Supply of Key Ingredient in advanced infant formula by Jennewein is secured

Rheinbreitbach (ots) - Jennewein Biotechnologie GmbH, a worldwide leading
manufacturer of human milk oligosaccharides (HMOs) announces today that the U.S.
International Trade Commission (ITC) issued on May 19, 2020 a Final
Determination finding that one of Jennewein's advanced bacterial production
strains for producing 2'-fucosyllactose (2'-FL) does not infringe Complainant
Glycosyn's US Patent No. 9,970,018. While the patent relates to methods for
producing certain HMOs using a bacterial strain that comprises a functional
exogenous ?-galactosidase gene which comprises a low level of ?-galactosidase
activity between 0.05 and 200 units, the Commission granted Jennewein's Request
for Review and overruled the ITC's administrative law judges Final Initial
Determination which excluded Jennewein's advanced 2'-FL production strain from
adjudication. Moreover, the Commission confirmed Jennewein's position that the
genetic make-up of Jennewein's advanced 2'-FL production strain does not
comprise a functional ?-galactosidase gene or an equivalent thereof, and ruled
that 2'-FL produced by using said advanced 2'-FL production strain does not
infringe the asserted patent.

"We are pleased that the Commission acknowledges non-infringement of 2'-FL being
produced by bacterial strains that can not possess ?-galactosidase activity from
exogenously inserted genetic information." said Stefan Jennewein, CEO of
Jennewein Biotechnologie GmbH. "This allows us to continue supplying our US
customers with 2'-FL such that bringing advantageous baby formula to infants is
secured, especially given that we have already obtained clearance by US FDA for
2'-FL that is produced with such an advanced 2'-FL production strain."

While asserting that 2'-FL made by such an advanced production strain does not
infringe Glycosyn's '018 patent , the Commission confirmed the Initial
Determination in that the use of Jennewein's former 2'-FL production strain
infringes the asserted patent, and issued a limited exclusion order restricted
to 2'-FL made by Jennewein's former 2'-FL production strain.

"We are dissatisfied that the Commission concurred with the Administrative Law
Judge's finding that 2'-FL produced by our former production strain shall
infringe the asserted patent." was stated by Andreas Hübel, Head of Intellectual
Property at Jennewein Biotechnologie GmbH. "We strongly disagree with this
assessment and believe that the Commission did not consider all our arguments
provided in our Petition for Review. Of course, we reserve our rights to appeal
the decision. Nonetheless, we are fortunately able to continue providing US
customers with 2'-FL."

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 formula 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-neo tetraose, 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.

Press Contact:

Dr. Bettina Gutierrez
Phone: [phone]
[e-mail]

Additional content: https://www.presseportal.de/pm/77411/4602437
OTS: Jennewein Biotechnologie GmbH