US Customs rules in favor of Jennewein Biotechnologie regarding importation of 2'-Fucosyllactose

Jennewein Biotechnologie GmbH the leading manufacturer of human milk oligosaccharides (HMOs) in the world, announced today that the Intellectual Property Rights Branch, Regulations and Rulings, U.S. Customs and Border Protection issued a Ruling Letter which asserts that the HMO 2'-fucosyllactose (2'-FL) being produced by Jennewein Biotechnologie's current production strain does not infringe U.S. Patent No. 9,970,018 for Glycosyn LLC, and that such 2'-fucosyllactose is not subject to the existing limited exclusion order that was issued by the U.S. International Trade Commission (ITC) against 2'-FL made by using a former production strain of Jennewein Biotechnologie GmbH.

Respecting valid intellectual property rights and the ITC's limited exclusion order, Jennewein Biotechnology GmbH produces it's 2'-FL by a non-infringing process and can resume import of its non-infringing 2'-FL as well as products containing non-infringing 2'-FL into the US for safeguarding customer supply with these advanced key ingredients of infant formula.

About HMOs:

Human milk oligosaccharides (HMOs) are complex sugar molecules that are only present in breast milk. Excluding water, they are the third most abundant constituent of human milk after fats and lactose. More than 200 structurally different HMOs have been identified.
The most abundant HMO is 2′-fucosyllactose, which is produced by about 80% of all lactating mothers at concentrations of up to 3 g/L.Scientific studies have shown that HMOs, and 2′‑fucosyllactose in particular, have a positive impact on infant development. HMOs are prebiotic, i.e. they specifically promote the growth of beneficial microorganisms, and at the same time they inhibit the growth of pathogens by directly and indirectly preventing colonisation. Jennewein Biotechnologie launched 2′-fucosyllactose onto the global baby food market in 2015, and several infant milk formulae around the world now contain 2′-fucosyllactose.

About Jennewein Biotechnologie:

Jennewein Biotechnologie is a leading international industrial biotechnology company with a range of products in the field of human milk oligosaccharides (HMOs) and rare monosaccharides such as L-Fucose and Sialic acid.The company manufactures an extensive portfolio of innovative HMO products, such as 2′‑fucosyllactose, 3′-fucosyllactose, Lacto-N-neotetraose, and lacto-N-tetraose. These rare sugars are used in the food industry (particularly infant milk formulas), the pharmaceutical industry, and the cosmetic industry. The manufacturing process involves state-of-the-art fermentation techniques. In 2015, the US Food and Drug Administration (FDA) granted Jennewein Biotechnologie a license to market 2′-fucosyllactose in the USA. This was followed in 2017 by European Union marketing authorisation under the Novel Food Regulation.