DCT

1:26-cv-00140

Abraxis Bioscience LLC v. Qilu Pharmaceutical Hainan Co Ltd

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00140, D.N.J., 01/08/2026
  • Venue Allegations: Venue is asserted on the basis that Defendant is a foreign corporation and may therefore be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the cancer drug Abraxane® constitutes an act of infringement of seven patents covering compositions and methods of use for the drug.
  • Technical Context: The technology concerns nanoparticle albumin-bound paclitaxel, an injectable suspension formulation used for treating various cancers, which avoids certain solvents used in earlier formulations of the drug.
  • Key Procedural History: The certification filed with the complaint notes that certain of the patents-in-suit were previously at issue in litigation against other generic drug manufacturers, namely Abraxis v. HBT Labs and Abraxis v. Hainan Shuangcheng Pharmaceuticals. This indicates a history of enforcement for this patent portfolio.

Case Timeline

Date Event
2005-02-18 Earliest Priority Date for all Patents-in-Suit
2010-07-20 U.S. Patent 7,758,891 Issues
2011-10-11 U.S. Patent 8,034,375 Issues
2012-09-18 U.S. Patent 8,268,348 Issues
2015-08-11 U.S. Patent 9,101,543 Issues
2016-07-19 U.S. Patent 9,393,318 Issues
2016-12-06 U.S. Patent 9,511,046 Issues
2017-03-21 U.S. Patent 9,597,409 Issues
2025-11-26 Alleged date of Defendant's Paragraph IV Notice Letter
2026-01-08 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 background describes challenges in cancer treatment, including severe side effects from chemotherapy, the development of multi-drug resistance (MDR), and the failure of many tumors to respond to drug or radiation therapy (’891 Patent, col. 1:26-32; col. 2:6-12). Conventional formulations of drugs like paclitaxel required solvents that caused hypersensitivity reactions and could reduce anti-cancer activity (’891 Patent, col. 5:30-49).
  • The Patented Solution: The invention proposes combination therapies for treating proliferative diseases like cancer. The core of the solution is a first therapy comprising a taxane, such as paclitaxel, formulated in a nanoparticle composition with a carrier protein like albumin. This nanoparticle formulation is administered in combination with a second therapy, which can include other chemotherapeutic agents, radiation, or surgery (’891 Patent, Abstract; col. 7:1-14). This approach seeks to overcome the problems of prior art therapies by, among other things, providing a taxane formulation free of problematic solvents like Cremophor® (’891 Patent, col. 5:50-54).
  • Technical Importance: The use of an albumin-nanoparticle carrier system for a poorly soluble drug like paclitaxel represented a method to improve the drug's safety profile and therapeutic index, potentially enabling more effective combination treatments without the dose-limiting toxicities of prior formulations (’891 Patent, col. 5:56-62).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more of the claims" of the ’891 Patent but does not identify any specific independent or dependent claims being asserted (Compl. ¶30, ¶32).

U.S. Patent No. 8,034,375 - “Combinations and Modes of Administration of Therapeutic Agents and Combination Therapy”

Issued October 11, 2011 (’375 Patent)

The Invention Explained

  • Problem Addressed: The patent addresses the significant side effects, dose-limiting toxicities, and drug resistance associated with conventional cancer treatments like chemotherapy and radiation (’375 Patent, col. 1:26-32; col. 2:6-12). It specifically notes that solvents used in prior paclitaxel formulations could cause severe hypersensitivity reactions and compromise the drug's antiangiogenic activity (’375 Patent, col. 5:30-49).
  • The Patented Solution: The patent describes methods of treating proliferative diseases by administering a taxane (e.g., paclitaxel) in a nanoparticle composition with a carrier protein (e.g., albumin). This formulation is used as part of a combination therapy with other treatments, such as different chemotherapeutic agents or radiation therapy, to create a more effective and less toxic cancer treatment regimen (’375 Patent, Abstract; col. 7:1-14).
  • Technical Importance: The albumin-based nanoparticle delivery system was designed to improve the safety and efficacy of taxanes, which could in turn allow for more effective combination therapies against proliferative diseases like cancer (’375 Patent, col. 5:56-62).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the ’375 Patent but does not identify any specific independent or dependent claims being asserted (Compl. ¶39, ¶41).

U.S. Patent No. 8,268,348 - “Combinations and Modes of Administration of Therapeutic Agents and Combination Therapy”

Issued September 18, 2012 (’348 Patent)

Technology Synopsis

The patent describes methods of treating proliferative diseases, such as cancer, using combination therapies. The core technology involves administering a taxane formulated as nanoparticles with a carrier protein, such as albumin-bound paclitaxel, in conjunction with a second therapeutic agent or treatment modality to improve efficacy and reduce toxicity compared to conventional treatments (’348 Patent, Abstract; col. 1:12-24).

Asserted Claims

The complaint asserts infringement of "one or more claims" of the ’348 Patent (Compl. ¶48, ¶50).

Accused Features

The accused instrumentality is Defendant's proposed generic version of Abraxane®, referred to as "Qilu's ANDA Product" (Compl. ¶1, ¶48).

U.S. Patent No. 9,101,543 - “Combinations and Modes of Administration of Therapeutic Agents and Combination Therapy”

Issued August 11, 2015 (’543 Patent)

Technology Synopsis

The patent discloses methods of treating cancer through combination therapy. The described invention involves administering a first therapy comprising a taxane, such as paclitaxel, formulated in a nanoparticle composition with a carrier protein like albumin, along with a second therapy such as another chemotherapeutic agent, to enhance treatment effectiveness and safety (’543 Patent, Abstract; col. 1:18-28).

Asserted Claims

The complaint asserts infringement of "one or more claims" of the ’543 Patent (Compl. ¶57, ¶59).

Accused Features

The accused instrumentality is "Qilu's ANDA Product," a proposed generic version of paclitaxel protein-bound particles for injectable suspension (Compl. ¶1, ¶57).

U.S. Patent No. 9,393,318 - “Methods of Treating Cancer”

Issued July 19, 2016 (’318 Patent)

Technology Synopsis

The patent relates to methods of treating cancer by administering a composition of nanoparticles comprising paclitaxel and a carrier protein, such as albumin. The administration is described as part of a combination therapy, for example with another chemotherapeutic agent, to treat various cancers (’318 Patent, Abstract; col. 1:17-27).

Asserted Claims

The complaint asserts infringement of "one or more claims" of the ’318 Patent (Compl. ¶66, ¶68).

Accused Features

The accused instrumentality is "Qilu's ANDA Product," which arises from Qilu's ANDA submission seeking approval for a generic version of Abraxane® (Compl. ¶1, ¶66).

U.S. Patent No. 9,511,046 - “Methods of Treating Pancreatic Cancer”

Issued December 6, 2016 (’046 Patent)

Technology Synopsis

This patent discloses methods for treating metastatic pancreatic cancer in a human. The method involves administering a composition of nanoparticles comprising paclitaxel and an albumin, in combination with gemcitabine, based on a specific dosing regimen (’046 Patent, Abstract).

Asserted Claims

The complaint asserts infringement of "one or more claims" of the ’046 Patent (Compl. ¶75, ¶77).

Accused Features

Infringement allegations are directed at "Qilu's ANDA Product," a generic version of Abraxane® for which Defendant is seeking FDA approval (Compl. ¶1, ¶75).

U.S. Patent No. 9,597,409 - “Methods of Treating Cancer”

Issued March 21, 2017 (’409 Patent)

Technology Synopsis

The patent describes methods for treating cancer by administering a composition comprising nanoparticles of paclitaxel and a carrier protein, such as albumin. This administration can be part of a combination therapy, intended to provide a more effective treatment for cancer (’409 Patent, Abstract; col. 1:17-27).

Asserted Claims

The complaint asserts infringement of "one or more claims" of the ’409 Patent (Compl. ¶84, ¶86).

Accused Features

The infringement allegations target "Qilu's ANDA Product," which is Qilu's proposed generic version of the Abraxane® drug product (Compl. ¶1, ¶84).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Qilu’s ANDA Product," a generic version of the Abraxane® drug product (paclitaxel protein-bound particles for injectable suspension) for which Qilu has filed Abbreviated New Drug Application No. 220144 with the FDA (Compl. ¶1).

Functionality and Market Context

As an ANDA product, Qilu’s product is intended to be a bioequivalent generic substitute for Abraxis’s FDA-approved Abraxane®, which is used for the treatment of certain forms of metastatic breast cancer, non-small cell lung cancer, and pancreatic cancer (Compl. ¶1, ¶11). The complaint alleges that the claims of the patents-in-suit cover methods of use and administration of this type of paclitaxel product (Compl. ¶11). The filing of the ANDA itself is the statutory act of infringement alleged in the complaint, which seeks to prevent the commercial manufacture, use, and sale of the generic product prior to the expiration of the patents-in-suit (Compl. ¶1, ¶30). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that Qilu’s submission of its ANDA constitutes infringement of "one or more claims" of each of the seven asserted patents (Compl. ¶30, ¶39, ¶48, ¶57, ¶66, ¶75, ¶84). However, the complaint does not identify any specific claims being asserted, nor does it provide a claim chart or any element-by-element mapping of accused functionality to claim limitations. The complaint does not provide sufficient detail for a claim-element-level analysis of infringement.

V. Key Claim Terms for Construction

The complaint does not identify any specific asserted claims; therefore, no key terms for construction can be analyzed at this stage.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement for all seven patents-in-suit. The inducement allegations are based on the assertion that, upon FDA approval, Qilu will "intentionally encourage acts of direct infringement with knowledge of the" patents (e.g., Compl. ¶33, ¶42, ¶51). The contributory infringement allegations are based on the assertion that Qilu's ANDA product "is especially adapted for a use that infringes one or more claims" of the patents and that there is "no substantial non-infringing use" for the product (e.g., Compl. ¶34, ¶43, ¶52).

Willful Infringement

Willfulness is not pleaded as a separate count, but for each patent, the complaint asserts that the case is "an exceptional one" and seeks an award of attorneys' fees under 35 U.S.C. § 285 (e.g., Compl. ¶37, ¶46, ¶55). The factual basis for pre-suit knowledge is Defendant’s alleged submission of a Paragraph IV Certification and its sending of a "Notice Letter" to Abraxis, which informed Abraxis that Qilu seeks approval to market its generic product before the patents-in-suit expire (Compl. ¶27-28).

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

Given the procedural posture of an ANDA filing, this case will likely center on two fundamental inquiries for the court, which cannot be resolved from the face of the complaint alone:

  • Validity of Asserted Claims: A primary issue will be whether the specific patent claims Abraxis ultimately asserts against Qilu's proposed product are valid over the prior art. The litigation will likely focus on whether the claimed methods of administration, dosing regimens, and combination therapies were novel and non-obvious at the time of invention.
  • Scope of Infringement: A key question will be one of definitional infringement: assuming the asserted claims are valid, does the proposed label for Qilu's ANDA product instruct or encourage physicians and patients to perform all the steps of at least one valid patent claim? The outcome will depend on a comparison between the specific language of the patent claims and the methods of use described in the proposed generic drug's labeling.