Jennewein Biotechnologie, a German company that manufactures rare functional sugars for a wide range of applications, has filed a patent infringement lawsuit with the regional court in Mannheim against Nestlé Nutrition and its holding company Nestlé Deutschland.
The legal battle is based on the claim that Nestlé uses human milk oligosaccharides (HMO) for the manufacturing of its infant formula that are produced by a process being protected — among other IP rights — by European Patents EP 2 896 628 and EP 3 131 912 (start of protection: January 22, 2020), which are thus infringed by Nestlé.
Jennewein said it is currently investigating measures against the assumed infringement of its corresponding foreign patents by the manufacturing of products such as Illuma, SMA, NAN and Gerber Good Start, as Nestlé offers its infant food containing HMO not just in Germany.
Dr Andreas Hübel, Jennewein’s patent attorney, told Nutrition Insight that the company holds "patent protection for processes of purifying a neutral HMO from a fermentation broth on an industrial scale".
The process, Hübel explained, is "an economically feasible manner to obtain the neutral HMO in a purity that renders said neutral HMO suitable for human consumption".
If Jennewein's lawsuit against Nestlé prevails, the dairy giant will be required to remove the products from the shelves.
The suit against Nestle was filed on 9 January, the same day Jennewein Biotechnology announced a milestone in the GRAS approval of its new HMO-Mix
The suit against Nestle was filed on 9 January, the same day Jennewein Biotechnology announced a milestone in the GRAS approval of its new HMO-Mix: data of the toxicological study “A Safety Evaluation of Mixed Human Milk Oligosaccharides in Rats”, was accepted for publication by the journal “Food and Chemical Toxicology”.
"After the EU Novel Food Dossier was submitted to the European Commission in August 2019, the way is now clear for the GRAS decision at the US FDA," Jennewein explained in a statement.
The study examined the tolerability of a mixture of HMOs as a foodstuff. The HMO-Mix consists of the five most common HMOs 2’-fucosyllactose, 3-fucosyllactose, lacto-N-tetraose, 3’-sialyllactose and 6’-sialyllactose. The results show that the consumption of the HMO-Mix is well tolerated and harmless, even in high doses. The study was carried out in accordance with the internationally recognized OECD guidelines.
Jennewein said that proof of the safety of the product was also a prerequisite for the “Growth and Tolerance” study currently being carried out by a team of in-house experts.
In this study, baby food with the HMO-Mix is being used in a concentration on par with the individual HMOs that can also be found in breast milk.
Jennewein pointed out that one aspect of this clinical study is the evaluation of the positive effects of the HMOs on the gut microbiome of the participating babies who consumed the baby food with HMOs, compared to a control group that consumes conventional baby food or a group of breastfed children.
CEO Dr Stefan Jennewein commented: “In 2015 Jennewein Biotechnologie introduced 2’-fucosyllactose onto the Infant Food Market. With the commercialisation of the 5 HMO-Mix for baby food and its use in natural concentration there is a revolution of the baby food market.”
For Dr Jennewein, by supplementing infant formula with HMOs in their natural concentration, consumers can completely replace artificial prebiotics such as GOS and FOS.