DCT
3:17-cv-00275
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 and Israel)
- Defendant: Sandoz Inc and Momenta Pharmaceuticals Inc (Colorado and Delaware)
- Plaintiff’s Counsel: Walsh Pizzi Oreilly Falanga LLP; Goodwin Procter LLP (Of Counsel)
- Case Identification: 3:17-cv-00275, D.N.J., 01/13/2017
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Sandoz Inc. has its principal place of business in the district, has engaged in systematic and continuous business contacts there, and has previously availed itself of the forum in other patent litigation.
- Core Dispute: Plaintiff alleges that Defendants' process for manufacturing a generic version of the multiple sclerosis drug COPAXONE® (glatiramer acetate) infringes a patent covering a specific manufacturing method.
- Technical Context: The case concerns the manufacturing process for glatiramer acetate, a complex biologic drug used to treat relapsing-remitting multiple sclerosis, where manufacturing methods can significantly impact the final product's composition and efficacy.
- Key Procedural History: This action arises from Defendants' filing of an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of Teva’s COPAXONE® 40 mg/mL product. The complaint asserts that for the generic product to be approved as "the same as" the brand-name drug, Defendants must necessarily use the patented manufacturing process.
Case Timeline
| Date | Event |
|---|---|
| 2015-01-28 | '775 Patent Application Filing Date |
| 2015-10-13 | '775 Patent Issue Date |
| 2017-01-13 | Complaint Filing Date |
| 2017-01-28 | Alleged earliest date for Defendants' ANDA approval eligibility |
| 2017 Q1 | Alleged intended launch date for Defendants' generic product |
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: In manufacturing a higher concentration (40 mg/mL) formulation of glatiramer acetate, filtering the solution at controlled room temperature results in a pressure build-up on the sterilizing filters (’971 Patent, col. 10:9-17). This pressure increase complicates and potentially hinders the efficiency of commercial-scale production (’971 Patent, col. 10:14-17; Compl. ¶45).
- The Patented Solution: The invention is a manufacturing process that solves the pressure problem by cooling the aqueous solution of glatiramer acetate and mannitol to a specific temperature range (above 0°C up to 17.5°C) before or during the sterilizing filtration step (’971 Patent, Abstract; col. 2:54-65). This cooling reduces the solution's viscosity, which in turn improves its "filterability" and allows the process to proceed at lower pressures, making it more suitable for large-scale production (’971 Patent, col. 11:7-17; col. 18:14-24). Figure 1 of the patent illustrates a process setup where a receiving vessel and filter housing are cooled to implement this method (’971 Patent, Fig. 1).
- Technical Importance: The complaint alleges that this specific cooling process is the "only commercially feasible means" of producing commercial quantities of the 40 mg/mL glatiramer acetate product (Compl. ¶56).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶59). Independent claim 1 is the broadest process claim.
- Independent Claim 1, Essential Elements:
- A process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol 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 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.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is not a final product but the process used by Defendants to manufacture their "Glatiramer Acetate Product," a generic version of Teva’s COPAXONE® 40 mg/mL (Compl. ¶47).
- Functionality and Market Context: The complaint alleges that to secure FDA approval for their generic drug under an ANDA, Defendants must demonstrate that their active ingredient is "the same as" Teva's (Compl. ¶51). Because the manufacturing method is believed to play a critical role in the final composition and effectiveness of the complex drug, the complaint alleges that Defendants "must produce their generic glatiramer acetate product using a process that infringes" the ’775 patent (Compl. ¶53, ¶55). The complaint further alleges that the patented process is the "only commercially feasible means" for producing the drug at commercial scale (Compl. ¶56). Defendants allegedly intend to launch their product upon receiving FDA approval, which was anticipated as early as the first quarter of 2017 (Compl. ¶57).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart. The infringement allegations are made "upon information and belief" and are based on the inference that Defendants must use the patented method to achieve a bioequivalent product for their ANDA submission.
'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 necessarily starts with an aqueous solution. | ¶54 | col. 2:54-57 |
| (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. to 17.5° C. to produce a filtrate, | Upon information and belief, Defendants' manufacturing process must include filtering the solution at a reduced temperature. | ¶55-56 | col. 2:58-62 |
| wherein the filterability of the aqueous pharmaceutical solution is improved compared to the filterability of the solution at controlled room temperature; and | This step is allegedly necessary for Defendants' product to be determined "the same as" Teva's product by the FDA and to be a "commercially feasible means" of production. | ¶55-56 | col. 20:54-60 |
| (iii) filling the suitable container with the filtrate... | Defendants have filed an ANDA to manufacture, use, and sell their product, which would be supplied in a final container form, such as a prefilled syringe. | ¶47, ¶57 | col. 2:63-65 |
- Identified Points of Contention:
- Evidentiary Question: The infringement theory hinges on the assertion that Defendants must be using the patented process. A primary point of contention will be whether Plaintiff can produce direct evidence of Defendants' actual manufacturing process, which is likely confidential, or if its inferential theory based on FDA requirements and commercial feasibility is sufficient to sustain the claim.
- Technical Question: Assuming Defendants use a cooled filtration process, a key question will be whether it meets the functional limitation that filterability is "improved compared to the filterability of the solution at controlled room temperature." The parties may dispute the definition, measurement, and degree of "improvement" required to fall within the claim scope.
V. Key Claim Terms for Construction
- The Term: "filterability... is improved compared to the filterability of the solution at controlled room temperature"
- Context and Importance: This functional language is central to defining an infringing act. The infringement case rests not just on filtering at a certain temperature, but on achieving a specific outcome relative to a baseline (filtering at "controlled room temperature"). Practitioners may focus on this term because its definition will determine whether any cooled process infringes, or only those achieving a certain quantifiable level of improvement as demonstrated in the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification broadly describes the problem as a "pressure build-up on the second filter" when filtering at room temperature (’971 Patent, col. 10:9-12). One might argue that any process using cooling to measurably reduce this pressure build-up meets the "improved filterability" limitation.
- Evidence for a Narrower Interpretation: The patent provides detailed experimental data, including tables and figures, showing specific pressure reductions and increased volumes filtered over time (’971 Patent, Fig. 3-5, Tables 2-4). A party could argue that "improved" should be construed to require a degree of improvement consistent with these specific examples, rather than any de minimis reduction in pressure.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Sandoz and Momenta have "acted in concert" to "aid, abet, contribute to and/or constitute tortious patent infringement" (Compl. ¶17, ¶28, ¶61). The allegations suggest that Momenta will manufacture the product on behalf of Sandoz, and Sandoz will act as the agent for sale, supporting a claim of joint action to infringe (Compl. ¶35).
- Willful Infringement: Willfulness is alleged based on Defendants' "knowledge of the '775 patent" and their proceeding to infringe "without a reasonable basis for believing that they would not be liable" (Compl. ¶62, ¶68). The complaint does not specify the source of this alleged knowledge (e.g., pre-suit notice).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to be a classic ANDA dispute over a process patent, where the core questions for the court will likely be:
- A central evidentiary question of inference versus proof: Can Teva's allegation—that for Defendants' generic to be approvable and commercially viable it must be made using the patented process—survive a challenge in the absence of direct evidence of the secret manufacturing steps used by Defendants?
- A key question of claim scope: Will the functional limitation "filterability... is improved" be construed broadly to cover any reduction in filtration pressure from cooling, or will it be narrowly tied to the specific, quantitative improvements demonstrated in the patent's examples?
- A foundational factual question of commercial necessity: The infringement theory rests heavily on the factual assertion that the patented method is the "only commercially feasible means" of production. The viability of the entire case may turn on whether this assertion is proven correct.