On July 1, 2021(U.S. time), the International Trade Commission (hereinafter referred to as “ITC”) made a final ruling on the Section 337 Investigation case of Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor (Case No.: 337-TA-1239), in support of the closing decision of the Administrative Judge in this case, that is, it is agreed that ARK Diagnostics (hereinafter referred to as “ARK”), the plaintiff in this case,  will withdraw the lawsuit against Zhejiang Orient Gene Biotech Co., Ltd. and its US subsidiary, Healgen Scientific, LLC (collectively referred to as “Orient Gene”). Since then, the Section 337 Investigation case has been concluded with Orient Gene winning a complete victory.

Orient Gene and other IVD enterprises won the lawsuit in the Section 337 Investigation on Gabapentin immunoassay products!

Review on the event:

Gabapentin is a common antiepileptic drug, but in recent years, the abuse of Gabapentin has become more and more serious in the United States, which has brought increasing health and safety risks. As a result, there is a growing demand for gabapentin immunoassay kits/strips from drug detection agencies and law enforcement agencies in the United States for rapid detection of gabapentin levels in human body. On December 1, 2020, ARK Diagnostics, Inc. filed an application with the United States International Trade Commission in accordance with the provisions in Section 337 of the U.S. Tariff Act of 1930, claiming that its patent rights were infringed upon by the Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor exported to, imported from and sold in the United States, and requesting ITC to issue a limited exclusion order and an injunction. Zhejiang Orient Gene Biotech Co., Ltd., Healgen Scientific (a subsidiary of Orient Gene), Zhejiang Hangzhou Alltest Biotech Co., Ltd., Shanghai Chemtron Biotech Co., Ltd., Chemtron Biotech Co., Ltd. (U.S.), Kappa City Biotech (France), 12PanelMedical, Inc.(U.S.), Acro Biotech, Inc. (U.S.), AlcoPro, Inc. (U.S.), American Screening, LLC (U.S.), Confirm Biosciences, Inc. (U.S.), Mercedes Medical, LLC(U.S.), TransMed Co., LLC(U.S.), Transmetron, Inc. (U.S.) are listed as defendants.

Image source: https://www.usitc.gov/press_room/news_release/2021/er0119ll1702.htm

Following ARK’s request to institute Section 337 Investigation, with the advice and assistance of lawyers from Covington & Burling LLP, Orient Gene actively responded to the lawsuit, quickly identified the critical flaws in ARK’s complaint, and sent a letter to ITC on December 15, 2020 to request that the case not be filed, which successfully forced ARK to amend the complaint. On January 19, 2021, the United States International Trade Commission (ITC) voted to institute a Section 337 Investigation (Investigation Code: 337-TA-1239) of Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor. Due to the positive response attitude and effective response strategy of Orient Gene, after more than three months upon the filing of the case, ARK took the initiative to submit a motion to request for the withdrawal of the case against Orient Gene (on May 27, 2021). On June 14, 2021, ITC issued a preliminary ruling to grant the withdrawal of the case, and made a final ruling on July 1, 2021, deciding not to review the preliminary ruling, thus the Section 337 Investigation was officially concluded.

About U.S. Section 337 Investigation:

The. U.S. Section 337 Investigation, based on the U.S. Tariff Act of 1930, allows the United States International Trade Commission (USITC) to institute an investigation and take sanctions against unfair practices in import trade. Because it is based on the provisions of Section 337 of Tariff Act of 1930, such kind of investigation is generally called “Section 337 Investigation”. The Section 337 Investigation aims to investigate the infringement of U.S. intellectual property rights in imported products and other unfair competition in import trade. In practice, most of the Section 337 Investigations involving the infringement of U.S. intellectual property rights are aimed at patent or trademark infringement, and a few also involve copyright, industrial design and integrated circuit layout design infringement. Other forms of unfair competition include infringement of trade secrets, counterfeit operation, false advertising, violation of anti-monopoly law, etc.

The United States International Trade Commission (USITC), responsible for conducting Section 337 Investigation, is an independent quasi-judicial federal agency in the United States with comprehensive powers to investigate trade-related matters. Its functions mainly include import investigation based on intellectual property rights and taking sanctions; Industry and economic analysis; Domestic industry injury investigation in anti-dumping and countervailing investigations; Investigation of safeguard measures; Trade information services; Trade policy support; Maintenance of U.S. customs tariff schedule. The lawyer of Covington & Burling LLP said that in this case, Orient Gene actively defended itself before filing the case, and made a quick breakthrough at the early stage of the case, which provides a sample of great referential significance for Chinese enterprises to respond to Section 337 Investigation.