DCT
1:22-cv-00978
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: 1:22-cv-00978, D. Del., 09/14/2023
- Venue Allegations: Plaintiff alleges venue is proper because Defendant has consented to jurisdiction and venue in the District of Delaware for this action and has regularly litigated patent disputes 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 Plaintiff’s Sodium Thiosulfate Injection product constitutes an act of infringement of five patents related to highly purified pharmaceutical compositions of sodium thiosulfate.
- Technical Context: The technology concerns high-purity sodium thiosulfate formulations suitable for pharmaceutical use, particularly as an antidote for acute cyanide poisoning.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s notification to Plaintiff of its ANDA filing, which included a Paragraph IV Certification asserting that Plaintiff’s patents are invalid, unenforceable, or will not be infringed by the proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2009-07-08 | Priority Date for all Patents-in-Suit |
| 2012-02-14 | Plaintiff's NDA Product for Sodium Thiosulfate Injection Approved by FDA |
| 2013-07-30 | U.S. Patent No. 8,496,973 Issues |
| 2016-05-24 | U.S. Patent No. 9,345,724 Issues |
| 2017-03-07 | U.S. Patent No. 9,585,912 Issues |
| 2019-11-19 | U.S. Patent No. 10,479,686 Issues |
| 2022-06-13 | Defendant Notifies Plaintiff of ANDA Filing |
| 2023-09-12 | U.S. Patent No. 11,753,301 Issues |
| 2023-09-14 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,496,973 - "Sodium Thiosulfate-Containing Pharmaceutical Compositions" (Issued Jul. 30, 2013)
The Invention Explained
- Problem Addressed: The patent’s background section states that while sodium thiosulfate has established medical uses, the raw material available on the market did not meet the new, more stringent FDA quality standards required for "pharmaceutical grade" products intended for new clinical therapies (U.S. Patent No. 10479686, col. 2:32-51). A further problem identified is the lack of an effective analytical method to measure total non-purgeable organic carbon (NPOC) in sodium thiosulfate samples, as conventional methods are prone to interference (’686 Patent, col. 4:52-61).
- The Patented Solution: The invention provides for a highly purified form of sodium thiosulfate pentahydrate characterized by very low levels of specific impurities, such as non-purgeable organic carbon, heavy metals like mercury, and other substances like selenium and carbonate (’686 Patent, col. 3:14-39). The patent also discloses methods for producing this high-purity material and a novel analytical method using supercritical water oxidation to accurately measure NPOC levels (’686 Patent, Abstract; col. 14:1-15).
- Technical Importance: This high-purity formulation and its associated manufacturing and testing methods enable the development of new, FDA-approved sodium thiosulfate therapies beyond its historically "grandfathered" uses (’686 Patent, col. 2:47-51).
Key Claims at a Glance
The complaint alleges infringement of "one or more claims" of the patent without specifying which claims are asserted (Compl. ¶44). The following is a representative independent claim from a related patent in the same family.
- Representative Independent Claim 1 (from U.S. Patent No. 10,479,686):
- A pharmaceutical composition comprising sodium thiosulfate pentahydrate and one or more pharmaceutically acceptable carriers or excipients,
- wherein the sodium thiosulfate pentahydrate contains no greater than 8 ppm of non-purgeable organic carbon,
- contains no greater than 0.05 ppm of mercury,
- contains no greater than 2 ppm of aluminum,
- contains no greater than 0.003% by weight of selenium,
- and meets numerous other purity and physical property limitations,
- wherein the composition is formulated for parenteral administration.
U.S. Patent No. 9,345,724 - "Sodium Thiosulfate-Containing Pharmaceutical Compositions" (Issued May 24, 2016)
The Invention Explained
- Problem Addressed: As with the ’973 Patent, this patent addresses the need for a "pharmaceutical grade" sodium thiosulfate raw material that conforms to modern, stringent FDA quality specifications, which existing commercial supplies did not meet (’686 Patent, col. 2:32-51).
- The Patented Solution: The patented solution is a pharmaceutical composition containing sodium thiosulfate pentahydrate defined by a specific profile of low-level impurities, ensuring its suitability for new clinical applications (’686 Patent, Abstract; col. 3:14-39).
- Technical Importance: The invention facilitates the translation of recent research discoveries involving sodium thiosulfate into FDA-approved clinical therapies by providing a raw material that meets the necessary quality and purity standards (’686 Patent, col. 2:47-51).
Key Claims at a Glance
The complaint alleges infringement of "one or more claims" of the patent without further specification (Compl. ¶52). The asserted claims likely parallel those of the ’973 Patent, focusing on pharmaceutical compositions with specific purity profiles.
U.S. Patent No. 9,585,912 - "Sodium Thiosulfate-Containing Pharmaceutical Compositions"
- Patent Identification: U.S. Patent No. 9585912, "Sodium Thiosulfate-Containing Pharmaceutical Compositions," issued March 7, 2017 (Compl. ¶37).
- Technology Synopsis: This patent, part of the same family as the lead patents, is directed to high-purity sodium thiosulfate compositions. It claims pharmaceutical formulations that meet stringent impurity limits, solving the problem of inadequate raw material quality for modern drug development (’686 Patent, col. 2:32-51).
- Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶60).
- Accused Features: The accused instrumentality is Defendant's Accord ANDA Product, a generic sodium thiosulfate injection (Compl. ¶60).
U.S. Patent No. 10,479,686 - "Sodium Thiosulfate-Containing Pharmaceutical Compositions"
- Patent Identification: U.S. Patent No. 10,479,686, "Sodium Thiosulfate-Containing Pharmaceutical Compositions," issued November 19, 2019 (Compl. ¶39).
- Technology Synopsis: This patent continues the inventive subject matter of the family, claiming pharmaceutical compositions of sodium thiosulfate characterized by low levels of specific impurities like non-purgeable organic carbon and heavy metals. This purity profile addresses the FDA's heightened quality standards for new drug products (’686 Patent, Abstract; col. 2:32-51).
- Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶68).
- Accused Features: The infringement allegations are directed at Defendant's Accord ANDA Product (Compl. ¶68).
U.S. Patent No. 11,753,301 - "Sodium Thiosulfate-Containing Pharmaceutical Compositions"
- Patent Identification: U.S. Patent No. 11753301, "Sodium Thiosulfate-Containing Pharmaceutical Compositions," issued September 12, 2023 (Compl. ¶41).
- Technology Synopsis: As the most recent patent in the asserted family, it likely covers further aspects of the high-purity sodium thiosulfate compositions or methods of their use. The core invention remains a pharmaceutical formulation that overcomes the purity limitations of previously available raw materials (’686 Patent, Background).
- Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶76).
- Accused Features: Infringement is alleged based on Defendant’s submission of its ANDA for a generic sodium thiosulfate injection product (Compl. ¶76).
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is Defendant’s "Accord ANDA Product," identified as a generic sodium thiosulfate injection USP, 12.5 grams/50 mL (250 mg/mL) single-dose vial, submitted to the FDA under ANDA No. 217214 (Compl. ¶7).
- Functionality and Market Context: The Accord ANDA Product is a purported generic version of Hope’s NDA Product and is intended for the same therapeutic use, namely the treatment of acute cyanide poisoning (Compl. ¶5, ¶9). By filing the ANDA, Defendant has represented to the FDA that its product is bioequivalent to Hope’s approved drug product (Compl. ¶11). The act of filing the ANDA to seek approval for commercial manufacture and sale prior to the expiration of the patents-in-suit is the basis for the infringement action (Compl. ¶7, ¶9).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint does not contain a claim chart or specify which claims are asserted. The following chart summarizes the infringement theory for a representative claim from the patent family, illustrating how the general allegations in the complaint map to the claim elements.
’973 Patent Infringement Allegations
(Based on representative Claim 1 of U.S. Patent No. 10,479,686)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising sodium thiosulfate pentahydrate and one or more pharmaceutically acceptable carriers or excipients… | Defendant's Accord ANDA Product is a sodium thiosulfate injection, which necessarily contains the active pharmaceutical ingredient and excipients to form an injectable solution. | ¶7 | col. 15:13-17 |
| …wherein the sodium thiosulfate pentahydrate contains no greater than 8 ppm of non-purgeable organic carbon… | By seeking approval as a generic version of Plaintiff's NDA product, Defendant's product is alleged to meet the same purity profile, which is covered by the claim's negative limitations. | ¶9, ¶11 | col. 9:1-17 |
| …contains no greater than 0.05 ppm of mercury… | The complaint alleges that Defendant’s ANDA product is bioequivalent to Plaintiff's product, which implies it possesses the claimed high-purity characteristics, including low levels of heavy metals. | ¶9, ¶11 | col. 9:18-24 |
| …contains no greater than about 0.003% by weight of selenium… | The allegation of infringement is based on the submission of an ANDA for a bioequivalent product, which Plaintiff alleges will, upon approval, meet all limitations of the asserted claims, including this impurity limit. | ¶9, ¶11 | col. 9:48-56 |
| …wherein the composition is formulated for parenteral administration. | Defendant’s Accord ANDA Product is described as a "sodium thiosulfate injection USP" in a "single-dose vial," which is a form of parenteral administration. | ¶7 | col. 15:37-42 |
- Identified Points of Contention:
- Evidentiary Questions: The complaint does not provide any test results or specific compositional data for the Accord ANDA Product. A primary point of contention will be an evidentiary one: what does analytical testing of Defendant’s product reveal about its impurity profile? Does it, in fact, meet the specific quantitative thresholds required by the negative limitations of the asserted claims?
- Scope Questions: The dispute may focus on whether "bioequivalence," as alleged in the complaint (Compl. ¶11), legally and factually necessitates that the accused product meets every purity limitation of the patent claims covering the branded product.
V. Key Claim Terms for Construction
- The Term: "non-purgeable organic carbon (NPOC)"
- Context and Importance: The patents-in-suit identify NPOC as a critical impurity and the inability of conventional methods to accurately measure it as a key technical problem solved by the invention (’686 Patent, col. 4:52-61). The definition of this term and the proper method for its measurement will be central to determining whether the accused product infringes claims that recite a specific maximum level of this impurity.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification notes that NPOC is "also known as non-volatile organic carbon" (’686 Patent, col. 3:16-17), which could suggest that any scientifically accepted method for measuring non-volatile organic carbon is sufficient.
- Evidence for a Narrower Interpretation: The specification explicitly teaches that conventional analytical methods fail for sodium thiosulfate samples and discloses a specific method using supercritical water oxidation (SCWO) as the solution (’686 Patent, col. 14:1-67). A party could argue that the term "NPOC" must be construed in the context of this specific disclosed methodology, as it is presented as the only way to accurately determine the claimed purity level.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon FDA approval, Defendant will induce infringement by marketing and selling the Accord ANDA Product with instructions for its use, thereby encouraging direct infringement by end-users (Compl. ¶47, ¶55, ¶63, ¶71, ¶79). It also alleges contributory infringement on the basis that the product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶48, ¶56, ¶64, ¶72, ¶80).
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. The prayer for relief includes a request for attorneys' fees for an "exceptional case" under 35 U.S.C. § 285 (Compl., Prayer for Relief (j)), but willfulness is not pleaded as a separate count or factual allegation.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of analytical proof: Can Plaintiff demonstrate through discovery and testing that Defendant’s proposed generic product, as described in its ANDA, will necessarily meet the specific, quantitative purity thresholds of the asserted composition claims? The case will likely depend heavily on the results of chemical analysis of Defendant's product.
- A key question of claim scope may arise: Will the term "non-purgeable organic carbon" be construed broadly to allow for measurement by any standard technique, or will it be limited to the specific supercritical water oxidation (SCWO) method that the patent discloses as uniquely capable of providing an accurate measurement for this specific composition?
- A central legal question will be one of infringement by equivalents: If Defendant's product does not literally meet every negative limitation (e.g., is found to have 9 ppm of NPOC instead of the claimed "no greater than 8 ppm"), can Plaintiff successfully argue for infringement under the doctrine of equivalents for a claim defined by such precise numerical boundaries?