DCT

1:17-cv-00249

Teva Pharma USA Inc v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00249, N.D.W. Va., 01/17/2017
  • Venue Allegations: Venue is alleged to be proper based on Defendant Mylan Pharmaceuticals Inc. being incorporated and having its principal place of business in West Virginia, and Defendant Mylan Inc. being registered to do business in the state.
  • Core Dispute: Plaintiff alleges that Defendant’s manufacturing process for its proposed generic version of the multiple sclerosis drug COPAXONE® (40 mg/mL) will infringe a patent related to an improved method for producing the drug.
  • Technical Context: The technology concerns a specific filtration process for manufacturing glatiramer acetate, a complex polypeptide drug used to treat relapsing-remitting forms of multiple sclerosis.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of Plaintiff's COPAXONE® product before the expiration of the patent-in-suit.

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
2017-01-17 Complaint Filing Date
2017-01-28 Defendant's stated target for ANDA approval
Q1 2017 Defendant's anticipated product launch upon FDA approval

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

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

The Invention Explained

  • Problem Addressed: In the large-scale manufacturing of glatiramer acetate solutions, filtering the product at controlled room temperature can cause a pressure build-up on the sterilizing filters. This phenomenon, which can be exacerbated by the solution's viscosity, limits the volume that can be filtered and can impair the efficiency of the manufacturing process (’775 Patent, col. 9:10-17, col. 10:18-22).
  • The Patented Solution: The invention is a process that involves cooling the aqueous pharmaceutical solution of glatiramer acetate and mannitol to a specific temperature range—from above 0° C up to 17.5° C—before filtering it. This cooling step reduces the solution's viscosity, thereby improving its filterability, preventing pressure build-up, and facilitating the efficient, commercial-scale production of the drug product (’775 Patent, Abstract; col. 1:55-65).
  • Technical Importance: This process improvement is presented as facilitating the commercial production of a higher-concentration (40 mg/mL) glatiramer acetate product, which offers a different dosing regimen for patients (Compl. ¶65).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the ’775 Patent; a representative independent claim is Claim 1 (Compl. ¶¶ 79-81).
  • The essential elements of independent Claim 1 are:
    • (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 identify any specific dependent claims but reserves the right to assert them.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is not a product currently on the market but rather the process for manufacturing "Mylan's Glatiramer Acetate Product" (Compl. ¶67). This is a proposed generic glatiramer acetate injection (40 mg/mL) for which Defendants have filed Abbreviated New Drug Application (ANDA) No. 206936 with the FDA (Compl. ¶¶ 67-68).

Functionality and Market Context

  • The complaint alleges that for Defendants' generic product to be approved by the FDA, its active ingredient must be "the same as" the innovator's product (Compl. ¶71).
  • Based on this requirement, the complaint alleges, upon information and belief, that Defendants "must produce their generic glatiramer acetate product using a process that infringes at least one of the claims of the '775 patent" (Compl. ¶75). The complaint further alleges that the patented processes "are the only commercially feasible means of producing commercial scale quantities of COPAXONE® 40 mg/mL" (Compl. ¶76).

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; The complaint alleges that Defendants' ANDA product is purported to be a generic version of Teva’s COPAXONE® 40 mg/mL product, which is an aqueous solution of glatiramer acetate and mannitol. ¶¶64, 67, 71 col. 20:53-54
(ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. to 17.5° C. to produce a filtrate... The complaint alleges on information and belief that Defendants must use a process that infringes the ’775 Patent claims, including this specific temperature-controlled filtration step, in order to achieve FDA approval and produce the generic product at a commercial scale. ¶¶75, 76 col. 20:55-57
...wherein the filterability of the aqueous pharmaceutical solution is improved compared to the filterability of the solution at controlled room temperature; and This functional result is alleged to be an inherent outcome of using the patented process, which the complaint contends Defendants must use. The patent describes this improvement as a key feature of the invention. ¶¶65, 75 col. 20:57-61
(iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation... The complaint alleges that Defendants' ANDA seeks approval to manufacture, market, and sell a final drug product, which by definition requires the step of filling the solution into a suitable container (e.g., a syringe) for distribution and sale. ¶¶67, 79 col. 20:62-65
  • Identified Points of Contention:
    • Factual Question: The central issue in the case will be a factual one: what is the actual manufacturing process detailed in Defendants' confidential ANDA submission? The complaint's infringement theory rests on the inference that to be bioequivalent, Defendants' process must fall within the patent's claims. The primary dispute will revolve around evidence from the ANDA concerning the specific temperatures and conditions used in Defendants' filtration step.
    • Technical Question: A related question is whether the process claimed in the ’775 Patent is, as the complaint alleges, the "only commercially feasible means" of producing the 40 mg/mL formulation (Compl. ¶76). Defendants may present evidence of alternative, non-infringing manufacturing methods that can produce a bioequivalent product.

V. Key Claim Terms for Construction

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

    • Context and Importance: This temperature range is the central technical limitation of the claimed process. The infringement analysis will likely depend entirely on whether Defendants' process, as described in their ANDA, operates within this specific window.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain language "from above 0° C. up to 17.5° C." appears to clearly define the boundaries. A party might argue that this language should be read as written, encompassing the full range without being limited to the specific examples.
      • Evidence for a Narrower Interpretation: A party seeking to avoid infringement might argue that the term should be interpreted in light of the patent's examples, which show filtration at temperatures such as "6.6-10.7° C." ('775 Patent, Table 2) or "6.4-12° C." ('775 Patent, col. 13:21). However, limiting a claim's scope to its examples is generally disfavored.

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

    • Context and Importance: This is a functional limitation that defines the outcome of performing the claimed temperature step. Practitioners may focus on this term because its construction will determine what level of proof is required to show infringement and could be a basis for an indefiniteness challenge under 35 U.S.C. § 112.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification provides a clear antecedent basis, describing "controlled room temperature" filtration as causing pressure build-up (’775 Patent, col. 9:10-17) and providing experimental data where room temperature was "17.8-24.6° C." (’775 Patent, Table 2). This suggests "improved" filterability can be objectively measured by a reduction in pressure or an increase in the volume filtered over time, as shown in the patent's figures (e.g., Fig. 3, 4).
      • Evidence for a Narrower Interpretation: A party could argue that "controlled room temperature" is not explicitly defined in the claims and is therefore ambiguous. They might contend that the degree of "improvement" must be significant and commercially meaningful, not merely any detectable change, pointing to the substantial differences shown in the patent's own comparative examples.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants have "acted in concert" to aid, abet, and encourage the infringing manufacture, and will induce infringement upon launch (Compl. ¶¶ 82, 87). These allegations appear to be directed at the collective actions of the Mylan and Natco entities in preparing and submitting the ANDA.
  • Willful Infringement: The complaint alleges willful infringement based on Defendants' purported knowledge of the ’775 Patent and the allegation that they acted "without a reasonable basis for believing that they would not be liable for infringing" (Compl. ¶83).

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

  • A core issue will be one of evidentiary proof: does the manufacturing process detailed in Defendants' confidential ANDA submission in fact utilize a filtration step that operates within the "above 0° C. to 17.5° C." temperature range recited in the '775 Patent's claims? The case will likely turn on a direct comparison of the ANDA's technical specifications to the claim language.
  • A central factual dispute will be whether a non-infringing process for manufacturing a bioequivalent 40 mg/mL glatiramer acetate product is commercially feasible. The viability of Teva's infringement theory may depend on its ability to prove its assertion that the patented method is the "only commercially feasible means" of production.
  • A potential claim construction question will be what objective standard governs the functional requirement that filterability be "improved compared to... controlled room temperature." The resolution of this issue will define the scope of the claim and the evidence needed to prove infringement.