ITC Monthly Wrap-Up: February 2023


The U.S. International Trade Commission’s Sua Sponte Order of 100-Day Proceeding

Over the past 10 years, the Commission’s 100-day program has evolved from a pilot program launched in 2013 to codification under Rule 210.10(b)(3).1 Rule 210.10(b)(3) authorizes the Commission to order the Administrative Law Judge to issue an initial determination within 100 days of institution of an investigation ruling on a potentially dispositive issue.2 The Commission infrequently grants requests for disposition through the 100-day program, and typically it has been invoked to resolve dipositive domestic industry issues. Breaking from this pattern, on February 3, 2023, the Commission exercised its authority to sua sponte order a 100-day proceeding relating to trade secret misappropriation.

On December 29, 2022, Viking Therapeutics, Inc., filed a complaint that the Commission institute an investigation under Section 337 concerning drug products and drug substances that are selective thyroid hormone receptor-beta agonists for the treatment of metabolic disorders and liver diseases.3 Viking specifically alleges misappropriation of trade secrets, which it alleges threatens the destruction of or substantial injury to the domestic industry for its drug products.4 In its Public Interest Statement accompanying the complaint, Viking contends that the issuance of remedial orders would not pose any health, safety, or welfare concerns because the accused drug products are among several selective thyroid hormone receptor-beta agonists in clinical trials and pending approval by the Food and Drug Administration.5

In response to Viking’s complaint and the Commission’s subsequent request for comments on the public interest6, respondents Ascletis Pharma, Inc., Ascletis Pharmaceuticals Co., Ltd., Ascletis Bioscience Co., Ltd., Gannex Pharma Co., Ltd., and Jinzi Jason Wu (collectively “Ascletis”) urged the Commission not to institute the investigation.7 Ascletis argued that not only would the investigation cause the Commission to waste valuable time and resources but also that Viking’s requested remedies would harm the public interest by depriving consumers of the opportunity to access currently non-existent therapies and pay much higher prices for drug therapies.8

Noticeably absent from both Viking’s complaint and Ascletis’s response is a request for a 100-day expedited proceeding. Yet the Commission ordered that the ALJ issue an initial determination within 100 days as to whether Viking can show that the “threat or effect of the alleged unfair acts is to (i) to destroy or substantially injure an industry in the United States, or (ii) to prevent the establishment of such an industry.”9 Commissioner Schmidtlein dissented, objecting to the use of a 100-day proceeding in the investigation.10 While Commissioner Schmidtlein did not dispute that “injury and domestic industry may be potentially dispositive issues,” the Commissioner found the majority’s decision unsuitable for this investigation because neither party requested a 100-day proceeding and based on the complexities of the alleged trade secret misappropriation.11 A flurry of motions regarding the scope and timing of the expedited proceedings have already commenced between the parties.12

In February, the Commission also instituted one other Section 337 investigation, Certain Pick-Up Truck Folding Bed Cover Systems and Components Thereof (III), Inv. No. 337-TA-1353, wherein the 100-day program was neither requested by the parties nor invoked by the Commission. Also, on February 23, the Commission announced the appointment of the latest ALJ—ALJ Doris Johnson Hines.13

1 83 Fed. Reg. 21140 (May 8, 2018).

2 19 C.F.R § 210.10(b)(3).

3 Certain Selective Thyroid Hormone Receptor-Beta Agonists, Processes for Manufacturing or Relating to Same, and Products Containing Same, Inv. No. 337-TA-1352, Complaint, D.I. 787052 (Dec. 29, 2022).

4 Id.

5 Id. at 7-8.

6 88 Fed. Reg. 883 (Jan. 5, 2023).

7 Inv. No. 337-TA-1352, Comments on the Public Interest, D.I. 787961 (Jan. 12, 2023).

8 Id.

9 Inv. No. 337-TA-1352, Notice of Institution, D.I. 789470, at 2 (Feb. 3, 2023).

10 Inv. No. 337-TA-1352, Memorandum No. C086-VV-002, D.I. 789512, at 2 (February 3, 2023).

11 Id.

12 See Inv. No. 337-TA-1352, Motion for PO Regarding Discovery, D.I. 791105 (Feb. 24, 2023) (requesting limitations on discovery to the scope of the 100-day proceeding); Inv. No. 337-TA-1352, Motion to Extend the Deadline for Early ID and Modify Procedural Schedule, D.I. 791152 (Feb. 24, 2023).