DCT

1:17-cv-00992

Teva Pharma USA Inc v. Amneal Pharma LLC

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00416, E.D.N.Y., 01/25/2017
  • Venue Allegations: Plaintiff alleges venue is proper based on Defendant Amneal Pharmaceuticals LLC’s significant commercial operations in the district, including manufacturing, research, and development facilities.
  • Core Dispute: Plaintiff alleges that Defendant’s process for manufacturing a generic version of the multiple sclerosis drug COPAXONE® (40 mg/mL) infringes a patent covering a specific, temperature-controlled filtration method.
  • Technical Context: The technology concerns pharmaceutical manufacturing processes for complex biologic drugs, specifically for glatiramer acetate, where filtration efficiency is critical for commercial-scale production.
  • Key Procedural History: This action arises from Defendants’ Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic drug. The complaint alleges Defendants intend to launch their product upon approval, referencing a target approval date from prior, related litigation.

Case Timeline

Date Event
2015-01-28 U.S. Patent No. 9,155,775 Priority Date
2015-10-13 U.S. Patent No. 9,155,775 Issued
2017-01-25 Complaint Filed
2017-01-28 Alleged Target Date for Defendant's ANDA Approval

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

U.S. Patent No. 9,155,775 - “Process for Manufacturing Glatiramer Acetate Product”

  • Patent Identification: U.S. Patent No. 9,155,775, “Process for Manufacturing Glatiramer Acetate Product,” issued October 13, 2015.

The Invention Explained

  • Problem Addressed: The patent describes a problem encountered when filtering a high-concentration (40 mg/mL) formulation of glatiramer acetate (GA) at standard room temperature. This process resulted in a significant "pressure build-up on the second filter," which could hinder or stop the manufacturing process (’775 Patent, col. 10:8-14).
  • The Patented Solution: The invention is a manufacturing process that solves the pressure problem by cooling the GA solution before and during filtration. Specifically, the process involves filtering the aqueous GA solution at a reduced temperature (above 0° C. and up to 17.5° C.), which "significantly improved the filterability" compared to filtration at room temperature ('775 Patent, col. 1:56-65, col. 18:15-19). This cooling step reduces the solution's viscosity, allowing for a more efficient and reliable filtration process at commercial scale ('775 Patent, col. 10:15-26).
  • Technical Importance: This improved process facilitates the commercial production of a higher-dose (40 mg/mL) version of COPAXONE®, a treatment for relapsing forms of multiple sclerosis ('775 Patent, col. 1:41-45, col. 8:25-29).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying them (Compl. ¶61). Independent claim 1 is the broadest process claim.
  • Independent Claim 1:
    • (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol;
    • (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. to 17.5° C. to produce a filtrate, wherein the filterability of the aqueous pharmaceutical solution is improved compared to the filterability of the solution at controlled room temperature; and
    • (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container.
  • The complaint does not explicitly reserve the right to assert dependent claims but maintains a broad allegation against the patent generally.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is "Amneal's Glatiramer Acetate Product," a proposed generic version of Teva's COPAXONE® 40 mg/mL injection, and the process used to manufacture it (Compl. ¶49).
  • Functionality and Market Context: The product is a complex mixture of polypeptides intended for the treatment of relapsing forms of multiple sclerosis (Compl. ¶1, 44). The complaint alleges that Amneal has filed an ANDA with the FDA seeking approval to manufacture and sell this product (Compl. ¶49). The core of the action is based on a product-by-process theory, wherein Plaintiff alleges that for Defendants' product to be bioequivalent to Teva's COPAXONE®, it must be made using a process that infringes the ’775 Patent (Compl. ¶57). Plaintiff further alleges that the patented processes are the "only commercially feasible means" of producing the drug at commercial scale (Compl. ¶58).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'775 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol; On information and belief, Defendants' generic product is intended to be the "same as" Teva's COPAXONE®, which is an aqueous solution of glatiramer acetate and mannitol. ¶49, 53, 57 col. 9:5-11
(ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. to 17.5° C. to produce a filtrate, wherein the filterability of the aqueous pharmaceutical solution is improved compared to the filterability of the solution at controlled room temperature; On information and belief, Defendants must use the patented temperature-controlled filtration process because it is the "only commercially feasible means" of producing commercial quantities of a 40 mg/mL GA product that can meet FDA bioequivalence requirements. ¶57, 58 col. 1:58-62
(iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation... Defendants are seeking FDA approval to manufacture, sell, and import a finished drug product supplied in a final container, such as a prefilled syringe. ¶49, 61 col. 1:62-65
  • Identified Points of Contention:
    • Evidentiary Question: The complaint is based on "information and belief" rather than direct evidence of Defendants' manufacturing process. A central question will be what evidence Plaintiff can obtain through discovery to prove that Defendants' process actually involves filtration within the specific temperature range of "above 0° C. to 17.5° C." as required by the claim.
    • Technical Question: The case may turn on Plaintiff's assertion that the patented process is the "only commercially feasible means" to create a bioequivalent product (Compl. ¶58). The viability of any potential non-infringing alternative manufacturing processes will be a key point of technical dispute.

V. Key Claim Terms for Construction

  • The Term: "filtering...at a temperature of from above 0° C. up to 17.5° C."

    • Context and Importance: This term is the central inventive concept and the primary basis for the infringement allegation. The dispute will focus on whether Defendants' process, once revealed, falls within this precise numerical range.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself provides a clear numerical range. The specification provides multiple examples that fall within this range, such as 6.6-10.7° C and 10.2-11.7° C, suggesting the patent is not limited to a single, specific temperature but covers the entire claimed range ('775 Patent, Tables 2 & 4).
      • Evidence for a Narrower Interpretation: A party could argue that the term must be read in light of the associated functional requirement for "improved filterability" compared to "controlled room temperature," potentially limiting the effective scope to temperatures where such improvement is significant ('775 Patent, col. 20:55-59).

  • The Term: "wherein the filterability...is improved"

    • Context and Importance: This functional language qualifies the temperature limitation. Practitioners may focus on this term because infringement requires not just meeting a temperature range, but also achieving a specific result. A defendant could argue its process does not achieve "improved" filterability relative to a baseline.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification describes "improved filterability" in terms of avoiding "pressure build-up" and allowing filtration to be "completed without the pressure increase" seen at room temperature ('775 Patent, col. 10:12-14, col. 12:21-23). This provides a qualitative, if not quantitative, metric for improvement.
      • Evidence for a Narrower Interpretation: A party might argue that the "improvement" must be commercially or statistically significant, or that the baseline for comparison—"controlled room temperature"—is itself ambiguous and must be defined by the specific examples in the patent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement and contributory infringement under 35 U.S.C. § 271(b) and (c) based on Defendants' intent to "manufacture, market, sell, offer to sell and/or import" the accused product, which would constitute direct infringement (Compl. ¶67-68). It also alleges Defendants acted "in concert" to direct the infringing activities (Compl. ¶63).
  • Willful Infringement: Willfulness is alleged based on Defendants' purported knowledge of the ’775 Patent and the assertion that they "acted without a reasonable basis for believing that they would not be liable" (Compl. ¶64, 70).

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

  • The primary issue is one of evidentiary proof in a product-by-process case: Can Plaintiff, through discovery, uncover direct evidence that Defendants' confidential manufacturing process performs the specific temperature-controlled filtration step of Claim 1, moving beyond the initial allegations based on "information and belief"?
  • A crucial factual question concerns technical necessity: Is the patented method, as Plaintiff alleges, the "only commercially feasible means" to produce a 40 mg/mL glatiramer acetate product that meets FDA bioequivalence standards, or can Defendants demonstrate the existence of a viable, non-infringing alternative process?