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¡°Joint Fact Sheet on Strengthening U.S.-China Economic Relations¡±date£º2014-1-26 9:40:02 from£º ¡¾close¡¿

Editor has noticed the publication of ¡°Joint Fact Sheet on Strengthening U.S.-China Economic Relations¡± (Joint Fact Sheet) on Xinhua News, December 5th, and believes that a series consensuses reached by both Chinese and U.S. governments expressed in the Joint Fact Sheet, especially those expressed in the portion of ¡°Protecting Innovation and Promoting Trade in Safe Food and Drugs¡± pertaining to Active Pharmaceutical Ingredients (APIs) and to the Guidelines for Patent Examination in SIPO will make a big impact on the patent practice of generic drug companies, and it is worth to pay serious attention for the decision makers and patent practitioners of these companies.
In editor¡¯s initial thoughts, at least two points should be paid attention to:
First, since the regulatory record system for APIs will be implemented, the APIs exporting companies will have to register the related information of APIs to the national Drug Master File management authority in the near future. This information can directly correlate the exported APIs to their producers. If there is a conflict between an API and any Chinese/foreign patent rights, the related producer/exporter can hardly avoid being involved in a dispute which is aroused by the conflict, due to this direct correlation. Therefore, before the production/exportation of this API, a Freedom-to-Operate (FTO) analysis is quite necessary to avoid possible patent infringement.
Second, as China affirms that the Guidelines for Patent Examination in SIPO will permit patent applicants to file additional data after filing date of a patent application to ensure that their chemistry, biotechnology and pharmaceutical related inventions can enjoy patent protection, this will affect the examination standards of Article 26.3 (sufficient disclosure) and Article 22.3 (inventive step) of the Chinese Patent Law which are applicable to the substantive examination process of patent application and to the patents invalidation as well as the succeeding administrative lawsuit processes.
Considering effects of the implementation, patent applications which may be rejected or declared invalid due to the lack of experimental data in the past can be granted or upheld valid with some additional data furnished after filing date. The negative effects to the generic drug companies are obvious.
For the sake of succinctness, only the portions closely relating to intellectual properties have been adopted from the Joint Fact Sheet, while the rest is omitted.
Should you want to have a deep discussion about this document, please contact us.
Text portion of the Joint Fact Sheet:

Joint Fact Sheet on Strengthening U.S.-China Economic Relations
Building on President Barack Obama and President Xi Jinping¡¯s shared commitment to building a new model of major country relations, both countries affirm their commitment to practical cooperation for the benefit of our two economies and to address global economic challenges. The United States and China reached the following outcomes on energy and climate change, innovation, and food and drug safety, under the framework of the Economic Track of the U.S.-China Strategic and Economic Dialogue (S&ED). The United States and China further reaffirm their commitment to implement fully the concrete measures pledged by each country during the Economic Track of the S&ED, in order to further support strong domestic and global growth, promote open trade and investment, enhance international rules and global economic governance, and foster financial market stability and reform.
Strengthening Cooperation on Energy and Climate Change
(Omitted, if interested, please search the related report on Xinhua dated December 5.)
Protecting Innovation and Promoting Trade in Safe Food and Drugs
Building on successful discussions during the 2012 U.S.-China High-Level Agricultural Symposium, the July 2013 S&ED, and looking towards a productive and mutually beneficial December 2013 meeting of the Joint Commission on Commerce and Trade (JCCT), the United States and China affirm the importance of deepening cooperation to address a range of food and drug issues of common concern. Availability of high-quality and safe food and drugs are essential to the growth of our economies and well-being of our peoples. The United States and China therefore commit to the following measures related to promoting and protecting innovation, as well as ensuring safe and well-regulated bilateral trade in food and pharmaceuticals.
The United States and China commit to carry out communication and cooperation on agro-chemical regulation, standards for testing methods and drug and pesticide residue limits and regulation on edible agricultural products for import and export.
In line with the reform goals of the Third Plenary Session of the 18th CPC Central Committee, China commits to promote the reform of its regulatory system for active pharmaceutical ingredients (APIs) by implementing Drug Master File (DMF) management for APIs and to study the possibility of setting up a framework for the registration of bulk chemicals that can be used as APIs. The two sides mutually affirm the central role of drug manufacturers in ensuring drug quality, and will exercise appropriate regulatory oversight over manufacturers towards this end. The U.S. Food and Drug Administration commits to review its authorities to determine whether it can exclude from consideration for import APIs from Chinese firms that are not registered with the China Food and Drug Administration.
China affirms that the Chinese Patent Examination Guidelines permit patent applicants to file additional data after filing their patent applications, and that the Guidelines are subject to Article 84 of the Law on Legislation, to ensure that pharmaceutical inventions receive patent protection. China affirms that this interpretation is currently in effect.
To promote bilateral communication and cooperation in pharmaceuticals, medical products and food safety, the Chinese side commits to issuing visas for U.S. Food and Drug Administration (FDA) food inspectors, drug inspectors and food expert referenced in Diplomatic Note 1252 of November 19, 2012 and Diplomatic Note 0843 of August 20, 2013. These personnel will be posted to the U.S. Embassy in China, with diplomatic privileges and immunities. At the same time, the United States commits that, on a reciprocal basis, China increases its relevant staff in the Chinese Embassy in the United States, with diplomatic privileges and immunities. No later than January 17, 2014, the two sides commit to signing an memorandum of understanding to specify the scope of activity of these personnel.
The United States and China commit to discuss issues concerning China raised in the Consolidated and Further Continuing Appropriation Act, 2013.
The United States and China recognize the importance of promoting non-discriminatory government procurement policies. The two sides commit to have further consultation on China¡¯s concerns regarding non-discriminatory treatment of Chinese-invested enterprises established in the United States in U.S. government procurement.

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