For Chinese Companies Entering the U.S.
For device companies based in China, the U.S. patent plan starts before the first U.S. filing, because Chinese law governs when an invention developed in China may be filed abroad. From there, the portfolio has to be rebuilt for a system with no utility models and a different view of prior disclosures.
China's device industry ranges from thousands of smaller manufacturers to large diversified groups. Mindray, founded in 1999 and headquartered in Shenzhen, works across patient monitoring and life support, in vitro diagnostics, and medical imaging. The China Association for Medical Devices Industry (CAMDI), founded in 1991, reports more than 4,000 member companies. At home, the National Medical Products Administration (NMPA) regulates devices in three classes, with Class I products filed and Class II and III products registered, under regulations revised effective June 1, 2021. Volume-based procurement has pooled hospital purchasing into single tenders and, in some categories, cut prices by more than 95 percent, a pricing environment many Chinese manufacturers weigh as they consider overseas markets.
The China National Intellectual Property Administration (CNIPA) administers patents under the Patent Law as amended in 2021, and China is a PCT contracting state. Article 19 is the first issue for any U.S. strategy: an entity or individual intending to file abroad for an invention or utility model accomplished in China must first request a confidentiality examination from CNIPA. An invention is treated as accomplished in China when the substantive content of the technical solution was made there. The request can be made directly, in connection with a Chinese application, or by filing a PCT application with CNIPA as receiving office. If a foreign application is filed in violation of Article 19, the corresponding Chinese application will not be granted, and Article 78 provides for further sanctions. China's grace period is also narrow: six months, available only for disclosures in a state emergency for the public interest, at government-sponsored or recognized international exhibitions, at prescribed academic or technical conferences, or by others without consent.
Many Chinese portfolios lean on utility models, which carry a ten-year term in China. The United States has no utility model system, so inventions protected at home only by utility models need invention-grade U.S. applications that will survive full examination. On the regulatory side, FDA's three-class system and its 510(k), De Novo, and premarket approval routes differ from NMPA registration, and only PMA-route devices can support U.S. patent term extension.
U.S. patents are territorial. A Chinese filing supports U.S. priority only if the U.S. or PCT application follows within 12 months, and PCT applications must enter the U.S. national stage within 30 months of priority. For export-oriented manufacturers, import exposure deserves particular attention: importing an infringing device is infringement, and the International Trade Commission can order infringing products excluded at the border. A freedom-to-operate review before U.S. launch is prudent. We coordinate with Chinese counsel on Article 19 and CNIPA practice and focus on the U.S. portfolio.
Home-country organizations active in this sector include China Association for Medical Devices Industry (CAMDI). Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
A U.S. provisional or nonprovisional application for an invention developed in China should follow, not precede, the CNIPA confidentiality examination. Where inventors sit in both China and the United States, both countries' foreign filing rules may apply, and the filing sequence has to satisfy each.
Utility models can be obtained quickly in China, but the United States offers no counterpart. Identify which utility-model-only inventions matter commercially in the U.S. and prepare full applications that can withstand U.S. examination for novelty and non-obviousness.
Because many Chinese manufacturers reach U.S. customers through imports, exposure extends beyond district court suits to Section 337 proceedings at the ITC. Clearance work on U.S. patents held by incumbents should begin while the product design can still change.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Chinese or European law are for your home-country counsel; the work here is coordinated with them so priority claims, filings and deadlines line up. Consultations are scheduled across time zones.
Request a Confidential ConsultationCommon Questions
Filing a PCT application with CNIPA as receiving office is treated as including a confidentiality examination request. Chinese counsel should confirm the approach for a particular filing, including eligibility to use CNIPA as receiving office.
Possibly. U.S. law excludes an inventor's own disclosure made one year or less before the effective filing date. China's six-month grace period is limited to specific circumstances, so the same disclosure may affect Chinese and U.S. rights differently. Both should be evaluated before filing.
No. We advise on U.S. patent strategy and prosecution and work alongside the company's Chinese patent counsel on CNIPA matters.
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