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Federal Circuit Affirms ITC Victory for Glycosyn

Mintz today announced a victory before the U.S. Court of Appeals for the Federal Circuit, which affirmed an International Trade Commission (ITC or Commission) ruling from May 2020 finding that Jennewein Biotechnologie GmbH (Jennewein), a German biotechnology company, infringed Glycosyn LLC’s patent for the biosynthesis of human milk oligosaccharides (HMOs) in engineered bacteria, that the patent was neither invalid nor unenforceable, and issuance of a Limited Exclusion Order against Jennewein. 

Mintz argued on behalf of Glycosyn, a Greater Boston Area biotechnology company developing products based on bioactive sugars found in human milk, as an intervener to the appeal brought by Jennewein against the Commission. Mintz also prosecuted the patent that was ultimately asserted against Jennewein in the ITC investigation, U.S. Patent Number 9,970,018; served as counsel to Glycosyn in the ITC investigation; and successfully defeated a patent validity challenge brought by Jennewein in the Patent Office pursuant to a Post-Grant Review petition.

Jennewein, which was acquired last fall by Chr. Hansen A/S, a global bioscience company based in Denmark, appealed the Commission’s finding of infringement, arguing the Commission incorrectly determined that: (1) Jennewein’s methods of producing a certain sugar found in human milk satisfied a claim limitation requiring certain enzymatic activity of the provided bacterium to be between 0.05 and 200 units; (2) Jennewein’s bacterial strains at issue included an “exogenous . . . gene” under the doctrine of equivalents; and (3) the required enzymatic activity level did not need to occur “substantially at all times” during production and retrieval of the sugar.  

The Federal Circuit concluded that the Commission did not err in its claim construction or in its finding of infringement. The Federal Circuit held that substantial evidence supported the Commission’s ruling that Jennewein desired to use a negative control in the agreed-upon test for enzymatic activity that would “minimize the measured” activity level, and that Jennewein’s proposed negative control technique was “unreliable on its face, or implemented unreliably, or some other assumption was incorrect.” It also agreed that substantial evidence supported a conclusion that Jennewein’s bacterial strains included gene fragments that originated from outside of a wild-type bacterium, making those gene fragments “exogenous.” Finally, the Federal Circuit found nothing in the claim language that suggested the enzymatic activity level must be present substantially at all times. Rather, the enzymatic level was “an inherent characteristic of the provided bacterium, and not the level of activity required throughout performance of the claimed method.” Further, the Federal Circuit reasoned that adopting Jennewein’s construction would have excluded a key embodiment identified in the claim, which is antithetical to the tenets of claim construction.

“We are pleased to see Glycosyn’s position vindicated,” said Michael Newman, a Member of Mintz’s Intellectual Property Practice. “Glycosyn has dedicated itself to the research and development of breakthrough technologies in the field of HMOs. Glycosyn respects the intellectual property of others, and expects others to do the same.”

In addition to Mr. Newman, Glycosyn was represented by Mintz Member and Chair of the firm's Intellectual Property Division Michael Renaud, Members Thomas Wintner and James Wodarski, and Associates Courtney Herndon and Matthew Karambelas.