DCT
1:17-cv-00597
Teva Pharma USA Inc v. Sandoz Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., and Teva Neuroscience, Inc. (Delaware, Israel)
- Defendant: Sandoz Inc. and Momenta Pharmaceuticals, Inc. (Colorado, Delaware)
- Plaintiff’s Counsel: Walsh Pizzi O'Reilly Falanga LLP; Goodwin Procter LLP
- Case Identification: 1:17-cv-00597, D.N.J., 01/13/2017
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Sandoz Inc.'s principal place of business being located there, its continuous business contacts within the state, and its history of litigating in the district without challenging personal jurisdiction.
- Core Dispute: Plaintiff alleges that Defendants' process for manufacturing a generic version of the multiple sclerosis drug COPAXONE® (40 mg/mL) infringes a patent covering a method of filtering the drug substance at a reduced temperature.
- Technical Context: The technology concerns the commercial-scale manufacturing of glatiramer acetate, a complex biologic drug product used for treating relapsing-remitting multiple sclerosis.
- Key Procedural History: The action arises from Defendants' filing of an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic glatiramer acetate product. The complaint alleges Defendants intend to launch their product upon receiving FDA approval, which could occur as early as January 28, 2017.
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 |
| 2017-01-13 | Complaint Filing Date |
| 2017-01-28 | Earliest Alleged Date for FDA Approval of Defendants' ANDA |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,155,775 - "Process for Manufacturing Glatiramer Acetate Product," issued October 13, 2015
The Invention Explained
- Problem Addressed: The patent addresses a manufacturing challenge that arose when producing a higher-concentration (40 mg/mL) formulation of glatiramer acetate. Specifically, filtering this more concentrated solution at controlled room temperature led to a "pressure build-up on the second filter," which could impair the manufacturing process (’971 Patent, col. 9:10-16).
- The Patented Solution: The invention is a process that solves this problem by filtering the aqueous solution of glatiramer acetate and mannitol at a reduced temperature, specifically "from above 0° C. up to 17.5° C." (’971 Patent, Claim 1). This cooling step, as described in the patent's examples and figures, improves the solution's "filterability" by preventing the pressure increase, thereby allowing for a more efficient and reliable commercial-scale manufacturing process (’971 Patent, col. 11:1-17; Fig. 1).
- Technical Importance: This process is alleged to be the "only commercially feasible means of producing commercial scale quantities" of the 40 mg/mL glatiramer acetate product, facilitating its stable and high-quality production (Compl. ¶45, ¶56).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶59). Independent claim 1 is representative of the core inventive process.
- 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 the general allegation of infringing "one or more claims" preserves this option (Compl. ¶59).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the process used by Defendants Sandoz and Momenta to manufacture their "Glatiramer Acetate Product," which is an injectable drug purported to be a generic version of Teva’s COPAXONE® 40 mg/mL product (Compl. ¶47).
Functionality and Market Context
- The complaint alleges, upon information and belief, that for Defendants’ generic product to be determined by the FDA to be "the same as" Teva's branded product, Defendants "must produce their generic glatiramer acetate product using a process that infringes at least one of the claims of the '775 patent" (Compl. ¶55).
- The complaint further alleges that the patented process is the "only commercially feasible means" of producing the drug at commercial scale, implying that any commercially viable generic manufacturing process necessarily reads on the claims (Compl. ¶56). Defendants allegedly intend to launch their product as soon as they receive FDA approval (Compl. ¶57).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
9,155,775 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; | Defendants are alleged to have begun manufacturing commercial batches of their Glatiramer Acetate Product, which requires obtaining such a solution. | ¶54, ¶55 | col. 1:10-12 |
| (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. up 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; | The complaint alleges on information and belief that Defendants must use a manufacturing process that includes this specific low-temperature filtration step to meet FDA requirements for their ANDA and to produce the product at a commercial scale. | ¶55, ¶56 | col. 2:58-63 |
| (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation... | Defendants are alleged to manufacture, market, and sell a generic glatiramer acetate injection product, which would require filling a suitable container (e.g., a syringe) with the filtrate. | ¶47, ¶59 | col. 2:63-65 |
Identified Points of Contention
- Evidentiary Question: The complaint's infringement theory rests on the allegation, made on "information and belief," that the patented process is the only commercially feasible way to produce a generic equivalent of COPAXONE® 40 mg/mL. A central question will be whether discovery yields direct evidence that Defendants' actual manufacturing process performs the claimed low-temperature filtration step, or if Teva can otherwise prove infringement through product-by-process analysis.
- Technical Question: What evidence demonstrates that Defendants' process results in "improved" filterability "compared to the filterability of the solution at controlled room temperature" as required by the claim? The parties may dispute the proper baseline for comparison and the definition of "improvement."
V. Key Claim Terms for Construction
Term: "filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. up to 17.5° C."
- Context and Importance: This term defines the central manipulative step of the invention. Its construction will be critical because infringement hinges on whether Defendants' process operates within this specific temperature range.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language provides a clear, broad numerical range. A party could argue that any filtration performed at any temperature point within this range meets the limitation.
- Evidence for a Narrower Interpretation: The specification discloses several more specific sub-ranges (e.g., "between 0° C. and 12° C.," "4° C.-12° C.") and specific experimental conditions (e.g., 6.4-12° C) (’971 Patent, col. 4:1-14; col. 13:13). A party might argue the claim should be construed to be limited to these demonstrated embodiments or to a range where a significant, non-trivial improvement in filterability is achieved.
Term: "wherein the filterability... is improved compared to the filterability of the solution at controlled room temperature"
- Context and Importance: This functional language conditions the temperature limitation on achieving a specific result. Practitioners may focus on this term because the parties will likely contest what constitutes "improved" filterability and how it must be proven.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language suggests that any measurable improvement (e.g., reduced pressure, increased flow rate) over a room-temperature baseline would satisfy the claim. The patent's examples demonstrate such improvements without setting a specific quantitative threshold (’971 Patent, col. 11:18-21, Table 2).
- Evidence for a Narrower Interpretation: The specification frames the invention as a solution to a specific problem: a pressure build-up that impaired manufacturing (’971 Patent, col. 9:10-16). A party could argue that "improved" should be construed to mean an improvement sufficient to overcome this specific commercial-scale manufacturing problem, not merely any de minimis or incidental change in filtration characteristics.
VI. Other Allegations
Indirect Infringement
The complaint alleges that Defendants Sandoz and Momenta "acted in concert by assisting with, participating in, encouraging, contributing, aiding and abetting and/or directing the manufacture" of the accused product, thereby satisfying the requirements for induced and contributory infringement (Compl. ¶61, ¶66). The allegations focus on the collaborative actions between the two corporate defendants in performing the allegedly infringing manufacturing process.
Willful Infringement
The complaint alleges that Defendants' infringement is willful and continues despite "knowledge of the '775 patent" and that they "acted without a reasonable basis for believing that they would not be liable" (Compl. ¶62).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: Can Teva, through discovery, obtain direct evidence that Defendants’ confidential manufacturing process practices the specific low-temperature filtration step required by claim 1? The case may depend on the strength of Teva's assertion that its patented method is the "only commercially feasible means" to create an FDA-approvable generic.
- A key legal question will be one of functional scope: How will the court construe the claim limitation "wherein the filterability...is improved"? The outcome of the case may turn on whether this requires a specific quantum of improvement tied to solving the commercial-scale problem described in the patent, or if any measurable improvement over a room-temperature baseline is sufficient to prove infringement.