Evolve BioSystems, Inc. v. Abbott Laboratories

CourtDistrict Court, N.D. Illinois
DecidedMarch 22, 2022
Docket1:19-cv-05859
StatusUnknown

This text of Evolve BioSystems, Inc. v. Abbott Laboratories (Evolve BioSystems, Inc. v. Abbott Laboratories) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Evolve BioSystems, Inc. v. Abbott Laboratories, (N.D. Ill. 2022).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

EVOLVE BIOSYSTEMS, INC.; and ) THE REGENTS OF THE UNIVERSITY ) OF CALIFORNIA, a corporation, ) ) Plaintiffs/Counter-plaintiffs, ) No. 19 C 5859 ) v. ) Judge John Z. Lee ) ABBOTT LABORATORIES, ) ) ) Defendant/Counter-defendant. )

MEMORANDUM OPINION AND ORDER Plaintiffs Evolve Biosystems, Inc. and the Regents of the University of California (“Evolve”) filed patent infringement claims against Defendant Abbott Laboratories (“Abbott”) related to patents covering Evolve’s EVIVO product. In turn, Abbott filed counterclaims for, among other things, false advertising under the Lanham Act, 15 U.S.C. § 1051 et seq., and unfair competition under Illinois and California state law. Evolve countered with its own counterclaims under these same laws. Specifically, Evolve alleges that Abbott made false and misleading advertising statements about Abbott’s competing Similac Probiotic Tri-Blend product. Abbott has moved to dismiss Evolve’s Lanham Act false advertising and state law unfair competition counterclaims under Federal Rule of Civil Procedure 12(b)(6). For the reasons provided below, Abbott’s motion to dismiss is denied. I. Procedural History A. Evolve’s Complaint Evolve conducts and sponsors research related to infant gut dysbiosis. Am.

Compl. ¶¶ 9–10, ECF No. 20. Evolve developed and markets a Bifidobacterium longum subsp. infantis (“B. infantis”) probiotic product for preterm infants called EVIVO. Id. ¶¶ 10–11. Research indicates that EVIVO, in combination with human milk oligosaccharide prebiotics, promotes B. infantis colonization in the infant gut, improving patient outcomes. Id. ¶ 11. Evolve’s EVIVO product is used in newborn intensive care units (“NICUs”) across the country. Id. Beginning in 2018, Evolve’s success with EVIVO led to conversations with

Abbott concerning a potential partnership. Id. ¶ 14. Abbott produces its own line of infant care products called Similac; the idea was that Abbott might co-promote Evolve’s EVIVO product alongside Abbott’s Similac products. Id. After over a year of discussion between Evolve and Abbott, however, rumors began to emerge that Abbott was preparing to launch a B. infantis product that would compete with EVIVO. Id. Evolve lost the potential business of an important

customer who put “discussions about using Evolve’s EVIVO in their NICUs on hold, so they could consider Abbott’s imminent probiotic offering.” Id. According to Evolve, Abbott, in fact, did intend to launch a B. infantis product—called Similac Probiotic Tri-Blend (“Tri-Blend”)—that would compete directly with Evolve’s EVIVO. Id. As of October 2019, Abbott had prepared marketing materials, as well as care provider product instructions, and had trained its sales team for the Tri-Blend product launch. Id. ¶ 15. Abbott also released directions for care providers for its Tri-Blend product at an Advances in Neonatal Nursing conference. Id. ¶ 16. Furthermore, Tri-Blend was listed for sale on Abbott’s website, leading Evolve’s then-

current and potential customers to believe that Tri-Blend would launch no later than two months from October 2019. Id. ¶ 15. Evolve continued to lose business from potential customers who paused discussions with Evolve to wait for Tri-Blend’s imminent release. Id. ¶ 18. In October 2019, Evolve filed a patent infringement action against Abbott, alleging that Abbott’s Tri-Blend product would infringe two of Evolve’s patents with claims related to Evolve’s EVIVO product. Id. ¶ 1.

B. The Counterclaims In November 2020, Abbott responded with counterclaims against Evolve for, among other things, false advertising under the Lanham Act and unfair competition under Illinois and California state law. Def.’s Answer, Affirmative Defenses, & Countercls. ¶ 1, ECF No. 144. In response, Evolve filed its own set of counterclaims against Abbott. These

included counterclaims for false advertising under the Lanham Act, 15 U.S.C. § 1125(a)(1)(B), and unfair competition under Illinois and California state law. Pls.’ Countercls., Answer, & Affirmative Defenses (“Pls.’ Countercls.”) ¶ 1, ECF No. 184. And Abbott has moved to dismiss those counterclaims. II. Factual Background1 Evolve’s counterclaims allege the following facts. Evolve’s EVIVO product utilizes a particular strain of B. infantis: the EVC001 strain. Id. ¶ 12. Evolve’s

EVC001 strain has specialized metabolic processes that other probiotic species and strains lack, allowing it to utilize a wide range of milk oligosaccharides. Id. Oligosaccharide-utilization is important to the positive effect of probiotic bacteria because oligosaccharide metabolism generates lactate and acetate that reduces fecal pH, suppressing pathogen growth. Id. The EVC001 strain that Evolve uses in its EVIVO product is an “H5-positive strain” that possesses the full repertoire of oligosaccharide-utilization genes, while

other strains (the “H5-negative strains”) lack an ABC-type transporter known to bind core oligosaccharide structures. Id. ¶ 13. Evolve asserts that “[d]ue to their genetic differences, H5-positive strains achieve superior growth on milk oligosaccharides.” Id. Because the EVIVO EVC001 strain can metabolize some human milk oligosaccharides more effectively than H5-negative B. infantis strains, it can “grow

more robustly in an infant’s gut.” Id. ¶ 14. Increased colonization of the infant gut, in turn, can improve patient outcomes. Id. ¶ 15. In fact, preterm infants receiving B. infantis EVC001 had “significantly reduced necrotizing enterocolitis . . . compared

1 For the purposes of this motion to dismiss, this Court “must accept as true all well- pleaded factual allegations.” See Heredia v. Capital Mgmt. Servs., L.P., 942 F.3d 811, 814 (7th Cir. 2019) (citing Marquez v. Weinstein, Pinson & Riley, P.S., 836 F.3d 808, 810 (7th Cir. 2016)). to cohorts receiving no probiotics.” Id. Also, infants receiving B. infantis EVC001 “had significantly reduced late onset sepsis . . . compared to those receiving the probiotics bacterium L. reuteri and those receiving no probiotics.” Id.

Abbott’s Tri-Blend product differs from Evolve’s EVIVO product in that Tri- Blend consists of three different bacteria: B. infantis, like in Evolve’s EVIVO product, as well as B. lactis and S. thermophilus. Id. ¶ 16. However, unlike Evolve’s EVIVO product, Tri-Blend utilizes the H5-negative B. infantis strain BB-02. Id. ¶ 17. The BB-02 strain utilizes milk oligosaccharides less effectively than H5-positive strains, such as the EVC001 strain in Evolve’s EVIVO product. Id. This difference is important to the overall efficacy of Abbott’s Tri-Blend product, as B. lactis and S.

termophilus cannot utilize milk oligosaccharides like B. infantis can. Id. ¶ 17. In addition, the BB-02 strain in Abbott’s Tri-Blend product has viability issues that adversely affect manufacturing and transport of the product. Id. ¶ 18. Also, although the EVC001 B. infantis strain can “grow more robustly in an infant’s gut,” id. ¶ 14, the BB-02 strain, in contrast, “may not survive well in the infant gut,” id. ¶ 18. In support of its counterclaims for false advertising and unfair competition,

Evolve asserts that Abbott has made a number of misleading statements related to its Tri-Blend product. Id. ¶¶ 19–20. For example, Abbott states that Tri-Blend has “potency” and “stability” and is composed of “high-quality probiotic strains.” Id. ¶ 20. Yet Abbott is aware that B.

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