DCT
2:23-cv-21385
Impact Biomedicines Inc v. Teva Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Impact Biomedicines, Inc. (Delaware)
- Defendant: Teva Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Saul Ewing LLP
- Case Identification: 2:23-cv-21385, D.N.J., 10/23/2023
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Teva is registered with the state, maintains a regular and established physical place of business in Parsippany, New Jersey, which it identifies as its "US Headquarters," and has purposefully availed itself of the rights and privileges of the state.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's drug Inrebic® (fedratinib) constitutes an act of infringement of two patents covering pharmaceutical compositions and treatment methods related to the drug.
- Technical Context: The technology concerns pharmaceutical formulations and methods for treating myelofibrosis, a rare and serious bone marrow cancer, using the active ingredient fedratinib, a Janus Associated Kinase 2 (JAK2) inhibitor.
- Key Procedural History: The litigation was triggered by Defendant Teva’s submission of ANDA No. 218907 to the FDA, which included a Paragraph IV Certification alleging that Plaintiff's patents are invalid and/or will not be infringed by Teva's proposed generic product. Teva provided written notice of this certification to Impact on or after September 11, 2023, prompting this lawsuit under the Hatch-Waxman Act.
Case Timeline
| Date | Event |
|---|---|
| 2010-11-07 | U.S. Patent No. 10,391,094 Priority Date |
| 2018-09-25 | U.S. Patent No. 11,400,092 Priority Date |
| 2019-08-27 | U.S. Patent No. 10,391,094 Issued |
| 2022-08-02 | U.S. Patent No. 11,400,092 Issued |
| 2023-09-11 | Teva sends Paragraph IV Certification Notice Letter (on or after this date) |
| 2023-10-23 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
No probative visual evidence provided in complaint.
U.S. Patent No. 10,391,094 - "Compositions and Methods for Treating Myelofibrosis," issued August 27, 2019
The Invention Explained
- Problem Addressed: The patent’s background section notes that myelofibrosis ("MF") is a rare disease with limited treatment options and that there is a need for additional therapies for MF patients (’094 Patent, col. 1:21-25; col. 2:1-2).
- The Patented Solution: The invention provides specific oral capsule formulations of the compound fedratinib, a JAK2 inhibitor, for treating myelofibrosis. The solution is not just the active ingredient, but a specific admixture comprising the compound, microcrystalline cellulose as a filler/diluent, and sodium stearyl fumarate as a lubricant, with the components present in particular weight ratios (’094 Patent, col. 2:5-13; Abstract). This specific formulation is intended to provide a stable and effective oral dosage form.
- Technical Importance: The invention provides a specific, manufacturable oral dosage form for fedratinib, enabling its use as a therapy for a disease where management options were previously considered inadequate (’094 Patent, col. 1:58-61).
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims (Compl. ¶25). Independent claim 1 is representative of the patented composition.
- Essential Elements of Claim 1:
- A capsule comprising a formulation.
- The formulation comprises (i) N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate (a specific salt form of fedratinib).
- The formulation comprises (ii) a microcrystalline cellulose.
- The formulation comprises (iii) sodium stearyl fumarate.
- The weight ratio of the fedratinib compound to the microcrystalline cellulose is about 1:1.5 to about 1:9.
- The sodium stearyl fumarate is about 1% by weight of the formulation.
- The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against "one or more claims" of the patent (Compl. ¶27).
U.S. Patent No. 11,400,092 - "Methods of Treating Myeloproliferative Disorders," issued August 2, 2022
The Invention Explained
- Problem Addressed: While not explicitly stated in the background, the invention addresses the clinical management of patients with myeloproliferative disorders being treated with fedratinib. The claims suggest the problem is the risk of thiamine deficiency, a potential adverse event associated with the drug that can lead to serious neurological conditions such as Wernicke's encephalopathy (’092 Patent, col. 2:56-61; col. 20:15-21).
- The Patented Solution: The patent describes a method of treatment that combines administering the therapeutic compound (fedratinib) with a safety protocol. The method involves actively monitoring a patient's thiamine levels and administering thiamine supplements if those levels fall below a specified reference standard, thereby mitigating a potential adverse event (’092 Patent, Abstract; col. 2:50-55).
- Technical Importance: This invention provides a method for safely administering fedratinib by creating a protocol to proactively identify and manage a potentially severe side effect, which may enhance the drug's overall risk-benefit profile for patients.
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims (Compl. ¶34). Independent claim 1 is representative of the patented method.
- Essential Elements of Claim 1:
- A method for treating a patient with a myeloproliferative disorder.
- The method comprises (i) administering Compound I (fedratinib).
- The method comprises (ii) monitoring the thiamine level in the patient.
- The method comprises (iii) administering thiamine or a thiamine equivalent if the patient's thiamine level is below a reference standard of from about 74 to about 222 nM/L of whole blood.
- The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against "one or more claims" of the patent (Compl. ¶36).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Teva's Proposed Product," identified as 100 mg fedratinib capsules for which Teva seeks FDA approval via ANDA No. 218907 (Compl. ¶14).
Functionality and Market Context
- Teva’s Proposed Product is a generic version of Impact’s Inrebic®, a drug used to treat adult patients with certain types of myelofibrosis (Compl. ¶¶1, 9). The complaint alleges that Teva intends to manufacture, use, sell, and import this generic product in the United States upon receiving FDA approval, prior to the expiration of the patents-in-suit (Compl. ¶¶14, 15). The complaint does not provide specific details on the formulation or proposed labeling of Teva's Proposed Product.
IV. Analysis of Infringement Allegations
'094 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A capsule comprising a formulation comprising (i) a compound that is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate | Teva’s Proposed Product is alleged to be a capsule containing this specific salt form of fedratinib. | ¶14, 25 | col. 60:12-18 |
| (ii) a microcrystalline cellulose | Teva’s Proposed Product is alleged to contain microcrystalline cellulose as an excipient. | ¶25 | col. 60:19 |
| (iii) sodium stearyl fumarate | Teva’s Proposed Product is alleged to contain sodium stearyl fumarate as a lubricant. | ¶25 | col. 60:20 |
| the weight ratio of [the compound] to microcrystalline cellulose in the formulation is about 1:1.5 to about 1:9 | The formulation of Teva's Proposed Product is alleged to have a compound-to-cellulose ratio in this range. | ¶25 | col. 60:21-24 |
| sodium stearyl fumarate is about 1% by weight of the formulation | The formulation of Teva's Proposed Product is alleged to contain this specific weight percentage of sodium stearyl fumarate. | ¶25 | col. 60:25-26 |
- Identified Points of Contention:
- Factual Scope Question: The complaint does not provide the specific formulation of Teva's Proposed Product. A central question will be whether discovery reveals that Teva's product contains the exact combination of excipients (microcrystalline cellulose and sodium stearyl fumarate) in the claimed ratios. Teva may have designed its formulation to use different excipients or ratios to avoid infringement.
- Claim Construction Question: The interpretation of the term "about" will be critical. The parties will likely dispute how much deviation from the specific ratio "1:1.5 to 1:9" and the "1% by weight" limitation is permissible for a finding of literal infringement.
'092 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating a patient comprising... administering to the patient Compound I | Teva's proposed product label is alleged to instruct physicians and patients to administer fedratinib for the treatment of myelofibrosis. | ¶9, 10, 37 | col. 26:40-45 |
| (ii) monitoring thiamine level in the patient | Teva's proposed product label is alleged to instruct or encourage physicians to monitor patient thiamine levels during treatment. | ¶9, 10, 37 | col. 26:46 |
| (iii) administering to the patient thiamine or a thiamine equivalent if the patient's thiamine level is below a reference standard of from about 74 to about 222 nM/L of whole blood | Teva's proposed product label is alleged to instruct or encourage physicians to administer thiamine if a patient's levels fall below the specified standard. | ¶9, 10, 37 | col. 26:47-50 |
- Identified Points of Contention:
- Inducement Question: The infringement theory rests on inducement. A core factual question will be whether the language in Teva's proposed product label, once produced in discovery, rises to the level of actively encouraging or instructing the performance of all steps of the claimed method, as opposed to merely providing general medical information.
- Divided Infringement Question: The claim requires actions by both a healthcare provider (monitoring, prescribing) and potentially a patient (taking the drug). This raises the possibility of a divided infringement defense, where the defendant argues that no single actor performs all steps of the claimed method.
V. Key Claim Terms for Construction
Term: "about" (from '094 Patent, Claim 1)
- Context and Importance: This term modifies the claimed weight ratios (e.g., "about 1:1.5 to about 1:9") and percentage ("about 1% by weight"). Its construction is critical because Teva's generic formulation could be designed to fall just outside the numerical ranges. The breadth of "about" could determine literal infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent repeatedly uses "about" when describing dosage amounts and ratios in the general description, which may suggest the patentee did not intend to be limited to the exact numerical values stated (’094 Patent, col. 2:14-24).
- Evidence for a Narrower Interpretation: The patent provides numerous tables with specific, precise formulation weights and ratios from clinical studies (e.g., Table 14). A defendant may argue these examples define the practical and intended scope of "about," limiting it to minor variations consistent with standard pharmaceutical manufacturing tolerances (’094 Patent, col. 48:45-65).
Term: "monitoring thiamine level" (from '092 Patent, Claim 1)
- Context and Importance: The definition of "monitoring" is central to the method claim. A defendant could argue that routine or sporadic blood tests do not meet the claimed "monitoring" step, potentially contending that the patent requires a more specific or systematic protocol.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses the clinical need to address thiamine deficiency generally, which may support an interpretation that any medically appropriate act of checking thiamine levels qualifies as "monitoring" (’092 Patent, Abstract).
- Evidence for a Narrower Interpretation: The specification details a specific clinical trial protocol that includes assessing thiamine levels at screening and at the start of specific treatment cycles (e.g., "Cycle 2, 3 and every third cycle thereafter"). A party could argue that this detailed protocol informs the meaning of "monitoring," requiring a similarly structured and periodic assessment rather than ad-hoc testing (’092 Patent, col. 20:45-52).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. For the '094 patent, this is based on the allegation that Teva will encourage acts of direct infringement and that its product has no substantial non-infringing use (Compl. ¶¶28, 29). For the '092 patent, which claims a method of treatment, the primary infringement theory is inducement, alleging Teva's product label will instruct healthcare providers and patients to perform the claimed method steps (Compl. ¶37).
- Willful Infringement: The complaint does not use the term "willful," but it does seek attorneys' fees for an "exceptional case" under 35 U.S.C. § 285 (Compl. ¶¶32, 41). The basis for this allegation is Teva's knowledge of the patents-in-suit, as evidenced by its Paragraph IV certification and the associated notice letter sent to Impact (Compl. ¶23).
VII. Analyst’s Conclusion: Key Questions for the Case
A central issue will be one of factual correspondence: Does the specific formulation of Teva's proposed generic product, as detailed in its ANDA, contain the same excipients in the same "about" ratios as claimed in the '094 patent? This question will depend entirely on evidence produced during discovery.
A key legal question will be one of inducement: Will the instructions for use on Teva's proposed product label be found to actively encourage or instruct medical professionals to perform the specific steps of thiamine monitoring and supplementation recited in the '092 patent, thereby meeting the legal standard for induced infringement?
A pivotal claim construction dispute will be the definitional scope of "about": How much variance from the numerical ranges recited in the '094 patent claims is permissible? The court's interpretation of this term could be dispositive for the infringement analysis of the composition patent.