On May 18, 2015, the Commission issued a Notice of Investigation (“NOI”) in Certain Recombinant Factor VIII Products, Inv. No. 337-TA-956, effectively declining Respondent Novo’s request for 100-Day early disposition of the issue of infringement. On April 16, Complainant Baxter filed a Complaint asserting that proposed Respondent Novo’s NovoEight® product for controlling bleeding for patients with Hemophilia A infringes asserted patents. During the 30 day pre-institution period, Novo submitted two letters on May 1, one a Public Interest Statement requesting that the Commission direct the ALJ to develop a complete record and issue a recommended determination on the issue of public interest. Novo asserted that any exclusion order will deprive patients of NovoEight® and harm the public interest. The second letter requested that the Commission direct that the investigation be “placed in the Pilot Program for Early Disposition” so that the ALJ issues an ID within 100 days on the dispositive issue of infringement. Novo argued that their NovoEight® product is produced in a medium containing protein and that all of the asserted claims require “protein-free conditions.” In the NOI, the Commission directed the ALJ to address the public interest issues during the Investigation but did not place the investigation in the Pilot Program for Early Disposition, illustrating the Commission's reluctance at this time to extend the 100-Day ID Procedure to issues beyond domestic industry, standing and importation. When the Commission announced the launch of the Pilot Program in 2013, the Commission stated that the program “is not limited to the issue of domestic industry (for example, other possible issues might include importation and standing.)” Notably, on June 18, ALJ Lord, assigned to the investigation, issued Order No. 6 granting the parties joint motion for an early Markman Hearing. The Markman Hearing was originally scheduled for October 21, 2015, but Judge Lord expedited the hearing to August 18, based on the parties request that “an earlier Markman hearing will have the potential to simplify the Investigation.”