In a recently issued order, Chief ALJ Bullock granted Respondent’s motion to amend its Response to the Complaint almost nine months after the investigation had been instituted to include the defense of inequitable conduct in prosecuting the asserted patents. Certain Human Milk Oligosaccharides and Methods of Producing the Same, Inv. 337-TA-1120, Order No. 29.

According to the Respondent Jennewein Biotechnologies GmbH (“Jennewein”), they became aware of certain facts supporting an inequitable conduct defense but were unable to fully plead the defense before its deposition of the prosecuting attorney for the asserted patents, which occurred on February 19, 2019. Jennewein contended it became aware of certain facts supporting an affirmative defense of inequitable conduct during this deposition and began the process of filing its motion less than a week later. Jennewein also argued that the amendment would not prejudice Complainant Glycosyn LLC (“Glycosyn”) because it was made aware of the defense by virtue of the noticed topics of deposition to the prosecuting attorney, and because the parties included inequitable conduct arguments related in the preliminary exchange of prehearing briefs.

Glycosyn and the Staff opposed the motion. Staff argued that Jennewein should have sought to include the additional defense long ago. Glycosyn also argued that the delay in seeking to add the defense was too long and also prejudicial. In particular, they argued that the key document Jennewein relies on to support its inequitable conduct defense had been in Jennewein’s possession for a long time.

Ultimately, ALJ Bullock sided with Jennewein and allowed the addition of the defense. ALJ Bullock explained that inequitable conduct was a serious allegation, and it was appropriate for Jennewein to refrain from accusing persons of this malfeasance until all relevant parties had been interviewed or deposed.


It is uncommon for the ITC to permit the addition of defenses this late into an investigation. However, as this order highlights, in the right circumstances, ALJs may make an exception. In this case, the defense was fact intensive, requiring a significant amount of discovery and Respondents were able to show that the Complainant had been made aware of the defense. These factors seemed to outweigh the fact that the material document relied upon had been in Respondents’ possession for some time.