Certain In Vitro Fertilization Products, Components Thereof, and Products Containing the Same; Commission Decision Not To Review a Final Initial Determination Finding a Violation of Section 337; Schedule for Filing Written Submissions on Remedy, the Public Interest, and Bonding

AGENCY:

U.S. International Trade Commission.

ACTION:

Notice.

SUMMARY:

Notice is hereby given that the U.S. International Trade Commission has determined not to review a final initial determination (“FID”) of the presiding Administrative Law Judge (“ALJ”) finding a violation of section 337 by respondents Fast IVF of Scottsdale, Arizona (“Fast IVF”) and Hermes Ezcanesi of Istanbul, Turkey (collectively, the “Defaulting Respondents”). The Commission also requests written submissions from the parties, interested government agencies and interested persons, under the schedule set forth below, on remedy, the public interest, and bonding.

FOR FURTHER INFORMATION CONTACT:

Houda Morad, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708-4716. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

SUPPLEMENTARY INFORMATION:

On April 16, 2020, the Commission instituted this investigation under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based on a complaint filed by complainant EMD Serono, Inc. of Rockland, Massachusetts (“Complainant”). See 85 FR 21267-68 (Apr. 16, 2020). The complaint, as amended and supplemented, alleges a violation of section 337 based on the importation into the United States, the sale for importation, and the sale within the United States after importation of certain in vitro fertilization products, components thereof, and products containing same (collectively, “Gray Market IVF Products”), by reason of infringement of U.S. Trademark Registration Nos. 4,689,651; 1,772,761; 3,777,170; 3,389,332; 3,816,320; 1,972,079; 3,604,207; and 3,185,427 (collectively, “the Asserted Trademarks”); unfair methods of competition and unfair acts in the importation and sale of Gray Market IVF Products by reason of false designation of source; and unfair methods of competition and unfair acts in the importation and sale of the Gray Market IVF Products by reason of false advertising. See id. In addition to the Defaulting Respondents, the notice of investigation names General Plastik Drug Stores (“Unserved Respondent”) of Istanbul Suadiye, Turkey as a respondent in this investigation. See id. The Office of Unfair Import Investigations is also a party to the investigation. See id.

On September 1, 2020, the Chief ALJ issued an initial determination (“ID”) finding each of the Defaulting Respondents in default. See Order No. 6 (Sept. 1, 2020), unreviewed by Comm'n Notice (Sept. 24, 2020). On October 13, 2020, the Chief ALJ also issued an ID terminating Unserved Respondent from the investigation based on the withdrawal of the complaint allegations as to that respondent. See Order No. 8 (Oct. 13, 2020), unreviewed by Comm'n Notice (Oct. 26, 2020).

On April 16, 2021, the Chief ALJ issued an ID (Order No. 10) (“SD”) granting in part Complainant's motion for summary determination of violation of section 337 by the Defaulting Respondents with respect to Complainant's claim under section 337(a)(1)(C) (infringement of the Asserted Trademarks) but denied the motion with respect to Complainant's unfair competition claims under section 337(a)(1)(A). The SD also finds that Complainant has satisfied the economic prong of the domestic industry requirement under subsection (C) of section 337(a)(3).

On May 18, 2021, the Commission determined to review the SD (Order No. 10) in part. See Comm'n Notice (May 18, 2021). Specifically, the Commission determined to review the SD's findings with respect to the economic prong of the domestic industry requirement. See id. The Commission determined not to review any other findings in the SD.

On October 6, 2021, the Commission determined to vacate the SD in part. Specifically, the Commission vacated the SD's finding that Complainant has satisfied the economic prong of the domestic industry requirement. Consequently, the Commission also vacated the SD's finding of a violation of section 337 and remanded the investigation to the Chief ALJ. Commissioners Karpel and Schmidtlein dissented from the Commission's decision that Complainant had failed to satisfy the economic prong of the domestic industry requirement and would have found a violation of Section 337 based on substantial, reliable, and probative evidence.

After the Commission decision to vacate the SD, EMD Serono abandoned its request for a general exclusion order; thereafter, it requested a limited exclusion order against both defaulting respondents and a cease and desist order against FastIVF. See FID at 6 (citing Motion Docket No. 1196-008 at 1 n.1, 8-9). On December 15, 2021, the ALJ issued an ID partially terminating the investigation as to Complainant's unfair competition claims under section 337(a)(1)(A). See Order No. 13 (Dec. 15, 2021), unreviewed by Comm'n Notice (Jan 10, 2022).

On December 15, 2021, the ALJ issued the FID finding a violation of section 337 based on the infringement by the Defaulting Respondents of Complainant's Asserted Trademarks pursuant to section 337(g)(1), 19 U.S.C. 1337(g)(1). In addition, the ALJ recommended that the Commission issue a limited exclusion order (“LEO”) against the infringing articles imported by or on behalf of the Defaulting Respondents and a cease and desist order (“CDO”) against FastIVF.

No petition for review of the FID was filed.

On January 4, 2022, Complainant filed a statement on the public interest pursuant to Commission Rule 210.50, 19 CFR 210.50. On the same day, Complainant filed a declaration requesting relief against the Defaulting Respondents, namely, an LEO against the Defaulting Respondents' infringing products and a CDO against FastIVF. No third-party submissions were filed in response to the Federal Register notice requesting public interest comments. See 86 FR 72620-21 (Dec. 22, 2021).

The Commission has determined not to review the FID.

In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue one or more cease and desist orders that could result in the respondent(s) being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843, Comm'n Op. at 7-10 (Dec. 1994).

If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove, or take no action on the Commission's determination. See Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

Written Submissions: Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should also address the recommended determination by the ALJ on remedy and bonding. Complainant is also requested to submit proposed remedial orders for the Commission's consideration. Complainant is further requested to provide the HTSUS numbers under which the accused products are imported, and to supply the names of known importers of the products at issue in this investigation.

Written submissions and proposed remedial orders must be filed no later than close of business on February 28, 2022. Reply submissions must be filed no later than the close of business on March 7, 2022. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (March 19, 2020). Submissions should refer to the investigation number (“Inv. No. 337-TA-1196”) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All non-confidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.

While temporary remote operating procedures are in place in response to COVID-19, the Office of the Secretary is not able to serve parties that have not retained counsel or otherwise provided a point of contact for electronic service. Accordingly, pursuant to Commission Rules 201.16(a) and 210.7(a)(1) (19 CFR 201.16(a), 210.7(a)(1)), the Commission orders that the Complainant(s) complete service for any party/parties without a method of electronic service noted on the attached Certificate of Service and shall file proof of service on the Electronic Document Information System (EDIS).

The Commission's vote for this determination took place on February 11, 2022.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).