DCT

2:18-cv-11971

Arjuna Natural Ltd v. Dolcas Biotech LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-11971, D.N.J., 07/23/2018
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the parties conduct business in the district, witnesses and evidence are located there, and some of the alleged infringing acts occurred within the district.
  • Core Dispute: Plaintiff alleges that Defendants’ turmeric herbal dietary supplements, sold under the BCM-95 mark, infringe a portfolio of patents related to compositions and methods for enhancing the bioavailability of curcumin.
  • Technical Context: The technology addresses the historically poor absorption of curcumin, a bioactive compound in turmeric, by combining it with turmeric essential oil to improve its uptake in the human body.
  • Key Procedural History: The dispute arises from an alleged breach of a 2010 Supply and Distribution Agreement, under which Plaintiff was the exclusive supplier of its patented product to Defendant DolCas Biotech. The complaint alleges that Defendants began sourcing and selling a "counterfeit product" from other manufacturers while representing it as Plaintiff's patented product, thereby infringing the patents-in-suit.

Case Timeline

Date Event
2005-05-30 Earliest Priority Date for Asserted Patents
2010-06-15 U.S. Patent No. 7,736,679 Issues
2010-07-19 Supply and Distribution Agreement Entered
2011-02-01 U.S. Patent No. 7,879,373 Issues
2011-02-08 U.S. Patent No. 7,883,728 Issues
2012-04-10 U.S. Patent No. 8,153,172 Issues
2012-06-12 U.S. Patent No. 8,197,869 Issues
2012-12-11 U.S. Patent No. 8,329,233 Issues
2014-01-07 U.S. Patent No. 8,623,431 Issues
2014-11-25 U.S. Patent No. 8,895,087 Issues
2015-03-31 U.S. Patent No. 8,993,013 Issues
2017-03-29 Plaintiff Alleges Discovery of Defendants' Unlawful Acts
2018-07-23 Complaint Filed

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

U.S. Patent No. 7,736,679 - "Composition to enhance the bioavailability of curcumin"

  • Patent Identification: U.S. Patent No. 7,736,679, "Composition to enhance the bioavailability of curcumin," issued June 15, 2010.

The Invention Explained

  • Problem Addressed: The patent addresses the low systemic bioavailability of curcumin in humans and animals following oral administration, which limits its therapeutic potential despite its numerous beneficial bioactivities (’679 Patent, col. 5:56-61).
  • The Patented Solution: The invention solves this problem by creating a composition that combines a specific mixture of curcuminoids (the active compounds) with an "added essential oil of turmeric." The specification teaches that the presence of the essential oil, particularly its component ar-turmerone, significantly enhances the absorption of curcumin into the bloodstream (’679 Patent, Abstract; col. 6:50-58). Figure 1 of the patent graphically illustrates this enhanced bioavailability compared to curcumin alone (’679 Patent, Fig. 1).
  • Technical Importance: This formulation provides a method to achieve pharmacologically effective levels of curcumin in the body via oral dosing, a key challenge that had previously hindered its clinical application (Compl. ¶35; ’679 Patent, col. 6:35-40).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the patent (Compl. ¶110). Independent claim 1 is representative of the core composition invention.
  • Claim 1 of the ’679 Patent requires:
    • A composition for enhanced bioavailability of curcumin comprising a curcuminoid mixture and added essential oil of turmeric.
    • A weight ratio of the curcuminoid mixture to the added essential oil of turmeric ranging from about 3:1 to about 99:1.
    • The curcuminoid mixture consists of curcumin, demethoxycurcumin, and bisdemethoxycurcumin.
    • The composition provides a 5-fold to 16-fold enhancement of bioavailability compared to the curcuminoid mixture alone.
    • The essential oil of turmeric comprises about 45% ar-turmerone.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,883,728 - "Composition to enhance the bioavailability of curcumin"

  • Patent Identification: U.S. Patent No. 7,883,728, "Composition to enhance the bioavailability of curcumin," issued February 8, 2011.

The Invention Explained

  • Problem Addressed: Like the ’679 Patent, this patent addresses the poor systemic bioavailability of orally administered curcumin, which is attributed to inadequate absorption and fast metabolism (’728 Patent, col. 5:60-63).
  • The Patented Solution: The invention is a specific method for preparing the bioavailability-enhanced curcumin composition. The claimed process involves suspending a curcuminoid mixture in water, adding the essential oil of turmeric, homogenizing the combination into a fine slurry, and then drying the slurry to form a uniform blend (’728 Patent, Abstract; col. 8:1-11). This process ensures the intimate mixture of the curcuminoids and the essential oil.
  • Technical Importance: The patent protects a specific manufacturing process for creating a uniform, orally administrable product that leverages the synergistic effect between curcuminoids and turmeric essential oil to improve therapeutic potential (’728 Patent, col. 8:7-14).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the patent (Compl. ¶116). Independent claim 1 is a representative method claim.
  • Claim 1 of the ’728 Patent requires a method comprising the steps of:
    • Suspending a curcuminoid mixture in water to form a suspension.
    • Adding an essential oil of turmeric to the suspension to form a second mixture.
    • Homogenizing the second mixture to obtain a slurry.
    • Drying the slurry under heat and vacuum to form a uniform blend.
    • The claim also specifies the weight ratios and chemical composition of the curcuminoid mixture and essential oil, similar to the ’679 Patent.
  • The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsule: U.S. Patent No. 8,153,172

  • Patent Identification: U.S. Patent No. 8,153,172, "Composition to enhance the bioavailability of curcumin," issued April 10, 2012.
  • Technology Synopsis: This patent claims a method of preparing a gelatin capsule containing the bioavailability-enhanced curcumin composition. It covers the manufacturing process of the final dosage form by suspending the curcuminoid mixture, adding the essential oil, homogenizing, drying, and then preparing a gelatin capsule with the resulting blend (’172 Patent, Abstract; Claim 1).
  • Asserted Claims: "one or more claims" (Compl. ¶122).
  • Accused Features: The complaint alleges infringement under 35 U.S.C. § 271(g), indicating that Defendants are importing, selling, or using "counterfeit products" that are made by the process claimed in the ’172 Patent (Compl. ¶122).

Multi-Patent Capsule: U.S. Patent No. 8,197,869

  • Patent Identification: U.S. Patent No. 8,197,869, "Composition to enhance the bioavailability of curcumin," issued June 12, 2012.
  • Technology Synopsis: This patent also claims a method of preparing the bioavailability-enhanced curcumin composition, similar to the '728 patent. The claims specify various weight ratios and recite the 2-fold to 16-fold enhancement in bioavailability as a characteristic of the resulting product (’869 Patent, Abstract; Claim 1).
  • Asserted Claims: "one or more claims" (Compl. ¶128).
  • Accused Features: The complaint alleges infringement under 35 U.S.C. § 271(g), accusing Defendants of importing or selling "counterfeit products" made by the patented process (Compl. ¶128).

The complaint also asserts U.S. Patent Nos. 8,329,233; 8,895,087; 8,993,013; 7,879,373; and 8,623,431, all titled "Composition to enhance the bioavailability of curcumin." The allegations for these patents mirror those for the patents analyzed above, targeting the "counterfeit products" as embodying the claimed compositions or being made by the claimed methods (Compl. ¶¶132-159).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are "counterfeit and/or infringing turmeric herbal dietary supplements" (Compl. ¶1). The complaint alleges these products are manufactured by third parties, including Defendant Dolphin International, by "copying or reverse engineering Plaintiffs' formula" and are then sold by the DolCas Defendants under the BCM-95 trademark (Compl. ¶28, 29).

Functionality and Market Context

  • The complaint alleges that Defendants market the accused "counterfeit product" as if it were Plaintiff's patented product, which is known in the industry for its high bioavailability and purity (Compl. ¶28, 35). The core of the infringement allegation is that the counterfeit product has the same formulation and is made by the same process as Plaintiff's product, and therefore embodies the patented inventions (Compl. ¶111, 116).
    No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

7,736,679 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition for enhanced bioavailability of curcumin comprising a curcuminoid mixture and added essential oil of turmeric... The accused counterfeit product is alleged to be a composition containing a curcuminoid mixture combined with turmeric essential oil. ¶29, 111 col. 6:47-58
...wherein the weight ratio of the curcuminoid mixture to the added essential oil of turmeric ranges from about 3:1 to about 99:1... The counterfeit product is alleged to meet the claimed ratio limitations, based on claims that it was made by copying Plaintiff's formula. ¶29, 111 col. 9:28-31
...wherein the curcuminoid mixture consists of curcumin, demethoxycurcumin and bisdemethoxycurcumin... The counterfeit product is alleged to contain the specifically claimed three-component curcuminoid mixture. ¶29, 111 col. 9:32-34
...wherein the composition...shows about a 5 fold to about a 16 fold enhancement of bioavailability... The complaint's theory is that by copying the formula and selling it as BCM-95, the counterfeit product necessarily exhibits this functional property. ¶29, 111 col. 9:34-39
...and wherein the essential oil of turmeric comprises about 45% ar-turmerone. The essential oil component of the counterfeit product is alleged to meet this specific compositional requirement. ¶29, 111 col. 9:39-41

7,883,728 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of preparing a composition comprising a curcuminoid mixture and added essential oil of turmeric, the method comprising: Defendants are accused of making, using, or selling products manufactured by the claimed process steps. ¶29, 116 col. 10:1-4
suspending a curcuminoid mixture in water to form a suspension; The manufacturing process for the counterfeit product is alleged to include this initial step. ¶29, 116 col. 10:5-6
adding an essential oil of turmeric to the suspension to form a second mixture; The manufacturing process is alleged to include the step of combining the essential oil with the aqueous suspension. ¶29, 116 col. 10:7-8
homogenizing the second mixture to obtain a slurry; and The manufacturing process is alleged to include a homogenization step to create a slurry. ¶29, 116 col. 10:9-10
drying the slurry under heat and vacuum to form a uniform blend... The manufacturing process is alleged to conclude with a specific drying step to produce the final blend. ¶29, 116 col. 10:10-12

Identified Points of Contention

  • Evidentiary Questions: A central issue may be the complaint's reliance on an "infringement by admission" theory. The complaint alleges that by asserting the '679 patent covered products sold under the BCM-95 mark, Defendants have "admitted that the counterfeit Products infringe" (Compl. ¶111). The court will have to determine whether Plaintiff can prove such assertions were made and if they constitute a legally sufficient basis for an infringement finding, particularly for a product Plaintiff alleges is "counterfeit."
  • Technical Questions: The complaint does not provide technical evidence, such as chemical analysis of the accused products, to demonstrate that they meet the specific compositional and ratio limitations of the claims. The case may turn on whether discovery reveals that the "counterfeit product" contains the specific three-component "curcuminoid mixture," an "added essential oil of turmeric," and the claimed concentration of ar-turmerone, or if it is a different formulation that may not literally infringe.

V. Key Claim Terms for Construction

  • The Term: "added essential oil of turmeric"

  • Context and Importance: This term appears in the independent claims of both the ’679 and ’728 Patents. Its construction is critical to distinguishing the claimed invention from a simple turmeric extract that naturally contains both curcuminoids and essential oils. Infringement will depend on whether the accused manufacturing process involves the affirmative step of adding a separately prepared essential oil to a curcuminoid mixture.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the components separately, stating "Curcuminoid and the essential oil are blended" (’679 Patent, col. 7:61-62), which could suggest that any process of combination after separate isolation falls within the claim scope.
    • Evidence for a Narrower Interpretation: The detailed description of the preparation method involves isolating curcuminoid crystals and then suspending them before adding the essential oil (’679 Patent, col. 6:41-43). This could support an argument that the term requires the curcuminoid to be in a purified, crystalline state before the essential oil is "added."

  • The Term: "curcuminoid mixture"

  • Context and Importance: Claim 1 of the ’679 Patent requires a mixture that "consists of curcumin, demethoxycurcumin and bisdemethoxycurcumin." The use of the transitional phrase "consists of" is highly restrictive. The infringement analysis will require determining if the accused product contains only these three components (and impurities) or if it contains other active or structural components that would place it outside the scope of the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term "mixture" itself may imply that the relative proportions can vary, as long as the three named components are present.
    • Evidence for a Narrower Interpretation: The patent's description of isolating the curcuminoids via crystallization from a solvent extract (’679 Patent, col. 6:10-29) suggests a specific purity and composition profile. A defendant might argue that a crude turmeric oleoresin, which contains these compounds among many others, is not the claimed "curcuminoid mixture."

VI. Other Allegations

  • Willful Infringement: The complaint alleges that Defendants' infringement was knowing and willful. The basis for this allegation is Defendants' alleged knowledge of the patents-in-suit, purportedly evidenced by their own act of "asserting and causing to assert" that the patents covered the products sold under the BCM-95 trademark, while continuing to sell the accused counterfeit products (Compl. ¶114, 120).

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

  • A core issue will be one of proof and legal theory: can Plaintiff prevail on its "infringement by admission" theory, or will the case depend entirely on technical evidence obtained during discovery to prove that the accused "counterfeit" products literally meet the chemical composition, ratio, and process limitations of the asserted claims?
  • A key claim construction question will be one of definitional scope: does the term "added essential oil of turmeric," when read in light of the specification, require the combination of two distinct, separately isolated streams, and can the term "curcuminoid mixture" be limited to a specific, purified composition, potentially excluding cruder turmeric extracts from the claims' scope?