DCT

0:19-cv-00351

Econugenics Inc v. Bioenergy Life Science Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 0:19-cv-00351, D. Minn., 02/13/2019
  • Venue Allegations: Venue is based on the Minnesota residence of Defendants Bioenergy Life Science (BLS) and Chengzhi, and on allegations that Defendant Gold Kropn manufactures and sells Modified Citrus Pectin (MCP) to Chengzhi with the knowledge that it will be imported and sold in Minnesota for infringing purposes.
  • Core Dispute: Plaintiff alleges that Defendants’ sale and promotion of Modified Citrus Pectin products infringes five patents related to methods of using low-molecular-weight MCP for various therapeutic purposes.
  • Technical Context: The technology concerns the use of specially processed Modified Citrus Pectin with a low molecular weight, enabling its absorption into the bloodstream to provide systemic therapeutic benefits such as detoxification, immune support, and anti-inflammation.
  • Key Procedural History: The complaint alleges extensive pre-suit history, including a September 2017 meeting to discuss the patent portfolio, a July 2017 cease and desist letter, and alleged agreements by Defendants in 2018 to respect the patents, which were purportedly not honored. The complaint also references a prior, separate lawsuit against another Chinese manufacturer that resulted in an agreement to cease infringing sales, as well as a prior lawsuit between the current parties that was dismissed without prejudice.

Case Timeline

Date Event
1999-02-23 Priority Date for ’029 and ’871 Patents
2002-10-08 ’029 Patent Issue Date
2005-08-26 Priority Date for ’567, ’449, and ’329 Patents
2008-11-18 ’871 Patent Issue Date
2013-04-23 ’567 Patent Issue Date
2016-Mid BLS allegedly expresses desire to acquire Plaintiff's patent portfolio
2016-08-30 ’449 Patent Issue Date
2017-05-16 ’329 Patent Issue Date
2017-07-XX Plaintiff sends cease and desist letter to BLS
2017-09-26 Gold Kropn meets with Plaintiff to discuss infringement
2017-09-XX BLS allegedly unveils advertising banner for accused Zypect product
2018-03-XX Gold Kropn allegedly agrees again to respect Plaintiff's patents
2018-10-18 BLS posts online product description for accused Zypect product
2018-11-05 SupplySide West tradeshow where Defendants promoted accused products
2019-02-13 Complaint Filing Date

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

U.S. Patent No. 6,462,029 - "Compositions and Methods for Treating Mammals with Modified Alginates and Modified Pectins," Issued October 8, 2002

The Invention Explained

  • Problem Addressed: The patent describes that while gelling agents like pectin are known to bind to substances in vitro, their naturally occurring high molecular weight and low water solubility make it difficult for them to be absorbed from the gut into the bloodstream, limiting their therapeutic utility for systemic conditions (ʼ029 Patent, col. 2:25-33).
  • The Patented Solution: The invention is a method of using modified pectin or alginate that has been processed—via hydrolysis or enzymatic degradation—to have a low molecular weight (under 40,000 daltons). This modification makes the pectin water-soluble and allows it to be absorbed into the bloodstream, where it can bind to and facilitate the removal of circulating deleterious agents like heavy metals and environmental toxins (ʼ029 Patent, Abstract; col. 3:40-56).
  • Technical Importance: This approach enabled the systemic use of an orally administered compound for chelation therapy, targeting toxins throughout the body rather than only within the digestive tract (ʼ029 Patent, col. 3:30-38).

Key Claims at a Glance

  • The complaint asserts at least dependent Claim 8 (Compl. ¶44). The corresponding independent claim is Claim 8.
  • Claim 8 (Method of treating poisoning):
    • A method of treating or preventing poisoning in a mammal caused by circulating poisons (e.g., toxic metals).
    • The method comprises administering to a mammal in need an effective amount of modified pectin.
    • The modified pectin has a molecular weight of no more than 40,000 daltons.
    • The pectin is administered in an amount to effectively bind the poison.
  • The complaint does not explicitly reserve the right to assert other claims of the ’029 Patent.

U.S. Patent No. 7,452,871 - "Compositions and Methods for Treating Mammals with Modified Alginates and Modified Pectins," Issued November 18, 2008

The Invention Explained

  • Problem Addressed: The patent addresses the same fundamental problem as the ’029 Patent: the inability of conventional high-molecular-weight pectins to be absorbed into the bloodstream to counteract circulating harmful agents like toxins or excess minerals (ʼ871 Patent, col. 2:30-39).
  • The Patented Solution: The invention claims a method of treating conditions mediated by circulating agents (poisonous metals, toxins, or calcium) by administering a modified pectin. The pectin is defined as a partially esterified polymer of galacturonic acid with a molecular weight below 40,000 daltons, which allows it to enter the bloodstream and bind to the target agents (ʼ871 Patent, Abstract; col. 3:23-40).
  • Technical Importance: The invention provides a specified composition of modified pectin for use in orally-administered, systemic treatments for a range of conditions, including those associated with heavy metal toxicity and excess calcium (ʼ871 Patent, col. 1:11-24).

Key Claims at a Glance

  • The complaint asserts at least independent Claim 1 (Compl. ¶49).
  • Claim 1 (Method of treating a condition):
    • A method of treating a condition or disease mediated by an agent (poisonous metal, environmental toxin, or calcium) circulating in the blood.
    • The method comprises administering an effective amount of pectin to a mammal in need.
    • The pectin is composed of partially esterified polymers of galacturonic acid.
    • The pectin has a molecular weight of no more than 40,000 daltons.
    • The pectin is administered in an amount to effectively bind the agent.
  • The complaint does not explicitly reserve the right to assert other claims of the ’871 Patent.

U.S. Patent No. 8,426,567 - "Method for Enhancing Mammalian Immunological Function," Issued April 23, 2013

  • Technology Synopsis: This patent addresses the need for effective immunostimulators. It discloses a method for stimulating a mammal's immune response by administering low-molecular-weight modified pectin, which is alleged to modulate functions such as cell-mediated immunity, macrophage function, and NK cell activity (’567 Patent, Abstract; col. 2:1-8).
  • Asserted Claims: At least independent Claim 1 is asserted (Compl. ¶55).
  • Accused Features: The accused feature is the sale and promotion of MCP for "immune support" (Compl. ¶¶27, 37, 55).

U.S. Patent No. 9,427,449 - "Binding of Galectin-3 by Low Molecular Weight Pectin," Issued August 30, 2016

  • Technology Synopsis: The patent addresses conditions mediated by the protein galectin-3, such as inflammation and fibrosis. The invention is a method of reducing active galectin-3 levels by administering a low-molecular-weight (3,000-20,000 daltons) modified citrus pectin, thereby inhibiting inflammation (’449 Patent, Abstract).
  • Asserted Claims: At least independent Claim 2 is asserted (Compl. ¶59).
  • Accused Features: The accused feature is the marketing and sale of MCP to "reduce inflammation" (Compl. ¶¶27, 37, 59).

U.S. Patent No. 9,649,329 - "Binding of Galectin-3 by Low Molecular Weight Pectin," Issued May 16, 2017

  • Technology Synopsis: This patent, related to the ’449 Patent, also concerns the role of galectin-3 in biological conditions. The invention is a method of using low-molecular-weight modified citrus pectin to bind galectin-3 to inhibit or reduce the formation of fibrosis in organs and tissues (’329 Patent, Abstract).
  • Asserted Claims: At least independent Claim 2 is asserted (Compl. ¶64).
  • Accused Features: The accused feature is the promotion of MCP for the "inhibition or reduction of fibrosis" (Compl. ¶¶27, 64).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Modified Citrus Pectin (MCP) manufactured by Gold Kropn, imported by Chengzhi, and sold by BLS in the United States, including under the brand name ZyPect™ (Compl. ¶¶2, 4, 30, 37).

Functionality and Market Context

  • The complaint alleges the accused MCP is a dietary supplement specifically processed to have a low molecular weight, which allegedly falls within the ranges claimed in the patents-in-suit (Compl. ¶¶21, 25). The complaint includes a screenshot of an online product description for ZyPect™, which describes the product as an "enzyme treated, highly purified Modified Citrus Pectin (MCP)" that "detoxifies toxins and heavy metals, provides immune support, reduces inflammation," and is marketed to North America (Compl. ¶37). The complaint further alleges that a Certificate of Analysis for the accused MCP shows a molecular weight range of 5,000–22,000 Daltons, which is consistent with the patent claims but inconsistent with Defendants' alleged public representations that the product is made according to a different patent that would yield a much lower molecular weight (Compl. ¶25).

IV. Analysis of Infringement Allegations

’029 Patent Infringement Allegations

Claim Element (from Independent Claim 8) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating or preventing poisoning in a mammal which is caused by circulation in the blood of said mammal of a poison selected from the group consisting of toxic metals, environmental toxins and mixtures thereof, Defendants' MCP is advertised and sold for the purpose of detoxifying the body of "toxins and heavy metals." ¶¶27, 37, 44 col. 5:8-19
comprising administering to a mammal in need of same an effective amount of modified pectin BLS allegedly "administers or provides" its MCP product to individuals identified as needing detoxification. ¶¶19, 44 col. 3:60-65
having a molecular weight of no more than 40,000 daltons, The accused MCP is alleged to have a molecular weight between 5,000 and 22,000 daltons, based on a Certificate of Analysis. ¶25 col. 3:26-29
and obtained by hydrolysis or enzymatic degradation of pectin, in an amount to effectively bind said poison. The accused MCP is advertised as "enzyme treated" and is allegedly provided in an amount sufficient to provide the recited relief. ¶¶19, 37 col. 3:42-44

’871 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a condition or disease mediated by an agent selected from the group consisting of a poisonous metal, an environmental toxin and calcium circulating in the blood, The accused ZyPect™ product is marketed for its ability to "detoxify toxins and heavy metals." ¶¶37, 49 col. 5:1-12
the method comprising administering to a mammal in need of same an effective amount of pectin BLS is alleged to provide or "administer" its MCP to individuals for the advertised purposes. ¶49 col. 3:55-65
comprised of partially esterified polymers of galacturonic acid The accused product is Modified Citrus Pectin, which is a polymer of galacturonic acid. ¶¶1, 16 col. 2:8-10
having a molecular weight of no more than 40,000 daltons, The accused MCP product is alleged to have a molecular weight of 5,000-22,000 daltons. ¶25 col. 2:12-14
in an amount to effectively bind said agent. The product is allegedly provided in amounts sufficient to achieve the advertised detoxifying effects. ¶19 col. 5:1-12

Identified Points of Contention

  • Scope Questions: The asserted claims are for "methods of treating" a disease or condition. Defendants sell a non-prescription dietary supplement. A central legal question will be whether the act of "providing" or selling a supplement with marketing materials that describe therapeutic benefits (e.g., "detoxifies toxins," "reduces inflammation") constitutes infringement of a method claim requiring the steps of "administering" a composition for "treating" a specified condition. The complaint preemptively argues for a broad interpretation, stating that in a non-prescription context, "administration typically amounts to no more than providing the composition to an individual" (Compl. ¶19).
  • Technical Questions: The infringement case hinges on the specific molecular weight of the accused MCP. The complaint relies on a "Certificate of Analysis" (Exhibit I, not attached) to allege the product's molecular weight is 5,000–22,000 daltons, squarely within the patents' scope (Compl. ¶25). A key factual dispute may arise over the actual, verifiable technical specifications of the product sold by Defendants, especially since the complaint alleges Defendants' own marketing falsely links the product to a different patent covering a <1,000 dalton composition (Compl. ¶25).

V. Key Claim Terms for Construction

The Term: "administering"

  • Context and Importance: This term is critical for determining direct infringement. The defendants are primarily sellers of a product, not medical providers. Whether their actions constitute "administering" a method of treatment will be a focal point. Practitioners may focus on this term because its construction could determine whether the sale of a dietary supplement with specific health claims can be considered direct infringement of a method patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specifications of the asserted patents contemplate both oral and intravenous administration, and the discussion of oral administration is consistent with use as a dietary supplement or food product ('029 Patent, col. 5:56-65; '871 Patent, col. 4:51-60). This may support an argument that "administering" encompasses providing a product for self-administration by a consumer.
    • Evidence for a Narrower Interpretation: The patents also discuss intravenous administration and use phrases like "chelation therapy," which may suggest a more formal, clinical context under the supervision of a practitioner ('029 Patent, col. 3:30-32; '871 Patent, col. 3:30-32). This could support an argument that "administering" requires more than an over-the-counter sale.

The Term: "method of treating"

  • Context and Importance: The patents claim methods of "treating" or "preventing" specific conditions like "poisoning" or "disease." Defendants market a dietary supplement, which is legally distinct from a drug intended to treat disease. The case will question whether marketing a supplement for its structural or functional benefits (e.g., "immune support") constitutes practicing a "method of treating" a condition as claimed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patents' backgrounds describe addressing conditions caused by "deleterious agents," a broad category that aligns with the general wellness and detoxification claims made for supplements ('029 Patent, col. 2:51-56). The abstract of the '029 Patent refers to "preventing and/or treating diseases and/or conditions."
    • Evidence for a Narrower Interpretation: The claims themselves recite specific, medical-sounding ailments such as "poisoning," "arteriosclerosis," and "calcinosis" ('029 Patent, Claims 8, 14, 16; '871 Patent, Claim 1). This language could support a narrower construction limited to formal medical treatment of diagnosed diseases, rather than general health maintenance.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement against all defendants. The factual basis for inducement includes allegations that Defendants, with knowledge of the patents, advertise and provide instructions (e.g., through online product descriptions) that encourage end-users to use the MCP in an infringing manner (Compl. ¶¶27, 31, 45). Contributory infringement is alleged on the basis that the low-molecular-weight MCP is "particularly adapted" for the infringing methods and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶44, 49).

Willful Infringement

  • The complaint makes detailed allegations to support willfulness. It claims Defendants had pre-suit knowledge of the patents through direct communications, meetings, and a cease-and-desist letter beginning as early as mid-2016 (Compl. ¶¶28, 31, 33). The complaint further alleges that Defendants acknowledged the patents' value, entered discussions, and then proceeded with the accused activities, demonstrating egregious and willful conduct (Nature of the Action, p.1; Compl. ¶¶5, 39).

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

  • A core issue will be one of infringement scope: can the act of marketing and selling a non-prescription dietary supplement for its general health benefits (e.g., "detoxification," "immune support") be legally construed as the "administering" of a "method of treating" specific medical conditions recited in the patent claims?
  • A key evidentiary question will be one of technical fact: does the accused ZyPect™ product actually possess the low molecular weight (e.g., 5,000-22,000 daltons) that the complaint alleges and the patents require, and how will this be proven or disproven in court?
  • A third central question, pertinent to damages, will be one of intent: given the extensive history of communication alleged in the complaint, was the defendants' conduct, if found to be infringing, willful, thereby exposing them to the risk of enhanced damages?