A 43% increase in an intestinal enzyme might not sound like much outside a nutrition laboratory. But for researchers developing infant formula, it is the kind of result that deserves a closer look.
That figure appears in a patent granted to Nutricia, Danone’s specialized nutrition business, in August 2026. Researchers tested an infant formula containing 2′-fucosyllactose (2′-FL), dietary butyrate, and several other ingredients. In laboratory-grown intestinal cells, the experimental formula increased the activity of an enzyme associated with intestinal development and barrier function.
It is an early-stage laboratory finding, not evidence that the formula improves gut health in infants. Still, it offers a useful window into where Danone is directing some of its nutrition research.
The company is investigating how different ingredients work together inside a formulation, particularly those associated with gut bacteria, intestinal development, and immune function.
And its patents reveal why developing such products can be more complicated than adding another functional ingredient to an existing formula.
What Does Danone’s 2-FL and Butyrate Patent Protect?
Granted on August 12, 2026, EP4151097B1 covers an infant or young-child nutritional composition containing 2′-FL and dietary butyrate within specified concentration ranges, alongside DHA, ARA, and EPA.
Its first claim includes 0.02–1 g of 2′-FL and 10–175 mg of dietary butyrate per 100 mL, with the three long-chain fatty acids representing at least 1% of total fatty acids. The claim also provides alternative concentration expressions.
These ranges define patent claim limitations, not recommended feeding quantities.
Further claims address ingredients such as beta-3′-galactosyllactose (beta-3′-GL), galactooligosaccharides, fructooligosaccharides, and partially fermented compositions.
The patent also considers different butyrate sources, including bovine milk fat, fermentation-derived ingredients, and triglyceride-bound forms such as tributyrin.
The distinction is important for formulation development. Increasing butyrate through milk fat may also change the overall fatty-acid profile, processing characteristics, and digestion behavior.
For competitors, the relevant protection concerns the specific claimed combination and its limitations, rather than exclusive rights over 2′-FL or butyrate individually.
What Did Danone’s Experiments Actually Show?
In Example 1 of EP4151097B1, researchers compared an experimental infant formula with a control after simulated gastrointestinal digestion.
The digested formulations were applied to cultured human intestinal cells, and researchers measured intestinal alkaline phosphatase activity, a marker associated with intestinal-cell maturation and protective functions.
The experimental formula produced higher enzyme activity at all three tested concentrations.
| Formula concentration | Control formula (mU/mg protein) | Experimental formula (mU/mg protein) | Increase |
| 0.34% (w/v) | 0.845 | 1.208 | 43% |
| 0.17% (w/v) | 1.161 | 1.576 | 36% |
| 0.085% (w/v) | 1.493 | 1.963 | 32% |
The experimental formulation contained 2′-FL, approximately 50% bovine milk fat within its lipid component, and butyric acid representing around 1.5% of total fatty acids. Other ingredients, including beta-3′-GL and fermented components, also differed from the control.
Consequently, the experiment establishes a response to the complete formulation, without isolating which changes were responsible.
Additional experiments reported higher lactase activity and changes in intestinal-cell proliferation markers.
More directly relevant to ingredient interaction was an immune-cell experiment involving samples from ten donors.
Researchers combined 0.2% (w/v) 2′-FL with 0.2 mM butyrate and measured interleukin-10 (IL-10), a protein involved in immune regulation.
The combination produced a normalized IL-10 response of 14.77, compared with a calculated combined response of 4.272 based on the individual treatments.
This suggests an interaction worth investigating, although the cell-culture findings do not establish improved immune or gastrointestinal outcomes in infants.
The unresolved issue is how much of the measured benefit comes from the specific ingredient pairing and how much comes from the wider formulation.
Why the Complete Formulation Matters
Changing one ingredient in infant formula can affect several others.
Replacing vegetable oil with bovine milk fat, for example, may increase dietary butyrate while also changing fatty-acid proportions. Adding HMOs introduces further questions about compatibility and interactions with the existing nutritional system.
For developers, the challenge is maintaining nutritional requirements, processing stability, and consistent performance while investigating additional biological functions.
This is where controlled formulation comparisons become essential.
Testing 2′-FL and butyrate individually, then together under otherwise equivalent conditions, would help establish their respective contributions. Comparing different butyrate sources could also show whether the delivery form affects biological responses.
Such evidence would strengthen formulation decisions and clarify whether alternative ingredient combinations offer meaningful differentiation.
It would also help IP teams assess proposed formulations against granted claims rather than relying on ingredient substitutions that may provide little technical or legal advantage.
Why a 2026 Patent Grant Traces Back to 2019
Although EP4151097B1 was granted in August 2026, its earliest priority dates to June 4, 2019.
The international application was published as WO2020245311A2 in December 2020. The original European application was granted as EP3883393B1 in September 2022, while a related divisional application ultimately received the EP4151097B1 grant in August 2026.
The later grant reflects continued prosecution of an earlier disclosure, rather than a newly initiated research program.
The family’s legal history is particularly relevant.
On September 4, 2026, the European Patent Office’s Board of Appeal revoked the parent patent EP3883393B1 following Nutricia’s withdrawal of approval of the patent text and pending claim requests.
The decision was not a substantive finding that the invention lacked novelty or inventive step. It also did not directly revoke the separately granted divisional EP4151097B1.
The proceedings involved opponents including FrieslandCampina, Abbott Laboratories, Nestlé, and Reckitt Benckiser Health.
Their involvement highlights the commercial significance of the claimed technology and the importance of monitoring related patent proceedings.
For portfolio assessment, the key consideration is which claims remain enforceable across jurisdictions and how those claims intersect with competing formulations.
How Are Nestlé and FrieslandCampina Approaching Similar Problems?
Danone’s research is part of a wider effort to improve the functional performance of infant formula. However, competitor patents reveal important differences in the mechanisms being investigated.
FrieslandCampina: Controlling Formula Behavior During Digestion
FrieslandCampina’s WO2020239722A1 focuses on casein behavior during gastric digestion.
The patent examines how protein-bound calcium influences curd formation in the stomach. Its published claims include protein-bound calcium levels of no more than 7.5 mmol per 10 g of casein, together with other compositional requirements.
Additional claims describe fat compositions containing 0.5–2.2% butanoate groups within triglyceride fatty-acid residues and allow the inclusion of HMOs, preferably 2′-FL.
This creates some ingredient overlap with Danone’s disclosed formulations, although the central technical problems differ.
FrieslandCampina’s experiments examined curd formation during simulated gastric digestion. Formulations with lower protein-bound calcium showed reduced or absent persistent curd formation under the disclosed conditions compared with a higher-calcium formulation.
Danone’s experiments instead measured intestinal-cell enzyme activity and immune-related responses.
The distinction carries through to patent protection.
FrieslandCampina’s relatedUS12661375B2, granted in June 2026, centers its independent claim on calcium and casein parameters, while dependent claims introduce further compositional features.
For developers, the comparison shows how overlapping ingredients can support inventions addressing different stages of digestion.
It also cautions against assuming that changing an HMO or fat component necessarily provides an alternative to the claimed invention.
Nestlé: Targeting Microbial GABA Production
Nestlé’s EP4536241A1 investigates another mechanism: the production of gamma-aminobutyric acid (GABA) by intestinal microorganisms.
The published application describes combinations of galactooligosaccharides (GOS) with HMO mixtures, including 2′-FL and difucosyllactose (DFL), or lacto-N-tetraose (LNT) and 6′-sialyllactose (6′-SL).
Rather than targeting intestinal barrier markers, the research examines microbial metabolites relevant to gut–brain-axis pathways.
The patent reports fermentation experiments using microbiota from three healthy children aged approximately 3.2–3.3 years.
Combined GOS/HMO treatments produced higher GABA abundance than the individual ingredient treatments under the disclosed conditions. The GOS plus 2′-FL/DFL combination produced a higher response than the GOS plus LNT/6′-SL combination.
The findings support further investigation of specific carbohydrate combinations. They do not establish improved neurological or stress-related outcomes in children.
Compared with Danone’s research, Nestlé is evaluating a different biological endpoint using a different experimental system.
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What the Comparison Reveals
The three patent approaches illustrate different priorities within functional nutrition.
| Company | Technical focus | Experimental evidence |
| Danone / Nutricia | 2′-FL, dietary butyrate, and intestinal function | Intestinal enzyme activity and immune-cell responses |
| FrieslandCampina | Protein-bound calcium and gastric digestion | Curd formation in simulated gastric conditions |
| Nestlé | GOS/HMO combinations and gut–brain-axis mechanisms | Microbial GABA production during fermentation |
These selected patents are not a comprehensive comparison of the companies’ portfolios.
Their value lies in showing that competition extends beyond ingredient selection. The differentiation is found in the claimed compositions, intended functions, and experimental evidence.
For R&D teams, those differences help identify distinct formulation research directions. For IP teams, they provide a starting point for comparing claim scope, legal status, and potential overlap.
Where Should Formulation Research Go Next?
Danone’s disclosures leave three practical questions for further development.
First, can butyrate delivery be optimized? Comparing milk-fat-derived butyrate with alternative sources under otherwise equivalent conditions could clarify whether delivery form influences intestinal-cell responses.
Second, do additional oligosaccharides improve performance? The patent includes beta-3′-GL alongside 2′-FL, but comparative experiments would be needed to establish its contribution.
Third, can different lipid compositions produce similar biological effects? A separate Nutricia patent, EP4362708B1, investigates intestinal barrier function using oleic acid, palmitic acid, and beta-3′-GL.
Comparing these approaches could help identify which combinations deserve further development.
However, finding a technically promising alternative does not establish freedom to operate. Companies would still need to evaluate the relevant patent claims, experimental evidence, and manufacturing requirements before deciding whether to develop internally, partner, or explore licensing.
What Danone’s Patents Reveal About Infant Formula Development
Danone’s 2′-FL and butyrate patent provides measurable laboratory evidence supporting further research into intestinal function. Its limitation is equally important: multiple formulation differences make it difficult to isolate the contribution of individual ingredients.
The competitor patents add perspective. FrieslandCampina is investigating gastric digestion through protein and calcium composition, while Nestlé is exploring microbial metabolite production through specific carbohydrate combinations.
These inventions pursue different outcomes and require different forms of validation.
For infant formula developers, the next advance may depend less on introducing another functional ingredient and more on establishing precisely which combinations produce reproducible biological effects.
For IP teams, the challenge is identifying where those combinations intersect with enforceable patent claims.
Ultimately, the strongest differentiation will come from formulations supported by convincing experimental evidence and a clear understanding of the patent rights surrounding them.
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