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

Rheinbreitbach (ots) - 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.

For further information, please contact:
Dr. Andreas Hübel
Head of Intellectual Property
+49 (0)2224/988 10791
andreas.huebel@jennewein-biotech.de

Original-Content von: Jennewein Biotechnologie GmbH, übermittelt durch news aktuell