IP Law Daily, PATENT—N.D. Ill.: Abbot Labs largely prevails in biotech company’s infringement and false advertising lawsuit over infant probiotic formula, (Jan 8, 2025)

By Saurabh Kashyap, B.A., LL.B., LL.M.

Infringement claims dismissed for patent invalidity; false advertising claims failed due to insufficient evidence of literal falsity or consumer deception in Abbot's marketing materials.

Ruling on multiple motions in a patent infringement and false advertising lawsuit filed by Evolve Biosystems, Inc. against Abbot Laboratories, the federal district court in Chicago, Illinois, issued a decision largely favoring the defendant. The court invalidated Evolve’s asserted patents under 35 U.S.C. § 102, finding that the claimed methods were anticipated by prior art. It also dismissed Evolve’s false advertising claims under the Lanham Act, concluding that Evolve failed to provide sufficient evidence of literal falsity or consumer deception in Abbot’s marketing statements. However, the court ruled in favor of Evolve on Abbot’s false advertising counterclaims, determining that Evolve’s communications about its patent rights were not made in bad faith (Evolve Biosystems, Inc. v. Abbott Laboratories, No. 1:19-cv-05859 (N.D. Ill. Jan. 7, 2025)).

Background. The plaintiff, Evolve Biosystems, Inc., is a pioneer in infant gut health, known for its flagship product, EVIVO—a probiotic specifically designed for preterm infants. The defendant, Abbot Laboratories, is a leading global healthcare company.

In this lawsuit, Evolve asserted its U.S. Patents Nos. 8,197,872 (the ’872 patent) and 9,200,091 (the ’091 patent). The ’872 patent described a method for producing synthetic food products or supplements by combining human milk oligosaccharides (HMOs) with B. infantis and a food ingredient. The ’091 patent focused on methods for treating certain conditions by administering compositions containing bovine milk oligosaccharides (BMOs) and B. infantis.

Evolve filed this lawsuit alleging that Abbot’s Similac Probiotic Tri-Blend infringed its asserted patents and claimed that Tri-Blend when combined with infant formula or breast milk, constituted indirect infringement by encouraging end-users to create infringing compositions. Abbot denied the allegations and counterclaimed, seeking declaratory judgments of non-infringement and invalidity of the asserted patents. Additionally, Abbot counterclaimed, alleging false advertising under the Lanham Act, asserting that Evolve’s marketing and communications misrepresented the scope of its patents and the benefits of its product, EVIVO.

Evolve filed a motion for summary judgment to dismiss Abbot’s counterclaims of patent invalidity and false advertising, arguing that its patents were enforceable and its marketing statements were accurate. Abbot countered with its own motion for summary judgment, asserting that the patents-in-suit were invalid under the anticipation doctrine, that Similac Probiotic Tri-Blend had substantial non-infringing uses, and that Evolve's false advertising claims lacked evidentiary support. Both parties also filed Daubert motions to exclude expert testimony on infringement, validity, and false advertising.

Patent invalidity and anticipation. The court invalidated Evolve’s patents, holding that the methods described were anticipated by prior art. Specifically, the court relied on the 2005 Bin-Nun study and the 2005 Lin clinical trial, which disclosed administering probiotics, including B. infantis, with donor milk or formula to assess their impact on preterm infant health. Citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008), the court noted that a claimed invention is anticipated if it lacks novelty and merely restates what the prior art teaches.

Further, the court was unpersuaded by Evolve’s argument that the prior art did not explicitly disclose the specific oligosaccharides required by its patents. The court also found this argument inconsistent with Evolve’s own infringement theory, which did not require detailed testing of milk products to establish the presence of the claimed oligosaccharides. Referencing Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001), the court emphasized that anticipation does not require recognition of inherent properties in prior art compositions.

By asserting that combining B. infantis with donor milk or formula was sufficient for infringement, Evolve effectively conceded that the same combination disclosed in the Bin-Nun and Lin studies rendered its patents invalid. The court concluded that these references made the patented methods unpatentable under 35 U.S.C. § 102, as they were neither novel nor inventive.

Infringement claims. Evolve alleged that Abbot indirectly infringed its patents by instructing users to mix Tri-Blend with formula or breast milk, as demonstrated in Abbot’s marketing materials. The court acknowledged that some end-users combined Tri-Blend with milk products containing HMOs or BMOs, which could potentially constitute infringement under 35 U.S.C. § 271(b). The court cited Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d 1301 (Fed. Cir. 2009), which requires proof of direct infringement for liability under inducement claims.

However, Abbot successfully demonstrated that Tri-Blend had substantial non-infringing uses, such as mixing with sterile water or glucose water. The court relied on Fujitsu Ltd. v. Netgear Inc., 620 F.3d 1321 (Fed. Cir. 2010), which establishes that a product’s non-infringing uses preclude liability for contributory infringement. Given the invalidation of Evolve’s patents, the infringement claims were dismissed.

Evolve’s false advertising claims. Additionally, Evolve alleged that Abbot’s marketing statements about Tri-Blend’s “stability,” “potency,” and “functional advantages” were misleading. It also argued that Abbot’s labeling, which stated that Tri-Blend contained “1 billion CFU,” implied equal contributions from its three probiotic strains, including B. infantis. However, the court found no evidence of literal falsity or implied deception in Abbot’s advertising. It cited Hot Wax, Inc. v. Turtle Wax, Inc., 191 F.3d 813 (7th Cir. 1999), which requires proof of literal falsity or actual consumer confusion under the Lanham Act.

Evolve relied on a consumer survey and internal Abbot documents to show implied deception, but the court deemed these insufficient. It highlighted that the survey did not demonstrate how consumers understood the challenged statements, as required under Mead Johnson & Co. v. Abbot Lab’ys, 201 F.3d 883 (7th Cir. 2000). Consequently, the court granted summary judgment to Abbot on the false advertising claims.

Evolve’s state law claims. Further, Evolve asserted state-law claims of unfair competition under Illinois and California law, mirroring its federal Lanham Act allegations against Abbot. The court ruled that these state-law claims were dependent on the outcome of the Lanham Act claims, which the court dismissed due to Evolve’s failure to present evidence of literal falsity or consumer deception. As a result, Evolve’s state-law unfair competition claims were dismissed alongside its federal claims.

Abbot’s counterclaims. Abbot counterclaimed that Evolve’s 2020 letters to healthcare providers overstated its patent rights and constituted false advertising under the Lanham Act. Abbot argued that the letters implied all uses of B. infantis were infringing, which it contended was a bad-faith assertion. However, the court rejected this argument, finding that the letters were consistent with Evolve’s litigation positions and did not misrepresent its patent rights.

The court emphasized that bad faith requires an objectively baseless assertion of rights, as established in Dominant Semiconductors Sdn. Bhd. v. OSRAM GmbH, 524 F.3d 1254 (Fed. Cir. 2008). Without evidence of blatant exaggeration or malice, Abbot’s counterclaims could not stand. The court dismissed them and granted Evolve’s motion for summary judgment on this issue.

Conclusion. Thus, dismissing Evolve’s infringement claims, the court invalidated its asserted patents and dismissed its false advertising claims. However, it granted the plaintiff’s motion for summary judgment on Abbot’s counterclaims of false advertising. Further, it denied both parties’ Daubert motions as moot due to the summary judgment rulings.

The Case is No. 1:19-cv-05859.

Judge: Alonso, J.

Attorneys: Matthew Alan Chivvis (Morrison & Foerster LLP) for Evolve Biosystems, Inc. Charles Bennett Klein (Winston & Strawn LLP) for Abbott Laboratories.

Companies: Evolve Biosystems, Inc.

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