Attorneys from Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo P.C., led by Michael C. Newman and Thomas H. Wintner, represented Glycosyn LLC in a victory in Certain Human Milk Oligosaccharides and Methods of Producing the Same, Inv. No. 337-TA-1120, in the International Trade Commission. 

Following the evidentiary hearing, Administrative Law Judge Cameron Elliot issued an Initial Determination finding that the respondent, Jennewein Biotechnologie GmbH’s, production bacterial strains infringed certain biosynthesis method claims of U.S. Patent No. 9,970,018 (“the ’018 patent”).  The judge also found that ’018 patent was neither invalid nor unenforceable.  Judge Elliot also recommended that a limited exclusion order issue, including a certification provision with heightened requirements, “wherein said certification provision is required to state with particularity the grounds of non-infringement of the imported oligosaccharide and be accompanied by sufficient corroborating evidence of the type provided in this investigation.”

Significantly, Judge Elliot further declined to adjudicate whether the respondent’s 2ʹ-fucosyllactose (“2ʹ-FL”) produced by a non-accused bacterial strain infringed the ’018 patent because there was insufficient discovery regarding that strain in the investigation. This decision likely forecloses the respondent’s ability to import 2ʹ-FL or any other fucosylated oligosaccharides produced by the non-accused strain through a certification provision, if the recommended limited exclusion order issues. 

Through his analysis of recent Commission precedent regarding the circumstances under which non-accused methods or products should fall within the scope of the investigation, Judge Elliot “divine[d] a four-factor test as to whether a respondent has met its burden to show the infringement of a redesigned product should be adjudicated. The product must be: (1) within the scope of the investigation, (2) imported, (3) sufficiently fixed in design, and (4) subject to extensive discovery.”

The judge concluded that the respondent had not met its burden with regard to the fourth factor, showing that the non-accused strain was subject to extensive discovery.  He reasoned that the respondent only produced two documents that provided any specific information on the non-accused strain.  However, only one document, an undated article, which Judge Elliot determined had low probative value, actually put the complainant on notice of the non-accused strain’s construction. 

Additionally, Judge Elliot noted that the respondent failed to timely update its discovery responses regarding the non-accused strain.  The respondent either waited until the last day of discovery or never updated its discovery responses at all to identify the non-accused strain.  Most significantly, the respondent admitted that it only used its production strain to produce the 2ʹ-FL imported into the United States.  Although the respondent had the burden to prove that the 2ʹ-FL produced by the non-accused strain was imported into the United States, it never supplemented its admission to include the non-accused strain.  

Judge Elliot concluded that “[i]t is the burden of the respondent to provide the ‘extensive’ or ‘sufficient’ discovery on the redesigned product, and [respondent] has not met this burden, from either a document production or discovery response perspective.  An earnest effort to force [2ʹ-FL produced by the non-accused strain] into the investigation would have seen [respondent] prove to [complainant] the nature of [the non-accused strain], and how it had been used to produce imported 2'-FL, before the very last day of fact discovery.”

This ruling is significant because it clearly articulates Commission precedent regarding the respondent’s burden to establish that a non-accused method or product is properly within the scope of an investigation. Ingrid Beattie, a member at Mintz and long-time patent counsel for Glycosyn said: “I am thrilled for Glycosyn and its leadership with whom I have worked closely since the company’s launch. Their scientists and leadership are visionary and with this innovation have helped improve the welfare of countless children.”

In addition to Michael Newman and Thomas Wintner, the full attorney team working on behalf of Glycosyn in this litigation included members Michael T. Renaud, Aarti Shah, and James M. Wodarski; Of Counsel Phillip C. Ducker; and associates Kara Grogan, Courtney Herndon, Matthew A. Karambelas, and Nana Liu.