ADMINISTRATIVE LAW JUDGE ISSUES RULING IN PATENT DISPUTE CONCERNING 2’-FL PRODUCTION AND BETA-GALACTOSIDASE ACTIVITY
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.”
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).
For further information, please contact:
Dr. Andreas Hübel
Head of Intellectual Property
+49 (0)2224/988 10791
About Jennewein Biotechnologie GmbH
+49 / (0)2224 - 998 100http://jennewein-biotech.de
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.
Subscribe to releases from Jennewein Biotechnologie GmbH
Subscribe to all the latest releases from Jennewein Biotechnologie GmbH by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Jennewein Biotechnologie GmbH
Jennewein Biotechnologie GmbH enforces its patents in the field of human milk oligosaccharides against Nestlé in Germany10.1.2020 15:23:21 EET | Press release
Jennewein Biotechnologie GmbH filed a patent infringement suit with the regional court in Mannheim on January 09, 2020 against Nestlé Nutrition GmbH and its holding company Nestlé Deutschland AG. Nestlé offers its infant formula Beba Supreme which contains two human milk oligosaccharides – unique saccharides naturally occurring in human breast milk only – for sale in Germany. Pursuant to the findings of Jennewein Biotechnologie, Nestlé uses human milk oligosaccharides for the manufacturing of its infant formula that are produced by a process being protected - among other IP rights - by European Patents EP 2 896 628 and EP 3 131 912 (start of protection: January 22, 2020) which are thus infringed by Nestlé.
Jennewein Biotechnologie sues Glycom for patent infringement in Denmark25.11.2019 11:31:29 EET | Press release
Jennewein Biotechnologie develops fermentative processes for manufacturing of human milk oligosaccharides (HMOs) cost efficiently in an industrial scale since 2005 to make these special sugars available for affordably priced infant formula and other uses in food. Jennewein Biotechnologie was the first commercial vendor of HMOs, and brought the HMO 2’-fucosyllactose for the first time on the market in 2015.
Jennewein Biotechnologie and Yili Group join forces in China for microbiome research and human milk oligosaccharides to bring innovation to the largest baby food market5.2.2019 11:00:00 EET | Press release
-China represents the largest market for baby food globally -Human milk oligosaccharides are key for the development of a healthy infant microbiome Hohhot, China & Rheinbreitbach, Germany - Jennewein Biotechnologie GmbH, the global leader in the research and manufacture of human milk oligosaccharides (HMO),and Inner Mongolia Yili Industrial Group (Yili Group), China’s leading dairy company,announce today the signing of a Memorandum of Understanding on infant microbiome and human milk oligosaccharides, with the goal to develop an innovative infant formula and dairy products specifically tailored to the Chinese market. "After already having introduced human milk oligosaccharides in other world regions, such as the key U.S. market and selected European countries, we are very excited to work with Yili, the domestic market leader for microbiome/baby food in China" statedDr. Stefan Jennewein, CEO and Co-Founder of JenneweinBiotechnologie. "With 50% of the total global market volume (2021e: 7
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom