Health & Medicine

UC and tiny Davis company sue maker of Similac over infringing on infant formula patents

Using patents licensed from the University of California, Davis’ tiny Evolve BioSystems funneled every dollar it could raise into figuring out how to correct dangerous imbalances in the guts of newborn infants and developing supplements to foster the growth of healthy bacteria.

The company’s investment and intellectual property now stands at risk of being compromised because pharmaceutical industry giant Abbott Laboratories is introducing a product that would infringe upon UC and Evolve patents, leaders of the Davis company and UC alleged in a lawsuit they announced Monday.

In a statement emailed to The Bee, Abbott Labs said: “This lawsuit is without merit. Abbott will defend itself against these baseless accusations.”

Evolve executives said in the lawsuit, filed Aug. 30 in U.S. District Court for the Northern District of Illinois in Chicago, that their team had been courting an important potential customer for business. But when that customer subsequently learned Abbott Labs would be introducing “Similac Probiotic Tri-blend,” the company put its talks with Evolve on hold until they could learn more.

“While scientists have long appreciated that the composition of microbes — or the microbiome — in the infant gut can impact infant health, not much was known about which microbes were necessary for a healthy gut and what substances promoted their growth,” company leaders assert in their lawsuit. Evolve “founders hail from the university’s Davis campus, where they performed fundamental research on ... the bacteria strains needed to establish a healthy gut microbiome.”

The Evolve founders found that one bacterium was particularly crucial, the subspecies infantis of Bifidobacterium longum subsp. infantis, or “B. infantis” for short, according to the lawsuit. They also found that this particular bacterium thrived in infant guts with sizable supplies of specific complex sugars known as oligosaccharides.

In fact, without these innate sugars, human breast milk wouldn’t be digestible for babies. The researchers determined through studies that it was crucial to seed the newborn guts with these oligosaccharides, essentially creating a prebiotic to encourage the growth of a probiotic, B. infantis.

Evolve’s product developed a formula under the trademark EVIVO that had the probiotic B. infantis in it as well as a prebiotic containing human milk oligosaccharides, company officials said in the suit, and Evolve instructed medical teams in the neonatal intensive care to add the EVIVO formula to the prebiotic prior to administration.

The new product from Abbott Labs will provide the same instructions, the UC and Evolve lawsuit alleged, prompting their claims that the product infringes upon their patents. The lawsuit also noted that Abbott has recognized the scientific work done by Evolve’s scientists, acknowledging that both prebiotics and probiotics are necessary to promoting infant gut health.

In fact, Evolve leaders say in their suit, Abbott has even made reference to David Mills, one of Evolve’s founders and inventors, in its company materials.

Evolve and the UC are seeking a jury trial and hope to prevent Abbott from introducing products that would “irreparably damage” its business. The UC and the Davis-based company also are seeking damages resulting from any infringement and reimbursement of legal fees.

Abbott, which reported revenue of $30.6 billion in 2018, is based in Abbott Park, Ill., about 40 miles north of Chicago.

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Cathie Anderson covers health care for The Bee. Growing up, her blue-collar parents paid out of pocket for care. She joined The Bee in 2002, with roles including business columnist and features editor. She previously worked at papers including the Dallas Morning News, Detroit News and Austin American-Statesman.