Certain Products Having Laminated Packaging, Laminated Packaging, And Components Thereof, Inv. No. 337-TA-874


On March 22, 2013, the Commission issued a Notice instituting Certain Products Having Laminated Packaging, Laminated Packaging, And Components Thereof, Inv. No. 337-TA-874 ("the 874 Investigation"). Unlike the typical Notice of Investigation, the Notice in the -874 Investigation directed Administrative Law Judge Theodore Essex to issue an early decision on whether the Complainant satisfied the economic prong of the domestic industry requirement by initial determination ("ID") “within 100 days of institution,” subject to a limited extension of the ID for good cause. Because the Complainant in this investigation is a nonpracticing entity ("NPE"), there has been speculation that the Commission may be scrutinizing all NPEs who file a Section 337 Complaint and requiring them to prove their domestic industry before addressing the remaining merits of the investigation. Alternatively this may have been a more limited reaction by the Commission to the Amended Complaint in this investigation. More specifically, the Complaint initially did not allege that the asserted domestic industry was based on money spent on a licensing program in the United States, and subsequently was amended after considering comments by the Office of Unfair Import Investigations (“OUII”) during the 30-day pre-institution period.

As it turns out, this 100-day ID procedure was not intended to be limited Complaints brought by NPEs or involving an isolated defective pleading. Rather, based on Chairman Williamson’s recent comments made to the Spring Meeting of the ITC Trial Lawyers Association (“ITC TLA”), the Commission intends to employ this approach more broadly to address dispositive issues in other investigations, beyond the issue of economic prong of the domestic industry requirement. In fact, the Commission has employed such an approach in the past to address the dispositive issue of patent infringement.

In Certain Products And Pharmaceutical Compositions Containing Recombinant Human Erythropoietin, Inv. No. 337-TA-568, during the 30-day pre-institution period, proposed Respondents Roche Holding Ltd., F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH and Hoffmann-La Roche Inc. (collectively “Roche”), raised the issue with the Commission that all of Roche’s importation of the accused product was solely for the purposes of obtaining FDA approval under 35 U.S.C. §271(e)(1), and therefore, the asserted patents were not infringed. Thereafter, the Commission’s May 9, 2006 Notice of Investigation directed the ALJ (former Chief Judge Paul J. Luckern) “to consider at an early date any motions for summary determination based upon 35 U.S.C. §271(e).” Judge Luckern subsequently issued a Procedural Schedule requiring an expedited discovery period followed by briefing on Roche’s motion for summary determination of noninfringement under 35 U.S.C. §271(e)(1). Judge Luckern granted Roche’s motion for summary determination (Fed. Reg.Vol. 71, No. 172). Ultimately, after remand to the ITC following rehearing en banc by the Federal Circuit (Amgen Inc. v. ITC 565 F.3d 846 (Fed. Cir. 2009)), the investigation was terminated by the ITC on November 9, 2011 on the basis of settlement without issuance of an exclusion order or consent order (Fed. Reg.Vol. 76, No. 203).

Chairman Williamson did not address the specifics of any procedure during the 30-day pre-institution period by which the Complainant or a proposed Respondent or a member of the public could notify the Commission of a dispositive issue that it contends should be subject to the 100-Day ID procedure. In appropriate circumstances, a letter to the Commission during this time period could prompt the Commission to require a 100-Day ID procedure in the Notice Instituting the Investigation.

In any event, the ALJ’s comments during the Judicial Panel at the ITC TLA Spring Meeting made clear that the Commission is certainly poised to begin the 100-Day ID procedure for early resolution of dispositive issues in more investigations. Specifically, Judge Essex commented on the -874 Investigation that the expedited hearing was just completed in this case on the economic prong issue and he intends to issue an ID on this issue within the 100-Day period. He advised that this approach may work very well. Chief Judge Bullock then advised that there is a procedure in place for assigning a Judge to an investigation involving a 100-Day ID procedure. This determination is made by the Chief Judge and a factor that is considered is finding a Judge who has a schedule that will least likely be disrupted.