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ITC Issues Exclusion Order To Protect Glycosyn’s Innovation

Industry: Life Sciences

Key Facts

  • Exclusion Order, enforced by US Customs, went into effect against Jennewein Biotechnologie on July 19, 2020
  • Long-time patent prosecution client Glycosyn turned to Mintz to protect its exclusive patent rights to an innovative method for manufacturing Human Milk Oligosaccharides (HMOs), which were previously found only in breast milk
  • Mintz team secured a victory at the International Trade Commission in its first life sciences case in the venue
  • Following Oral Hearing, Glycosyn’s patent was ruled valid and infringed by the ITC, which also recommended the limited exclusion order

The Situation

In recent years, it became clear that Jennewein Biotechnologie GmbH, a large global competitor, was infringing patented technology at the core of Glycosyn’s patent portfolio. Mintz has long represented Glycosyn as patent counsel, helping its founders develop a strong portfolio protecting their innovations in human milk science, specifically biosynthesis of human milk oligosaccharides in engineered bacteria. The company’s mission is to use their patented technology to develop products to enhance infant and child health worldwide.

The Approach

Glycosyn turned to Mintz to help it devise and implement a strategy to stop the infringing activity.

On March 5, 2018, on behalf of Glycosyn, Mintz filed filed a complaint against Jennewein for patent infringement in the District of Massachusetts, and on April 2 followed with a parallel action at the International Trade Commission (ITC). The ITC is a forum that has an exceptionally quick path to resolution as well as the power to issue an exclusion order, and can lead to a ban on importation into the United States of any infringing product. The complaints alleged unlawful and unauthorized importation and production and/or manufacture of 2'-fucosyllactose oligosaccharides that directly infringe one or more claims of Glycosyn's patents. The District Court case was stayed pending results of the ITC investigation. Oral hearing of the ITC investigation took place the week of May 14, 2019.

The Outcome

The result of the ITC case was vindication for Glycosyn. The Administrative Law Judge issued an Initial Determination finding that Jennewein had infringed Glycosyn’s patent rights, and that the patent was neither invalid nor unenforceable. (The Mintz team also successfully helped Glycosyn beat back a separate patent validity challenge brought by Jennewein in the Patent Office via a so-called “Post-Grant Review” petition.)

In its Final Determination, the ITC concurred with the ALJ and recommended issuance of the Limited Exclusion Order, which was then subject to Presidential review. The Presidential review period has concluded, and on July 19, 2020, the limited exclusion order went into effect and will be enforced by US Customs, eliminating the ability of the infringing ingredient from being legally imported into the United States.



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