DCT

1:18-cv-06334

AIDP Inc v. Terapeutics Group Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-06334, E.D.N.Y., 11/07/2018
  • Venue Allegations: Venue is alleged to be proper in the Eastern District of New York because Defendant AIDP Inc v. Terapeutics Group Inc is incorporated in New York and its principal place of business is located within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s "Magnesium L-Threonate" nutritional supplement infringes ten patents related to magnesium compositions and their use for treating neurological, cognitive, and metabolic disorders.
  • Technical Context: The patents relate to formulations of magnesium, particularly magnesium L-threonate, designed to improve bioavailability and effectively increase magnesium levels in the brain to enhance cognitive functions.
  • Key Procedural History: Plaintiff AIDP holds an exclusive license from the patents' assignor, Magceutics, Inc., to market, sell, and distribute the patented ingredient under the brand name Magtein®. The complaint alleges that Plaintiff provided Defendant with written notice of the asserted patents on or about August 30, 2018, prior to filing the lawsuit.

Case Timeline

Date Event
2007-03-22 Earliest Priority Date for Asserted Patents
2012-03-27 U.S. Patent No. 8,142,803 Issues
2012-04-24 U.S. Patent No. 8,163,301 Issues
2012-05-15 U.S. Patent Nos. 8,178,118, 8,178,132, 8,178,133 Issue
2013-02-19 U.S. Patent No. 8,377,473 Issues
2013-06-25 U.S. Patent No. 8,470,352 Issues
2014-01-28 U.S. Patent No. 8,637,061 Issues
2014-05-27 U.S. Patent No. 8,734,855 Issues
2015-09-08 U.S. Patent No. 9,125,878 Issues
2018-08-30 Plaintiff allegedly sent written notice of infringement to Defendant
2018-11-07 Complaint Filing Date

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

U.S. Patent No. 9,125,878

  • Patent Identification: U.S. Patent No. 9125878, “Magnesium compositions and uses thereof for neurological disorders,” issued September 8, 2015 (Compl. ¶12).
  • Technology Synopsis: This patent addresses cognitive decline associated with neurological disorders, which may be linked to magnesium deficiency (Compl. ¶9). It discloses the use of magnesium compositions, specifically including magnesium L-threonate, as a method to ameliorate these neurological effects, presumably by improving magnesium's bioavailability and ability to address synaptic plasticity (Compl. ¶9; ’803 Patent, col. 1:13-24, col. 2:36-44).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶28).
  • Accused Features: The manufacturing, offering for sale, and selling of the "Magnesium L-Threonate" product for uses such as "brain health," "cognitive function," and "slowing age-related memory decline" are the accused features (Compl. ¶¶24, 25, 28).

U.S. Patent No. 8,734,855

  • Patent Identification: U.S. Patent No. 8734855, “Slow release magnesium composition and uses thereof,” issued May 27, 2014 (Compl. ¶13).
  • Technology Synopsis: This patent appears directed at providing magnesium compositions in a slow-release formulation. This approach may be intended to manage absorption rates and maintain physiological concentrations over time, potentially avoiding side effects associated with conventional magnesium supplements while treating conditions related to magnesium deficiency (Compl. ¶9; ’473 Patent, col. 1:18-28).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶36).
  • Accused Features: The accused instrumentality is the "Magnesium L-Threonate" product, which is sold in capsule form and is alleged to embody the patented invention (Compl. ¶¶24, 36).

U.S. Patent No. 8,637,061

  • Patent Identification: U.S. Patent No. 8637061, “Magnesium compositions and uses thereof for neurological disorders,” issued January 28, 2014 (Compl. ¶14).
  • Technology Synopsis: Similar to the ’878 Patent, this patent appears to address cognitive issues linked to neurological disorders by using magnesium compositions like magnesium L-threonate. The technology likely focuses on enhancing synaptic plasticity and increasing brain magnesium levels to counteract age-related or disease-related cognitive decline (Compl. ¶9; ’803 Patent, col. 1:13-24, col. 2:36-44).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶44).
  • Accused Features: The accused features are the manufacture, sale, and advertising of Defendant's "Magnesium L-Threonate" product for various cognitive benefits (Compl. ¶¶24, 25, 44).

U.S. Patent No. 8,470,352

  • Patent Identification: U.S. Patent No. 8470352, “Magnesium compositions and uses thereof for metabolic disorders,” issued June 25, 2013 (Compl. ¶15).
  • Technology Synopsis: This patent is directed toward using magnesium compositions to treat metabolic disorders. The patented solution likely involves administering a bioavailable form of magnesium, such as magnesium L-threonate, to address conditions like diabetes or hypertension, which are identified as potential applications in related patents (’301 Patent, Abstract).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶52).
  • Accused Features: Defendant's product is accused of infringement through its advertised uses, which include improving sleep, a function that may be linked to metabolic health (Compl. ¶¶25, 52).

U.S. Patent No. 8,377,473

  • Patent Identification: U.S. Patent No. 8377473, “Slow release magnesium composition and uses thereof,” issued February 19, 2013 (Compl. ¶16).
  • Technology Synopsis: This patent, similar to the ’855 Patent, appears to disclose slow-release formulations of magnesium and threonate. This approach likely aims to provide sustained physiological concentrations of magnesium, potentially improving efficacy and reducing side effects compared to immediate-release supplements (’473 Patent, col. 1:18-28).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶60).
  • Accused Features: The accused instrumentality is the encapsulated "Magnesium L-Threonate" product sold by the Defendant (Compl. ¶¶24, 60).

U.S. Patent No. 8,178,133

  • Patent Identification: U.S. Patent No. 8178133, “Magnesium compositions and uses thereof,” issued May 15, 2012 (Compl. ¶17).
  • Technology Synopsis: Given its broad title, this patent likely covers fundamental compositions of magnesium, such as magnesium L-threonate, for administration as a nutritional supplement. The core technology is likely the composition itself, designed for enhanced bioavailability to improve health and cognitive function (’118 Patent, Abstract).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶68).
  • Accused Features: The accused features are the manufacturing and sale of a nutritional supplement comprising magnesium L-threonate (Compl. ¶¶24, 68).

U.S. Patent No. 8,178,132

  • Patent Identification: U.S. Patent No. 8178132, “Magnesium-containing food compositions,” issued May 15, 2012 (Compl. ¶18).
  • Technology Synopsis: This patent appears to cover the incorporation of magnesium compositions, such as magnesium L-threonate, into food products. This could be intended to provide a convenient vehicle for oral administration as part of a regular diet, potentially leveraging food components to enhance magnesium absorption (’132 Patent, col. 3:41-45).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶76).
  • Accused Features: The accused features are the manufacturing and sale of Defendant's product, which is a nutritional supplement intended for consumption as part of a diet (Compl. ¶¶24, 76).

U.S. Patent No. 8,178,118

  • Patent Identification: U.S. Patent No. 8178118, “Magnesium compositions and uses thereof for cognitive function,” issued May 15, 2012 (Compl. ¶19).
  • Technology Synopsis: This patent appears to specifically claim methods of using magnesium compositions to improve cognitive functions. The disclosed invention likely involves administering magnesium L-threonate to enhance learning and memory by increasing synaptic plasticity (’118 Patent, col. 2:36-41).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶84).
  • Accused Features: The accused features include the sale and advertisement of Defendant's product for enhancing "cognitive function," "improving recall," and "slowing age-related memory decline" (Compl. ¶¶25, 84).

U.S. Patent No. 8,163,301

  • Patent Identification: U.S. Patent No. 8163301, “Magnesium compositions and uses thereof,” issued April 24, 2012 (Compl. ¶20).

The Invention Explained

  • Problem Addressed: The patent's background describes that while magnesium is crucial for health, dietary intake is often inadequate, and existing supplements suffer from poor bioavailability, undesirable side effects like diarrhea, or poor palatability (’301 Patent, col. 1:55 - col. 2:67).
  • The Patented Solution: The invention provides magnesium compositions, such as magnesium L-threonate, designed to offer reliable absorption and bioavailability for administration to a subject to treat or prevent various health conditions, including metabolic disorders (’301 Patent, Abstract; col. 3:3-13). The specification describes experiments demonstrating improved magnesium absorption rates with certain formulations (’301 Patent, Fig. 2; col. 10:33-45).
  • Technical Importance: This technology aimed to provide a form of magnesium that is both well-tolerated and effective at raising physiological magnesium levels to address health issues associated with magnesium deficiency (’301 Patent, col. 2:63-67).

Key Claims at a Glance

  • The complaint does not identify specific claims, but Claim 1 is representative:
    • A method of ameliorating an effect of a metabolic disorder
    • comprising administering to a subject in need for supplementing a magnesium-containing compound
    • in an amount that is effective to ameliorate said effect of the metabolic disorder
    • wherein the magnesium-containing compound comprises magnesium threonate

U.S. Patent No. 8,142,803

  • Patent Identification: U.S. Patent No. 8142803, “Magnesium compositions and uses thereof for neurological disorders,” issued March 27, 2012 (Compl. ¶21).

The Invention Explained

  • Problem Addressed: The patent identifies a link between magnesium deficiency, loss of synaptic plasticity in the brain, and pathological conditions like mild cognitive impairment (MCI) and Alzheimer's disease (AD) (’803 Patent, col. 2:36-54). It notes that conventional magnesium supplements are not ideal for addressing this due to poor bioavailability and side effects (’803 Patent, col. 2:6-24).
  • The Patented Solution: The invention discloses magnesium compositions, particularly magnesium threonate, for administration to a subject to ameliorate neurological disorders (’803 Patent, Abstract). The detailed description provides experimental data from animal studies suggesting that magnesium threonate supplementation enhances learning and memory in both young and aged rats (’803 Patent, Figs. 12-13; col. 11:30-34).
  • Technical Importance: The invention provided a potential therapeutic pathway for using a nutritional supplement to address the physiological underpinnings of age-related and disease-related cognitive decline (’803 Patent, col. 1:13-24).

Key Claims at a Glance

  • The complaint does not identify specific claims, but Claim 1 is representative:
    • A method of ameliorating the effects of a neurological disorder
    • the method comprising administering to a subject in need for supplementing a magnesium-containing compound (MCC)
    • in an amount that is effective to ameliorate the effects of said neurological disorder
    • wherein the MCC comprises magnesium threonate

III. The Accused Instrumentality

  • Product Identification: The accused product is a nutritional supplement labeled "Magnesium L-Threonate" (the "Infringing Product") (Compl. ¶24).
  • Functionality and Market Context: The Infringing Product is sold in bottles of 100 capsules, each containing 500mg of the supplement (Compl. ¶24). Defendant advertises the product for uses including "brain health," "cognitive function," "increased concentration," "slowing age-related memory decline," and to "improve sleep" (Compl. ¶25). The complaint references an advertisement, attached as Exhibit K, which allegedly states that the product consists of magnesium "capable of crossing the blood brain barrier, allowing for it to be absorbed by the brain" (Compl. ¶¶25-26). Defendant allegedly markets its product online through its own website and Amazon.com (Compl. ¶23).

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,163,301 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of ameliorating an effect of a metabolic disorder Defendant offers for sale and sells its product for uses including to "improve sleep," which may be related to metabolic health. ¶25, ¶52 col. 5:31-36
comprising administering to a subject in need for supplementing a magnesium-containing compound The product is a nutritional supplement sold in capsule form for oral administration to end-users. ¶24 col. 3:19-24
wherein the magnesium-containing compound comprises magnesium threonate The accused product is explicitly labeled and marketed as "Magnesium L-Threonate." ¶24 col. 3:9-11

U.S. Patent No. 8,142,803 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of ameliorating the effects of a neurological disorder Defendant markets and sells its product for uses including improving "brain health," "cognitive function," and "slowing age-related memory decline." ¶25, ¶100 col. 4:5-13
comprising administering to a subject... a magnesium-containing compound (MCC) The product is a nutritional supplement sold in capsules intended for oral administration by consumers. ¶24 col. 3:19-24
wherein the MCC comprises magnesium threonate The product is explicitly labeled and marketed as "Magnesium L-Threonate." ¶24 col. 3:9-11
  • Identified Points of Contention:
    • Scope Questions: The asserted claims of the ’301 Patent are directed to methods for treating "metabolic disorders." A central question for the court may be whether the Defendant’s advertised use of its product to "improve sleep" (Compl. ¶25) constitutes a method of ameliorating a metabolic disorder as contemplated by the patent. Similarly, for the ’803 Patent, a question may arise as to whether advertising for general "brain health" and "cognitive function" meets the claim limitation of ameliorating a "neurological disorder," or if that term requires a specific diagnosed condition.
    • Technical Questions: The infringement allegations for all ten asserted patents appear to be method-of-use claims. A key evidentiary question for the court will be whether the Plaintiff can establish the elements of indirect infringement, particularly inducement. This analysis will likely focus on whether Defendant's advertisements and product instructions, such as those described in the complaint (Compl. ¶25), provide specific instructions and intent for end-users to perform the patented methods.

V. Key Claim Terms for Construction

  • The Term: "neurological disorder" (from Claim 1 of the ’803 Patent)

  • Context and Importance: The definition of this term is critical because the Defendant's advertisements focus on general wellness concepts like "brain health" and "cognitive function" rather than specific diseases (Compl. ¶25). The infringement analysis may turn on whether these general cognitive benefits are encompassed by the term "neurological disorder."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The abstract of the ’803 Patent lists improving "cognitive, learning, and/or memory function" alongside specific diseases like Alzheimer's, which may suggest the term covers general functional improvements (’803 Patent, Abstract).
    • Evidence for a Narrower Interpretation: The background section of the ’803 Patent discusses specific "pathological conditions" such as "mild cognitive impairment (MCI)" and "Alzheimer's disease (AD)," which could support a narrower construction limited to diagnosed conditions (’803 Patent, col. 2:39-44). Dependent claims of the patent also recite specific disorders like dementia and depression, which may imply the independent claim's term is broader but still directed at medically recognized disorders.

  • The Term: "metabolic disorder" (from Claim 1 of the ’301 Patent)

  • Context and Importance: Infringement of the ’301 Patent may depend on whether any of the advertised product uses fall under this term. The complaint's primary allegations relate to cognitive benefits, with "improve sleep" being the main potential link to metabolic health (Compl. ¶25).

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The abstract of the ’301 Patent suggests uses for "maintaining, enhancing, and/or improving health, nutrition," which could be interpreted broadly (’301 Patent, Abstract). The specification of the related ’803 patent also links magnesium deficiency to a wide range of "pathological symptoms" beyond classic metabolic diseases (’803 Patent, col. 2:62-65).
    • Evidence for a Narrower Interpretation: The abstract of the ’301 Patent explicitly lists "diabetes, migraine, anxiety disorder, mood disorder, and/or hypertension" as examples, suggesting the term is directed at recognized medical conditions rather than general wellness (’301 Patent, Abstract).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges indirect infringement for each of the ten asserted patents (e.g., Compl. ¶¶28, 36, 44). The factual basis appears to rest on the allegation that Defendant manufactures and sells the Infringing Product with knowledge of the patents and with the intent that its customers will use the product for the patented methods, as encouraged by its advertisements (Compl. ¶¶22, 25).
  • Willful Infringement: The complaint alleges willful infringement for each asserted patent, based on the allegation that Defendant received "written notice of AIDP's intellectual property rights" and "actual knowledge" of the patents on or about August 30, 2018, before the suit was filed (Compl. ¶¶22, 29, 37, 45).

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

  • A core issue will be one of definitional scope: Can terms like "neurological disorder" and "metabolic disorder," which appear in the asserted claims, be construed to cover the general wellness benefits such as "brain health," "cognitive function," and "improve sleep" that are allegedly advertised by the Defendant?
  • A second key issue will be one of indirect infringement: Because all asserted claims appear to be method-of-use claims, the case will likely depend on whether Plaintiff can prove that Defendant's product marketing and instructions specifically encouraged and intended for consumers to use the product in a manner that practices the steps of the patented methods.
  • A third central question will be one of evidence: The complaint is based on "information and belief" regarding the composition of the accused product and alleges it is a "less expensive generic" (Compl. ¶26). The case may turn on factual evidence discovered regarding the actual chemical composition, manufacturing process, and formulation of Defendant's product to determine if it truly embodies the patented inventions.