DCT

1:17-cv-00693

Teva Pharma USA Inc v. DR Reddy's Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00693, D.N.J., 01/25/2017
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Dr. Reddy's Laboratories, Inc. is incorporated and has its principal place of business in New Jersey, and Defendant Dr. Reddy's Laboratories, Ltd. markets products in the state, has continuous business contacts, and has previously availed itself of the forum in other patent litigation.
  • Core Dispute: Plaintiff alleges that Defendant’s process for manufacturing a generic version of the multiple sclerosis drug COPAXONE® infringes a patent related to a specific filtration method.
  • Technical Context: The lawsuit concerns the manufacturing process for a complex biologic drug, glatiramer acetate, where precise process controls can be critical to achieving the final product's approved characteristics.
  • Key Procedural History: This action arises from Defendant's Abbreviated New Drug Application (ANDA) filed with the FDA to market a generic version of Plaintiff's COPAXONE® 40 mg/mL product. The complaint alleges that to obtain FDA approval, Defendant's product must be "the same as" the innovator product, and further alleges that the only commercially feasible way to produce such a product is by using the patented manufacturing process.

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 Issue Date
2016-10-25 Dr. Reddy's earnings call mentioned in complaint
2017-01-25 Complaint Filing Date
2017-01-28 Defendant's alleged target date for 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, issued October 13, 2015.

The Invention Explained

  • Problem Addressed: The patent describes a problem encountered when manufacturing a 40 mg/mL formulation of glatiramer acetate. Specifically, filtering the higher-concentration solution at controlled room temperature resulted in a "pressure build-up on the second filter," which could hinder commercial-scale production (’775 Patent, col. 9:11-17).
  • The Patented Solution: The invention solves this problem by filtering the aqueous solution of glatiramer acetate and mannitol at a reduced temperature, specified as being from above 0° C up to 17.5° C (’775 Patent, Abstract; col. 2:56-65). This cooling step, according to the patent, decreases the solution's viscosity and improves its "filterability," allowing for the completion of the filtration process without the prohibitive pressure increase observed at room temperature (’775 Patent, col. 9:18-24).
  • Technical Importance: This process improvement allegedly facilitates the "commercial production of COPAXONE® 40 mg/mL" by providing a reliable and feasible method for sterile filtration at scale (Compl. ¶48, ¶59).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the ’775 patent (Compl. ¶62). The primary independent process claim is Claim 1.
  • Independent Claim 1:
    • Obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol.
    • Filtering the solution at a temperature between 0° C and 17.5° C to produce a filtrate, where the filterability is improved compared to filtering at controlled room temperature.
    • Filling a suitable container with the filtrate.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the allegation for "one or more claims" leaves this possibility open.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the manufacturing process used to create "DRL's Glatiramer Acetate Product," which is an injectable drug purported to be a generic version of Teva’s COPAXONE® 40 mg/mL (Compl. ¶50).

Functionality and Market Context

  • The final product is intended for the treatment of patients with relapsing forms of multiple sclerosis (Compl. ¶45). The infringement allegation, however, is not directed at the final product's therapeutic use but at the specific manufacturing process Defendant allegedly uses (Compl. ¶58). The complaint alleges that Defendant must use an infringing process for its generic product to be determined by the FDA to be "the same as" Plaintiff's COPAXONE® product and that the patented process is the "only commercially feasible means" of doing so (Compl. ¶58-59).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not provide a claim chart exhibit. The infringement theory is constructed from narrative allegations that Defendant must necessarily infringe to achieve a bioequivalent product for its ANDA.

’975 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; Defendant is alleged to be manufacturing a glatiramer acetate injection, which would require obtaining an aqueous solution of the active ingredient and an excipient like mannitol. ¶50, ¶58 col. 21:51-53
(ii) filtering the aqueous pharmaceutical solution at a temperature of 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 Plaintiff alleges that Defendant must use a process that infringes, and that the patented process is the only commercially feasible way to produce commercial quantities of the 40 mg/mL product, implying Defendant must filter within the claimed temperature range to achieve the required improved filterability. ¶48, ¶58-59 col. 21:54-61
(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. Defendant’s ANDA seeks approval for a glatiramer acetate injection, which would necessarily be filled into a suitable container (e.g., a syringe or vial) for distribution and sale. ¶50, ¶58 col. 21:62-66

Identified Points of Contention

  • Evidentiary Questions: The complaint is based on "information and belief" and the premise that infringement is a necessity for FDA approval. A central question for the court will be what direct or indirect evidence Plaintiff can adduce to prove the specific steps of Defendant’s proprietary manufacturing process.
  • Technical Questions: The case raises the question of whether Defendant has developed an alternative, non-infringing manufacturing process. For example, has Defendant found a different method to manage filtration pressure (e.g., different filters, different excipients, or a different temperature) that still results in a product the FDA considers bioequivalent? The complaint's assertion that the patented process is the "only commercially feasible means" will be a key point of dispute (Compl. ¶59).

V. Key Claim Terms for Construction

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

  • Context and Importance: The infringement analysis hinges on whether Defendant’s manufacturing process operates within this specific temperature range. The definition of this range is critical, as a process operating even slightly outside it would be non-infringing.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The plain language of the claim itself provides the explicit boundaries of above 0° C. and up to 17.5° C., which a party may argue should be applied without further limitation (’775 Patent, col. 21:56-57).
    • Evidence for a Narrower Interpretation: The specification discloses several examples where filtration was performed in a narrower subset of this range, such as 6.6-10.7° C. and 6.4-12° C. (’775 Patent, Tables 2 & 3). A party could argue these embodiments suggest the true inventive scope is more limited than the full claimed range.

  • The Term: "filterability... is improved compared to the filterability of the solution at controlled room temperature"

  • Context and Importance: This is a comparative limitation that forms the basis for the invention. Proving infringement requires showing not only that Defendant filters at a reduced temperature, but that this filtering results in an "improvement" relative to a "controlled room temperature" baseline. Practitioners may focus on how to define and measure both "improvement" and "controlled room temperature."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party could argue that any quantifiable improvement in filtration efficiency or a reduction in pressure qualifies as "improved."
    • Evidence for a Narrower Interpretation: The specification specifically identifies the problem to be solved as a "pressure build-up on the second filter" (’775 Patent, col. 9:11-14). A party may argue that "improved filterability" must be construed to mean, at a minimum, the mitigation of this specific pressure build-up problem, and not just any marginal improvement. The patent also provides examples of "controlled room temperature," such as 17.8-24.6° C. (’775 Patent, Table 2).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that the two Defendant entities, DRL Ltd. and DRL Inc., "will work in concert with one another to make, use, import, offer to sell, and sell a generic version" of the product (Compl. ¶37). It further alleges that DRL Ltd. will manufacture the product on behalf of DRL Inc., which will act as the agent for importation and sale (Compl. ¶38). These allegations are offered to support claims of induced and contributory infringement under 35 U.S.C. § 271(b) and (c) (Compl. ¶62, ¶69).
  • Willful Infringement: Plaintiff alleges that Defendant’s infringement "is willful and continues despite knowledge of the ’775 patent" and that Defendant "acted without a reasonable basis for believing that they would not be liable" (Compl. ¶65). The basis for this pre-suit knowledge is not specified beyond the existence of the patent itself.

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

  • A core issue will be one of evidentiary proof: The complaint’s infringement theory rests on the inference that Defendant must be using the patented process to create a bioequivalent generic. A key question for the case is whether Plaintiff can obtain and present sufficient evidence from Defendant’s confidential ANDA and manufacturing records to prove that its process actually meets the specific temperature and improved filterability limitations of the asserted claims.
  • The case will also turn on a question of technical necessity versus invention: Is the patented method of low-temperature filtration truly the only commercially viable path to producing a 40 mg/mL glatiramer acetate product that meets FDA standards, as Plaintiff alleges? Or will discovery reveal that Defendant developed a non-infringing alternative process, thereby challenging the premise of Plaintiff's infringement theory?