DCT
3:20-cv-03229
Bristol Myers Squibb Co v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bristol-Myers Squibb Company (Delaware/New Jersey)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware/New Jersey)
- Plaintiff’s Counsel: Kirkland & Ellis LLP
- Case Identification: 3:20-cv-03229, D.N.J., 03/25/2020
- Venue Allegations: Venue is based on Defendant having a regular and established place of business in New Jersey and having committed acts of infringement in the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the cancer drug SPRYCEL® (dasatinib) constitutes an act of infringement of a patent covering the process for manufacturing the drug.
- Technical Context: The patent relates to a chemical synthesis process for preparing a class of compounds known as 2-aminothiazole-5-aromatic carboxamides, which function as kinase inhibitors and are used in targeted cancer therapies.
- Key Procedural History: This is a Hatch-Waxman action initiated after Plaintiff received a Paragraph IV certification letter from Defendant asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint also notes that the patent-in-suit is the subject of other litigation against a different generic manufacturer.
Case Timeline
| Date | Event |
|---|---|
| 2004-02-06 | U.S. Patent No. 7,491,725 Priority Date |
| 2009-02-17 | U.S. Patent No. 7,491,725 Issue Date |
| 2020-02-14 | Plaintiff received Defendant's Paragraph IV Certification |
| 2020-03-25 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,491,725 - Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
- Patent Identification: U.S. Patent No. 7,491,725, "Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors," issued February 17, 2009. (Compl. ¶16).
The Invention Explained
- Problem Addressed: The patent describes prior art methods for synthesizing the subject chemical compounds as having significant drawbacks, including the production of side products, the use of expensive reagents, low yields, and the need for multiple reaction steps. ('725 Patent, col. 3:5-10).
- The Patented Solution: The invention claims a new and more efficient process for preparing these compounds. The process involves two main steps: first, reacting a specific starting material (a β-(P*)oxy acryl aromatic amide) with a halogenating reagent in the presence of water, and second, reacting the result with a thiourea compound to form the final 2-aminothiazole-5-aromatic amide product. ('725 Patent, col. 3:34-48, Abstract). The patent asserts that this specific sequence surprisingly avoids undesired side reactions, such as the halogenation of the aromatic amide, leading to a high-yield process. ('725 Patent, col. 3:49-55).
- Technical Importance: This process provides a more efficient manufacturing route for kinase inhibitors, an important class of compounds used in the treatment of oncological and immunological disorders. ('725 Patent, col. 1:36-46).
Key Claims at a Glance
- The complaint asserts infringement of "at least one claim" of the '725 patent without specifying claims. (Compl. ¶25). Independent claim 1 is representative of the core invention.
- Independent Claim 1 recites a process with the following essential elements:
- A process for preparing a 2-aminothiazole-5-aromatic amide having the chemical structure of formula (I).
- The process comprises reacting a starting compound having the chemical structure of formula (II).
- This reaction is performed with a "halogenating reagent in the presence of water."
- This is followed by reacting the intermediate product with a "thiourea compound" having the chemical structure of formula (III).
- This sequence provides the final compound of formula (I). ('725 Patent, col. 19:51-col. 20:30).
- The complaint reserves the right to assert additional claims. (Compl. ¶27).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Teva’s process for manufacturing its generic dasatinib tablets, which are the subject of ANDA No. 211094 ("Teva ANDA Products"). (Compl. ¶¶1, 5, 21).
Functionality and Market Context
The complaint alleges that Teva has filed an ANDA seeking FDA approval to manufacture and sell generic versions of Plaintiff's SPRYCEL® (dasatinib) tablets in various dosages. (Compl. ¶¶1, 5). The infringement alleged is the statutory act of filing the ANDA under 35 U.S.C. § 271(e)(2), which describes a process for manufacturing a drug claimed in the '725 patent. (Compl. ¶25). The complaint alleges that Teva’s ANDA contains data demonstrating the bioequivalence of its product to SPRYCEL®. (Compl. ¶22). The specific details of Teva's manufacturing process are confidential within its ANDA and not detailed in the complaint. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not include a claim chart. The infringement theory is that Teva's manufacturing process, as described in its confidential ANDA, necessarily falls within the scope of the asserted claims of the '725 patent.
'725 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A process for the preparation of a 2-aminothiazole-5-aromatic amide... | Teva's process as described in its ANDA is alleged to be for the manufacture of dasatinib, which is a 2-aminothiazole-5-aromatic amide. | ¶¶1, 21, 25 | col. 19:51-55 |
| comprising reacting a compound having the formula (II)... | Teva’s process is alleged to use a starting material corresponding to the β-(P*)oxy acryl aromatic amide of formula (II). | ¶24 | col. 20:15-22 |
| with a halogenating reagent in the presence of water | Teva’s process is alleged to involve a step of reacting its starting material with a halogenating agent in an aqueous environment. | ¶24 | col. 20:23-24 |
| followed by a thiourea compound having the formula (III) | Teva’s process is alleged to subsequently react the resulting intermediate with a thiourea compound to form the final product. | ¶24 | col. 20:25-28 |
| to provide the compound of formula (I). | Teva’s process is alleged to result in the dasatinib compound, which is covered by formula (I). | ¶¶1, 24 | col. 20:29-30 |
Identified Points of Contention
- Factual Question: The central dispute will be factual: does Teva’s confidential manufacturing process, which will be revealed during discovery, actually practice the specific sequence of steps recited in Claim 1 (or other asserted claims)? The complaint's allegations are based on "information and belief." (Compl. ¶21).
- Technical Questions: A key question is whether Teva might use a different, non-infringing synthesis pathway to arrive at the same final dasatinib product. The court will examine if Teva’s starting materials, reagents, and reaction conditions are the same as those recited in the claims.
V. Key Claim Terms for Construction
"halogenating reagent"
- Context and Importance: This term defines a critical reactant in the first step of the claimed process. The infringement analysis may hinge on whether the specific agent used in Teva's process falls within the patent’s definition. Practitioners may focus on this term because Teva could argue its process uses a novel or different type of reagent not contemplated by the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides a functional definition, stating the term means "an agent or agents capable of halogenating compounds of formula (II) herein," and provides a non-exhaustive list of examples including inorganic reagents (e.g., chlorine, bromine) and organic reagents (e.g., N-chlorosuccinimide (NCS), N-bromosuccinimide (NBS)). ('725 Patent, col. 14:50-59).
- Evidence for a Narrower Interpretation: A party seeking a narrower scope might argue the term should be limited by the examples actually used to carry out the invention, such as NBS, which is used in the patent's working examples. ('725 Patent, col. 28:52-53).
"in the presence of water"
- Context and Importance: This phrase defines a key condition of the halogenation step. A dispute could arise if Teva's process is anhydrous or uses only trace amounts of water. The question for the court would be whether "in the presence of" requires water to be a co-solvent or merely permits its incidental presence.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language does not specify a quantity, suggesting any amount could satisfy the limitation.
- Evidence for a Narrower Interpretation: The patent’s working examples describe using a mixture of an organic solvent (1,4-dioxane) and a substantial volume of water, suggesting water is an intended component of the reaction medium, not an impurity. ('725 Patent, col. 28:51-52).
VI. Other Allegations
Indirect Infringement
The complaint alleges active inducement of infringement, stating that Teva, through its "promotional activities and package inserts," knows or should know that it will aid and abet another's direct infringement. (Compl. ¶31). It also alleges contributory infringement. (Compl. ¶30). Since the asserted patent claims a manufacturing process, these allegations may relate to the importation or sale of the product made by the allegedly infringing process.
Willful Infringement
The complaint does not use the term "willful infringement," but it lays a foundation for such a claim by alleging that Teva had knowledge of the '725 patent via its listing in the FDA's Orange Book and from the Paragraph IV notice letter it sent to BMS. (Compl. ¶¶18, 23, 31). Plaintiff also seeks a finding that the case is "exceptional" to warrant attorney's fees pursuant to 35 U.S.C. § 285. (Compl. ¶34).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual correspondence: Will discovery reveal that Teva's confidential manufacturing process, as detailed in its ANDA, practices each step of the asserted process claims? The case's viability depends entirely on the technical details of a process not yet public.
- A second key issue will be one of claim scope: If Teva's process is similar but not identical, the case will turn on the construction of key terms. For example, can the term "halogenating reagent" be interpreted to cover the specific agent Teva uses, and does the phrase "in the presence of water" require a specific role or quantity for water in the reaction?
- Finally, a dispositive question will concern patent validity: Teva’s Paragraph IV certification signals its intent to challenge the validity of the '725 patent. The litigation will likely involve a significant dispute over whether the claimed process was obvious in light of prior art methods for synthesizing similar compounds.