How to deal with the "337 investigation" of pharmaceutical products in the United States"

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In recent years, "337 investigation" has become an important means for the United States to restrict the trade of Chinese pharmaceutical products. The low filing threshold and strict sanctions stimulate American applicants to file complaints frequently, and even make "337 investigation" a competitive tool for some enterprises (mainly American enterprises) to abuse procedures and maliciously attack Chinese enterprises; and the high cost of responding to lawsuits, complex The legal system and the changeable political environment have also increased the difficulty of responding to lawsuits for Chinese enterprises.

A number of pharmaceutical products encountered "337 investigation"

"337 investigation" refers to the practice of the United States International Trade Commission in accordance with Section 337 of the United States Tariff Act of 1930, on application or on its own initiative, to initiate investigations and take sanctions against unfair practices in import trade. The investigation mainly focuses on the infringement of intellectual property rights registered in the United States and other unfair competition by foreign imported products. If the investigation organ determines that the foreign imported products constitute infringement, the investigation organ has the right to take relief measures such as exclusion order and prohibition order to prohibit the infringing products from entering and selling in the U.S. market.

Because the intellectual property rights of pharmaceutical products are complex and difficult, they are easy to become the target of "337 investigation. According to statistics, since 1997, there have been 26 cases of "337 investigation" of pharmaceutical products in China, mainly drugs and medical devices. In the cases of "337 investigation", the vast majority of cases involve product patent or production process patent infringement, as well as trademark infringement and unfair acts.

Judging from the time period when the investigation was initiated, there was only one "337 investigation" before my country joined the World Trade Organization (WTO); after joining the WTO to the end of 2010, there were 8 "337 investigations"; since 2011, there have been 17 "337 investigations", showing an obvious upward trend. At present, the issue of intellectual property rights has become one of the key issues of Sino-US economic and trade frictions. It can be predicted that the "337 investigation" will continue to maintain a high incidence for a period of time.

Characteristics of "337 investigation" cases

The threshold for filing a case is low. Because the U.S. International Trade Commission, which is responsible for the "337 investigation", does not require "personal jurisdiction" over the defendant (the applicant), the threshold for U.S. applicants to file a "337 investigation" is relatively loose and it is easy to file a case.

Sanctions The sanctions of severe "337 investigation" include limited exclusion order, general exclusion order, prohibition order and confiscation order. Once the measures come into effect, they will be implemented for the duration of the intellectual property rights of the infringed products involved. For the defendant enterprise, this sanction is extremely severe.

The high cost of responding to investigations or judicial proceedings involving intellectual property rights can result in high costs for businesses. Moreover, the United States applicant to take advantage of its sound legal provisions, often before the filing of "337 investigation" in the United States domestic courts have filed judicial proceedings, two means of litigation at the same time, increase the difficulty of the accused enterprise defense, raise the cost of enterprises to respond. Once the accused enterprise is afraid of difficulties and gives up responding to the lawsuit, the U.S. investigation agency will make a default judgment ruling and other results that are unfavorable to the accused enterprise.

Compared with trade remedy measures such as anti-dumping and countervailing, the success rate of "337 investigation" is higher. Among the "337 investigations" encountered by my country's pharmaceutical industry, about 60% of the investigations were closed by the applicant withdrawing the lawsuit, the two parties reached a settlement, the investigation agency refused to file the case or determined that Chinese companies did not infringe. On the one hand, this is related to the active protection of rights and serious defense of Chinese enterprises; on the other hand, it also shows that the threshold for filing the investigation is low, but the investigation procedure is relatively strict, as long as the lawsuit is actively answered, the ideal result is likely to be obtained.

Facing difficulties and actively safeguarding rights

In recent years, the China Chamber of Commerce for Import and Export of Medicines and Health Products has actively implemented the requirements of the Ministry of Commerce's "four-body linkage" working mechanism in response to trade frictions, guided, organized and coordinated enterprises to respond to lawsuits, and achieved positive results.

The "four-body linkage" mechanism means that the central government departments and overseas agencies, local governments, industry organizations and enterprises perform their duties, assume their own responsibilities, coordinate from top to bottom, and respond properly in the process of dealing with trade frictions. As an industry organization, the Medical Insurance Chamber of Commerce has long played an important role in the "four-body linkage" working mechanism established by the Ministry of Commerce to deal with trade frictions: actively give play to the professionalism of industry organizations and the advantages of the endorsement industry, and assist the involved in the case through the "four-body linkage" working mechanism Enterprises participate in the response to "337 investigation" cases. The specific work includes filing and early warning, case guidance, coordinating positions, organizing and responding to lawsuits, being able to achieve full-process tracking and all-round services, building a bridge of communication between the government and enterprises, and strengthening cooperation with the government, enterprises involved in the case and professional lawyers. Defend our country's position and safeguard our country's interests. These efforts have enhanced the confidence of enterprises in responding to lawsuits and achieved better results. For example, in 2018, in the "337 investigation" of glycated stevioside, the Chamber of Commerce actively coordinated enterprises to respond to lawsuits and rights protection, and finally reached a settlement with the US applicant, and the US International Trade Commission terminated the investigation.

The United States is an important export market for my country's pharmaceutical products, and "337 investigation" is a difficulty that my country's pharmaceutical products may face when entering the U.S. market. It is also a "growth trouble" encountered by my country's pharmaceutical products on the road to internationalization. It is recommended that companies weigh the pros and cons., Face the difficulties and actively defend rights. The specific suggestions are as follows: first, to have basic legal concepts and awareness, especially to understand the intellectual property laws and relevant litigation system provisions of the United States; second, enterprises should establish intellectual property strategies, increase the protection of their own intellectual property rights, and take the initiative to apply and claim relevant rights abroad; third, strengthen the ties with industry organizations, integrate industry resources, and ask industry organizations to make timely and appropriate defense; the fourth is to strengthen coordination between enterprises, form a joint force, respond together, and strive to make applicants retreat in the face of difficulties; the fifth is to enhance their own innovation ability and competitiveness, and strengthen the necessary industry self-discipline.