Advances in Biopharmaceutical Technology in China
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Chapter 10:   Protection and Enforcement of Biopharmaceutical Intellectual Property Rights in China - a Rapidly Evolving System

Michael Wise
Perkins Coie LLP (Los Angeles)
1620 26th Street
Sixth Floor, South Tower
Santa Monica, CA 90404-4013 (USA)
Direct: (310) 788-3210

About the Authors:
Mr. Michael Wise is a partner in the Los Angeles office of Perkins Coie, a member of the firm's Intellectual Property Practice Group and chairs the firm's China Intellectual Property Practice. His practice focuses on patent matters in the life sciences industry. He serves as lead counsel in biotech litigation and interference matters, provides legal opinions regarding patents and manages a diverse portfolio of patent applications. He leads the Perkins Coie intellectual property-focused practice in China. He is a frequent author and speaker on China related intellectual property matters. Mr. Wise received his B.S. degree in Biology from the University of California, Los Angeles and his J.D. degree from Loyola Law School.
Dr. Zhaohui Wang (Zoe) is a senior patent associate and a member of the Intellectual Property Practice Group at Perkins Coie. Her practice focuses on patent infringement and validity opinions, patent prosecution, freedom-to-operate analyses, patentability analyses, technology transfers and licensing, primarily in the fields of life sciences, nanotechnologies, data processing, and devices. Dr. Wang received her B.S. degree in Virology and Molecular Biology from Wuhan University in China, her Ph.D. degree in Cell Biology and Biophysics from Duke University and her J.D. degree from Columbia University.
Dr. James Zhu is a senior patent associate and a member of the Intellectual Property Practice Group at Perkins Coie. His practice focuses on patent procurement, patent opinion, intellectual property litigation, and technology licensing, primarily in the fields of life science and material science. He is a frequent author and speaker on various China-related intellectual property subjects. Dr. Zhu earned his B.S. degree in Biology from Fudan University, Shanghai, his Ph.D. degree in Molecular and Cellular Biology from California Institute of Technology, and J.D. and MBA dual degrees from Columbia University.

Intellectual Property right (IPR) protection in China has had a history of little more than twenty-five years. Notwithstanding such a short period of time, China has made impressive progress in protecting and enforcing IPR. This Chapter addresses the development of IPR protection in China, details IPR-related laws and regulations relevant to biopharmaceutical products, including the PRC Patent Law and the PRC Regulations on Administrative Protection of Pharmaceuticals. The Chapter also presents statistics on patent application filings and grants in China, and describes the dual IPR enforcement system through court proceedings and administrative agencies. The Chapter also covers subjects such as the recent patent-related cases in China involving major multinational pharmaceutical companies and the proposed third round of amendments to the PRC Patent Law. Finally, the Chapter discusses IPR risk management strategies for foreign companies doing business in China. Overall, the Chapter offers a summary of the progress, laws and regulations of the IPR system in China for the pharmaceutical industry.

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Eric Langer
BioPlan Associates, Inc.
2275 Research Blvd, Suite 500
Rockville, MD 20850
Phone: 301-921-5979; Fax: 301-926-2455