Administrative Law Judge issues ruling in patent dispute concerning 2'-FL production and beta-galactosidase activity

September 11, 2019 - On September 09, 2019, Administrative Law Judge Cameron Elliot of the US International Trade Commission issued an Initial Determination finding that one of the bacterial strains used by Jennewein Biotechnologie to make 2'-fucosyllactose (2'-FL) infringes a patent owned by Glycosyn LLC.

In the ITC Investigation, Complainant Glycosyn initially asserted two separate patents and a total of 68 patent claims. After factual discovery, Glycosyn withdrew one of the patents in its entirety and limited the other patent to 14 patent claims.

Jennewein intends to appeal the ALJ's Initial Determination, which is subject to review by the entire Commission. According to President and CEO Stefan Jennewein, "We are disappointed in the ALJ's Initial Determination but continue to firmly believe that our process does not infringe any of Glycosyn's patent claims. We intend to appealing the decision to the entire Commission."

Jennewein has already made arrangements for the use of alternative strains lacking inducible beta-galactosidase activity to ensure that it will be able to continue to provide 2'-FL to its customers in the United States without any interruption. Says Mr. Jennewein, "Our company was the first to market 2'-FL in the United States and the first to obtain GRAS approval from the FDA, and we will continue to lead the way in bringing new and innovative human milk oligosaccharide products such as 2'-FL to the market for use in human infant formula and other products in the U.S. and globally."

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 2 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 formulas around the world now contain 2'-fucosyllactose (e.g. Abbott Similac).

About Jennewein Biotechnologie:

Jennewein Biotechnologie is a leading international industrial biotechnology company with a range of products in the field of complex oligosaccharides (HMOs) and rare monosaccharides. The company manufactures an extensive portfolio of innovative HMO products, such as 2'-fucosyllactose, 3'-fucosyllactose 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.