DCT
1:25-cv-00860
Hope Medical Enterprises Inc v. Accord Healthcare Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Hope Medical Enterprises, Inc., d/b/a Hope Pharmaceuticals (Arizona)
- Defendant: Accord Healthcare, Inc. (North Carolina)
- Plaintiff’s Counsel: Ashby & Geddes; Jones Day
- Case Identification: 1:25-cv-00860, D. Del., 07/10/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant has previously consented to venue in the district for other patent infringement actions, including other Hatch-Waxman cases.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic sodium thiosulfate injection constitutes an act of infringement of a patent covering highly purified pharmaceutical compositions of the drug.
- Technical Context: The technology concerns pharmaceutical-grade sodium thiosulfate compositions with stringent purity profiles, intended for applications such as an antidote for cyanide poisoning.
- Key Procedural History: This action was filed under the Hatch-Waxman Act following a series of notifications from the Defendant to the Plaintiff. The final notification, dated May 28, 2025, included a Paragraph IV certification asserting that U.S. Patent No. 12,304,813 is invalid, unenforceable, and/or will not be infringed by the Defendant's proposed generic product. This certification provides the statutory basis for the infringement lawsuit prior to the commercial launch of the generic drug.
Case Timeline
| Date | Event |
|---|---|
| 2009-07-08 | ’813 Patent Priority Date |
| 2012-02-14 | FDA approves Hope's New Drug Application (NDA) |
| 2012 | Hope commences commercial sales of its NDA Product |
| 2022-06-13 | Accord sends First Notice Letter regarding its ANDA |
| 2023-10-12 | Accord sends Second Notice Letter regarding its ANDA |
| 2025-05-20 | U.S. Patent No. 12304813 Issues |
| 2025-05-28 | Accord sends Third Notice Letter with Paragraph IV cert. for '813 Patent |
| 2025-07-10 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,304,813 - Sodium Thiosulfate-Containing Pharmaceutical Compositions
- Patent Identification: U.S. Patent No. 12,304,813, issued May 20, 2025.
The Invention Explained
- Problem Addressed: The patent's background section explains that while sodium thiosulfate has established medical uses, developing new pharmaceutical products was hindered by the lack of a "pharmaceutical grade" raw material that could meet modern, stringent FDA quality standards (’813 Patent, col. 2:6-18, 47-54). A specific challenge identified is the inability of conventional analytical methods to accurately measure total non-purgeable organic carbon (NPOC) in sodium thiosulfate samples, as the compound degrades in the acid used in standard tests, interfering with the analysis (’813 Patent, col. 3:1-27).
- The Patented Solution: The invention provides highly purified sodium thiosulfate compositions defined by very low maximum levels of specific impurities, such as NPOC, mercury, aluminum, and selenium (’813 Patent, col. 3:30-45). The patent also discloses methods for producing this high-purity material and an analytical method using supercritical water oxidation (SCWO) to overcome the problem of measuring NPOC, thereby enabling verification of the product's purity (’813 Patent, col. 4:55-67).
- Technical Importance: The invention claims to provide the first sodium thiosulfate raw material and associated quality controls sufficient to meet modern regulatory requirements for new drug applications, thereby enabling the development of new therapies using the compound (’813 Patent, col. 2:58-67).
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims. Independent claim 1 is representative of the patented composition.
- Essential elements of Independent Claim 1 include:
- A unit-dosage form comprising pharmaceutical grade sodium thiosulfate which:
- contains no greater than about 10 ppm of non-purgeable organic carbon;
- contains no greater than about 0.05 ppm of mercury;
- contains no greater than about 2 ppm of aluminum;
- contains no greater than about 0.003% by weight of selenium;
- contains no less than about 98% and no greater than about 102% by weight of sodium thiosulfate on an anhydrous basis as measured by ion chromatography; and
- meets numerous other specified limits for impurities such as lead, iron, calcium, and sulfite.
- The complaint reserves the right to assert other claims of the ’813 patent, including other independent and dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant Accord’s proposed generic drug product, identified as "Accord ANDA Product," submitted to the FDA under ANDA No. 217214 (Compl. ¶7, 25). It is described as a "sodium thiosulfate injection USP, 12.5 grams/50 mL (250 mg/mL) single-dose vial" (Compl. ¶7).
Functionality and Market Context
- The Accord ANDA Product is a proposed generic version of Plaintiff Hope’s FDA-approved Sodium Thiosulfate Injection (Compl. ¶1, 5). By filing an ANDA, Accord has represented to the FDA that its product is bioequivalent to Hope's product and is intended for the same indications, such as the treatment of acute cyanide poisoning (Compl. ¶5, 13). The complaint alleges that upon approval, Accord intends to manufacture, market, and sell this product in the United States (Compl. ¶10).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that Accord’s act of filing its ANDA with a Paragraph IV certification constitutes a technical act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶39). The infringement theory is based on the premise that because Accord's product is a generic version of Hope's product and is represented as bioequivalent, it will necessarily have the same characteristics and meet the purity limitations of the claims covering Hope's product (Compl. ¶6, 13).
’813 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A unit-dosage form... | The Accord ANDA Product is described as a "single-dose vial" (250 mg/mL). | ¶7 | col. 43:60-61 |
| ...comprising pharmaceutical grade sodium thiosulfate... | The Accord ANDA Product is a generic version of Hope's Sodium Thiosulfate Injection, a pharmaceutical drug product. | ¶1, 7 | col. 43:61 |
| ...which contains no greater than about 10 ppm of non-purgeable organic carbon... | As a purported bioequivalent generic, the Accord ANDA Product is alleged to meet the purity specifications of Hope's product, which is covered by the '813 patent's claims, including this NPOC limitation. | ¶6, 13 | col. 43:62-63 |
| ...contains no greater than about 0.05 ppm of mercury... | As a purported bioequivalent generic, the Accord ANDA Product is alleged to meet the purity specifications of Hope's product, which is covered by the '813 patent's claims, including this mercury limitation. | ¶6, 13 | col. 43:63-64 |
| ...contains no greater than about 2 ppm of aluminum... | As a purported bioequivalent generic, the Accord ANDA Product is alleged to meet the purity specifications of Hope's product, which is covered by the '813 patent's claims, including this aluminum limitation. | ¶6, 13 | col. 43:64-65 |
| ...contains no less than about 98% by weight and no greater than about 102% by weight of sodium thiosulfate on an anhydrous basis... | As a purported bioequivalent generic, the Accord ANDA Product is alleged to meet the purity specifications of Hope's product, which is covered by the '813 patent's claims, including this assay purity limitation. | ¶6, 13 | col. 44:1-5 |
Identified Points of Contention
- Evidentiary Question: A primary point of contention will be factual: does the product described in Accord’s ANDA actually meet every limitation of the asserted claims? The complaint relies on the inference of bioequivalence, but provides no direct evidence (e.g., test results) of the composition of Accord's product. Accord’s Paragraph IV notice asserts non-infringement, creating a direct factual conflict for the court to resolve through discovery.
- Scope Questions: The interpretation of the term "about," which precedes nearly every numerical limit in the claims, may be a central issue. The dispute will center on how much variance from the recited values (e.g., "10 ppm") is permissible for a product to still fall within the claim scope.
V. Key Claim Terms for Construction
The Term: "about"
Context and Importance
This term appears in Claim 1 before each numerical impurity limit (e.g., "about 10 ppm," "about 0.05 ppm"). Its construction is critical because it defines the precise boundaries of the claimed purity profile. A broader reading of "about" would make it easier for the Plaintiff to prove infringement, while a narrower reading would favor the Defendant.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent consistently uses "about" when reciting numerical ranges and limits throughout the specification, which may suggest the patentee intended to claim some degree of variation around the stated values rather than requiring exact figures (’813 Patent, col. 9:30-51).
- Evidence for a Narrower Interpretation: The patent provides highly specific examples with precise measurement results (e.g., Example 2, Table 1). A party may argue these examples, coupled with the detailed analytical methods described, imply that "about" should be construed narrowly to cover only the minor variations inherent in those specific measurement techniques.
The Term: "pharmaceutical grade"
Context and Importance
This term qualifies the core component of the claimed invention. Its definition is fundamental to the claim's scope. Practitioners may focus on this term because its construction could either incorporate the patent's detailed discussion of new FDA standards or be limited to a more general industry meaning.
Intrinsic Evidence for Interpretation
- Evidence for a Broader (Patent-Specific) Interpretation: The specification appears to act as its own lexicographer by explicitly linking "pharmaceutical grade" to the problem the invention solves: the need for a material manufactured under Good Manufacturing Practices (GMP) that meets new, stringent FDA quality specifications (’813 Patent, col. 2:13-18, col. 6:25-33). This context suggests the term is meant to be defined by the high purity levels detailed in the patent itself.
- Evidence for a Narrower (General) Interpretation: A party could argue that "pharmaceutical grade" is a well-understood term of art that simply means the material is suitable for human administration, and that it does not implicitly import all the specific purity limitations from the specification into the claim, which already recites those limitations explicitly.
VI. Other Allegations
Indirect Infringement
- The complaint alleges both induced and contributory infringement. The inducement allegation is based on the assertion that Accord, with knowledge of the ’813 patent, will encourage infringement by marketing its generic product with a label that instructs its use for patented indications (Compl. ¶42). The contributory infringement allegation is based on the assertion that Accord's product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶43).
Willful Infringement
- The complaint does not use the term "willful," but it alleges that Accord had pre-suit knowledge of the ’813 patent via the Paragraph IV notice letter (Compl. ¶9, 14). This allegation, combined with the request for attorneys' fees for an "exceptional case" under 35 U.S.C. § 285, lays the groundwork for a potential finding of willfulness if infringement is found (Compl., Prayer for Relief ¶(j)).
VII. Analyst’s Conclusion: Key Questions for the Case
This case presents several central questions for the court that are characteristic of Hatch-Waxman litigation over pharmaceutical formulations.
- A primary issue will be one of factual composition: Does the product detailed in Accord’s ANDA actually meet the specific, multi-faceted purity profile required by the asserted claims of the ’813 patent? The resolution will depend entirely on chemical analysis and expert testimony developed during discovery.
- A second key issue will be one of claim construction: How broadly should the term "about" be interpreted when applied to the precise parts-per-million impurity limits in the claims? The court's definition of this term will directly impact whether Accord's product, if its impurity levels are near the claimed thresholds, is ultimately found to infringe.
- Finally, a critical battleground will be patent validity. Accord’s Paragraph IV certification signals its intent to challenge the ’813 patent, likely arguing that the claimed purity levels were either disclosed in the prior art or would have been obvious to a person of ordinary skill, thus rendering the patent invalid.