Akeso Health Sciences LLC v. United Natural Foods Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Akeso Health Sciences, LLC (California)
  • Defendant: United Natural Foods, Inc. (Delaware) and United Natural Foods West, Inc. (California)
  • Plaintiff’s Counsel: Nixon Peabody LLP
• Case Identification: 2:17-cv-01531, C.D. Cal., 02/24/2017
• Venue Allegations: Venue is alleged to be proper in the Central District of California because Defendants have principal places of business in California and have allegedly placed infringing goods into the stream of commerce with the expectation of purchase in the state.
• Core Dispute: Plaintiff alleges that Defendants' making, using, and selling of the "MigreLief®" dietary supplement infringes two patents directed to compositions for treating migraine headaches.
• Technical Context: The technology relates to dietary supplements for migraine prophylaxis, a significant market segment where formulations often combine vitamins, minerals, and herbal extracts to address the multifactorial nature of the condition.
• Key Procedural History: The '450' patent is a continuation-in-part of the application for the '999' patent and is subject to a terminal disclaimer over it, linking the enforceability of the two patents. The complaint alleges Plaintiff marks its own "MigreLief®" products with the patent numbers, asserting this provides constructive notice to infringers.

Case Timeline

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

U.S. Patent No. 6,068,999, "Dietary Supplement for Supporting Cerebrovascular Tone and Treating Migraine Headaches," issued May 30, 2000

• The Invention Explained:
  • Problem Addressed: The patent describes the challenge of formulating an effective treatment for migraine headaches, noting that existing pharmaceutical therapies can have significant side effects and that many different biological pathways may be involved in migraine pathogenesis (’999 Patent, col. 3:1-4:29). The patent posits that combining the correct compounds in therapeutically effective dosages into a single formulation is a "most challenging question" (’999 Patent, col. 4:51-53).
  • The Patented Solution: The invention is a dietary supplement that combines three specific components—an extract of the feverfew plant (containing parthenolide), magnesium, and riboflavin—into a single formulation (’999 Patent, Abstract). This combination is intended to provide "broad spectrum therapeutic benefits with minimal side effects" by simultaneously addressing several potential migraine-related mechanisms, such as platelet aggregation, vasospasm, and mitochondrial energy deficiencies (’999 Patent, col. 5:29-34, col. 5:21-29, col. 6:62-67).
  • Technical Importance: The invention proposed a non-pharmaceutical, multi-component approach in a single dosage form to address a "long-felt but unresolved need" for natural migraine relief (Compl. ¶13).
• Key Claims at a Glance:
  • The complaint asserts at least one claim, specifically referencing method claim 9 (Compl. ¶¶18, 29). Independent composition claim 1 is also foundational.
  • Independent Claim 1: A dietary supplement comprising:
    • an extract from the feverfew plant,
    • magnesium, and
    • riboflavin,
    • wherein the feverfew extract contains about 0.7% parthenolide and the magnesium is provided as a combination of magnesium oxide and magnesium citrate.
  • Independent Claim 9: A method for reducing migraine symptoms by administering a supplement comprising:
    • an extract of the feverfew plant,
    • riboflavin, and
    • magnesium,
    • wherein the feverfew extract contains about 0.7% parthenolide and the magnesium is provided as a combination of magnesium oxide and magnesium citrate.
  • The complaint reserves the right to assert additional claims (Compl. ¶29).

U.S. Patent No. 6,500,450, "Composition for Treating Migraine Headaches," issued Dec. 31, 2002

• The Invention Explained:
  • Problem Addressed: The patent addresses the same technical problem as its parent '999 patent: creating a single, effective, multi-component dietary supplement for migraine sufferers (’450 Patent, col. 1:13-18).
  • The Patented Solution: The ’450 patent refines the combination of feverfew, magnesium, and (optionally) riboflavin by introducing a specific quantitative relationship between the active ingredients. The key feature is a claimed minimum ratio of magnesium to parthenolide, which is intended to ensure a therapeutically significant amount of magnesium is delivered (’450 Patent, col. 7:41-54; Abstract). The specification also highlights that the combination of magnesium oxide with a magnesium salt of an organic acid allows for the delivery of high quantities of magnesium in a "body absorbable form" (’450 Patent, col. 7:46-51).
  • Technical Importance: This invention aimed to improve upon earlier formulations by optimizing the quantitative ratio of its key components, a feature purported to enhance the composition's overall efficacy.
• Key Claims at a Glance:
  • The complaint asserts at least one claim, specifically referencing method claim 16 (Compl. ¶¶18, 35). Independent composition claim 1 is also foundational.
  • Independent Claim 1: A dietary supplement comprising:
    • an extract from the feverfew plant, magnesium, and riboflavin,
    • the extract containing parthenolide,
    • the magnesium provided as a combination of magnesium oxide and a magnesium salt of an organic acid,
    • wherein the ratio of magnesium to parthenolide is at least about 430:1.
  • Independent Claim 16: A method of reducing migraine symptoms by administering a therapeutically effective amount of:
    • parthenolide,
    • a magnesium salt (provided as a salt of an organic acid), and
    • riboflavin.
  • The complaint reserves the right to assert additional claims (Compl. ¶35).

III. The Accused Instrumentality

• Product Identification: The accused instrumentality is the "MigreLief®" dietary supplement (Compl. ¶16).
• Functionality and Market Context: The complaint alleges that "MigreLief®" is a product developed and sold by the Plaintiff, Akeso, under its own patents (Compl. ¶14). The infringement allegations center on Defendants' making, using, or selling this same "MigreLief®" product (Compl. ¶¶16, 25). The complaint alleges the product is a natural, drug-free supplement for migraine headaches that has enjoyed "great commercial success" and met a "long-felt but unresolved need" (Compl. ¶13). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'999 Patent Infringement Allegations

'450 Patent Infringement Allegations

• Identified Points of Contention:
  • Evidentiary Question: A central issue will be establishing the exact chemical composition of the MigreLief® products sold by the Defendants. The complaint's theory relies on the premise that this product is identical to the patented formulation, which will require factual proof, likely through chemical analysis.
  • Technical Question: Does the accused product meet the specific quantitative limitations of the claims? The complaint does not provide specific factual allegations showing that the accused product contains "about 0.7% parthenolide" (required by the ’999 Patent) or meets the "at least about 430:1" magnesium-to-parthenolide ratio (required by the ’450 Patent). These will be critical points of proof for the plaintiff.

V. Key Claim Terms for Construction

• The Term: "at least about 430:1" (’450 Patent, Claim 1)

  • Context and Importance: This ratio is a core limitation distinguishing the '450 patent. Infringement directly depends on whether the accused product's composition meets this numerical threshold. The interpretation of "about" will determine how much, if any, deviation from 430:1 is permissible.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the word "about" itself suggests the patentee did not intend the number to be an exact, rigid floor. An argument could be made that it covers a range of ratios that achieve the same result.
    • Evidence for a Narrower Interpretation: The specification provides a specific calculation for this ratio based on a preferred embodiment (150 mg of magnesium and 0.35 mg of parthenolide) (’450 Patent, col. 7:45-48). A court may construe "about" narrowly to mean only minor variations attributable to standard measurement tolerances, holding the patentee to the specific example disclosed.

• The Term: "a combination of magnesium oxide and a magnesium salt of an organic acid" (’999 Patent, Claim 9; ’450 Patent, Claim 1)

  • Context and Importance: This term defines the specific form of the magnesium ingredient. Practitioners may focus on this term because infringement requires the presence of both chemical species. The dispute could center on whether the accused product actually contains both forms in meaningful quantities, or if it primarily contains one form with trace amounts of another.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification explains that this combination "allows delivery of high quantities of magnesium in a body absorbable form" (’450 Patent, col. 7:48-50). This functional language could support an argument that other combinations achieving the same function are equivalent.
    • Evidence for a Narrower Interpretation: The claim language explicitly requires a "combination," not just one or the other. The patent repeatedly identifies this specific two-part formulation as a component of the preferred embodiment, suggesting it is a deliberate and necessary feature of the invention (’999 Patent, col. 8:57-58).

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Defendants "affirmatively direct and encourage users to directly infringe" by providing product label instructions for administering the supplement (Compl. ¶18). The complaint further alleges that Defendants act with knowledge of the patents and specific intent to induce (Compl. ¶¶20, 36).
• Willful Infringement: Willfulness is alleged based on Defendants' purported "actual and/or constructive knowledge" of the Patents-in-Suit, derived from Plaintiff's marking of its own MigreLief® products and the product's general renown in the industry (Compl. ¶19). The complaint characterizes the alleged infringement as "willful, wanton, malicious, bad-faith, deliberate, consciously wrongful, flagrant, and/or characteristic of a pirate" (Compl. ¶18).

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

• A key evidentiary question will be one of factual proof: can the plaintiff produce evidence, such as chemical analysis, demonstrating that the "MigreLief®" product sold by Defendants contains the precise combination of ingredients, including the specific parthenolide percentage and magnesium-to-parthenolide ratio, required by the asserted claims?
• A core issue will be one of claim construction: how will the court interpret the scope of quantitative terms like "about 0.7%" and "at least about 430:1"? The viability of the infringement case may depend on whether these terms are construed to allow for a range of values or are limited to the precise figures disclosed in the patent.
• A foundational question concerns the nature of the alleged wrong: given that the accused product is allegedly the plaintiff's own patented product, the case may test the boundaries between patent infringement and commercial disputes. The court will need to consider whether the defendants' alleged unauthorized sales fall under the patent statutes or if the patent exhaustion doctrine limits the plaintiff's recourse to other areas of law, such as contract or tort.