:
    • a) administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel and a carrier protein; and
    • b) a second therapy selected from the group consisting of radiation therapy, surgery, or combinations thereof.
  • The complaint generally alleges infringement of the patents-in-suit, which would include dependent claims by extension (Compl. ¶35, 37-39).

U.S. Patent No. 7,820,788 - "Compositions and Methods of Delivery of Pharmacological Agents," Issued October 26, 2010 (’788 Patent)

The Invention Explained

  • Problem Addressed: The patent background identifies undesirable side effects associated with the parenteral administration of many drugs, particularly water-insoluble drugs that require irritating solvents or emulsifiers for formulation, such as the cancer drug paclitaxel (US 7,820,788 B2, col. 1:21-41).
  • The Patented Solution: The invention provides a pharmaceutical composition where a drug agent is combined with a carrier protein, such as human serum albumin. This formulation aims to create stable particles, reduce administration-related side effects by avoiding harsh solvents like Cremophor, and potentially enhance drug transport to cells (US 7,820,788 B2, Abstract; col. 5:53-64).
  • Technical Importance: Developing solvent-free formulations for poorly soluble but effective drugs like paclitaxel was a significant goal in pharmaceutical science, intended to improve patient tolerance and potentially enhance therapeutic efficacy (US 7,820,788 B2, col. 1:21-25; col. 2:42-45).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the patent (Compl. ¶46). Independent claim 1 is representative of the invention's composition claims.
  • Independent Claim 1:
    • A pharmaceutical composition for injection comprising paclitaxel and a pharmaceutically acceptable carrier,
    • wherein the pharmaceutically acceptable carrier comprises albumin,
    • wherein the albumin and the paclitaxel in the composition are formulated as particles,
    • wherein the particles have a particle size of less than about 200 nm, and
    • wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1.
  • The complaint's general allegations of infringement would extend to dependent claims (Compl. ¶46, 48-50).

Multi-Patent Capsule Analysis

  • U.S. Patent No. 7,923,536 (’536 Patent): This patent, titled "Compositions and Methods of Delivery of Pharmacological Agents," addresses the side effects of drugs formulated with irritating solvents by disclosing pharmaceutical compositions comprising a drug agent and a protein carrier, such as albumin. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶57).
  • U.S. Patent No. 8,034,375 (’375 Patent): This patent, titled "Combinations and Modes of Administration of Therapeutic Agents and Combination Therapy," describes methods of treating proliferative diseases like cancer by using a taxane in a nanoparticle composition in combination with a second therapy, such as radiation or another chemotherapeutic agent. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶68).
  • U.S. Patent No. 8,138,229 (’229 Patent): This patent, titled "Compositions and Methods of Delivery of Pharmacological Agents," discloses pharmaceutical compositions of a drug agent and a protein carrier, like albumin, formulated as particles to reduce side effects associated with conventional solvents. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶79).
  • U.S. Patent No. 8,268,348 (’348 Patent): This patent, titled "Combinations and Modes of Administration of Therapeutic Agents and Combination Therapy," claims methods for treating cancer using a combination of a taxane nanoparticle composition and a second therapy, such as another chemotherapeutic agent or radiation. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶90).
  • U.S. Patent No. 8,314,156 (’156 Patent): This patent, titled "Compositions and Methods of Delivery of Pharmacological Agents," describes pharmaceutical compositions of a drug (e.g., paclitaxel) and a carrier protein (e.g., albumin) formulated as particles of a specific size and weight ratio. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶101).
  • U.S. Patent No. 9,101,543 (’543 Patent): This patent, titled "Combinations and Modes of Administration of Therapeutic Agents and Combination Therapy," discloses methods of treating proliferative diseases using a combination of a taxane nanoparticle formulation and a second therapy. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶112).
  • U.S. Patent No. 9,393,318 (’318 Patent): This patent, titled "Methods of Treating Cancer," claims methods of treating cancer by administering a composition of nanoparticles comprising paclitaxel and albumin. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶123).
  • U.S. Patent No. 9,511,046 (’046 Patent): This patent, titled "Methods of Treating Pancreatic Cancer," describes methods for treating metastatic pancreatic cancer by administering a taxane nanoparticle composition in combination with gemcitabine. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶134).
  • U.S. Patent No. 9,597,409 (’409 Patent): This patent, titled "Methods of Treating Cancer," discloses methods for treating non-small-cell lung cancer by administering a nanoparticle composition of paclitaxel and albumin with a platinum-based agent like carboplatin. The complaint asserts infringement by Defendant's ANDA Product (Compl. ¶145).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendant HNSP’s generic drug product, for which it filed Abbreviated New Drug Application (ANDA) No. 216355 with the U.S. Food and Drug Administration (FDA) (Compl. ¶1).
  • Functionality and Market Context: The complaint alleges that HNSP's ANDA Product is a generic version of Plaintiff's Abraxane® drug product, which is described as "paclitaxel protein-bound particles for injectable suspension" (Compl. ¶1). The filing of the ANDA itself, seeking FDA approval to market this generic version prior to the expiration of the patents-in-suit, constitutes the act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶35, 46). The Abraxane® product is an FDA-approved prescription medicine for treating certain forms of cancer, including metastatic breast cancer, non-small cell lung cancer, and pancreatic cancer (Compl. ¶15).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed claim chart or specific mapping of the accused product to claim limitations. The infringement allegation is based on the statutory act of filing an ANDA seeking to market a generic version of Plaintiff's Abraxane® product, which Plaintiff alleges is covered by the patents-in-suit. The following tables summarize the infringement theory for representative claims based on the allegation that the HNSP ANDA Product is a generic equivalent of Abraxane®.

No probative visual evidence provided in complaint.

’891 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a proliferative disease in an individual, comprising: a) administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel and a carrier protein HNSP's ANDA Product is alleged to be a generic version of Abraxane®, a paclitaxel-protein nanoparticle composition, and its proposed labeling will instruct for its use in treating cancer. ¶1, 15, 17 col. 7:8-14
and b) a second therapy selected from the group consisting of radiation therapy, surgery, or combinations thereof. The proposed labeling for the ANDA product allegedly instructs for uses that are covered by the claims of the patents-in-suit, some of which involve combination therapies for cancer treatment. ¶15, 17 col. 7:8-14

’788 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition for injection comprising paclitaxel and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises albumin, HNSP's ANDA Product is alleged to be a generic version of Abraxane®, which is a composition of paclitaxel and albumin for injection. ¶1, 15 col. 5:53-55
wherein the albumin and the paclitaxel in the composition are formulated as particles, HNSP's ANDA Product is alleged to be "paclitaxel protein-bound particles for injectable suspension." ¶1, 15 col. 5:53-55
wherein the particles have a particle size of less than about 200 nm, The complaint alleges the ANDA product is a generic version of Abraxane®, which has these properties. The ANDA filing itself is the act of infringement for a product that would meet this limitation if sold. ¶1, 15, 46 col. 5:53-55
and wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1. The complaint alleges the ANDA product is a generic version of Abraxane®, which has these properties. The ANDA filing is the act of infringement for a product that would meet this limitation if sold. ¶1, 15, 46 col. 5:53-55
  • Identified Points of Contention:
    • Scope Questions: A central question in Hatch-Waxman litigation is whether the generic product, as described in its ANDA, falls within the scope of the asserted patent claims. The dispute may center on whether HNSP's specific formulation (e.g., particle size, albumin-to-paclitaxel ratio, excipients) meets every limitation of the asserted composition claims.
    • Validity Questions: Defendant HNSP, in its Paragraph IV Certification, has alleged that the claims of the patents-in-suit are invalid (Compl. ¶30-31). The litigation will therefore likely involve significant disputes over whether the patents are valid in light of prior art.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim terms that may be in dispute. However, based on the technology and the claims, certain terms are frequently central to such disputes.

  • The Term: "nanoparticles comprising paclitaxel and a carrier protein" (’891 Patent, Claim 1)

  • Context and Importance: The definition of this term is fundamental to the scope of both the method and composition patents. Practitioners may focus on this term because its construction will determine what specific formulations are covered, including whether the term requires the carrier protein (albumin) to be a component of the particle itself or merely associated with it.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the composition in various ways, including simply "comprising" the agent and the protein, which could suggest a broad range of association (US 7,758,891 B2, col. 7:11-14).
    • Evidence for a Narrower Interpretation: Specific embodiments describe the paclitaxel as being "coated with" albumin, which may suggest a more limited structural requirement (US 7,820,788 B2, col. 9:18-19).

  • The Term: "a second therapy" (’891 Patent, Claim 1)

  • Context and Importance: This term defines the scope of the method claims covering combination treatments. The dispute may involve whether the "second therapy" must be part of a coordinated treatment plan with the nanoparticle paclitaxel or if it can include any other cancer treatment an individual happens to receive.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim language is broad ("a second therapy selected from..."), and the specification discusses administering the therapies "sequentially or simultaneously," which could encompass a wide range of treatment scenarios (US 7,758,891 B2, col. 8:11-12).
    • Evidence for a Narrower Interpretation: The patent's title and purpose focus on "Combination Therapy," which may imply a planned, integrated treatment regimen rather than two disconnected therapeutic events (US 7,758,891 B2, Title).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, HNSP will induce infringement by encouraging physicians and patients to use the ANDA product in ways that infringe the method claims (Compl. ¶38, 49). It further alleges contributory infringement, stating the ANDA product is especially adapted for an infringing use with no substantial non-infringing use (Compl. ¶39, 50).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that HNSP's submission of its ANDA constitutes infringement and that HNSP had knowledge of the patents via the Paragraph IV notice letter (Compl. ¶31, 35). Plaintiff also asserts that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶42, 53), which is often associated with findings of willful infringement or litigation misconduct.

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

  • A core issue will be one of validity: has Defendant HNSP identified prior art or other arguments sufficient to invalidate the asserted claims of Plaintiff's extensive patent portfolio, which has been asserted in multiple prior litigations?
  • A second key question will be one of claim scope: does the specific formulation detailed in HNSP's ANDA meet every limitation of the asserted composition claims, particularly concerning the defined particle size and albumin-to-paclitaxel ratio, and will its proposed label instruct uses that meet the limitations of the asserted method claims?