Pharma
China Releases Draft Implementation Guidelines for the Drug Administration Law
2 June 2022The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval […]
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CHINA: How Prohibiting "Illegal" Inventions Runs into Food Safety Law
22 October 2021Chinese Patent Law has an interesting provision that specifically prohibits patent protection on “illegal” or “immoral” inventions. What does this mean, exactly? According to Article 5.1 of the Chinese Patent Law, “no patent shall be granted for an invention that contravenes any law or social moral or that is detrimental to public interests.” On its […]
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China Patent Office (CNIPA) Releases More Details About Patent Term Adjustment (PTA) in the Draft Examination Guidelines
19 October 2021The new 4th Amendment of the Chinese Patent Law came into effect on June 1, 2021. Right before that date, the Chinese Patent Office (“CNIPA”) released some “Interim Measures” to give us a taste of what was to come, though they have yet to released the actual Implementation Rules. Two months later, CNIPA finally released […]
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Breaking: China Released New Implementation Measures for the New Patent Linkage System
14 July 2021On July 4, 2021, China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) released details on the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage”), effective July 4, 2021. Below is a summary highlighting key provisions and changes from the draft measures. Creation of an […]
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China Top 10 Patent Re-Examination and Invalidation Cases of 2020 CNIPA Upholds Bayer’s Rivaroxaban Patent
9 June 2021The development of China’s approach to patents, especially those in the pharmaceutical and biotech space, has been fascinating to watch. Those of us who have practiced in the area for a long time have been frustrated by the Chinese patent office’s overly strict rules regarding patentability (e.g., high data support standard and refusal to consider […]
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China Top 10 Cases of 2020 – CNIPA Upholds Second Medical Use Patent from University of Bordeaux
24 May 2021The development of China’s approach to patents, especially those in the pharmaceutical and biotech space, has been fascinating to watch. Those of us who have practiced in the area for a long time have been frustrated by the Chinese patent office’s overly strict rules regarding patentability (e.g., high data support standard and refusal to consider […]
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China’s Newest Examination Guidelines: Inventive Step for Biological / Life Science Inventions (Part III)
30 April 2021This is Part III of a three-part series summarizing the Examination Guidelines that were released by the CNIPA on January 15, 2021, one year to the date of Phase 1 of the US and China Economic and Trade Agreement. That agreement included specific provisions where China "shall permit pharmaceutical patent applicants to rely on supplemental […]
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China’s Newest Examination Guidelines: Novelty and Inventive Step for Compounds (Part II)
29 April 2021This is Part II of a three-part series summarizing the Examination Guidelines that were released by the CNIPA on January 15, 2021, one year to the date of Phase 1 of the US and China Economic and Trade Agreement. That agreement included specific provisions where China "shall permit pharmaceutical patent applicants to rely on supplemental […]
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China’s Newest Examination Guidelines: Post-Filing Supplemental Data for Compounds (Part I)
28 April 2021Post-filing data in China has been a constant issue for many patent practitioners around the world. Examiners seem to require it often, and yet the rules regarding when it is acceptable have seemed much stricter than other jurisdictions worldwide. In fact, we tried to summarize the latest state of the law in an earlier blog […]
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A Detailed Dive into China’s New Patent Term Extension Provisions
11 December 2020This article is a part of a larger article that highlights the newest draft implementation rules of the new Chinese Patent Law. This particular article takes a detailed dive into the patent term extension/adjustment provisions. One of the biggest and most exciting provisions in the newly amended patent law is patent term extension for delay […]
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