DCT
2:17-cv-00416
Teva Pharma USA Inc v. Amneal Pharma LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Teva Pharmaceuticals USA, Inc. (Delaware), Teva Pharmaceutical Industries Ltd. (Israel), and Teva Neuroscience, Inc. (Delaware)
- Defendant: Amneal Pharmaceuticals LLC (Delaware) and Amneal Pharmaceuticals Co. GmbH (Switzerland)
- Plaintiff’s Counsel: Goodwin Procter LLP
- Case Identification: 2:17-cv-00416, E.D.N.Y., 01/25/2017
- Venue Allegations: Venue is alleged to be proper based on Defendant Amneal Pharmaceuticals LLC’s significant commercial operations within the district, including manufacturing, research, and development facilities.
- Core Dispute: Plaintiff alleges that Defendant’s proposed generic version of the multiple sclerosis drug COPAXONE® (40 mg/mL) will infringe a patent covering a specific process for its manufacture.
- Technical Context: The technology concerns a pharmaceutical manufacturing process for glatiramer acetate, a complex mixture of polypeptides, where controlling temperature during filtration is critical to enabling commercial-scale production.
- Key Procedural History: The action was initiated in response to Defendant Amneal’s Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of Plaintiff's drug product. The complaint notes a target approval and launch date for the generic product as early as the first quarter of 2017, referencing statements made in a separate litigation.
Case Timeline
| Date | Event |
|---|---|
| 2015-01-28 | '775 Patent Priority Date |
| 2015-10-13 | '775 Patent Issue Date |
| 2017-01-25 | Complaint Filing Date |
| 2017-Q1 | Alleged Target Launch for Accused Product |
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 challenges encountered when scaling up the manufacture of a higher-concentration (40 mg/mL) glatiramer acetate solution. Specifically, filtering the solution at controlled room temperature resulted in a significant pressure build-up on the sterilizing filters, impairing the filtration process and hindering production. (’775 Patent, col. 9:8-14).
- The Patented Solution: The invention is a process based on the discovery that, counterintuitively, reducing the temperature of the aqueous glatiramer acetate solution to a specific range (above 0° C to 17.5° C) before filtration substantially improves its "filterability." (’775 Patent, Abstract; col. 12:19-22). This cooling step prevents the pressure build-up observed at room temperature, allowing for the successful and efficient filtration of large, commercial-scale batches. (’775 Patent, col. 11:5-14).
- Technical Importance: This process enables the reliable, commercial-scale manufacturing of a high-concentration, less frequently administered formulation of a widely used treatment for relapsing forms of multiple sclerosis. (Compl. ¶47).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims of the ’775 Patent. (Compl. ¶61). Independent claim 1 is representative:
- A process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of:
- (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol;
- (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
- (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 specify any dependent claims but reserves the right to assert them.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant Amneal’s “Glatiramer Acetate Product,” an injection purported to be a generic version of Teva’s COPAXONE® 40 mg/mL product. (Compl. ¶49).
Functionality and Market Context
The product is a drug intended for the treatment of patients with relapsing-remitting forms of multiple sclerosis. (Compl. ¶1). The complaint states that Amneal has filed Abbreviated New Drug Application (ANDA) No. 207553 with the FDA seeking approval to manufacture and sell this product in the United States. (Compl. ¶49-50). To gain approval, the active ingredient in an ANDA product must be demonstrated to be "the same as" the innovator's active ingredient. (Compl. ¶53). The complaint alleges that Amneal intends to launch its product upon receiving FDA approval. (Compl. ¶59).
IV. Analysis of Infringement Allegations
The complaint does not provide a detailed claim chart but alleges infringement based on the theory that Amneal must use the patented process to produce a generic product that the FDA would find to be "the same as" Teva's COPAXONE®. The complaint further alleges that the patented processes are the "only commercially feasible means" of producing commercial quantities of the drug. (Compl. ¶57-58).
No probative visual evidence provided in complaint.
’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; | In order for its product to be "the same as" Teva's, Amneal's manufacturing process must begin with an aqueous solution containing glatiramer acetate and mannitol. | ¶49, ¶53, ¶57 | col. 1:35-37 |
| (ii) filtering the aqueous pharmaceutical solution at a temperature of above 0° C. to 17.5° C. to produce a filtrate, | The complaint alleges that Amneal must use a process that infringes, and that the patented process of low-temperature filtration is the only commercially feasible method to produce the required product. | ¶57, ¶58 | col. 1:62-64 |
| wherein the filterability of the aqueous pharmaceutical solution is improved compared to the filterability of the solution at controlled room temperature; | By using the patented low-temperature process, Amneal's process necessarily achieves the improved filterability that is a central discovery of the invention and is practiced by Teva. | ¶48, ¶57 | col. 20:53-59 |
| (iii) filling the suitable container with the filtrate obtained after performing step (ii)... | Amneal's process concludes with filling the filtered solution into containers (syringes) to create its final drug product for sale and importation. | ¶49, ¶61 | col. 1:65-col. 2:2 |
Identified Points of Contention
- Evidentiary Question: A central issue will be factual: what manufacturing process does Amneal actually use? The complaint’s allegations are based on information and belief and the theory that Amneal must infringe to secure FDA approval. The case will likely depend on evidence obtained during discovery regarding Amneal’s proprietary manufacturing methods.
- Technical Question: Can a commercially viable, non-infringing process exist to create a product that is "the same as" COPAXONE® 40 mg/mL? The litigation may focus on whether Amneal has developed an alternative manufacturing technique (e.g., using different filtration technologies, pressures, or excipients) that falls outside the patent's claims but still meets FDA bioequivalence standards. The complaint’s assertion that the patented method is the "only commercially feasible means" suggests this will be a key area of dispute. (Compl. ¶58).
- Scope Question: Does the term "improved" in the "wherein" clause require a specific threshold of improved filterability? The parties may dispute whether any minor process variation meets this comparative limitation, or if it requires achieving the substantial benefits described in the patent's examples.
V. Key Claim Terms for Construction
The complaint does not explicitly identify terms for construction, but the following terms from claim 1 appear central to a potential infringement dispute.
- The Term: "controlled room temperature"
- Context and Importance: This term provides the essential baseline for the claim's functional limitation ("improved compared to..."). The definition of this baseline is critical for determining whether infringement has occurred. Practitioners may focus on this term because its potential ambiguity could either broaden or narrow the scope of infringing activities.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification does not provide a strict numerical definition, which may support an argument that the term refers generally to any standard, non-refrigerated manufacturing environment. (’775 Patent, col. 9:11-12).
- Evidence for a Narrower Interpretation: The patent’s examples provide a specific range for a tested "controlled room temperature" process: "17.8-24.6° C." A party could argue the term should be construed consistent with the conditions under which the comparative experiments were actually performed. (’775 Patent, col. 12:Table 2).
- The Term: "filterability... is improved"
- Context and Importance: This is a term of degree that lies at the heart of the invention. The dispute will turn on what constitutes an "improved" process and how that improvement is measured.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes the improvement as allowing filtration "to be completed without the pressure increase" that plagued the room-temperature process, suggesting any process that avoids such failure could qualify as "improved." (’775 Patent, col. 12:19-22).
- Evidence for a Narrower Interpretation: The examples show a dramatic, quantifiable improvement where the reduced-temperature process filtered a full 125 L batch while the room-temperature process failed after only 85 L. A party could argue "improved" requires a similarly substantial and commercially meaningful difference in performance, not a de minimis change. (’775 Patent, col. 12:Table 2).
VI. Other Allegations
Indirect Infringement
The complaint alleges that Defendants acted in concert to "assist with, participate in, encourage, contribute, aid and abet and/or direct" the manufacture and importation of the accused product. (Compl. ¶63). It specifically alleges that Amneal GmbH will manufacture the product on behalf of Amneal LLC for importation and sale in the U.S. (Compl. ¶37).
Willful Infringement
The complaint alleges on information and belief that Defendants' infringement "is willful and continues despite knowledge of the '775 patent." (Compl. ¶64). It further alleges Defendants acted without a reasonable basis for believing they would not be liable. (Compl. ¶64).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidence and inference: The complaint is premised on the theory that to gain FDA approval, the defendant must use the patented manufacturing process. The case will therefore turn on what Amneal’s actual, proprietary process is and whether discovery will validate the plaintiff’s inference of infringement.
- A key technical question will be one of process equivalence: Can a generic manufacturer develop a different, non-infringing manufacturing process—for example, one that operates outside the patent’s claimed temperature range or uses novel filtration media—that nonetheless produces a complex polypeptide mixture deemed "the same as" the branded drug by regulatory authorities?
- The resolution may also depend on a question of definitional scope: How will the court construe the comparative limitation "filterability... is improved compared to... controlled room temperature"? The outcome could hinge on whether any measurable improvement suffices, or if a substantial, commercially transformative improvement as shown in the patent's examples is required to meet the claim limitation.