Second 100-Day ID Finds Complainant Has Standing In 949 Investigation – As mentioned in prior coverage, on March 12, 2015, the Commission issued a Notice of Investigation in Certain Audio Processing Hardware and Software, Inv. No. 337-TA-949, ordering ALJ Pender to hold an early evidentiary hearing and issue an Initial Determination (“ID”) within 100 days of institution as to whether Complainant Andrea has standing to assert the patents-in-suit. This was only the second time the Commission has ordered early disposition; the first occurred in June 2013 in Certain Products Having Laminated Packaging, Laminated Packaging, Inv. No. 337-TA-874, resulting in an ID finding insufficient domestic industry-economic prong and termination. However, in the 949 Investigation, after a hearing held on April 30, ALJ Pender issued an ID on June 11 ruling that Andrea has standing alone to assert the patents-in-suit. A public version of the ID has not yet issued. Respondents filed a Petition to Review the ID on June 16 and a Motion for Oral Argument on review. Respondents assert that the ID found that “non-party AND34…, a special vehicle created by Andrea’s financier Fortress…, was a bare licensee.” They argue “[c]ritically, the ID did not address whether AND34 should be joined as a co-complainant in the Investigation.” OUII’s Response to Respondents’ Motion disagrees that oral argument is necessary, if review is granted by the Commission. Andrea’s Opposition to Respondents’ Petition requests that the Commission deny the Petition and adopt the ID. This Update will monitor the Commission’s decision on Respondents’ Petition.

Commission Declines Implementing 100-Day ID Procedure In 956 Investigation – 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.”

Commission Issues General Exclusion Order In Certain Loom Kits For Creating Linked Articles – On June 26, 2015, the Commission issued its final decision in Certain Loom Kits For Creating Linked Articles, Inv. No. 337-TA-923. The Commission found a violation of Section 337 based on respondent’s infringement of claim 4 of U.S. Patent No. 8,485,565 and issued a general exclusion order (“GEO”) prohibiting the unlicensed importation of infringing loom kits for creating linked articles. In particular, the Commission found that a GEO was necessary to prevent circumvention of a limited exclusion order because (a) manufacturers of infringing look kits could ship kits without manufacturer identification, (b) online sales by anonymous vendors would allow the defaulting respondents to circumvent a limited exclusion order, and (c) the modest tooling costs to make loom kits constituted low barriers to entry into the loom kit market. The Commission also found “a pattern of violation of . . . section [337] and [that] it [would be] difficult to identify the source of infringing products” based on the number of exporters of loom kits to the U.S. and the other facts that made circumvention likely. Unlike limited exclusion orders, which are limited to the articles imported, sold for importation, or sold after importation by the named respondents and their affiliates, a GEO is an in rem remedy that excludes all covered articles irrespective of whether the articles were imported, sold for importation, or sold after importation by a respondent. The Commission also imposed a bond during the Presidential Review phase of the investigation equal to 100 percent of the entered value of the covered articles. The Commission did not enter a cease and desist order.