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

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 β-galactosidase gene which comprises a low level of β-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 β-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 β-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-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.