DCT

1:23-cv-00033

Abraxis Bioscience LLC v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00033, N.D.W. Va., 04/06/2023
  • Venue Allegations: Venue is alleged to be proper as Defendant is incorporated and maintains its principal place of business in the Northern District of West Virginia.
  • Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Abraxane® drug product constitutes an act of infringement of a patent related to pharmaceutical compositions of paclitaxel.
  • Technical Context: The technology concerns formulations of the poorly water-soluble chemotherapy drug paclitaxel, using a protein-based carrier to improve safety and administration.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act, triggered by Defendant’s filing of an ANDA with a Paragraph IV certification. The certification alleges that the patent-in-suit is invalid and/or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2002-12-09 U.S. Patent No. 7,820,788 Priority Date
2010-10-26 U.S. Patent No. 7,820,788 Issues
2023-02-22 Mylan's ANDA pending and Notice Letter sent to Abraxis (on or after)
2023-04-06 Complaint Filed

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

  • Patent Identification: U.S. Patent No. 7,820,788, Compositions and Methods of Delivery of Pharmacological Agents, issued October 26, 2010.

The Invention Explained

  • Problem Addressed: The patent describes the significant side effects associated with the intravenous administration of water-insoluble drugs, such as paclitaxel. These drugs historically required formulation with irritating solvents or emulsifiers (such as Cremophor) that could cause venous irritation, phlebitis, and other adverse reactions. ('788 Patent, col. 1:21-46).
  • The Patented Solution: The invention is a pharmaceutical composition that avoids these harsh solvents by using a protein carrier, specifically albumin, to deliver the drug. The composition is formulated into small particles, which purportedly reduces side effects and improves drug delivery. ('788 Patent, Abstract; col. 2:54-61). The use of albumin as a carrier is described as a key feature for reducing administration-related side effects. ('788 Patent, col. 5:50-63).
  • Technical Importance: This technology provided a way to administer an effective anticancer agent, paclitaxel, without the toxicities associated with conventional solvent-based formulations. ('788 Patent, col. 12:1-7).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the '788 Patent (Compl. ¶18, 20). Independent claim 1 is central to the patent.
  • Independent Claim 1: A pharmaceutical composition for injection comprising:
    • paclitaxel and a pharmaceutically acceptable carrier,
    • wherein the carrier comprises albumin,
    • wherein the albumin and paclitaxel are formulated as particles,
    • wherein the particles have a particle size of less than about 200 nm, and
    • wherein the weight ratio (w/w) of albumin to paclitaxel is about 1:1 to about 9:1.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation of infringing "one or more claims" leaves this possibility open.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Mylan's ANDA Product," identified as ANDA No. 217877, which seeks FDA approval to market a generic version of Plaintiff's Abraxane® drug product (paclitaxel protein-bound particles for injectable suspension) (Compl. ¶1).

Functionality and Market Context

  • The complaint alleges that Mylan's ANDA Product is a generic version of Abraxane®, a prescription medicine used to treat various forms of cancer, including metastatic breast cancer, non-small cell lung cancer, and pancreatic cancer (Compl. ¶1, 5). The complaint asserts that Mylan's product, if approved, will be sold throughout the United States as a substitute for Abraxane® (Compl. ¶12). The complaint does not provide further technical details regarding the specific formulation of Mylan's ANDA Product.
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed, element-by-element breakdown of its infringement allegations. The statutory basis for the suit is Mylan's submission of its ANDA, which is a technical act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶18). The substantive infringement theory is that because Mylan's ANDA Product is a generic version of Abraxane®, and because the '788 Patent covers Abraxane® (Compl. ¶1, 5), Mylan's product will meet the limitations of the patent's claims. The following chart summarizes this implied infringement theory for representative Claim 1.

’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... The complaint alleges Mylan's ANDA Product is a generic version of Abraxane®, a paclitaxel composition for injectable suspension. ¶1, 5 col. 23:32-34
wherein the carrier comprises albumin... The complaint alleges Mylan's ANDA Product is a generic version of "paclitaxel protein-bound particles," implying the use of albumin as the carrier protein. ¶1, 5 col. 23:34-35
wherein the albumin and the paclitaxel in the composition are formulated as particles... The complaint identifies the product as "paclitaxel protein-bound particles for injectable suspension," alleging a particle-based formulation. ¶1 col. 23:36-38
wherein the particles have a particle size of less than about 200 nm... The complaint does not provide specific data but alleges the product is a generic version of Abraxane®, which is covered by the claims of the '788 patent. ¶1, 5 col. 23:38-39
and wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1. The complaint does not provide specific data but alleges the product is a generic version of Abraxane®, which is covered by the claims of the '788 patent. ¶1, 5 col. 23:39-42

Identified Points of Contention

  • Scope Questions: A central dispute may be the interpretation of the term "about" as it applies to the claimed particle size ("less than about 200 nm") and the weight ratio ("about 1:1 to about 9:1"). The parties may contest the degree of variance permitted by this term.
  • Technical Questions: A key evidentiary question will be whether the formulation described in Mylan's confidential ANDA actually meets the specific numerical limitations of the asserted claims. For example, what is the measured particle size distribution and albumin-to-paclitaxel weight ratio in Mylan's proposed product, and how is it measured?

V. Key Claim Terms for Construction

  • The Term: "the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1"

  • Context and Importance: This limitation defines a specific quantitative boundary for the claimed composition. Infringement will depend entirely on whether Mylan's product falls within this range. Practitioners may focus on this term because the patent's own examples could be used to argue for a broader or narrower interpretation of the upper limit.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The complaint does not provide a basis for this analysis.
    • Evidence for a Narrower Interpretation: The patent specification includes examples of compositions with albumin-to-paclitaxel ratios of approximately 10:1 (Example 49) and 27:1 (Example 47), which are outside the claimed 9:1 upper limit ('788 Patent, col. 36:40-62). A defendant could argue that by claiming a ratio up to "about 9:1" while disclosing but not claiming higher ratios, the patentee deliberately defined a clear boundary that should be strictly interpreted.

  • The Term: "particles have a particle size of less than about 200 nm"

  • Context and Importance: This term sets a physical parameter for the claimed particles. The infringement analysis will turn on whether Mylan's particles meet this size limitation, and the construction of "about" will be critical.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term "about" itself suggests the 200 nm limit is not an absolute, rigid cutoff. The patent also describes a resulting particle diameter in the "range 50-220 nm" in one example, which could suggest that particles slightly above 200 nm are contemplated within the scope of the invention ('788 Patent, col. 13:62-64).
    • Evidence for a Narrower Interpretation: The claim language recites "less than about 200 nm," which a party could argue sets a firm ceiling, with "about" only accounting for minor measurement variability. The majority of examples describe processes yielding particles well within this range, potentially supporting an interpretation that 200 nm is a meaningful upper bound.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges inducement, asserting that Mylan will intentionally encourage infringement with knowledge of the '788 Patent. This allegation appears to be based on the future product labeling for Mylan's ANDA product, which, as a generic, would be expected to instruct physicians and healthcare workers in a manner similar to the labeling for Abraxane®, which allegedly describes the patented methods (Compl. ¶7, 21). The complaint also alleges contributory infringement, stating that Mylan's product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶22).

Willful Infringement

  • The complaint does not use the term "willful infringement." However, it alleges that Mylan has had knowledge of the '788 Patent since at least February 22, 2023, the date of its Paragraph IV Notice Letter (Compl. ¶14, 17). It also seeks a finding that the case is "exceptional" and an award of attorneys' fees pursuant to 35 U.S.C. § 285, which can be predicated on a finding of willful infringement (Compl. ¶25; Prayer for Relief ¶J).

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

  • A core issue will be one of claim construction: how much flexibility does the term "about" afford the numerical boundaries of the claimed particle size ("less than about 200 nm") and the albumin-to-paclitaxel weight ratio ("about 9:1")? The patent's disclosure of embodiments with ratios outside the claimed range may become a focal point of this dispute.
  • The primary factual question will be one of evidentiary proof: does the specific formulation detailed in Mylan's confidential ANDA—including its particle size distribution and component ratios as determined by an agreed-upon measurement methodology—fall within the scope of the claims as construed by the court?