DCT

1:19-cv-05859

Evolve Biosystems Inc v. Abbott Laboratories

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-05859, N.D. Ill., 10/07/2019
  • Venue Allegations: Venue is alleged to be proper as Defendant Abbott Laboratories is incorporated in Illinois and has its principal place of business within the Northern District of Illinois.
  • Core Dispute: Plaintiffs allege that Defendant’s imminent launch of its Similac Probiotic Tri-blend product, which contains Bifidobacterium infantis, will indirectly infringe patents covering compositions and methods that combine specific milk-derived oligosaccharides with this particular bacterium to promote infant gut health.
  • Technical Context: The technology relates to the field of infant nutrition, specifically the use of targeted prebiotic oligosaccharides from human or bovine milk to selectively promote the growth of beneficial probiotic bacteria (B. infantis) in the infant gut microbiome.
  • Key Procedural History: The complaint alleges that the parties engaged in discussions regarding shared business opportunities and Evolve's technology and patents for over a year beginning in 2018, which may be relevant to allegations of pre-suit knowledge and willfulness.

Case Timeline

Date Event
2007-05-17 U.S. Patent No. 8,197,872 Priority Date
2010-07-12 U.S. Patent No. 9,200,091 Priority Date
2012-06-12 U.S. Patent No. 8,197,872 Issued
2015-12-01 U.S. Patent No. 9,200,091 Issued
2018 (Beginning) Evolve and Abbott allegedly enter partnership discussions
2019-10-07 Complaint Filing Date

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

U.S. Patent No. 8,197,872 - "Human Milk Oligosaccharides to Promote Growth of Beneficial Gut Bacteria," Issued June 12, 2012

The Invention Explained

  • Problem Addressed: The patent addresses the previously unknown molecular basis by which human breast milk supports the development of a protective intestinal microbiome in infants (ʼ872 Patent, col. 1:11-22, col. 7:1-9). While the importance of gut flora was recognized, the specific components in milk and the specific bacteria they nourished were not well understood.
  • The Patented Solution: The invention identifies a specific class of small human milk oligosaccharides (HMOs) that are preferentially consumed by the bacterium Bifidobacterium longum bv. infantis (B. infantis) (ʼ872 Patent, Abstract). By isolating and identifying these specific HMOs, the invention provides for prebiotic compositions that can selectively promote the growth of this beneficial bacterium over other strains, thereby helping to establish a healthy infant gut (ʼ872 Patent, col. 2:1-21).
  • Technical Importance: This discovery enabled a targeted approach to probiotic and prebiotic supplementation, moving beyond general bacterial strains to a specific, co-evolved symbiotic relationship between a key milk component and a key infant gut bacterium (ʼ872 Patent, col. 17:46-54).

Key Claims at a Glance

  • Independent Claim 1: A composition claim for a "synthetic prebiotic composition" comprising three purified oligosaccharides that naturally occur in human breast milk, defined by specific mass/charge (m/z) ratios (about 732.3, 1243.4, and 1389.5), where the composition is consumed at a higher rate by B. infantis compared to other Bifidobacterium strains (Compl. ¶26).
  • Independent Claim 16: A method claim for "producing a synthetic prebiotic food product or food supplement" by combining a food ingredient with the oligosaccharides of claim 1 (Compl. ¶27).
  • The complaint asserts at least claim 18 (dependent on 16) and claim 15 (dependent on 12), and reserves the right to assert other claims (Compl. ¶25).

U.S. Patent No. 9,200,091 - "Bovine Milk Oligosaccharides," Issued December 1, 2015

The Invention Explained

  • Problem Addressed: The patent addresses the lack of a scalable, non-human source for specific prebiotic oligosaccharides that can mimic the function of HMOs in selectively promoting beneficial infant gut bacteria (’091 Patent, col. 2:1-5).
  • The Patented Solution: The invention identifies specific oligosaccharides found in bovine milk (BMOs) that can be consumed by B. infantis or B. breve. The patent claims compositions comprising one or more of these specific BMOs combined with an inoculum of the beneficial bacteria, as well as methods of using these compositions to treat conditions like gut dysbiosis ('091 Patent, Abstract; col. 6:33-41).
  • Technical Importance: The invention provides a potential commercial-scale source for prebiotics that are functionally analogous to HMOs, enabling the development of infant nutritional products that can selectively nourish beneficial bacteria ('091 Patent, col. 6:42-51).

Key Claims at a Glance

  • Independent Claim 1: A composition claim comprising an oligosaccharide from bovine milk or milk product (selected from a large Markush group of specified chemical structures) and an inoculum of B. infantis or B. breve (Compl. ¶41).
  • Independent Claim 14: A method of treating a condition (e.g., diarrhea, necrotizing enterocolitis) in an individual by administering an amount of the composition of claim 1 (Compl. ¶42).
  • The complaint asserts at least claims 14 and 15, and reserves the right to assert other claims (Compl. ¶40).

III. The Accused Instrumentality

Product Identification

  • Abbott Laboratories’ "Similac Probiotic Tri-blend" (Compl. ¶15).

Functionality and Market Context

  • The accused product is a probiotic supplement in powder form containing, among other things, the bacterium B. infantis (Compl. ¶6, ¶15). It is marketed for hospital use, particularly in neonatal intensive care units (NICUs) (Compl. ¶16, p. 6).
  • The complaint alleges the product is intended to be mixed with either "human milk or infant formula" before being fed to an infant (Compl. ¶16). The product's packaging includes a visual depiction of the product box, which identifies B. infantis as one of three probiotic strains (Compl. p. 6). The complaint provides an image of the product's "Directions for Preparation and Use," which explicitly instruct users to "[p]our 3-5 mL of human milk or infant formula into mixing container" and then "[a]dd 1 packet of Similac Probiotic Tri-Blend powder" (Compl. p. 7).
  • The complaint alleges that Abbott is a leading seller of infant formula and has significant business relationships with NICUs, which are potential customers for Plaintiffs' competing product, EVIVO (Compl. ¶18).

IV. Analysis of Infringement Allegations

’872 Patent Infringement Allegations

Claim Element (from Independent Claim 1 and Dependent Claim 18) Alleged Infringing Functionality Complaint Citation Patent Citation
[A] synthetic prebiotic food product or food supplement... comprising a first, second and third purified oligosaccharide each of which naturally occur in human breast milk... The complaint alleges that synthetic, prebiotic human milk products used in NICUs, such as fortified donor milk, constitute the claimed "food product" and contain the three specified oligosaccharides. ¶30 col. 8:30-34
...further comprising combining an inoculum of B. infantis with the food ingredient... Abbott's "Similac Probiotic Tri-blend" product is alleged to be the "inoculum of B. infantis." Abbott's instructions allegedly direct NICU care providers to perform the claimed step of combining this inoculum with human milk products. ¶16, ¶28-30 col. 2:56-58

’091 Patent Infringement Allegations

Claim Element (from Independent Claim 1 and Independent Claim 14) Alleged Infringing Functionality Complaint Citation Patent Citation
[A] method of treating a condition... comprising administering an amount of the composition of claim 1... The complaint alleges that NICU care providers will administer the final mixture to infants to prevent gut dysbiosis, which is among the conditions recited in the patent. ¶45 col. 7:1-8
...wherein the composition comprises an oligosaccharide from bovine milk or milk product... and an inoculum of Bifidobacterium longum subsp. infantis... The complaint alleges that bovine milk products used in NICUs, including Abbott's own fortifiers, contain at least one of the claimed oligosaccharides. Abbott's product supplies the B. infantis inoculum, and its instructions direct users to combine the two components to form the claimed composition. ¶41, ¶44-45 col. 8:5-9
  • Identified Points of Contention:
    • Scope Questions: A primary question for the ’872 patent is whether the term "synthetic prebiotic composition" can be construed to read on standard-of-care fortified human milk products used in NICUs. For the ’091 patent, a question is whether the transient mixture of Abbott's powder and a bovine milk product, prepared by an end-user immediately before feeding, constitutes the claimed "composition."
    • Technical Questions: A key factual question for both patents is what evidence exists that the third-party human milk products ('872 patent) and bovine milk products ('091 patent) actually contain the specific oligosaccharides required by the claims. The complaint alleges this on "information and belief" but does not detail the basis for this technical assertion (Compl. ¶30, ¶45).

V. Key Claim Terms for Construction

  • Term: "synthetic prebiotic composition" (’872 Patent, Claim 1)

    • Context and Importance: This term's construction is critical to the infringement theory for the ’872 patent. Plaintiffs' case depends on this term encompassing commercially available, processed human milk products, not just a purpose-built formulation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification defines "synthetic" as a "non-naturally-occurring composition" which "can include ingredients that are purified or isolated" ('872 Patent, col. 8:30-34). This language may support an argument that processed or fortified donor milk, which is not in its natural state, falls within the definition.
      • Evidence for a Narrower Interpretation: The specification also describes the invention in terms of specific formulations like powders, tablets, and supplemented beverages ('872 Patent, col. 2:60-66). A defendant may argue this context limits the term "synthetic composition" to products intentionally formulated with the claimed oligosaccharides, not general-purpose milk fortifiers.

  • Term: "composition comprising" (’091 Patent, Claim 1)

    • Context and Importance: Practitioners may focus on this term because infringement depends on the combination of two separate products (Abbott's probiotic and a third-party milk product) to form the claimed "composition." The dispute will center on whether providing one component and instructions to combine it constitutes making or selling the final "composition."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim uses the open-ended term "comprising," and the plain language does not require the components to be pre-mixed or sold in a single package. The method of use claims (e.g., Claim 14) imply administration of the components together, supporting a view that the final mixture is the relevant composition.
      • Evidence for a Narrower Interpretation: The specification describes various finished product forms for the composition, such as powders, tablets, capsules, and supplemented beverages ('091 Patent, col. 8:5-66). This could support an argument that the claim contemplates a single, integrated product, not a kit of parts or a temporary mixture created by the end user.

VI. Other Allegations

  • Indirect Infringement: This is the central theory of the case. The complaint alleges Abbott will induce infringement by actively encouraging and instructing NICU care providers to combine the Similac Probiotic Tri-blend with milk products containing the claimed oligosaccharides, thereby performing the patented methods (Compl. ¶31-32, ¶46-47). The complaint further alleges contributory infringement, asserting that Abbott's product is a material part of the invention, is especially made for this infringing use, and is not a staple article of commerce suitable for substantial non-infringing use in this context (Compl. ¶33, ¶48).
  • Willful Infringement: The willfulness allegation is based on alleged pre-suit knowledge. The complaint asserts that Abbott had actual knowledge of the patents-in-suit and the related technology from over a year of partnership and licensing discussions with Evolve prior to the lawsuit (Compl. ¶32, ¶47). The complaint also serves as notice of the alleged infringement.

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

  • A core issue will be one of definitional scope: Can the term "synthetic prebiotic composition" in the ’872 patent be construed to cover standard, fortified human milk products, or is it limited to purpose-built formulations? The resolution of this claim construction dispute may be dispositive for a significant part of the infringement case.
  • A key evidentiary question will be one of technical proof: Can Plaintiffs produce sufficient evidence (e.g., chemical analysis) to demonstrate that the various third-party human and bovine milk products used in NICUs actually contain the specific, structurally-defined oligosaccharides required by the patent claims?
  • The case will likely turn on the law of indirect infringement: Assuming the underlying acts constitute direct infringement, does Abbott’s conduct—providing one component of a patented combination along with instructions for its use—rise to the level of specific intent required to prove active inducement or contributory infringement?