DCT

1:25-cv-05870

Mylan Institutional LLC v. Alora Pharma LLC

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-05870, N.D. Ga., 10/13/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the Northern District of Georgia because Defendant maintains a regular and established place of business within the district and has committed acts giving rise to the claims there.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) for a generic isosulfan blue injection product, and its intended commercialization of that product, infringes a family of eight patents related to processes for manufacturing high-purity isosulfan blue and the resulting high-purity compositions.
  • Technical Context: Isosulfan blue is a triarylmethane dye used as a contrast agent in medical diagnostics, particularly for mapping sentinel lymph nodes during cancer surgery, where high purity is a critical requirement for patient safety.
  • Key Procedural History: The complaint asserts that the validity of the patent family is "well established." It cites a prior case where a preliminary injunction on certain patents-in-suit was affirmed by the U.S. Court of Appeals for the Federal Circuit. The complaint also references several other litigations that concluded with consent judgments of infringement and validity or voluntary dismissals. Further, it notes a 2019 decision by the Patent Trial and Appeal Board (PTAB) denying institution of an inter partes review challenging the '050 Patent.

Case Timeline

Date Event
2007-05-11 Earliest Patent Priority Date ('992, '616, '050, '888, '080, '071, '086, '580 Patents)
2010-02-16 U.S. Patent No. 7,662,992 Issued
2015-03-03 U.S. Patent No. 8,969,616 Issued
2016-05-31 U.S. Patent No. 9,353,050 Issued
2019-03-06 PTAB Denies Institution of IPR on '050 Patent
2019-11-05 U.S. Patent No. 10,464,888 Issued
2019-12-17 U.S. Patent No. 10,508,080 Issued
2020-03-17 U.S. Patent No. 10,590,071 Issued
2020-04-21 U.S. Patent No. 10,626,086 Issued
2020-08-25 U.S. Patent No. 10,752,580 Issued
2025-09-17 Defendant Allegedly Received Notice Letter Regarding Patents-in-Suit
2025-10-13 Complaint Filed
2026-01-XX Defendant's Alleged Intended Product Launch

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,464,888 - *Process for the Preparation of Isosulfan Blue*

Issued November 5, 2019

The Invention Explained

  • Problem Addressed: The patent's background describes prior art methods for preparing triarylmethane dyes like isosulfan blue as involving strong acids, hazardous oxidizing agents (e.g., lead oxide), and crude purification methods that result in an impure product unsuitable for pharmaceutical applications ('888 Patent, col. 2:16-33).
  • The Patented Solution: The invention claims a process for preparing isosulfan blue acid that avoids these harsh conditions. The process involves reacting a precursor compound ("isoleuco acid") with a "mild oxidizing agent," followed by steps to recover and purify the resulting isosulfan blue acid to a level appropriate for pharmaceutical use ('888 Patent, Abstract; col. 2:50-56).
  • Technical Importance: The claimed process provides a simple, safe, and cost-effective method for producing isosulfan blue in bulk and at a high purity suitable for cGMP (current Good Manufacturing Practice) pharmaceutical production ('888 Patent, col. 2:40-46, col. 2:50-56).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶98).
  • Claim 1 recites a process with the essential elements of:
    • i) combining isoleuco acid... with a mild oxidizing agent to provide said isosulfan blue acid
    • ii) recovering said isosulfan blue acid
    • iii) purifying said recovered isosulfan blue acid
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent but makes general allegations of infringement.

U.S. Patent No. 10,508,080 - *Process for the Preparation of Isosulfan Blue*

Issued December 17, 2019

The Invention Explained

  • Problem Addressed: Similar to the '888 Patent, the '080 Patent addresses the need for an improved manufacturing process for isosulfan blue that can reliably produce the high-purity material required for pharmaceutical formulations, which prior art methods failed to do ('080 Patent, col. 2:28-34).
  • The Patented Solution: The invention claims a multi-step process for preparing the final drug substance, isosulfan blue sodium salt. The process begins with oxidizing the isoleuco acid precursor, recovering the resulting isosulfan blue acid, and then converting it to the sodium salt, with the final product having a purity of at least 99% as measured by HPLC ('080 Patent, Abstract; col. 7:45-57).
  • Technical Importance: The invention provides a complete, reliable, and scalable process to produce the final, highly pure sodium salt form of isosulfan blue required for injectable drug products ('080 Patent, col. 2:35-41).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶127).
  • Claim 1 recites a process with the essential elements of:
    • i) combining isoleuco acid... with an oxidizing agent
    • ii) recovering isosulfan blue acid
    • iii) obtaining isosulfan blue sodium salt therefrom, wherein said isosulfan blue sodium salt is obtained in a purity of at least 99% as measured by HPLC
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 7,662,992 - *Process for Preparation of Isosulfan Blue*

Issued February 16, 2010

  • Technology Synopsis: This patent claims a process for preparing isosulfan blue using specific quantities (2.0 to 3.0 equivalents) of silver oxide as the oxidizing agent, followed by pH adjustment and recrystallization steps to achieve high purity (Compl. ¶¶47, 51).
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶46).
  • Accused Features: Defendant's manufacturing process is alleged to include combining isoleuco acid with 2.0 to 3.0 equivalents of silver oxide, adjusting the pH to greater than 6.0, and recrystallizing the product to achieve a purity greater than 99.5% (Compl. ¶¶47-52).

U.S. Patent No. 8,969,616 - *Process for Preparation of Isosulfan Blue*

Issued March 3, 2015

  • Technology Synopsis: This patent claims a process similar to the '992 Patent, involving the use of silver oxide in a polar solvent to oxidize isoleuco acid, followed by pH adjustment and recrystallization to afford a high-purity product (Compl. ¶¶66, 70).
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶65).
  • Accused Features: The allegations against this patent mirror those for the '992 Patent, focusing on the alleged use of silver oxide, specific solvents, pH adjustments, and recrystallization to achieve high purity (Compl. ¶¶66-70).

U.S. Patent No. 9,353,050 - *Process for Preparation of Isosulfan Blue*

Issued May 31, 2016

  • Technology Synopsis: This patent claims the chemical composition of isosulfan blue itself, defined by specific purity characteristics. The claims cover isosulfan blue or its salt having a purity of at least 99.0% by HPLC and containing less than 20 ppm of silver.
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶83).
  • Accused Features: Defendant's ANDA product is alleged to be a composition that meets these purity and silver content limitations (Compl. ¶¶83-85).

U.S. Patent No. 10,590,071 - *Process for the Preparation of Isosulfan Blue*

Issued March 17, 2020

  • Technology Synopsis: This patent claims a process for preparing isosulfan blue wherein the oxidation of isoleuco acid is performed "in the absence of a strong acid," a key distinction from certain prior art methods.
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶148).
  • Accused Features: Defendant is alleged to use an oxidizing agent (silver oxide) in the absence of a strong acid, followed by purification and pH adjustment steps (Compl. ¶¶149, 158).

U.S. Patent No. 10,626,086 - *Process for the Preparation of Isosulfan Blue*

Issued April 21, 2020

  • Technology Synopsis: This patent claims a composition of isosulfan blue defined by high purity (at least 99.0% by HPLC), low silver content (less than 20 ppm), and specific impurity profiles (e.g., between 0.5% and 1% total impurities).
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶175).
  • Accused Features: Defendant's ANDA product is alleged to have the claimed purity, silver content, and impurity profile (Compl. ¶¶175-179).

U.S. Patent No. 10,752,580 - *Process for Preparation of Isosulfan Blue*

Issued August 25, 2020

  • Technology Synopsis: This patent claims a high-purity composition of isosulfan blue, with claims directed to purity levels of at least 99.0% and at least 99.5% by HPLC, combined with a silver content of less than 20 ppm.
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶192).
  • Accused Features: Defendant's ANDA product is alleged to meet the claimed thresholds for purity and silver content (Compl. ¶¶192-195).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendant's isosulfan blue ("ISB") injection product for which it has submitted an ANDA to the FDA ("Defendant's ANDA Product") (Compl. ¶¶2, 3).

Functionality and Market Context

  • The accused product is a generic version of Plaintiff's highly pure ISB product, which is used as an injectable diagnostic agent (Compl. ¶¶15, 26). The complaint alleges that Plaintiff’s product is the FDA-designated "Reference Standard," meaning any generic ANDA product must be comparable in quality and purity (Compl. ¶¶15, 42, 44). This regulatory status is used to support the inference that Defendant's product is manufactured by a similar, infringing process to achieve the required high purity (Compl. ¶45). Defendant allegedly intends to launch its product in January 2026 (Compl. ¶33).

IV. Analysis of Infringement Allegations

10,464,888 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
i) combining isoleuco acid... with a mild oxidizing agent to provide said isosulfan blue acid The API is prepared by combining isoleuco acid with a mild oxidizing agent, such as silver oxide. ¶¶99, 107 col. 7:50-58
ii) recovering said isosulfan blue acid The process includes a step of recovering the ISB acid. ¶100 col. 7:59-60
iii) purifying said recovered isosulfan blue acid The recovered ISB acid is purified, including through crystallization using specific solvents. ¶¶101-104 col. 7:61-63
  • Identified Points of Contention:
    • Evidentiary Question: The complaint's allegations regarding Defendant's specific manufacturing process are made "on information and belief." A primary point of contention will be whether Plaintiff can obtain evidence through discovery of Defendant's confidential ANDA file to prove that the process actually uses a "mild oxidizing agent" like silver oxide and includes the claimed recovery and purification steps.
    • Scope Question: The definition of "mild oxidizing agent" may be a key issue for claim construction. The patent distinguishes this term from "hazardous oxidizing agents" like lead oxide ('888 Patent, col. 2:20-22). The dispute may focus on whether the agent used by Defendant falls within the scope of "mild," particularly if it is not silver oxide (the primary example provided in the patent).

10,508,080 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
i) combining isoleuco acid... with an oxidizing agent The API is prepared by combining isoleuco acid with an oxidizing agent (allegedly silver oxide) in a polar solvent. ¶¶128-129, 132 col. 7:45-50
ii) recovering isosulfan blue acid The process includes recovering the resulting ISB acid. ¶128 col. 7:51-52
iii) obtaining isosulfan blue sodium salt therefrom, wherein said isosulfan blue sodium salt is obtained in a purity of at least 99% as measured by HPLC The ISB acid is combined with a sodium solution to obtain the final sodium salt with a purity of at least 99%. ¶¶128, 133, 134, 135 col. 7:53-57
  • Identified Points of Contention:
    • Technical Question: A factual dispute will likely arise over whether Defendant's manufacturing process consistently yields an isosulfan blue sodium salt that meets the "at least 99% as measured by HPLC" purity limitation as a direct result of the claimed process sequence. This will require analysis of Defendant's batch records and quality control data.
    • Process Integrity Question: The interpretation of "obtaining... therefrom" could be contested. The analysis may question whether Defendant's process is a single, integrated sequence as claimed, or if there are intervening steps that break the causal link between recovering the acid and obtaining the final, highly pure salt.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "mild oxidizing agent" ('888 Patent, claim 1)

    • Context and Importance: This term is central to distinguishing the claimed invention from prior art processes that used what the patent describes as "hazardous oxidizing agents" ('888 Patent, col. 2:20-22). Infringement of the '888 Patent will depend on whether the agent used by Defendant fits this definition. Practitioners may focus on this term because its scope is not explicitly defined beyond a list of what it is not.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a specific list of non-mild, "hazardous" agents: "lead oxide, chloranil, iron phthalocyanine/oxone" ('888 Patent, col. 2:20-22). This may support an interpretation where "mild" includes any oxidizing agent suitable for the reaction that is not on this list.
      • Evidence for a Narrower Interpretation: The patent's preferred embodiment and a dependent claim both identify "silver oxide" as the oxidizing agent ('888 Patent, claim 15; col. 7:53-55). This could support a narrower construction limited to silver oxide or agents with very similar reactivity and safety profiles.

  • The Term: "obtaining... therefrom" ('080 Patent, claim 1)

    • Context and Importance: This transitional phrase links the recovery of ISB acid (step ii) to the creation of the final, highly pure sodium salt (step iii). The dispute may turn on the required directness of this conversion. Practitioners may focus on this term because process claims can be sensitive to unrecited intermediate steps that may break the chain of causation implied by such language.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language does not forbid intermediate purification or conditioning steps between recovering the acid and forming the salt, which could support a reading that the final salt is "obtained therefrom" as long as it originates from the acid recovered in the prior step.
      • Evidence for a Narrower Interpretation: The structure of the claim as a sequence of steps (i) → (ii) → (iii) may suggest a more direct, linear process. A defendant could argue that if its process involves significant, distinct operations between these steps, the final salt is not "obtained therefrom" in the manner claimed.

VI. Other Allegations

  • Indirect Infringement: The complaint does not provide sufficient detail for analysis of indirect infringement. While the headings for each count mention infringement under 35 U.S.C. §§ 271(b) and (c), the factual allegations focus exclusively on Defendant's own acts of "making, using, offering to sell, and/or selling" its ANDA product, which constitutes direct infringement (e.g., Compl. ¶40).
  • Willful Infringement: The complaint alleges that Defendant had actual knowledge of the patents-in-suit at least as of September 17, 2025, the date it allegedly received a notice letter from Plaintiff's counsel (Compl. ¶¶53, 71, 86). It further alleges that Defendant acted without a reasonable basis for believing it would not be liable for infringement, which forms the basis for the willfulness claim (Compl. ¶¶55, 73, 88).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of evidentiary proof: The complaint's detailed allegations about Defendant's secret manufacturing process are made on "information and belief." The case will likely turn on whether Plaintiff, through discovery of Defendant's confidential ANDA filing, can prove that the accused manufacturing process in fact practices the specific steps of the asserted process patents (e.g., using silver oxide, in the absence of strong acid, achieving specified purity levels).
  • A key secondary issue will be one of product characterization: For the patents with composition claims ('050, '086, '580), the question is more direct: does Defendant's final drug substance, when tested, possess the claimed characteristics of high purity (e.g., >99.0% or >99.5%) and low silver content (<20 ppm)? This is a factual question that can be resolved through analytical testing of the accused product.
  • A potential legal question will be one of definitional scope: Should the case proceed to claim construction, a critical dispute may arise over the meaning of "mild oxidizing agent." The ability of this term to distinguish the invention from prior art, and whether it reads on Defendant's process, could be a determining factor for several of the asserted patents.