On January 28, 2013 Fordham and Jones Day sponsored a one-day conference on Biotech & Pharmaceutical Issues in China, which explored current topics in one of the hottest growth sectors within one of the world’s dominant economies.

AGENDA

8:50–9 a.m

Opening Comments
Sheila Foster, Vice Dean, Fordham Law

9–10 a.m.

WHERE ARE PHARMA AND BIOTECH HEADED IN CHINA?

– Role of China in the global pharmaceutical innovation value chain
– Market opportunities in China for pharmaceutical innovators
– Competition landscape and dynamic interaction of global and local players in China’s pharmaceutical market

Speakers
Roy Zwahlen, Legal & Policy Specialist, Biotechnology Industry Organization
Representatives from the investment, consultant & academic research communities who are active in China

10–11 a.m.

INNOVATION POLICIES UNDER NEW POWER/POLICY IN CHINA

– Implementation of the 15-year science and technology plan and national IP strategy
– U.S. government engagement with China on life science IP policies
– SIPO/USPTO Cooperation

Speakers
Teresa Rea, Deputy Director, USPTO
Mark Cohen, Senior Counsel for China, USPTO (invited)

(For Teresa Stanek Rea’s remarks, please visit the following page: http://www.uspto.gov/about-us/news-updates/intellectual-property-trends-and-developments-china)

11 a.m.–noon

WIND OF CHANGE FOR PHARMACEUTICAL INNOVATORS

– New rules for compulsory patent license
– A new round of patent law amendment
– Draft rules for inventor remuneration

Speaker
Tony Chen, Partner, Jones Day

noon–2 p.m.
NETWORKING LUNCH & TWO-ACT PERFORMANCE:
“MR. BIG IN WONDERLAND”

A mock patent prosecution interview and a mock patent litigation in China.

2–3 p.m.

DRUG REGISTRATION AND IP PROTECTION

– Patent linkage in SFDA drug registration regime
– Data protection under China’s Drug Registration Regulation
– Monitoring Period Exclusivity
– Industry initiatives and future directions

Speaker
Alice Hu, Associate, Jones Day

3–4 p.m.

SIPO EXAMINATION AND INVALIDATION

– “You cannot visit the same SIPO twice”—Evolution of SIPO guidelines and impact on pharmaceutical patent grant rate
– “Speed up by slowing down”—A patent prosecution strategy for blockbuster drugs
– “Invalidation by straw man”—A peculiar patent troll phenomenon in China

Speaker
Tony Chen, Partner, Jones Day

4–5 p.m.

PHARMACEUTICAL PATENT LITIGATION IN CHINA

– A tale of two venues: PRB & Intermediate Court
– Evidence collection & burden of proof
– Bolar exemption and definitive defense to patent infringement

Speaker
Yang Xu, Chief Patent Counsel, Simcere Pharmaceuticals